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1 | No | Generic Name | Category | Indications | Dosage | Adverse Reaction | Contraindications | Interactions | Prescribing Restrictions | Precautions | Brand | FUKKM System/Group | MDC | NEML | Method of Purchase | |||||||||||
2 | 1 | 2-deoxy-2-[18F] fluoro-D-glucose [18F] FDG Injection | A* | Indicated for positron emission tomography (PET) imaging in the following setting: i. Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer ii. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. iii. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci or epileptic seizures | The recommended dose is 6 Mbq/kg (0.162 mCi/kg). Example, for an adult with a body weight of 70 kg, the recommended dose is 420 Mbq (11 mCi) | Not known | It is contraindicated in pregnant and lactating women. | All iron-containing medications and diabetic medications (See Patient Preparation section in the package insert). | To be prescribed by Nuclear Medicine Specialist only | Patients should avoid extreme activity, and the blood glucose levels should be stabilized before FDG Putra Injection is administered (See Patient Preparation section in the package insert). The patient should be rested and kept isolated from anybody for at least 1 hour after injection. | Various > Diagnostic Radiopharmaceuticals | V09IX04-000-P30-02-XXX | No | LP | ||||||||||||
3 | 2 | Abacavir Sulphate 300mg tablet | A* | Antiretroviral combination therapy of HIV infection in adults and adolescents from 12 years of age. | Adult: 300mg twice daily or 600mg daily Children: i. Weighing 14 to <20kg: one-half of a scored abacavir tablet twice daily ii. Weighing ≥20kg to <25kg: one-half of a scored abacavir tablet in the morning and one whole tablet in the evening iii. Weighing at least 25kg: according to adult dose | Nausea, vomiting, diarrhoea, fever, lethargy, fatigue, rash, anorexia, headache, hyperlactatemia, pancreatitis, lactic acidosis, rash, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. | Hypersensitivity reaction to the active substance or to any excipients. | Ribavirin, ethanol, methadone and retinoids. | i. Patients unsuitable or failed other HAART treatment ii. Patients who have renal impairment (CrCl < 50ml/min) when Abacavir and Lamivudine fixed-dose combination is not recommended | Hypersensitivity, lactic acidosis/ severe hepatomegaly with steatosis, elevated serum lipids and blood glucose, immune reconstitution syndrome, opportunistic infections, transmission of infection, myocardial infarction | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AF06-183-T10-01-XXX | Yes | LP | ||||||||||||
4 | 3 | Abacavir Sulphate 600mg and Lamivudine 300mg Tablet | A* | Antiretroviral combination therapy of HIV infection in adults and adolescents from 12 years of age with the following criteria: i)Patients unsuitable or failed other HAART treatment. ii)Patients who are at high risk of renal impairment. iii)Patients with osteoporosis or at high risk of bone loss. | ADULTS & ADOLESCENT (> 12 years of age): Recommended dose is one tablet once daily. Not to be used in adults or adolescents weigh less than 40kg. CHILDREN : Not recommended | Hypersensitivity, anorexia, headache, insomnia, cough, nasal symptoms, nausea, vomiting, abdominal pain or cramps, diarrhea, rash, alopecia, fever, lethargy, fatigue, malaise. | Hypersensitivity reaction to the active substance or to any excipients, severe hepatic impairment | Co-trimoxazole, methadone, ribavirin | None | Close monitoring is required in patients with mild and moderate hepatic impairment. Discontinue treatment immediately if hypersensitivity is suspected. Not recommended in patients with creatinine clearance < 50ml/min | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AR02-964-T10-01-XXX | Yes | Government Contract | ||||||||||||
5 | 4 | Abemaciclib 100mg Film Coated Tablets | A* | Abemaciclib, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. | The recommended dosing is 150mg twice daily, taken orally with or without food for 2 years, or until disease recurrence or unacceptable toxicity occurs | Diarrhoea, neutropenia, nausea, abdominal pain, infections, fatigue, anaemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia. | Hypersensitivity to the active substance or any of the excipients listed. | CYP3A Inhibitors: ketoconazole, CYP3A Inducers | i. For high-risk stage II and III early breast cancer. High risk defined by clinical and pathological features: either ≥4 pALN (positive axillary lymph nodes) or 1 – 3 pALN and at least one of the following criteria: tumour size ≥5cm or histological grade 3. ii. To be prescribed by Oncologist only | Diarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity | Yulareb | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE50-000-T32-02-xxx | No | LP | |||||||||||
6 | 5 | Abemaciclib 150mg Film Coated Tablets | A* | Abemaciclib, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. | The recommended dosing is 150mg twice daily, taken orally with or without food for 2 years, or until disease recurrence or unacceptable toxicity occurs | Diarrhoea, neutropenia, nausea, abdominal pain, infections, fatigue, anaemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia. | Hypersensitivity to the active substance or any of the excipients listed. | CYP3A Inhibitors: ketoconazole, CYP3A Inducers | i. For high-risk stage II and III early breast cancer. High risk defined by clinical and pathological features: either ≥4 pALN (positive axillary lymph nodes) or 1 – 3 pALN and at least one of the following criteria: tumour size ≥5cm or histological grade 3. ii. To be prescribed by Oncologist only | Diarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity | Yulareb | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE50-000-T32-03-xxx | No | LP | |||||||||||
7 | 6 | Abemaciclib 50mg Film Coated Tablets | A* | Abemaciclib, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. | The recommended dosing is 150mg twice daily, taken orally with or without food for 2 years, or until disease recurrence or unacceptable toxicity occurs | Diarrhoea, neutropenia, nausea, abdominal pain, infections, fatigue, anaemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia. | Hypersensitivity to the active substance or any of the excipients listed. | CYP3A Inhibitors: ketoconazole, CYP3A Inducers | i. For high-risk stage II and III early breast cancer. High risk defined by clinical and pathological features: either ≥4 pALN (positive axillary lymph nodes) or 1 – 3 pALN and at least one of the following criteria: tumour size ≥5cm or histological grade 3. ii. To be prescribed by Oncologist only | Diarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity | Yulareb | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE50-000-T32-01-xxx | No | LP | |||||||||||
8 | 7 | Abiraterone Acetate 250mg tablet | A* | i. With prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men. ii. In combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 months of prior ADT. | 1,000mg once daily | Peripheral oedema, hypokalemia, hypertension, urinary tract infection, hematuria, aspartate aminotransferase increased, alanine aminotransferase increased, dyspepsia, fractures | • Hypersensitivity to the active substance or to any of the excipients • Women who are or may potentially be pregnant • Severe hepatic impairment (Child-Pugh Class C) | Food CYP3A4 inducers Drugs activated by or metabolised by CYP2D6 and CYP2C8 (e.g. pioglitazone, repaglinide) | Indikasi i. a. Those who have progressed on OR failed prior docetaxel chemotherapy b. Those who are contraindicated or unsuitable for chemotherapy Indikasi ii. - no prescribing restrictions | Hypertension, hypokalaemia, fluid retention due to mineralocorticoid excess, hepatotoxicity, hepatic impairment, decreased bone density, prior use of ketoconazole NPRA Safety Alert (29 Jan 2021) - Risk of hypoglycaemia due to drug interaction | Zytiga | Antineoplastic and Immunomodulating Agents > Endocrine Therapy | L02BX03-000-T10-01-XXX | Yes | Government Contract | |||||||||||
9 | 8 | Abiraterone Acetate 500 mg Tablet | A* | i. With prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men. ii. In combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 months of prior ADT. | 1,000mg once daily | Peripheral oedema, hypokalemia, hypertension, urinary tract infection, hematuria, aspartate aminotransferase increased, alanine aminotransferase increased, dyspepsia, fractures | • Hypersensitivity to the active substance or to any of the excipients • Women who are or may potentially be pregnant • Severe hepatic impairment (Child-Pugh Class C) | Food CYP3A4 inducers Drugs activated by or metabolised by CYP2D6 and CYP2C8 (e.g. pioglitazone, repaglinide) | Indikasi i. a. Those who have progressed on OR failed prior docetaxel chemotherapy b. Those who are contraindicated or unsuitable for chemotherapy Indikasi ii. - no prescribing restrictions | Hypertension, hypokalaemia, fluid retention due to mineralocorticoid excess, hepatotoxicity, hepatic impairment, decreased bone density, prior use of ketoconazole NPRA Safety Alert (29 Jan 2021) - Risk of hypoglycaemia due to drug interaction | Antineoplastic and Immunomodulating Agents > Endocrine Therapy | L02BX03-000-T32-02-xxx | Yes | LP | ||||||||||||
10 | 9 | Acalabrutinib 100mg Film Coated Tablet | A* | Indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. | 100 mg twice daily | Upper respiratory tract infection, sinusitis, pneumonia, urinary tract infection, nasopharyngitis, bronchitis, Herpes viral infections, headache, dizziness, atrial fibrillation/Flutter, diarrhoea, constipation, vomiting, abdominal pain, epistaxis, rash, bruising, contusion, petechiae, ecchymoses, haemorrhage/haematoma, gastrointestinal haemorrhage, intracranial haemorrhage, hypertension, musculoskeletal pain, arthralgia, asthenia, nausea, fatigue, cough, rash, leukopenia, neutropenia, anaemia, thrombocytopenia, secondary primary malignancy, and non-melanoma skin malignancy | Hypersensitivity to the active substance or to any of the excipients, and severe hepatic impairment. | CYP3A inhibitor (e.g. fluconazole, isavuconazole), CYP3A inhibitor/P-gp inhibitors (e.g. itraconazole, ketoconazole, conivaptan, clarithromycin, indinavir, ritonavir, telaprevir, posaconazole, voriconazole), CYP3A inducer (e.g. rifampicin, phenytoin, carbamazepine), cyclosporine, ergotamine, pimozide, theophylline, caffeine, methotrexate, metformin, St. John wort | To be prescribed by Haematologists only | Haemorrhage, infections, cytopenias, secondary primary malignancies, and atrial fibrillation | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01EL02-000-T32-01-xxx | No | LP | ||||||||||||
11 | 10 | Acetazolamide 250mg Tablet | B | Reduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma | 250mg 1-4 times a day, the dosage being titrated according to patient response | Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy NPRA Safety Alert 1. 5 May 2022 Choroidal effusion, acute myopia, acute angle closure glaucoma | Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, thiazide or sulphonamide hypersensitivity. Best avoided in the first trimester of pregnancy. Should not be used in chronic noncongestive closed-angle glaucoma | Aspirin, cyclosporin, digitalis , digoxin, lithium, phenytoin, quinidine, topiramate | None | Caution in patients with adrenal failure or Addisons disease; diabetis mellitus; hypokalemia, hyponatremia or other electrolyte imbalance; respiratory or hypochloraemic acidosis; hepatic or renal function impairment. Maintenance of high fluid intake may be advisable, especially in patients with hypercalciuria or gout, to reduce the risk of renal calculi. Care should be taken if potassium supplementation is indicated. Caution in elderly, pregnancy and lactation, Stevens-Johnson syndrome, toxic epidermal necrosis, high-dose aspirin | Diamox | Sensory Organs > Ophthalmologicals | S01EC01-000-T10-01-XXX | Yes | APPL | |||||||||||
12 | 11 | Acetazolamide 500mg Injection | B | Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma | Adult : 250-1000mg per 24hours, usually in divided doses for amounts over 250mg daily | Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy NPRA Safety Alert 1. 5 May 2022 Choroidal effusion, acute myopia, acute angle closure glaucoma | Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivity, Addison's disease, chronic non-congestive angle-closure galucoma | Aspirin, cyclosporin, digitalis, digoxin, lithium, phenytoin, quinidine, topiramate | None | Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction (risk of acidosis), elderly, pregnancy and lactation, Stevens-Johnson syndrome, toxic epidermal necrosis, high-dose aspirin, high dose may decrease diuresis and may increase drowsiness, pulmonary obstruction or emphysema, diabetes | Sensory Organs > Ophthalmologicals | S01EC01-000-P40-01-XXX | Yes | LP | ||||||||||||
13 | 12 | Acetylcysteine 200mg/ml Injection | A* | Antidote for paracetamol poisoning | Diluted with dextrose 5% and infused IV. Initial, 150 mg/kg IV in 200 ml over 60 minutes, then 50 mg/kg IV in 500 ml over 4 hours, followed by 100 mg/kg IV in 1000 ml over 16 hours. Total dose: 300mg/kg in 20 hour | Anaphylactic reactions, urticaria, angioedema, bronchospasm, nausea, vomiting, tachycardia, dizziness, fever | Hypersensitivity to acetylcysteine products, children under 2 years of age | Carbamazepine : increased risk of subtherapeutic carbamazepine levels. Nitroglycerin : enhanced hypotension and nitroglycerin-induced headache. Penicillin G, tetracycline : loss of antibiotic efficacy | None | Asthma, history of bronchospasm and risk of anaphylactoid reactions and history of peptic ulceration | Various > All Other Therapeutic Products | V03AB23-520-P30-01-XXX | Yes | Government Contract | ||||||||||||
14 | 13 | Acetylsalicylic Acid 100 mg & Glycine 45 mg Tablet | B | i) Prevention of myocardial infarct, stroke, vascular occlusion and deep vein thrombosis. ii) Transient ischaemic attacks | 1 tablet daily | Nausea, vomiting, dyspepsia, GI ulceration, haematemesis, malaena. Occasionally hepatotoxicity | Bleeding disorders. Hypersensitivity to salicylate | Alcohol, dipyridamole, metoclopramide, metoprolol, carbonic anhydrase inhibitors, corticosteroids, coumarin anticoagulants, sulphonylureas, methotrexate, phenytoin, valproic acid, probenecid, sulphinpyrazone | None | Dyspepsia, gastric mucosal lesions, haemorrhagic disorders, gout, intolerant to aspirin, renal or hepatic impairment, asthma and G6PD deficiency | Cardiprin | Blood and Blood Forming Organs > Antithrombotic Agents | B01AC06-259-T10-01-XXX | No | Government Contract | |||||||||||
15 | 14 | Acetylsalicylic Acid 150mg Dispersible Tablet | C | Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk. Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke | 150mg to be taken daily. Dose to be individualised. Use in children under 16 years old is not recommended | Gastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances; prolonged bleeding time, rhinitis, urticaria and epigastric discomfort; angioedema, salicylism, tinnitus, bronchospasm | Gastric and duodenal ulcers, haemorrhagic diathesis, hypersensitivity to aspirin or other NSAIDs, children under 12 years old. Hypersensitivity (attacks of asthma, angioedema, urticaria or rhinitis), pregnancy (third trimester), patients with haemophilia or haemorrhagic disorders, gout, severe renal or hepatic impairment, lactation | Acetazolamide, Dipyridamole: salicylate toxicity (vomiting, tachycardia, hyperpnea, mental confusion) or acetazolamide toxicity (fatigue, lethargy, somnolence, confusion, hyperchloremic metabolic acidosis). Alendronate : GI distress. Antacids, calcium. Alcohol, corticosteroids, phenylbutazone and oxyphenbutazone may increase risk of GI ulceration. Aspirin increases phenytoin levels. May antagonize actions of uricosurics and spironolactone | None | Renal disorders, G6PD deficiency, pregnancy, patients with flu, chicken pox or haemorrhagic fever. History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal lesion, asthma or allergic disorders, dehydrated patients, uncontrolled hypertension, impaired renal or hepatic function, elderly | Nervous System > Analgesics | N02BA01-000-T40-03-XXX | Yes | LP | ||||||||||||
16 | 15 | Acetylsalicylic Acid 300 mg Soluble Tablet | C | Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk. Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke. | 150mg to be taken daily. Use in children under 16 years old is not recommended | Gastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances, prolonged bleeding time, rhinitis, urticaria and epigastric discomfort, angioedema, salicylism, tinnitus; bronchospasm | Gastric and duodenal ulcers, haemorrhagic diathesis, hypersensitivity to aspirin or other NSAIDs, children under 12 years old. Hypersensitivity (attacks of asthma, angioedema, urticaria or rhinitis), pregnancy (third trimester), patients with haemophilia or haemorrhagic disorders, gout, severe renal or hepatic impairment, lactation | Acetazolamide, Dipyridamol: salicylate toxicity (vomiting, tachycardia, hyperpnea, mental confusion) or acetazolamide toxicity (fatigue, lethargy, somnolence, confusion, hyperchloremic metabolic acidosis). Alendronate : GI distress. Antacids, calcium. Alcohol, corticosteroids, phenylbutazone and oxyphenbutazone may increase risk of GI ulceration. Aspirin increases phenytoin levels. May antagonize actions of uricosurics and spironolactone | None | Renal disorders, G6PD deficiency, pregnancy, patients with flu, chicken pox or haemorrhagic fever. History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal lesion, asthma or allergic disorders, dehydrated patients, uncontrolled hypertension, impaired renal or hepatic function, elderly | Nervous System > Analgesics | N02BA01-000-T40-01-XXX | Yes | APPL | ||||||||||||
17 | 16 | Acetylsalicylic Acid 75mg Dispersible Tablet | C | Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk. Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke | Dose to be individualised. 150mg to be taken daily. Use in children under 16 years old is not recommended | Gastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances; prolonged bleeding time, rhinitis, urticaria and epigastric discomfort; angioedema, salicylism, tinnitus; bronchospasm | Gastric and duodenal ulcers, haemorrhagic diathesis, hypersensitivity to aspirin or other NSAIDs, children under 12 years old. Hypersensitivity (attacks of asthma, angioedema, urticaria or rhinitis), pregnancy (third trimester), patients with haemophilia or haemorrhagic disorders, gout, severe renal or hepatic impairment, lactation | Acetazolamide, Dipyridamol: salicylate toxicity (vomiting, tachycardia, hyperpnea, mental confusion) or acetazolamide toxicity (fatigue, lethargy, somnolence, confusion, hyperchloremic metabolic acidosis). Alendronate : GI distress. Antacids, calcium. Alcohol, corticosteroids, phenylbutazone and oxyphenbutazone may increase risk of GI ulceration. Aspirin increases phenytoin levels. May antagonize actions of uricosurics and spironolactone. | None | Renal disorders, G6PD deficiency, pregnancy, patients with flu, chicken pox or haemorrhagic fever. History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal lesion, asthma or allergic disorders, dehydrated patients, uncontrolled hypertension, impaired renal or hepatic function, elderly | Nervous System > Analgesics | N02BA01-000-T40-02-XXX | Yes | LP | ||||||||||||
18 | 17 | Acitretin 10mg Capsule | A* | i) Severe form of psoriasis including erythrodermic psoriasis and local or generalized pustular psoriasis. ii) Severe disorders of keratinization, such as -congenital ichthyosis -pityriasis rubra pilaris -Darier's disease -other disorders of keratinization which may be resistant to other therapies | ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according to response, usually within range 25-50 mg daily for further 6-8 weeks (max: 75 mg daily). In disorders of keratinization, maintenance therapy of less than 20mg/day and should not exceed 50mg/day CHILD: 0.5mg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods | Symptoms of hypervitaminosis A, dried mucous membranes and transitional epithelia, xeriophthalmia, conjunctivitis, corneal ulcerations, cheilitis, stomatitis, gingivitis and taste disturbances, vulvovaginitis, thinning and scaling of the skin, sticky skin, dermatitis, erythema and pruritus, increased hair loss, nail fragility and paronychia, blurred vision and impaired night vision, muscle and joint pain, peripheral edema and flushing, High dose: reversible elevation of serum triglycerides and serum cholesterol. | Pregnancy, women of childbearing potential unless strict contraception is practised 4 weeks before, during and for 2 years after treatment, severely impaired liver or kidney function and in patient with chronic abnormally elevated blood lipid values, hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. | Oral contraceptives, progestogen may result in loss of contraceptive effectiveness. Ethanol may result in a prolonged risk of teratogenicity. Risk of hypervitaminosis A with Vitamin A and other retinoids, reduces phenytoin's protein binding, increase risk of hepatitis with Methotrexate, increased intracranial pressure with tetracycline. | None | Long-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolism | Dermatologicals > Antipsoriatics | D05BB02-000-C10-01-XXX | No | LP | ||||||||||||
19 | 18 | Acitretin 25 mg Capsule | A* | i) Severe form of psoriasis including erythrodermic psoriasis and local or generalized pustular psoriasis. ii) Severe disorders of keratinization, such as -congenital ichthyosis -pityriasis rubra pilaris -Darier's disease -other disorders of keratinization which may be resistant to other therapies | ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according to response, usually within range 25-50 mg daily for further 6-8 weeks (max: 75 mg daily). In disorders of keratinization, maintenance therapy of less than 20mg/day and should not exceed 50mg/day CHILD: 0.5mg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods | Symptoms of hypervitaminosis A, dried mucous membranes and transitional epithelia, xeriophthalmia, conjunctivitis, corneal ulcerations, cheilitis, stomatitis, gingivitis and taste disturbances, vulvovaginitis, thinning and scaling of the skin, sticky skin, dermatitis, erythema and pruritus, increased hair loss, nail fragility and paronychia, blurred vision and impaired night vision, muscle and joint pain, peripheral edema and flushing, High dose: reversible elevation of serum triglycerides and serum cholesterol. | Pregnancy, women of childbearing potential unless strict contraception is practised 4 weeks before, during and for 2 years after treatment, severely impaired liver or kidney function and in patient with chronic abnormally elevated blood lipid values, hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. | Oral contraceptives, progestogen may result in loss of contraceptive effectiveness. Ethanol may result in a prolonged risk of teratogenicity. Risk of hypervitaminosis A with Vitamin A and other retinoids, reduces phenytoin's protein binding, increase risk of hepatitis with Methotrexate, increased intracranial pressure with tetracycline. | None | Long-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolism | Dermatologicals > Antipsoriatics | D05BB02-000-C10-02-XXX | No | LP | ||||||||||||
20 | 19 | Acriflavine 0.1% Cream | C+ | Infected skin, lesions, cuts, abrasions, wounds and burns. | Apply undiluted three times daily to the affected part . | Hypersensitivity to acriflavine compound | Hypersensitivity to acriflavine compound. | Not known | None | Prolonged application, may stain skin, hair & fabric. | Dermatologicals > Antiseptics and Disinfectants | D08AA03-000-G10-01-xxx | Yes | LP | ||||||||||||
21 | 20 | Acriflavine 0.1% Lotion | C+ | Infected skin, lesions, cuts, abrasions, wounds and burns. | Apply undiluted three times daily to the affected part . | Hypersensitivity to acriflavine compound | Hypersensitivity to acriflavine compound. | Not known | None | Prolonged application, may stain skin, hair & fabric. | - | Dermatologicals > Antiseptics and Disinfectants | D08AA03-000-L60-01-XXX | Yes | APPL | |||||||||||
22 | 21 | Actinomycin D (Dactinomycin) 500 mcg/ml Injection | A | i) For solid tumours ii) Gestational trophoblastic disease | i) ADULT: 500 mcg IV daily for max of 5 days. CHILD: 1.5 mg/m2 once every 3 weeks (if weight less than 10 kg, 50 mcg/kg) ii) 500 mcg IV on Days 2, 4, 6, 8, 10, repeat every 7 - 10 days or 500 mcg IV bolus on Days 1 and 2, repeat every 15 days | Myelosuppression, nausea, vomiting, mucositis, alopecia, rash, radiation recall reactions, hepatitis. Malaise, fatigue, fever, myalgia, gastrointestinal, haematologic and dermatologic effects | Pregnancy, lactation, chickenpox and shingles or herpes zoster infection. | Live vaccines may result in an increase risk of infection, radiation therapy, possibly reduced absorption of phenytoin | None | Avoid extravasation, severe soft tissue damage. Concomitant radiation therapy may exaggerate dactinomycin toxicity | Cosmegen | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01DA01-110-P40-01-XXX | Yes | LP | |||||||||||
23 | 22 | Acyclovir (Aciclovir) 200mg Tablet | A/KK | i) Treatment of Herpes simplex & Varicella zoster infections ii) Prophylaxis of Herpes simplex infections in immune-compromised patients | Indication (i) Treatment for Herpes Simplex: ADULT - 200mg 5 times daily; In severely immune-compromised patients: dose can be doubled to 400 mg. CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose. Treatment for Varicella Zoster: ADULT - 800mg 5 times daily; CHILD 6 years and over: 800 mg four times daily, 2 - < 6 years: 400 mg four times daily, Under 2 years: 200 mg four times daily. Indication (ii) ADULT - Immune-compromised patients: 200 mg four times daily. Severely immune-compromised patients: dose can be doubled to 400 mg. CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose. Dosing is according to Product Information Leaflet. | Skin rashes, GI effects, fatigue NPRA Safety Alert 1. 6 July 2026 Risk of Acute Generalised Exanthematous Pustulosis (AGEP) | Patients known to be hypersensitivity to acyclovir | Increased mean half-life & plasma concentration with probenecid | None | Patients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation | Zovirax | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AB01-000-T10-01-XXX | Yes | APPL | |||||||||||
24 | 23 | Acyclovir (Aciclovir) 200mg/5 ml Suspension | A* | i) Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii) Primary and recurrent Varicella Zoster infection in immunocompromised and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema herpeticum) iv) Severe primary HSV infections (eg. Neonatal herpes, encephalitis, eczema herpeticum, genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes) v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans) vi) Severe zoster infection in paediatrics (eg.Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster) | i) ADULT: initially 400 mg 5 times daily for 7 - 14 days. CHILD less than 2 years: 200 mg 4 times daily, CHILD more than 2 years: 400 mg 4 times daily ii), iii) and iv) ADULT: 200 - 400 mg 4 times daily. CHILD : less than 2 years, half adult dose; more than 2 years, adult dose. v) ADULT: 800 mg 5 times daily for 7 days vi) ADULT: 20 mg/kg (maximum: 800 mg) four times daily for 5 days, CHILD 6 years: 800 mg four times daily. CHILD: less than 2 years; 400mg 4 times daily, more than 2 years; 800 mg 4 times daily | Skin rashes, GI effects, fatigue NPRA Safety Alert 1. 6 July 2026 Risk of Acute Generalised Exanthematous Pustulosis (AGEP) | Patients known to be hypersensitivity to acyclovir | Increased mean half-life & plasma concentration with probenecid | None | Patients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation | Zovirax | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AB01-000-L80-01-XXX | Yes | LP | |||||||||||
25 | 24 | Acyclovir (Aciclovir) 250mg Injection | A* | i)Treatment of Herpes simplex & Varicella zoster infections ii)Prophylaxis of Herpes simplex infections in immune-compromised patients | ADULT: 5 mg/kg by IV infusion 8 hourly for 5 days, doubled to 10mg/kg every 8 hourly in varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for at least 10 days in encephalitis; possibly for 14 - 21 days). NEONATE & INFANT up to 3 months with disseminated herpes simplex: 20mg/kg every 8 hourly for 14 days (21 days in CNS involvement), varicella-zoster 10-20mg/kg every 8 hourly usually for 7 days. CHILD, 3 months - 12 years: Herpes simplex or Varicella Zoster: 250 mg/m2 8 hourly for 5 days, doubled to 500 mg/m2 8 hourly for varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for 10 days in encephalitis) | Skin rashes; GI effects, neurological reactions (IV infusion) NPRA Safety Alert 1. 6 July 2026 Risk of Acute Generalised Exanthematous Pustulosis (AGEP) | Patients known to be hypersensitivity to acyclovir | Increased mean half-life & plasma concentration with probenecid | None | In patients receiving Zovirax IV at higher doses, specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairment | Zovirax | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AB01-000-P4-001-XXX | Yes | APPL | |||||||||||
26 | 25 | Acyclovir (Aciclovir) 3% Eye Ointment | A* | Only for the treatment of herpes simplex keratitis | Apply 1 cm 5 times daily. Continue for at least 3 days after healing | Local irritation and inflammation reported , vision abnormalities | Hypersensitivity to acyclovir | Not known | None | Not known | Zovirax | Sensory Organs > Ophthalmologicals | S01AD03-000-G51-01-XXX | Yes | LP | |||||||||||
27 | 26 | Acyclovir (Aciclovir) 5% Cream | A* | Herpes simplex infections of the skin, including initial and recurrent labial and genital herpes simplex infections | Apply every 4 hours for 5 - 10 days | Transient burning or stinging or erythema, mild drying or flaking of the skin | Hypersensitivity to acyclovir or valacyclovir | Not known | None | Application to mucous membranes, pregnancy, lactation. Should not be used in the eyes | Dermatologicals > Antibiotics and Chemotherapeutics for Dermatological Use | D06BB03-000-G10-01-XXX | No | LP | ||||||||||||
28 | 27 | Acyclovir (Aciclovir) 800 mg Tablet | A/KK | i)Treatment of Herpes simplex & Varicella zoster infections ii)Prophylaxis of Herpes simplex infections in immune-compromised patients | Indication (i) Treatment for Herpes Simplex: ADULT - 200mg 5 times daily; In severely immune-compromised patients: dose can be doubled to 400 mg. CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose. Treatment for Varicella Zoster: ADULT - 800mg 5 times daily; CHILD - 6 years and over: 800 mg four times daily, 2 - < 6 years: 400 mg four times daily, Under 2 years: 200 mg four times daily. Indication (ii) ADULT - Immune-compromised patients: 200 mg four times daily. Severely immune-compromised patients: dose can be doubled to 400 mg. CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose. Dosing is according to Product Information Leaflet. | Skin rashes; GI effects; fatigue NPRA Safety Alert 1. 6 July 2026 Risk of Acute Generalised Exanthematous Pustulosis (AGEP) | Patients known to be hypersensitivity to acyclovir | Increased mean half-life & plasma concentration with probenecid | None | Patients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation | Zovirax | Antiinfectives for Systemic Use > Antivirals for Systemic Use | J05AB01-000-T10-02-XXX | Yes | LP | |||||||||||
29 | 28 | Adalimumab 40mg Injection | A* | i) Third line treatment of: - Severe rheumatoid arthritis - Psoriatic arthritis - For reducing signs and symptoms in patients with active ankylosing spondylitis, after failure of conventional DMARDs or other biologics. ii)Treatment of adults with moderate to severe chronic plaque psoriasis who have not responded to, have contraindication or are unable to tolerate phototherapy and/or systemic therapies including acitretin, methotreaxate and cyclosporine iii) Crohn's Disease a) For treatment of moderately to severely active Crohn's Disease in adult patients who have inadequate response to conventional therapy b) For treatment of moderately to severely active Crohn's Disease in adult patients who have lost response to or are intolerant to infliximab iv) Ulcerative Colitis - For treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies | i)Severe rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis : Subcutaneous 40 mg every other week ii)Chronic plaque psoriasis : Initial, 80 mg SC, followed by 40 mg SC every other week starting one week after the initial dose iii) & iv) Crohn's disease & Ulcerative colitis: 160mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80mg at week 2. After induction treatment, the recommended maintenance dose is 40mg every other week via subcutaneous injection. | Hypertension, injection site reaction, rash, autoantibody, erythema multiforme, primary cutaneous vasculitis, Stevens-Johnson Syndrome, aplastic anemia, leukopenia, thrombocytopenia, anaphylaxis, malignant lymphoma, multiple sclerosis, paraesthesia, subdural hematoma, interstitial lung disease, angioedema, fatal infectious disease including tuberculosis, invasive fungal infections and other opportunistic infections | Hypersensitivity to adalimumab or any component of the formulation, severe infection | Anakinra, abatacept, live vaccine, leflunomide, topical tacrolimus, trastuzumab | None | Reactivation of tuberculosis (patients should be evaluated for tuberculosis before treatment), serious infection, lupus-like syndrome & confirmed significant hematologic abnormalities, CHF & development of symptoms of blood dyscrasias, women of childbearing potential, pregnancy & lactation | Humira, Amgetiva (biosimilar) | Antineoplastic and Immunomodulating Agents > Immunosuppressants | L04AB04-000-P50-01-XXX | Yes | Government Contract | |||||||||||
30 | 29 | Adapalene 0.1% Cream | A* | Acne vulgaris where comedones, papules and pustules predominate in those sensitive to benzoyl peroxide or topical tretinoin [third line treatment] | Apply once daily to the affected areas after washing at bedtime | Erythema, scaling, dryness, pruritus, burning sensation | Hypersensitivity to adapalene or any of its components | Methotrexate | None | Avoid contact with eyes, lips angles of the nose and mucosa membranes. Do not apply to cuts, abrasion, eczematous skin or sunburned skin. Minimize exposure to slight, including sunlamps | Differin | Dermatologicals > Anti-acne Preparations | D10AD03-000-G10-01-XXX | No | LP | |||||||||||
31 | 30 | Adapalene 0.1% Gel | A/KK | Treatment for acne vulgaris where comedones, papules and pustules predominate | Apply once daily to the affected areas after washing at bedtime | Erythema, scaling, dryness, pruritus, burning sensation | Hypersensitivity to adapalene or any of its components | Methotrexate | None | Avoid contact with eyes, lips angles of the nose and mucosa membranes. Do not apply to cuts, abrasion, eczematous skin or sunburned skin. Minimize exposure to slight including sunlamps | Differin | Dermatologicals > Anti-acne Preparations | D10AD03-000-G30-01-XXX | No | LP | |||||||||||
32 | 31 | Adenosine 3 mg/ml Injection | B | Rapid conversion of paroxysmal supraventricular tachycardia to sinus rhythm | ADULT: Initially: 3 mg given as a rapid IV bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia with in 1 or 2 minutes, 6 mg should be given also as a rapid IV bolus. Third dose: If the second dose does not result in elimination of the supraventicular tachycardia with in 1-2 minutes, 12 mg should be given also as a rapid IV bolus | Facial flush, dyspnoea, a feeling of thorasic constriction, nausea, lightheadedness, feeling of discomfort, sweating, palpitations, hyperventilation, head pressure, apprehension, blurred vision, burning sensation, bradycardia, chest pains, headache, dizziness, heaviness in arms, arm, back and neck pains; metallic taste | Bradycardia, bronchoconstrictive or bronchospastic lung disease (eg. asthma). Hypersensitivity to adenosine, second-degree or third-degree AV block (unless pacemaker fitted), sinus node disease (eg. sick sinus syndrome) | Actions may be potentiated by dipyridamole and carbamazepine. Theophylline & caffeine inhibit its action | None | Avoid concomitant use of dipyridamole and methylxanthines (eg: caffeine, theophylline). Cardiac arrest, heart block, heart transplant patients, hypertension, hypotension, myocardial infarction. Proarrhythmic events; new rhythms, particularly at time of conversion and unstable angina | Adenocor | Cardiovascular System > Cardiac Therapy | C01EB10-000-P30-01-XXX | Yes | LP | |||||||||||
33 | 32 | Adrenaline Acid Tartrate (Epinephrine) 1 mg/ml Injection | B | Cardiopulmonary resuscitation | 1 mg by intravenous injection repeated every 3-5 minutes according to response | Hypertension, arrhythmias, nausea, vomiting, headache, shortness of breath, sneezing | Cardiac dilatation, coronary insufficiency. Within 2 weeks of MAOI use.Organic brain damage, narrow-angle glaucoma. Shock. Concurrent use with local anesthetics for injection of certain areas (eg; fingers, toes, ears); increased risk of vasoconstriction and sloughing of tissue. oncurrent use with cyclopropane or halogenated hydrocarbon anaesthetics; may produce fatal ventricular arrhythmias. Labor; may delay the second stage | Beta-blocking,alpha-adrenergic blockers agents,antihistamines,tricyclic antidepressants carvedilol, chlorpromazine, halothane, moclobemide, rocuronium, selegiline, timolol,methyldopa, diuretics, oxytoxic drugs | None | Elderly patients, patients with; CV disease, pulmonary oedema, hypertension, hyperthyroidism, diabetes, psychoneurotic illness, asthma, prefibrillatory rhythm, or anesthetic cardiac acidents. Bronchial asthma/emphysema,cerebrovascular hemorrhage, pregnancy, lactation, children | - | Cardiovascular System > Cardiac Therapy | C01CA24-123-P30-01-XXX | Yes | APPL | |||||||||||
34 | 33 | Afatinib Dimaleate 30mg Film-Coated Tablet | A* | First-line monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). | 40mg once daily to be taken without food. Maximum dose is 50mg once daily. | Paronychia; decreased appetite; epistaxis; diarrhoea, stomatitis, nausea, vomiting; rash, dermatitis acneiform, pruritus, dry skin; cystitis; dehydration, hypokalaemia; dysgeusia; conjunctivitis, dry eye; rhinorrhoea; dyspepsia, cheilitis; increased alanine aminotransferase or aspartate aminotransferase; Palmar-plantar erythrodysesthesia syndrome; nail disorders; muscle spasms; renal impairment/renal failure; pyrexia; decreased weight. | Hypersensitivity to Afatinib or to any of the excipients. | Strong P-gp inhibitors (e.g. ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) may increase exposure of afatinib; strong P-gp inducer (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital or St. John’s wort) may decrease afatinib exposure; high-fat meal. | i) Adenocarcinoma histology. ii) Patient's ECOG Performance Status 0-1. **To be prescribed by Consultants/Specialists from disciplines of oncology and oncology-trained respiratory physician)** | False results of EGFR mutation status assessment; patients with risk factors of diarrhoea (female, lower body weight & underlying renal impairment); patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever); severe hepatic impairment; keratitis; left ventricular function; patient’s fertility status, pregnancy and lactation. | Giotrif | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE13-253-T32-02-XXX | Yes | LP | |||||||||||
35 | 34 | Afatinib Dimaleate 40mg Film-Coated Tablet | A* | First-line monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). | 40mg once daily to be taken without food. Maximum dose is 50mg once daily. | Paronychia; decreased appetite; epistaxis; diarrhoea, stomatitis, nausea, vomiting; rash, dermatitis acneiform, pruritus, dry skin; cystitis; dehydration, hypokalaemia; dysgeusia; conjunctivitis, dry eye; rhinorrhoea; dyspepsia, cheilitis; increased alanine aminotransferase or aspartate aminotransferase; Palmar-plantar erythrodysesthesia syndrome; nail disorders; muscle spasms; renal impairment/renal failure; pyrexia; decreased weight. | Hypersensitivity to Afatinib or to any of the excipients. | Strong P-gp inhibitors (e.g. ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) may increase exposure of afatinib; strong P-gp inducer (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital or St. John’s wort) may decrease afatinib exposure; high-fat meal. | i) Adenocarcinoma histology. ii) Patient's ECOG Performance Status 0-1. **To be prescribed by Consultants/Specialists from disciplines of oncology and oncology-trained respiratory physician)** | False results of EGFR mutation status assessment; patients with risk factors of diarrhoea (female, lower body weight & underlying renal impairment); patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever); severe hepatic impairment; keratitis; left ventricular function; patient’s fertility status, pregnancy and lactation. | Giotrif | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE13-253-T32-03-XXX | Yes | LP | |||||||||||
36 | 35 | Aflibercept 40mg/ml solution for injection (vial) | A* | i) Treatment of neovascular (wet) age-related macular degeneration (wet AMD) ii) Visual impairment due to diabetic macular edema (DME) iii) Macular Oedema secondary to Retinal Vein Occlusion (branch RVO or central RVO) | i) The recommended dose is 2mg aflibercept, equivalent to 0.05mL (50 μL) given as intra-vitreal injection. Aflibercept treatment is initiated with one injection per month for three consecutive doses, followed by one injection every two months. ii) 2 mg aflibercept (equivalent to 50 microliters) administered by intravitreal injection monthly for the first 5 consecutive doses, followed by one injection every 2 months. There is no requirement for monitoring between injections. iii) 2 mg aflibercept (equivalent to 50 microliters) administered by intravitreal injection monthly. The interval between two doses should not be shorter than one month. | Endophthalmitis, traumatic cataract, transient increased intraocular pressure, conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, retinal pigment, epithelium tear, detachment of the retinal pigment, corneal erosion, blurred vision, corneal oedema, vitreous detachment, eye pain, injection site pain, foreign body sensation in eyes, lacrimation increase, eyelid oedema, injection site hemorrhage, conjunctival hyperaemia. Arterial thromboembolic events, immunogenicity. | Recent (<3months) cerebral vascular accident or cardiovascular disease. Ocular or periocular infection. Active severe intraocular inflammation. Known hypersensitivity to aflibercept or to any of the excipients. | No formal drug interaction studies have been performed with aflibercept. | For all indications: To be used by ophthalmologists only For indication (ii): a) Treatment of naive patients with visual acuity equal or worse than 20/50; or b) Patients with poor response to treatment with ranibizumab. For indication (iii): a) First line for patient not able to comply with monthly ranibizumab injection after initial loading doses b) Second line for patient who are refractory to ranibizumab injection c) To be prescribed by Ophthalmologist only | Endophthalmitis, increase in intraocular pressure. Pregnancy and lactation. NPRA Safety Alert (14 Dec 2016) -Risk of Osteonecrosis of the Jaw (ONJ) in Cancer Patients | Eylea | Sensory Organs > Ophthalmologicals | S01LA05-000-P30-01-XXX | No | Government Contract | |||||||||||
37 | 36 | Agomelatine 25mg Tablet | A* | Major depression | The recommended dose is 25mg once daily at bedtime, maybe increased to 50mg once daily at bedtime. | Headache, dizziness, somnolence, insomnia, migraine; anxiety; nausea, diarrhea, constipation, upper abdominal pain; hyperhidrosis; back pain; fatigue; increased ALAT &/or ASAT. | History of previous hypersensitivity to the active ingredient or any of the excipients. Hepatic impairment (i.e. cirrhosis or active liver disease). Taking potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) | CYP2C9 & CYP1A2 inhibitors (eg fluvoxamine, ciprofloxacin, propranolol, grepafloxacin, enoxacin), oestrogenS | None | Use in people with dementia or impaired liver function, renal impairment, mania or hypomania. Increased risk of suicidal tendencies, lactose intolerance. Perform liver function tests periodically. May impair ability to drive or operate machinery. Pregnancy & lactation, elderly, children. | Nervous System > Psychoanaleptics | N06AX22-000-T10-01-XXX | No | Government Contract | ||||||||||||
38 | 37 | Albendazole 200mg Tablet | C+ | i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection | i)Child 12-24months: 200mg as a single dose ii) Adult & Child above 2 years: 400mg as a single dose for 3 consecutive days; Child 12 - 24months: 200mg as a single dose for 3 consecutive days | Gastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity | Patients with hypersensitivity to albendazole or to the benzimidazole drug class, pregnancy (avoid pregnancy for at least one month following therapy) | Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects. | None | Discontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesions | Zentel | Antiparasitic Products, Insecticides and Repellents > Anthelmintics | P02CA03-000-T10-01-XXX | Yes | APPL | |||||||||||
39 | 38 | Albendazole 200mg/5 ml Suspension | C+ | i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection | i)Child 12-24months: 200mg as a single dose ii) Adult & Child above 2 years: 400mg as a single dose for 3 consecutive days; Child 12 - 24months: 200mg as a single dose for 3 consecutive days | Gastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity | Patients with hypersensitivity to albendazole or to the benzimidazole drug class. Pregnancy (avoid pregnancy for at least one month following therapy) | Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects | None | Discontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesions | Antiparasitic Products, Insecticides and Repellents > Anthelmintics | P02CA03-000-L80-01-XXX | Yes | APPL | ||||||||||||
40 | 39 | Alcohol 70% Solution | C+ | Use as antiseptic and disinfectant | Apply to the skin undiluted or when needed | Mental impairment, gastrointestinal disturbances, severe effects include respiratory depression, coma and death | Not known | Chlorpropamide, metronidazole, cefoperazone, cefoperazone/sulbactam and cefotaxime | None | Pregnancy, nursing mothers, elderly | - | Dermatologicals > Antiseptics and Disinfectants | D08AX08-000-L99-01-XXX | Yes | LP | |||||||||||
41 | 40 | Alectinib 150mg Hard Capsule | A* | As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). | 600 mg twice daily with food (total daily dose of 1200 mg). Treatment with alectinib should be continued until disease progression or unacceptable toxicity. | Anaemia, dysgeusia, vision disorders, bradycardia, interstitial lung disease / pneumonitis, constipation, nausea, diarrhoea, vomiting, stomatitis, increased bilirubin, increased AST, increased ALT, increased alkaline phosphatase, rash, photosensitivity, myalgia, increased blood creatine phosphokinase, blood creatinine increased, acute kidney injury, edema, weight increase NPRA Safety Alert 1. 15 June 2026 Guidance for Management of Severe Hypertriglyceridaemia | Hypersensitivity to alectinib or to any of the excipients | CYP3A inducers, CYP3A inhibitors, medicinal products that increase gastric pH, substrate of P-gp, BCRP substrates, CYP substrates | To be prescribed by Oncologist only | Interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, severe myalgia and creatine phosphokinase (CPK) elevation, bradycardia, hemolytic anemia, photosensitivity, women of child-bearing potential, lactose intolerance, sodium content | Alecensa | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XE36-110-C11-01-XXX | No | LP | |||||||||||
42 | 41 | Alendronate Sodium 70mg and Cholecalciferol 5600 IU Tablet | A* | i) Osteoporosis in postmenopausal women with a history of vertebral fracture and whom oestrogen replacement therapy is contraindicated ii) Male Osteoporosis | 1 tablet once weekly [70mg/5600 IU]. Patient should receive supplemental calcium or vitamin D, if dietary vitamin D inadequate. The tablet should be taken at least half and hour before the first food, beverage, or medication of the day with plain water only. To facilitate delivery to stomach and thus reduce the potential for esophageal irritation, it should only be swallowed upon arising for the day with a full glass of water and patient should not lie down for at least 30 minutes and until after their first food of the day. | Abdominal pain, dyspepsia, esophageal ulcer, dysphagia, abdominal distention, musculoskeletal (bone, muscle or joint) pain, constipation, diarrhea, flatulence, headache, acid regurgitation, muscle cramp, gastritis, gastric ulcer, urticaria, nausea, vomiting, esophagitis, esophageal erosions, dizziness, vertigo, dysgeusia, rash, pruritis, alopecia. | Abnornalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to any component of the product. Hypocalcemia. | If taken at the same time it is likely that calcium supplements, antacids, and other oral medications will interfere with absorption of alendronate. Therefore, patients must wait at least one-half hour after taking the alendronate/cholecalciferol before taking any other oral medication. | None | Review treatment after 2 years and if there is positive response, treatment may be continued up to 5 years and then re-evaluate. Treatment should be stopped if there is no positive response after 5 years. Otherwise, patient needs to be given drug holiday for 1 to 2 years and then continue treatment shall the benefit outweigh the risk. Discontinue in case of dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Active upper gastrointestinal problems (dysphagia, esophageal diseases, gastritis, duodenitis or ulcers). CrCl less 35 ml/min. Correct hypocalcemia and other disorders affecting mineral metabolism (eg vit D deficiency) before starting therapy. Monitor serum Calcium and urine. Children, pregnancy and lactation | Fosamax Plus | Musculo-skeletal System > Drugs for Treatment of Bone Diseases | M05BB03-972-T10-02-XXX | No | Government Contract | |||||||||||
43 | 42 | Alendronate Sodium 70mg Tablet | A*, A/KK | Kategori preskriber A*: Osteoporosis (Male) Kategori preskriber A/KK: Indicated for the treatment of osteoporosis in high-risk postmenopausal women | 70 mg once weekly. Swallow the tablet whole with a full glass of plain water only on an empty stomach at least 30 minutes before breakfast (and any other oral medication); stand or sit upright for at least 30 minutes and do not lie down until after eating breakfast | Oesophageal reactions, abdominal pain,musculoskeletal pain,headache,diarrhoea,constipation | Hypersensitivity to alendronate products, hypocalcaemia, esophageal abnormalities, inability to stand or sit upright for 30 minutes | Concurrent use with aspirin and mesalamine may result in gastrointestinal distress. Concurrent use with calcium and antacids may result in reduced alendronate absorption | None | Review treatment after 2 years and if there is positive response, treatment may be continued up to 5 years and then re-evaluate. Treatment should be stopped if there is no positive response after 5 years. Otherwise, patient needs to be given drug holiday for 1 to 2 years and then continue treatment shall the benefit outweigh the risk. Creatinine clearance less than 35 ml/min, vitamin D and mineral deficiencies to be corrected before initiating therapy | Fosamax | Musculo-skeletal System > Drugs for Treatment of Bone Diseases | M05BA04-520-T10-01-XXX | No | LP | |||||||||||
44 | 43 | Alfacalcidol 0.25mcg Capsule | A/KK | i) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalacia | Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily; CHILD under 20kg body weight : 0.05 mcg/kg/day. Maintenance dose : 0.25 mcg to 2 mcg daily Dosing is individualised based on serum calcium level and according to product insert/protocol | Hypercalcaemia-stop immediately until serum calcium levels return to normal (in about one week) and then resumed at half the previous dose. Anorexia, nausea, vomiting, diarrhoea, lassitude, polyuria, sweating, headache, thirst, vertigo, pruritus, rash, urticaria,hypercalciuria and ectopic calcification. In case of renal impairment, hyperphosphataemia. In hypercalcaemic dialysis patients, possibility of calcium influx from the dialysate should be considered | Hypercalcaemia, metastatic calcification, hyperphosphataemia (except when occurring with hypoparathyroidism), hypermagnesaemia, vitamin D overdose,known hypersensitivity to alfacalcidol, vitamin D or any of its analogues and derivatives. | Thiazide diuretics, calcium, phosphates, carbamazepine, phenobarbitone | None | Pregnancy, lactation, renal impairment, infants, elderly. Serum levels of calcium should be monitor regularly (weekly to monthly, depending in the progress of the patient) especially in children, renal impairment and patients receiving high doses. Caution in hypercalciuria esp in those with history of renal calculi and patients being treated with cardioactive glycosides or digitalis. | One-alpha | Alimentary Tract and Metabolism > Vitamins | A11CC03-000-C10-01-XXX | No | APPL | |||||||||||
45 | 44 | Alfacalcidol 1mcg Capsule | A/KK | i) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalacia | Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily; CHILD under 20kg body weight : 0.05 mcg/kg/day. Maintenance dose : 0.25 mcg to 2 mcg daily Dosing is individualised based on serum calcium level and according to product insert/protocol | Hypercalcaemia-stop immediately until serum calcium levels return to normal (in about one week) and then resumed at half the previous dose. Anorexia, nausea, vomiting, diarrhoea, lassitude, polyuria, sweating, headache, thirst, vertigo, pruritus, rash, urticaria,hypercalciuria and ectopic calcification. In case of renal impairment, hyperphosphataemia. In hypercalcaemic dialysis patients, possibility of calcium influx from the dialysate should be considered | Hypercalcaemia, metastatic calcification, hyperphosphataemia (except when occurring with hypoparathyroidism), hypermagnesaemia, vitamin D overdose,known hypersensitivity to alfacalcidol, vitamin D or any of its analogues and derivatives. | Thiazide diuretics, calcium, phosphates, carbamazepine, phenobarbitone, | None | Pregnancy, lactation, renal impairment, infants, elderly. Serum levels of calcium should be monitor regularly (weekly to monthly, depending in the progress of the patient) especially in children, renal impairment and patients receiving high doses. Caution in hypercalciuria esp in those with history of renal calculi and patients being treated with cardioactive glycosides or digitalis. | one-alpha | Alimentary Tract and Metabolism > Vitamins | A11CC03-000-C10-02-XXX | No | LP | |||||||||||
46 | 45 | Alfacalcidol 2 mcg/ml Injection | A* | i) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalacia | Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily; CHILD under 20kg body weight : 0.05 mcg/kg/day. Maintenance dose : 0.25 mcg to 2 mcg daily Dosing is individualised based on serum calcium level and according to product insert/protocol | Hypercalcaemia, nausea, vomiting, polydipsia, polyuria | Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products | Antiepileptics, diuretics, barbiturates | None | Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. | One-Alpha | Alimentary Tract and Metabolism > Vitamins | A11CC03-000-P30-01-XXX | No | LP | |||||||||||
47 | 46 | Alfacalcidol 2mcg/ml Drops | A* | i) Neonatal hypocalcemia ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalacia | NEONATES : 0.1 mcg/kg/day Dosing is individualised based on serum calcium level and according to product insert/protocol | Hypercalcaemia-stop immediately until serum calcium levels return to normal (in about one week) and then resumed at half the previous dose. Anorexia, nausea, vomiting, diarrhoea, lassitude, polyuria, sweating, headache, thirst, vertigo, pruritus, rash, urticaria,hypercalciuria and ectopic calcification. In case of renal impairment, hyperphosphataemia. In hypercalcaemic dialysis patients, possibility of calcium influx from the dialysate should be considered | Hypercalcaemia, metastatic calcification, hyperphosphataemia (except when occurring with hypoparathyroidism), hypermagnesaemia, vitamin D overdose,known hypersensitivity to alfacalcidol, vitamin D or any of its analogues and derivatives. | Thiazide diuretics, calcium, phosphates, carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, isoniazid, corticosteroid. | None | Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration | One-Alpha | Alimentary Tract and Metabolism > Vitamins | A11CC03-000-D50-01-XXX | No | LP | |||||||||||
48 | 47 | Alfentanil HCl 0.5 mg/ml Injection | A* | For use as short acting narcotic analgesic in short procedures and day-care surgical procedures | Initial dose: 20 - 40 mcg/kg. Supplemental dose: 15 mcg/kg or infusion 0.5 - 1.0 mcg/kg/min | Tacycardia, bradyarrhythmia, cardiac dysrhythmia, hypertension, hypotension, respiratory depression, apnoea, muscular rigidity, dizziness, nausea, CNS disturbances, vomiting and constipation | Hypersensitivity to alfentanil and other opioids. Intolerance to morphinomimetics. In labor or before clamping of the cord during caesarean section. Respiratory depression and obstructive airways disease; acute alcoholism, convulsive disorders; head injuries, and conditions in which intracranial pressure is raised | Diltiazem, fluconazole : prolonged alfentanil efficacy. Erythromycin : decreased alfentanil clearance. Itraconazole : increased alfentanil serum concentrations and potential alfentanil toxicity (CNS depression, respiratory depression). Naltrexone : precipitation of opioid withdrawal symptoms. Monoamine oxidase inhibitors (MAOIs), alcohol and central nervous system depressants | None | Continuous monitoring of vital signs. Initial dose reduction in the elderly and debilitated. Impaired hepatic or renal function. Concurrent diazepam may produce vasodilation and hypotension; resulting in delayed recovery. Head injury, increased intracranial pressure. Pulmonary disease, decreased respiratory reserve. Decreased respiratory reserve and pulmonary disease; prostatic hyperplasia; hypotension; shock; inflammatory or obstructive bowel disorders; myasthenia gravis; hypovolaemia; uncontrolled hypothyroidism; alcoholism; chronic opioid therapy and history of opioid abuse. Avoid rapid bolus Injection in compromised intracerebral compliance. Do not administer during the last 10 minutes of surgery. Pregnancy and lactation. May affect ability to drive and operate machinery | Rapifen | Nervous System > Anesthetics | N01AH02-110-P30-01-XXX | No | LP | |||||||||||
49 | 48 | Alfuzosin HCl 10mg Tablet | A* | Treatment of functional symptoms related with benign prostatic hypertrophy (BPH) | 10 mg once a day pre bed | Gastrointestinal disturbances, vertigo, malaise, dizziness, headache. Rarely orthostatic hypotension, syncope, tachycardia, palpitations, chest pain, asthenia, drowsiness, oedema, flushing, dry mouth, rash, pruritis | Orthostatic hypotension, hepatic insufficiency, severe renal insufficiency (CrCl less than 30 ml/min), intestinal occlusion. Avoid use with potent CYP3A4 inhibitors (eg:ritonavir etc). | Alpha blockers and other antihypertensives,potent CYP3A4 inhibitors | None | Elderly, coronary insufficiency, discontinue in the event of recurrence or exacerbation of angina, may impair ability to drive or operate machinery | Xatral XL | Genito Urinary System and Sex Hormones > Urologicals | G04CA01-110-T10-01-XXX | No | Government Contract | |||||||||||
50 | 49 | Alglucosidase alfa 5 mg/ml Injection | A* | Infantile-onset Pompe disease | 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion. Monitoring It is suggested that patients be monitored periodically for IgG antibody formation. Patients who experience Infusion-associated reactions suggestive of hypersensitivity may be tested for IgE antibodies to alglucosidase alfa. Treated patients who experience a decrease in benefit despite continued treatment with Alglucosidase Alfa, in whom antibodies are suspected to play a role, may be tested for neutralization of enzyme uptake or activity. | Rash, flushing, urticaria, pyrexia, cough, tachycardia, decreased oxygen saturation, vomiting, tachypnea, agitation, increased blood pressure, cyanosis, hypertension, irritability, pallor, pruritus, retching, rigors, tremor, hypotension, bronchospasm, erythema, face edema, feeling hot, headache, hyperhidrosis, lacrimation increased, livedo reticularis, nausea, periorbital edema, restlessness and wheezing. cardiorespiratory failure and anaphylactic reactions. | Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of this container. | Unknown | None | Patients with an acute underlying illness, immunogenicity, pregnancy, nursing mothers | Alimentary Tract and Metabolism > Other Alimentary Tract and Metabolism Products | A16AB07-000-P40-01-XXX | No | LP | ||||||||||||
51 | 50 | Alkaline Nasal Douche | B | To remove nasal plug | To be diluted with an equal volume of warm water before use | Excessive use can be toxic due to its absorption | Not known | Not known | None | Epistaxis, not to be used in cranial surgery or trans nasal neuro surgical procedure | Respiratory System > Nasal Preparations | R01A000-999-L50-01-XXX | No | LP | ||||||||||||
52 | 51 | Allopurinol 100 mg Tablet | A/KK | i) Frequent and disabling attacks of gouty arthritis (2 or more attacks/year). ii) Clinical or radiographic signs of erosive gouty arthritis. iii) The presence of tophaceous deposits. iv) Urate nephropathy. v) Urate nephrolithiasis. vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia | Initial dose: 50-100 mg daily. Maintenance: 300-900mg daily (depending on renal function). | Skin rash, maculopapular, pruritic, Stevens-Johnson Syndrome, peripheral neuritis, alopecia, GI upset, toxic epidermal necrolysis. Acute attack of gouty arthritis in early stages of therapy. Skin reactions (discontinue immediately at first sign of rash). Very rarely, granulomatous hepatitis. Occasionally; thrombocytopenia, agranulocytosis, & aplastic anaemia in patients with impaired renal function | Hypersensitivity to allopurinol, pregnancy, lactation, acute gout, asymptomatic hyperuricaemia | Oral anticoagulants, azathioprine, antidiabetics, mercaptopurine.Use only quarter of the usual dose of 6-mercaptopurine or azathioprine when given concurrently. Increases plasma half-life of adenine arabinoside. Effects decreased by uricosurics & large doses of salicylates | - | Renal/hepatic dysfunction, asymptomatic hyperuricaemia, hypersensitivity and pregnancy | Zyloric | Musculo-skeletal System > Antigout Preparations | M04AA01-000-T10-02-XXX | Yes | LP | |||||||||||
53 | 52 | Allopurinol 300 mg Tablet | A/KK | i) Frequent and disabling attacks of gouty arthritis (2 or more attacks/year). ii) Clinical or radiographic signs of erosive gouty arthritis. iii) The presence of tophaceous deposits. iv) Urate nephropathy. v) Urate nephrolithiasis. vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia | Initial dose: 50-100 mg daily. Maintenance: 300-900mg daily (depending on renal function). | Skin rash, maculopapular, pruritic, Stevens-Johnson Syndrome, peripheral neuritis, alopecia, GI upset, toxic epidermal necrolysis. Acute attack of gouty arthritis in early stages of therapy. Skin reactions (discontinue immediately at first sign of rash). Very rarely, granulomatous hepatitis. Occasionally; thrombocytopenia, agranulocytosis, & aplastic anaemia in patients with impaired renal function | Hypersensitivity to allopurinol, pregnancy, lactation, acute gout, asymptomatic hyperuricaemia | Oral anticoagulants, azathioprine, antidiabetics, mercaptopurine.Use only quarter of the usual dose of 6-mercaptopurine or azathioprine when given concurrently. Increases plasma half-life of adenine arabinoside. Effects decreased by uricosurics & large doses of salicylates | - | Renal/hepatic dysfunction, asymptomatic hyperuricaemia, Hypersensitivity and pregnancy | Zyloric | Musculo-skeletal System > Antigout Preparations | M04AA01-000-T10-01XXX | Yes | APPL | |||||||||||
54 | 53 | All-Trans Retinoic Acid (Tretinoin) 10 mg Capsule | A* | Acute promyelocytic leukaemia | Induction: 45 mg/m2 daily for 30 - 90 days. Maintenance: 45 mg/m2 daily for 2 weeks every 3 months. Renal/or hepatic insufficiency: 25mg/m2 daily for 30-90 days. Refer to protocols | Headache, fever, weakness, fatigue, nausea, vomiting, dry skin, rash, peripheral oedema, mycosis, conjunctivitis, hypotension, hypertension, arrhythmias, heart failure, flushing, dizziness, anxiety, depression, paresthesias, confusion, pseudotumour cerebri, gastrointestinal bleeding, abdominal pain, diarrhoea, constipation, retinoic acid syndrome, bone pain, muscle pain, joint pain, increase in serum triglycerides and cholesterol | Hypersensitivity to retinoids, pregnancy and lactation | Concurrent use with drugs which inhibit hepatic cytochrome P450 enzyme system, eg ketoconazole, cimetidine, ciclosporin, diltiazem, erythromycin, rifampicin, verapamil may increase risk of toxicity. Use together with vitamin A supplements may result in increase in toxicity. Avoid ethanol. Exposure to paclitaxel result in increased risk of paclitaxel toxicity. Tranexamic Acid may result in increased risk of thrombosis | None | Avoid pregnancy during and for at least 1 month after stopping treatment. Monitor haematological, coagulation profile, liver function test, serum lipid levels. To be used with caution in pre-existing hypertriglyceridaemia, diabetes mellitus, obesity. Anticipate and treat retinoic acid syndrome | Vesanoid | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L01XX14-000-C10-01-XXX | Yes | LP | |||||||||||
55 | 54 | Alprazolam 0.25mg Tablet | A/KK | Anxiety disorders | 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children | Drowsiness, blurred vision, coordination disorder, gastrointestinal disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation | Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression | Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity. Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity. Sertraline; increased risk of psychomotor impairment and sedation. Fluoxetine; increased risk of alprazolam toxicity. Fluvoxamine; increased risk of CNS side effects. Ritonavir; increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, mirtazapine, phenothiazines, venlafaxine;increased risk of CNS depression, psychomotor impairment. Sedative/hypnotics, tricyclic antidepressants; CNS depression. Potentiates action of alcohol. Reduced concentration by 50% with cigarette smoking. | None | Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients, obesity, untreated open angle glaucoma, impaired pulmonary function. Prolonged use can lead to dependence | Xanax | Nervous System > Psycholeptics | N05BA12-000-T10-01-XXX | No | LP | |||||||||||
56 | 55 | Alprazolam 0.5mg Tablet | A | Anxiety disorders | 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children | Drowsiness, blurred vision, coordination disorder, gastrointestinal disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation | Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression | Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity. Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity. Sertraline; increased risk of psychomotor impairment and sedation. Fluoxetine; increased risk of alprazolam toxicity. Fluvoxamine; increased risk of CNS side effects. Ritonavir; increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, mirtazapine, phenothiazines, venlafaxine;increased risk of CNS depression, psychomotor impairment. Sedative/hypnotics, tricyclic antidepressants; CNS depression. Potentiates action of alcohol. Reduced concentration by 50% with cigarette smoking. | None | Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients, obesity, untreated open angle glaucoma, impaired pulmonary function. Prolonged use can lead to dependence | Xanax | Nervous System > Psycholeptics | N05BA12-000-T10-02-XXX | No | LP | |||||||||||
57 | 56 | Alprazolam 1mg Tablet | A | Anxiety disorders | 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children | Drowsiness, blurred vision, coordination disorder, gastrointestinal disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation | Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression | Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity. Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity. Sertraline; increased risk of psychomotor impairment and sedation. Fluoxetine; increased risk of alprazolam toxicity. Fluvoxamine; increased risk of CNS side effects. Ritonavir; increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, mirtazapine, phenothiazines, venlafaxine;increased risk of CNS depression, psychomotor impairment. Sedative/hypnotics, tricyclic antidepressants; CNS depression. Potentiates action of alcohol. Reduced concentration by 50% with cigarette smoking. | None | Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients, obesity, untreated open angle glaucoma, impaired pulmonary function. Prolonged use can lead to dependence | Xanax | Nervous System > Psycholeptics | N05BA12-000-T10-03-XXX | No | LP | |||||||||||
58 | 57 | Alprostadil 500 mcg/ml Injection | A* | For treatment of congenital heart diseases which are ductus arteriosus dependent | 0.05 - 0.1 mcg/kg/min by continuous IV infusion, then decreased to lowest effective dose | Bradycardia, fever, hypotension, tachycardia, neonatal apnoea, seizures | Neonates with respiratory distress syndrome | Heparin | None | Concurrent anticoagulants, neonates with bleeding tendencies, spinal cord injury | Prostin VR | Cardiovascular System > Cardiac Therapy | C01EA01-000-P30-01-XXX | No | Government Contract | |||||||||||
59 | 58 | Alteplase 50 mg per vial Injection | A* | Thrombolytic treatment of acute ischaemic stroke. | 0.9 mg/kg (maximum of 90 mg) infused over 60 minutes with 10% of the total dose administered as an initial intravenous bolus. Treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging technique. | The most common and serious side effect with alteplase is bleeding. Minor bleeding is more common, but significant bleeding such as into the brain or fatal bleeding also occurs. Nausea, vomiting, and allergic reactions also occur. | In the indication acute ischaemic stroke the following contraindications apply in addition: Symptoms of ischaemic attack began more than 4.5 hours prior to infusion start or when time of symptom onset is unknown, symptoms of acute ischaemic stroke that were either rapidly improving or only minor before start of infusion, severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques, seizure at the onset of stroke, history of previous stroke or serious head-trauma within three months, a combination of previous stroke and diabetes mellitus, administration of heparin within 48 hours preceding the onset of stroke with an elevated activated partial thromboplastin time (aPTT) at presentation, platelet count of less than 100,000 / mm3 , systolic blood pressure > 185 or diastolic blood pressure > 110 mm Hg, or aggressive management (IV medication) necessary to reduce blood pressure to these limits, blood glucose < 50 or > 400 mg/dl. Alteplase is not indicated for the therapy of acute stroke in children and adolescents under 18 years. | Alteplase breaks down clots and thereby interferes with the body's ability to stop bleeding. Therefore, drugs which also interfere with the body's ability to form blood clots (or the clot-promoting effects of platelets) increase the risk of bleeding in patients receiving alteplase. Such drugs include warfarin, aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, nabumetone, and platelet inhibitors such as clopidogrel. | - | Bleeding disorders, high blood pressure, recent injury or surgery, liver disease, endocarditis, any allergies. Use extra caution to avoid injury and trauma while using this medication due to the increased risk of bleeding. This medication should be used only if clearly needed during pregnancy. | Blood and Blood Forming Organs > Antithrombotic Agents | B01AD02-000-P40-01-XXX | Yes | Government Contract | ||||||||||||
60 | 59 | Amantadine HCl 100mg Capsule | B | Parkinson's disease | Initial dose: 100 mg daily and is increased to 100 mg twice daily (not later than 4 p.m.) after a week. Elderly over 65 years: less than 100 mg or 100 mg at intervals of more than 1 day | Oedema of ankles, livedo reticularis, depression, hallucination, nausea, vomiting, dizziness, insomnia, blurred vision, dry mouth. Seizures, psychosis, confusion, ataxia, heart failure, depression, orthostatic hypotension, blood dyscrasias, urinary retention, irritability, gastrointestinal disturbances | Hypersensitivity to amantadine products, pregnancy, lactation, epilepsy, history of gastric ulceration, severe renal impairment | Alcohol, methyldopa, metoclopramide, domperidone, antipsychotic, antimuscarinics. Enhances the adverse effects of antimuscarinics and levodopa. Central nervous system stimulants, drugs that raise urinary pH | None | Seizure disorder, psychiatry disorder, recurrent eczema, gastric ulceration. Patients with cardiovascular or liver disease, impaired renal function. Elderly. Withdrawal of the drug should be gradual | Symmetrel | Nervous System > Anti-parkinson Drugs | N04BB01-110-C10-01-XXX | No | LP | |||||||||||
61 | 60 | Amikacin 125 mg/ml Injection | A | Infections due to susceptible organisms | ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day 8 - 12 hourly. Maximum: 1.5 g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day | Ototoxicity, nephrotoxicity, neuromuscular blockade. Tinnitus, vertigo; ataxia and overt deafness. | Pregnancy, perforated ear drum, myasthenia gravis, hypersensitivity. | Potentiation of toxicity in combination with loop diuretics, cephalothin, vancomycin, cyclosporin. Prolongs action of neuromuscular blockers. Increased risk of respiratory depression with either halothane, methoxyflurane & neuromuscular blockers | None | Renal impairment; vertigo, tinnitus. Discontinue if signs of ototoxicity, neurotoxicity or hypersensitivity occurs; lactation. Safety has not been established for treatment period >14 days. Monitor renal function before and during treatment. | Amikin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01GB06-183-P30-03-XXX | Yes | APPL | |||||||||||
62 | 61 | Amikacin 250mg/ml Injection | A | Infections due to susceptible organisms | ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day 8 - 12 hourly. Maximum: 1.5 g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day | Ototoxicity, nephrotoxicity, neuromuscular blockade. Tinnitus, vertigo; ataxia and overt deafness. | Pregnancy, perforated ear drum, myasthenia gravis, hypersensitivity. | Potentiation of toxicity in combination with loop diuretics, cephalothin, vancomycin, cyclosporin. Prolongs action of neuromuscular blockers. Increased risk of respiratory depression with either halothane, methoxyflurane & neuromuscular blockers | None | Renal impairment; vertigo, tinnitus. Discontinue if signs of ototoxicity, neurotoxicity or hypersensitivity occurs; lactation. Safety has not been established for treatment period >14 days. Monitor renal function before and during treatment. | Amikin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01GB06-183-P30-02-XXX | Yes | APPL | |||||||||||
63 | 62 | Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet | B | i) Diuretic as an adjunct to the management of oedematous states ii) Hypertension | i) Initially 1 - 2 tab daily adjusted according to response. Max : 4 tabs daily. ii) 1 -2 tabs daily as a single or divided dose | Headache, fatigue, nausea, anorexia, vomiting, arrhythmia, tachycardia, orthostatic hypotension, dyspnoea, elevated serum potassium levels. NPRA Safety Alert 1. 5 May 2022 Choroidal effusion, acute myopia, acute angle-closure glaucoma 2. 18 Apr 2024 Risk of Acute Respiratory Distress Syndrome (ARDS) | Hypersensitivity to other sulfonamides. Hyperkalaemia, antikaliuretic therapy or potassium supplementation, renal impairment. Children. | Angiotensin converting enzyme inhibitors: postural hypotension (first dose). Carbamazepine: hyponatraemia. Chlorpropamide: decreased chlorpropamide effectiveness. Digitalis: digitalis toxicity (nausea, vomiting, arrhythmias). Corticosteroids: hypokalaemia and subsequent cardiac arrhythmias. NSAIDs: decreased diuretic and antihypertensive efficacy. Propranolol: hyperglycaemia, hypertriglyceridemia. Cholestyramine and colestipol resins-absorption of hydrochlorothiazide is impaired in the presence of anion exchange resins. | None | Diabetes mellitus. Electrolyte imbalance, concomitant use of other diuretics can result in hyponatraemia and hypochloremia as well as increases in BUN levels. This is more frequent in patients with hepatic cirrhosis and ascites, metabolic alkalosis or those with resistant oedema. Metabolic or respiratory acidosis. Pregnancy & lactation. NPRA Safety Alert 1. 18 Apr 2024 Risk of Acute Respiratory Distress Syndrome (ARDS) | Moduride Tablet | Cardiovascular System > Diuretics | C03EA01-900-T10-01-XXX | No | APPL | |||||||||||
64 | 63 | Amino Acids & Glucose with Electrolytes Injection | A | Source of amino acids, carbohydrate and electrolytes in patients needing IV nutrition | Dose to be individualised. ADULT usual requirement for amino acid 1-2 g/kg/day, carbohydrate 4-6 g/kg/day | Hyperammonemia, encephalopathy, cholestasis, thrombophlebitis | Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis | Not known | None | Liver disease, renal impairment | Blood and Blood Forming Organs > Blood Substitutes and Perfusion Solutions | B05BA10-910-P30-03-XXX | No | LP | ||||||||||||
65 | 64 | Amino Acids Injection | A | Source of amino acids in patients needing IV nutrition | Dose to be individualised. ADULT usually 500-2000 ml by IV. ADULT usual requirement for amino acid: 1-2 g/kg/day | Gastrointestinal upset, flushing, sweating, thrombophlebitis | Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis | Not known | None | Liver disease, renal impairment | Blood and Blood Forming Organs > Blood Substitutes and Perfusion Solutions | B05BA01-910-P30-01-XXX | No | APPL | ||||||||||||
66 | 65 | Amino Acids with Electrolytes Injection | A | Source of amino acids and electrolytes in patients needing IV nutrition | Dose to be individualised. ADULT usual requirement for amino acid 1-2 g/kg/day | Gastrointestinal upset, flushing, sweating, thrombophlebitis | Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis | Not known | None | Liver disease, renal impairment | - | Blood and Blood Forming Organs > Blood Substitutes and Perfusion Solutions | B05BA10-910-P30-02-XXX | No | LP | |||||||||||
67 | 66 | Amino Acids, Glucose and Lipid with Electrolytes Injection | A | Source of amino acids, carbohydrate, lipid and electrolytes in patients needing IV nutrition | Dose to be individualised. ADULT: 500 - 2000 ml daily given by IV. ADULT usual requirement for amino acid 1-2 g/kg/ day, carbohydrate 4-6 g/kg/day, lipid 2-3 g/kg/day | Gastrointestinal upset, flushing, sweating, thrombophlebitis | Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis | Not known | None | Liver disease, renal impairment | - | Blood and Blood Forming Organs > Blood Substitutes and Perfusion Solutions | B05BA10-910-P30-01-XXX | No | LP | |||||||||||
68 | 67 | Amino Acids, Glucose and Lipid without Electrolytes Injection | A | Source of amino acids and carbohydrate in patients needing IV nutrition. | ADULT usual requirement for amino acid 1-2 g/kg/ day, carbohydrate 4-6 g/kg/day, lipid 2-3 g/kg/day. Dosing is individualised and according to product insert/protocol. | Gastrointestinal upset, flushing, sweating, thrombophlebitis | Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis | Not known | None | Liver disease, renal impairment | - | Blood and Blood Forming Organs > Blood Substitutes and Perfusion Solutions | B05BA10-910-P30-04-XXX | No | LP | |||||||||||
69 | 68 | Aminophylline 25mg/ml Injection | B | Reversible airways obstruction, acute severe brochospasm | Adult: Loading dose: 6 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min. Children: 6 months and over (if not previously on theophylline): Loading dose: 6mg/kg. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr. Dosing is individualised and according to product insert/protocol. | Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, CNS stimulation, insomnia, arrythmias, also allergy to ethylenediamine which can cause urticaria, erythema, and exfoliative dermatitis | Hypersensitivity to theophylline or derivatives, hypersensitivity to ethylenediamine | Azole antifungals, ciprofloxacin, clarithromycin, erythromycin : increased risk of theophylline toxicity. Caffeine : increased caffeine level. Halothane : increased risk of arrthmia | None | Should not be administered concurrently with ephedrine or with other xanthine medications. Use with caution paediatrics, elderly patients, smokers ,patients undergoing influenza immunisation, patient with reduced hepatic clearance.Patients with ischaemic heart disease, hypertension,hyperthyroidism, epilepsy, history of peptic ulcer disease, glaucoma, diabetis mellitus, severe hypoxemia, angina pectoris, acute mycardial injury or pre-existing arrythmias. | - | Respiratory System > Drugs for Obstructive Airway Diseases | R03DA05-000-P30-01-XXX | Yes | APPL | |||||||||||
70 | 69 | Amiodarone 200 mg Tablet | A* | Arrhythmias | 200 mg 3 times daily for 1 week, then reduced to 200 mg twice daily for another week. Maintenance dose, usually 200 mg daily or the minimum required to control the arrhythmia. Dosing is according to product insert / protocol. | Reversible corneal microdeposits; colored halos. Hyper or hypothyroidism. Rarely; photosensitization and pigmentation. Reversible diffuse interstitial pneumopathy or peripheral neuropathy NPRA Safety Alert 1. 14 Nov 2025 Risk of Primary Graft Dysfunction after Heart Transplantation | Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction | Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetics, ciclosporin | None | Acute myocardial infarction, sino-atrio, block AV or other severe conduction disorder (unless the patient has a pacemaker),severe hypotension,severe respiratory failure,bradycardia, cardiomegaly, corneal microdeposits (impaired vision) NPRA Safety Alert 1. 14 Nov 2025 Risk of Primary Graft Dysfunction after Heart Transplantation | Cardiovascular System > Cardiac Therapy | C01BD01-110-T10-01-XXX | Yes | LP | ||||||||||||
71 | 70 | Amiodarone 50 mg/ml Injection | A*, A/KK | Category A*: i) Arrhythmias ii) Cardiopulmonary resuscitation of shock-resistant ventricular fibrillation in cardiac arrest Category A/KK: Ventricular arrythmia (ventricular tachycardia and ventricular fibrillation) | i) Initial: 5mg/kg over 20-120minutes Maintenance: 10-20mg/kg/24hr Max. dose: 1.2g/24hr. ii) Initial: 300mg or 5mg/kg rapid Additional 150mg if condition persists. Dosing is according to product insert / protocol. | Reversible corneal microdeposits; colored halos. Hyper or hypothyroidism. Rarely; photosensitization and pigmentation. Reversible diffuse interstitial pneumopathy or peripheral neuropathy NPRA Safety Alert 1. 14 Nov 2025 Risk of Primary Graft Dysfunction after Heart Transplantation | Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction | Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetic, ciclosporin | Category A*: None Category A/KK: Use only for emergency cases in health clinic with Medical Officers (MO) upon consultation with Family Medicine Specialist (FMS) | Acute myocardial infarction, sino-atrio, block AV or other severe conduction disorder ( unless the patient has a pacemaker),severe hypotension,severe respiratory failure, bradycardia, cardiomegaly,corneal microdeposits (impaired vision) NPRA Safety Alert 1. 14 Nov 2025 Risk of Primary Graft Dysfunction after Heart Transplantation | Cardiovascular System > Cardiac Therapy | C01BD01-110-P30-01-XXX | Yes | LP | ||||||||||||
72 | 71 | Amisulpride 100mg Tablet | A* | Treatment of psychoses, particularly acute or chronic schizophrenia disorders characterized by positive symptoms(e.g. delusion, hallucinations, thought disorders) and/or negative symptoms(e.g. blunted emotions, emotional and social withdrawal) including when the negative symptoms predominate | Predominantly negative episodes: 50-300 mg once daily adjusted according to the patient's response. Mixed episodes with positive and negative symptoms: 400-800 mg/day in 2 divided doses adjusted according to the patient's response. Should be taken on an empty stomach (Preferably taken before meals) | Insomnia, anxiety, agitation, extrapyramidal symptoms, galactorrhea, gynecomastia, amenorrhea, breast pain, impotence, gastrointestinal disorder, weight gain | Hypersensitivity to amisulpride, pheochromocytoma, prolactinomas and breast cancer, pregnancy, lactation, children under 15 years of age | Amiodarone; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest). If concurrent use cannot be avoided, cautious dosing and telemetric monitoring is advised . Amitriptyline, chloral hydrate, chloroquine, chlorpromazine, cisapride, clarithromycin, erythromycin, fluconazole, fluoxetine, imipramine, isoflurane, mefloquine, octreotide, prochlorperazine, sulfamethoxazole, thioridazine, trifluoperazine, trimethoprim and vasopressin; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest) | None | Renal insufficiency (dose reductions), epilepsy, Parkinson's disease; concomitant use of dopamine agonists, previous hypersensitivity to other benzamide derivatives (sulpiride, metoclopramide, tiapride, sultopride), elderly patients (increased risk of adverse effects; reduced renal function may be present requiring dose adjustment), coadministration with other agents which depress the central nervous system or lower blood pressure | Solian | Nervous System > Psycholeptics | N05AL05-000-T10-01-XXX | No | Government Contract | |||||||||||
73 | 72 | Amisulpride 400mg Tablet | A* | Treatment of psychoses, particularly acute or chronic schizophrenia disorders characterized by positive symptoms(e.g. delusion, hallucinations, thought disorders) and/or negative symptoms(e.g. blunted emotions, emotional and social withdrawal) including when the negative symptoms predominate | Predominantly negative episodes: 50-300 mg once daily adjusted according to the patient's response. Mixed episodes with positive and negative symptoms: 400-800 mg/day in 2 divided doses adjusted according to the patient's response. Should be taken on an empty stomach (Preferably taken before meals) | Insomnia, anxiety, agitation, extrapyramidal symptoms, galactorrhea, gynecomastia, amenorrhea, breast pain, impotence, gastrointestinal disorder, weight gain | Hypersensitivity to amisulpride, pheochromocytoma, prolactinomas and breast cancer, pregnancy, lactation, children under 15 years of age | Amiodarone; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest). If concurrent use cannot be avoided, cautious dosing and telemetric monitoring is advised . Amitriptyline, chloral hydrate, chloroquine, chlorpromazine, cisapride, clarithromycin, erythromycin, fluconazole, fluoxetine, imipramine, isoflurane, mefloquine, octreotide, prochlorperazine, sulfamethoxazole, thioridazine, trifluoperazine, trimethoprim and vasopressin; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest) | None | Renal insufficiency (dose reductions), epilepsy, Parkinson's disease; concomitant use of dopamine agonists, previous hypersensitivity to other benzamide derivatives (sulpiride, metoclopramide, tiapride, sultopride), elderly patients (increased risk of adverse effects; reduced renal function may be present requiring dose adjustment), coadministration with other agents which depress the central nervous system or lower blood pressure | Solian | Nervous System > Psycholeptics | N05AL05-000-T10-02-XXX | No | Government Contract | |||||||||||
74 | 73 | Amitriptyline HCl 25 mg Tablet | B | i) Depression ii) Nocturnal enuresis where organic pathology has been excluded | i) Initial: 25mg 3 times a day in the evening Increase gradually in the late evening or at bedtime if necessary up to a maximum of 150mg per day Hospitalised patient: 100mg per day Increase gradually to 200-300mg per day ii) CHILD 6 YEARS AND UNDER: 10mg at bedtime CHILD OVER 6 YEARS Initial: 10mg at bedtime Increase gradually if necessary up to a maximum of 25mg at bedtime Not recommended for treatment of depression in children under 12 years of age. Dosing is individualised and according to product insert/ protocol. | Dry mouth, constipation, nausea, vomiting, urinary retention, blurred vision, drowsiness, dizziness, tachycardia, increased appetite, confusion, seizures, myocardial infarction, stroke, agranulocytosis, thrombocytopenia, rash and hypersensitivity reactions, blood sugar changes, endocrine side effects, impotence, menstrual irregularities, bone marrow depression | Hypersensitivity to drug/class. Immediate recovery phase after myocardial infarction, heart block, mania. MAOI use within the last 14 days | Barbiturate, phenytoin, carbamazepine, cimetidine, amphetamines, antiarrhythmics, class Ia and III, anticholinergics, antihistamines, beta 2 agonists, benzodiazepines, systemic carbonic anhydrase inhibitors, central alpha 2 agonists, cholinergic agents, clozapine, intranasal decongestants, flumazenil, halothane, lithium, MAOIs, methylphenidate, metoclopramide, muscle relaxants, nitrates, opiates, antipsychotics, phenytoin, protease inhibitors, sedatives/hypnotics, SSRIs, indirect/mixed sympathomimetics, cimetidine, fluoxetine, clonidine | None | Cardiac disease, hyperthyroidism, impaired hepatic and renal function, urinary retention, history of seizures, glaucoma, suicide risk, pregnancy, lactation, elderly, phaeochromocytoma, history of mania, phychoses, angle-closure glaucoma, concurrent anticonvulsive therapy, anaesthesia | Laroxyl | Nervous System > Psychoanaleptics | N06AA09-110-T10-01-XXX | Yes | LP | |||||||||||
75 | 74 | Amlodipine 10 mg and Valsartan 160 mg Tablet | A/KK | Essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy | Doses range from amlodipine besylate 5 mg/valsartan 160 mg to amlodipine besylate 10 mg/valsartan 320 mg ORALLY once daily, with dose titration occurring every 1 to 2 weeks if necessary. MAX amlodipine besylate 10 mg/valsartan 320 mg | Nasopharyngitis, flu, headache, oedema, peripheral oedema, fatigue, flushing, asthenia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, gastrointestinal disturbances, rash, erythema, joint swelling, back pain, arthralgia. Rare: Hypersensitivity. Amlodipine: Gastritis, gingival hyperplasia, gynaecomastia, leucopaenia, myalgia, pancreatitis, hepatitis, thrombocytopaenia, vasculitis. Valsartan: Neutropaenia, increases in creatinine, serum potassium and BUN NPRA Safety Alert 1. 28 May 2025 (ARBs) Intestinal Angioedema | Pregnancy and lactation, hypersensitivity to amlodipine, valsartan, or any component of the product | Potassium supplement. Potassium-sparing diuretic, potassium containing salt substitutes or other drugs that may increase potassium level | None | Risk of hypotension in sodium or volume depleted patient, beta blocker withdrawal should be gradual. Severe renal impairment, dialysis. Unilateral/ bilateral renal stenosis, stenosis to a solitary kidney, after recent kidney transplantation, hepatic impairment, biliary obstructive disorders. Aortic or mitral stenosis, obstructive hyperthrophic cardiomyopathy NPRA Safety Alert 1. 28 May 2025 (ARBs) Intestinal Angioedema | Exforge | Cardiovascular System > Agents Acting on the Renin-angiotensin System | C09DB01-935-T10-03-XXX | No | LP | |||||||||||
76 | 75 | Amlodipine 10 mg Tablet | B | Hypertension | 5 mg once daily. Max: 10 mg once daily | Headache, dizziness, gingival hyperplasia, tachycardia, peripheral oedema | Hypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failure | Cyclosporin, sildenafil, vardenafil, CYP3A4 inducers, CYP3A4 inducers(fluconazole, itraconazole, ketoconazole) | None | Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Aortic stenosis (reduced myocardial oxygenation with drug-induced hypotension), congestive heart failure, pregnancy, hepatic impairment, lactation. | Hovasc 10 mg Tablet | Cardiovascular System > Calcium Channel Blockers | C08CA01-000-T10-02-XXX | Yes | APPL | |||||||||||
77 | 76 | Amlodipine 5 mg and Valsartan 160 mg Tablet | A/KK | Essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy | Doses range from amlodipine besylate 5 mg/valsartan 160 mg to amlodipine besylate 10 mg/valsartan 320 mg ORALLY once daily, with dose titration occurring every 1 to 2 weeks if necessary. MAX amlodipine besylate 10 mg/valsartan 320 mg | Nasopharyngitis, flu, headache, oedema, peripheral oedema, fatigue, flushing, asthenia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, gastointestinal disturbances, rash, erythema, joint swelling, back pain, arthralgia. Rare: Hypersensitivity. Amlodipine: Gastritis, gingival hyperplasia, gynaecomastia, leucopaenia, myalgia, pancreatitis, hepatitis, thrombocytopaenia, vasculitis. Valsartan: Neutropaenia, increases in creatinine, serum potassium and BUN NPRA Safety Alert 1. 28 May 2025 (ARBs) Intestinal Angioedema | Pregnancy and lactation, hypersensitivity to amlodipine, valsartan or any component of the product | Potassium Supplement. Potassium-sparing diuretic, potassium containing salt substitutes or other drugs that may increase potassium level | None | Risk of hypotension in sodium or volume depleted patient, beta blocker withdrawal should be gradual. Severe renal impairment, dialysis. Unilateral/ bilateral renal stenosis, stenosis to a solitary kidney, after recent kidney transplantation, hepatic impairment, biliary obstructive disorders. Aortic or mitral stenosis, obstructive hyperthrophic cardiomyopathy NPRA Safety Alert 1. 28 May 2025 (ARBs) Intestinal Angioedema | Exforge | Cardiovascular System > Agents Acting on the Renin-angiotensin System | C09DB01-935-T10-02-XXX | No | LP | |||||||||||
78 | 77 | Amlodipine 5 mg Tablet | B | Hypertension | 5 mg once daily. Max: 10 mg once daily | Headache, dizziness, gingival hyperplasia, tachycardia, peripheral oedema | Hypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failure | Cyclosporin, sildenafil, vardenafil, CYP3A4 inducers, CYP3A4 inducers(fluconazole, itraconazole, ketoconazole). | None | Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Aortic stenosis (reduced myocardial oxygenation with drug-induced hypotension), congestive heart failure, pregnancy, hepatic impairment, lactation. | Hovasc 5 mg Tablet | Cardiovascular System > Calcium Channel Blockers | C08CA01-000-T10-01-XXX | Yes | APPL | |||||||||||
79 | 78 | Amorolfine 5% Nail Lacquer | A* | Fungal nail infections | Apply to affected nail once or sometimes twice a week after filling and cleansing, allow to dry, treat finger nail for 6 months, toe nail for 9 - 12 months (review at intervals of 3 months) | Slight transient burning sensation | Hypersensitivity to amorolfine | Not known | None | Avoid contact with eyes, previous hypersensitivity or intolerance to other topical antifungal agents | Loceryl | Dermatologicals > Antifungals for Dermatological Use | D01AE16-110-L50-01-XXX | No | LP | |||||||||||
80 | 79 | Amoxicillin (Amoxycillin) & Clavulanate 228 mg/5 ml Syrup | A/KK | Infections caused by susceptible organisms | Mild to Moderate infection: 25mg/kg/day (based on Amoxicillin dose) in 2 divided dose. Severe infection: 45mg/kg/day (based on Amoxicillin dose) in 2 divided dose | Diarrhoea, pseudomembraneous colitis, indigestion, GI upsets, increased liver enzyme | Hypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunction | Aminoglycosides, anticoagulants, probenecid, allopurinol, oral contraceptive | None | Caution use in patient with hepatic dysfunction, Cholestatic Jaundice has been reported. Possibility of crystalluria, adequate fluid intake and urinary output should be maintained. Dose adjustment needed for renal impairment patient. NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Augmentin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR02-961-F21-02-XXX | Yes | LP | |||||||||||
81 | 80 | Amoxicillin (Amoxycillin) 1g & Clavulanate 200mg Injection | A, A/KK | Prescriber Category: A i) Infections caused by susceptible organisms. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection & osteomyelitis. Prescriber Category: A/KK ii) Management of suspected sepsis or septic shock in primary care facility | CHILD less than 3 months: 30mg/kg 12 hourly. 3 months - 12 years: 30mg/kg 6 - 8 hourly. ADULT: 1.2 g by IV or intermittent infusion 6 - 8 hourly | Diarrhoea, pseudomembraneous colitis, GI upsets, increased liver enzyme, urticaria and erythematous multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemia | Hypersensitivity to penicillins, possible cross sensitivity with other ‚-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunction | Aminoglycosides, anti-coagulants, oral contraceptives, methotrexate | Indication (i): No prescribing restriction Indication (ii): Administered as a single stat dose prior to hospital transfer | Pregnancy, breast-feeding, renal or liver failure, pseudomembranous colitis NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Augmentin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR02-961-P40-02-XXX | Yes | Government Contract | |||||||||||
82 | 81 | Amoxicillin (Amoxycillin) 250mg Capsule | B | Infections caused by susceptible strains of gram positive and gram negative organisms | ADULT: 250 - 500 mg 3 times daily. CHILD: 20 - 40 mg/kg/day in divided doses 8 hourly | Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice | Hypersensitivity to penicillins | Aminoglycosides, oral contraceptives | None | Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA04-012-C10-01-XXX | Yes | APPL | ||||||||||||
83 | 82 | Amoxicillin (Amoxycillin) 250mg/5mL Oral Solution | B | Infections caused by susceptible strains of gram positive and gram negative organisms | CHILD less than 10 years: 125 - 250 mg 8 hourly. CHILD less than 20 kg: 20 - 40 mg/kg/day in 3 - 4 divided doses | Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice | Hypersensitivity to penicillins | Aminoglycosides, oral contraceptives | None | Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | - | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA04-012-L80-01-XXX | Yes | LP | |||||||||||
84 | 83 | Amoxicillin (Amoxycillin) 500mg & Clavulanate 125mg Tablet | A/KK | Infections due to beta-lactamase producing strain where amoxicillin alone is not appropriate. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection & osteomyelitis. | ADULT & CHILD ≥ 40 kg Mild to moderate infections: 625 mg twice daily Severe infections: 625 mg three times daily Dosing is individualised and according to product insert/protocol. | Diarrhoea, indigestion, nausea, vomiting, candidiasis, rash, pseudomembranous colitis, hepatitis, cholestatic jaundice, crystalluria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, reversible leucopaenia, thrombocytopaenia, haemolytic anaemia, CNS disturbances | Hypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillin-associated cholestatic jaundice/hepatic dysfunction | Aminoglycosides, anticoagulants, probenecid, allopurinol, oral contraceptive. | None | Renal or hepatic impairment. Patients on anticoagulation therapy. Prolonged use. Pregnancy. NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Augmentin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR02-961-T10-02-XXX | Yes | APPL | |||||||||||
85 | 84 | Amoxicillin (Amoxycillin) 500mg and Clavulanate 100mg Injection | A | Infections caused by susceptible organisms. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection and osteomyelitis | CHILD less than 3 months: 30mg/kg 12 hourly. 3 months - 12 years: 30 mg/kg 6 - 8 hourly. ADULT: 1.2 g by IV or intermittent infusion 6 - 8 hourly | Diarrhoea, pseudomembraneous colitis, gastrointestinal upsets, increased liver enzyme, urticaria and erythematous multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemia | Hypersensitivity to penicillins, possible cross sensitivity with other beta-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunction | Aminoglycosides, anti-coagulants, oral contraceptives, methotrexate | None | Pregnancy, breast-feeding, renal or liver failure, pseudomembranous colitis NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Augmentin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR02-961-P40-01-XXX | Yes | LP | |||||||||||
86 | 85 | Amoxicillin (Amoxycillin) 500mg Capsule | B | Infections caused by susceptible strains of gram positive and gram negative organisms | ADULT: 250 - 500 mg 3 times daily. CHILD: 20 - 40 mg/kg/day in divided doses 8 hourly | Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice | Hypersensitivity to penicillins | Aminoglycosides, oral contraceptives | None | Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA04-012-C10-02-XXX | Yes | LP | ||||||||||||
87 | 86 | Amoxicillin (Amoxycillin) Trihydrate 125 mg/5 ml Syrup | B | Infections caused by susceptible strains of gram positive and gram negative organisms | CHILD less than 10 years: 125 - 250 mg 8 hourly. CHILD less than 20 kg: 20 - 40 mg/kg/day in 3 - 4 divided doses | Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice | Hypersensitivity to penicillins | Aminoglycosides, oral contraceptives | None | Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic Meningitis | - | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA04-012-F10-01-XXX | Yes | APPL | |||||||||||
88 | 87 | Amphotericin B 50 mg Injection (Conventional) | A | Systemic fungal infections | ADULT: 0.25 mg/kg/day by IV infusion, gradually increase if tolerated to 1 mg/kg/day. Maximum in severe cases: 1.5 mg/kg daily or on alternate days. For neonates, lower doses are recommended | Fever, headache, anorexia, weight loss, GI disturbances, malaise, epigastric pain, dyspepsia, generalized pain, anaemia, abnormal renal function. Rarely cardiovascular toxicity, haematologic reactions, neurologic reactions, liver failure | Hypersensitivity | Corticosteroids, nephrotoxic antibiotics and antineoplastics | None | Avoid rapid infusion, renal impairment. Hepatic & renal function tests, blood count & plasma electrolyte monitoring are required. Pregnancy, lactation | Antiinfectives for Systemic Use > Antimycotics for Systemic Use | J02AA01-801-P40-01-XXX | Yes | APPL | ||||||||||||
89 | 88 | Ampicillin Sodium & Sulbactam Sodium 250 mg/5 ml Suspension | A | Treatment of susceptible bacterial infections | ADULT: 375-750mg twice daily. CHILDREN (weight < 30kg): 25-50mg/kg/day in two divided doses. For children weighing 30kg and more, follow usual adult dose. | GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection | History of allergic reaction to any penicillins | If applied concomitantly, probenecid may reduce the distribution and diffusion of ampicillin Allopurinol run a higher risk of developing rashes. | None | Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy | Unasyn Susp. | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR01-961-F21-01-XXX | No | LP | |||||||||||
90 | 89 | Ampicillin Sodium & Sulbactam Sodium 375 mg Tablet | A/KK | Treatment of susceptible bacterial infections | ADULT: 375-750mg twice daily CHILDREN AND INFANTS: 25-50mg/kg/day in 2 divided doses, if ≥ 30kg use an adult dose | GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection | History of allergic reaction to any penicillins | Allopurinol, Anticoagulants, Bacteriostatic drugs, Estrogen-containing oral contraceptives, Methotrexate, Probenecid | None | Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy | Unasyn | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR01-961-T10-01-XXX | No | Government Contract | |||||||||||
91 | 90 | Ampicillin Sodium 1g & Sulbactam Sodium 500mg Injection | A | Treatment of susceptible bacterial infections | ADULT: 1.5 - 12 g/day in divided doses 6 - 8 hourly. Maximum: 4 g Sulbactam. CHILD: 150-300 mg/kg/day 6 - 8 hourly. Prophylaxis of surgical infections: 1.5 - 3 g at induction of anaesthesia. May be repeated 6 - 8 hourly. NEONATES: First week of life, 75mg/kg/day in divided doses every 12 hour | Blood and Lymphatic System (e.g anaemia, hemolytic anaemic, thrombocytopenia etc) Gastrointestinal (e.g nausea, vomitting, diarrhoe etc) Hepatobiliary Disorders (e.g bilirubinemia, jaundice etc) Immune System (e.g anaphylactic reaction) Nervous System (e.g Rare reports of convulsion) Renal and Urinary System (e.g Rare reports of interstitial nephritis) Skin and Subcutaneous Tissue (e.g rash, itching reaction etc) Hepatic (e.g Transient elevation of ALT, AST) | History of allergic reaction to any penicillins | Alloprinol, Aminoglycosides, Bacteriostatic drugs (Cloramphenicol, erythromycin, sulphonamides and tetracyclines), Mthotrexate, Probenecid | None | Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy | Unasyn 1.5g | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR01-961-P40-02-XXX | No | Government Contract | |||||||||||
92 | 91 | Ampicillin Sodium 500 mg Injection | B | Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms); meningitis | 250 - 500 mg IM/IV every 4 - 6 hours. Maximum: 400 mg/kg/day. Meningitis: 2 g 6 hourly. CHILD: 150 mg/kg/daily IV in divided doses. Usual children dose less than 10 years, half adult dose | GI disturbances, skin rashes, pruritis, urticartia, fever, anaphylaxis, blood disorders, superinfection | Hypersensitivity to penicillins | Excretion impaired by probenecid. Increased risk of skin rashes with allopurinol. May decrease effectiveness of oral contraceptives and atenolol | None | Hypersensitivity to cephalosporins. Chronic treatment requires assessment of renal, hepatic& haematopoietic functions. Renal impairment, lymphatic leukaemia | Penbritin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA01-520-P40-01-XXX | Yes | APPL | |||||||||||
93 | 92 | Ampicillin Sodium 500mg & Sulbactam Sodium 250mg Injection | A | Treatment of susceptible bacterial infections | ADULT: 1.5 - 12 g/day in divided doses 6 - 8 hourly. Maximum: 4 g Sulbactam per day. CHILD: 150-300mg/kg/day 6 - 8 hourly. Prophylaxis: 1.5 -3 g at induction of anaesthesia. May be repeated 6 - 8 hourly | GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection | History of allergic reaction to any penicillins | Concurrent use with oral contraceptives may result in decreased contraceptive effectiveness | None | Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy | Unasyn 750 mg | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CR01-961-P40-01-XXX | No | LP | |||||||||||
94 | 93 | Ampicillin Trihydrate 125 mg/5 ml Suspension | B | Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms) | CHILD: 50 - 100 mg/kg/day 4 times daily. Under 1 year: 62.5 - 125 mg 4 times daily, 1 - 10 years: 125 - 250 mg 4 times daily | Diarrhoea, indigestion, nausea, vomiting, occasionally rashes | Hypersensitivity to penicillins | Bacteriostatic drugs, anticoagulants | None | Hypersensitivity to cephalosporins. Severe renal dysfunction, hepatic and hematolgic system. | Penbritin | Antiinfectives for Systemic Use > Antibacterials for Systemic Use | J01CA01-012-F21-01-XXX | Yes | LP | |||||||||||
95 | 94 | Anastrozole 1 mg Tablet | A* | Hormonal therapy in breast cancer in post-menopausal women if failed /contraindicated with Tamoxifen | 1 mg daily | Hot flashes, asthenia, peripheral oedema, vaginal bleeding, deep vein thrombosis, arthralgia, backpain, cough, dypsnea, headache, nausea, rash, hypercholesterolaemia NPRA Safety Alert 1. 29 Nov 2021 - Depression | Hypersensitivity to anastrazole, pregnancy. Not indicated for premenopausal women. Severe renal impairment (CrCl <20 mL/min), moderate or severe hepatic disease. | Oestrogens, tamoxifen | - | Hyperlipidemia, moderate to severe hepatic impairment, severe impairment of renal function (creatinine clearance less than 20 mL/min). Lowers circulating oestrogen levels which may cause a reduction in bone mineral density | Arimidex | Antineoplastic and Immunomodulating Agents > Endocrine Therapy | L02BG03-000-T10-01-XXX | Yes | LP | |||||||||||
96 | 95 | Anidulafungin 100mg Injection | A* | Treatment of invasive candidiasis, including candidemia in adults when intolerance or resistance to Amphotericin B or Fluconazole | Loading dose of 200 mg on day 1, then 100 mg once daily thereafter for at least 14 days after the last positive culture. | Diarrhoea, hypokalemia, hypomagnesemia, thrombocytopenia, coagulopathy, convulsion, headache, increased gamma-glutamyltransferase, blood alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase, rash, pruritus | Hypersensitivity to anidulofungin or other antifungals of echinocandin class eg caspofungin | Ciclosporine; Anidulafungin steady state AUC may be slightly increased. No dosage adjustment is needed. Antifungal agents: Antifungal agents may diminish the therapeutic effect | None | Insufficiently controlled Diabetes Mellitus, recent Myocardial Infarction, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, prostatic hypertrophy, bladder-neck obstruction, cystic fibrosis, predisposition to narrow-angle glaucoma. Pregnancy, lactation. Infusion rate should not exceed 1.1 mg/min. Hepatic dysfunction, significant, worsening hepatic failure, hepatitis/clinically significant hepatic abnormalities have occurred. | EraxisÆ | Antiinfectives for Systemic Use > Antimycotics for Systemic Use | J02AX06-000-P30-01-XXX | Yes | Government Contract | |||||||||||
97 | 96 | Anifrolumab 300mg/2ml Concentrate for Solution for Infusion | A* | Indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy. | The recommended dose is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks. In patients with a history of infusion-related reactions, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab. | Respiratory tract infection, bronchitis, Herpes Zoster, hypersensitivity, infusion related reaction | Hypersensitivity to the active substance or to any of the excipients | No interaction studies have been performed. Anifrolumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. | i) Use is restricted to patients without lupus nephritis or central nervous system (CNS) lupus ii) To be prescribed by Rheumatologists only | Hypersensitivity, infections, immunisations, malignancy | SAPHNELO | Antineoplastic and Immunomodulating Agents > Immunosuppressants | L04AA51-000-P33-01-xxx | No | LP | |||||||||||
98 | 97 | Anti Rhd Immunoglobulin Injection | B | Prevention of Rh(D) sensitisation to Rh(D)-negative woman: i) Pregnancy/delivery of Rh(D)-positive infant ii) Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole iii) Transplacental haemorrhage resulting from antepartum haemorrhage, amniocentesis, chorionic biopsy or obstetric manipulative procedures e.g. external version or abdominal trauma | i) Antenatal prophylaxis: According to general recommendations, currently administered doses range from 50 – 330 micrograms or 250 - 1650 IU. For specific details, please refer to product's package insert. ii) Postnatal prophylaxis: According to general recommendations, currently administered doses range from 100 – 300 micrograms or 500 – 1500 IU. For specific details, please refer to product's package insert. | Pain at injection site. Slight temperature elevation | Rh(D)-positive mother | Live virus vaccines | - | Never administer to infant. IgA deficiency. Hypersensitivity to thiomersal or human Ig | Antiinfectives for Systemic Use > Immune Sera and Immunoglobulins | J06BB01-000-P30-01-XXX | Yes | APPL | ||||||||||||
99 | 98 | Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection | A* | i) To be used when conventional anti-rejection therapy is not successful ii) Treatment of aplastic anaemia not responding to oxymethalone after 3 months, in which there is persistent pancytopenia with repeated attacks of septicaemia and bleeding. iii) Severe aplastic anaemia with the following parameters: a) Granulocyte less than 0.5x109/L b) Platelet less than 20x109/L c) Reticulocyte less than 20x109/L iv) As a conditioning regime prior to transplant. v) Graft-versus-host disease treatment | 10 - 30 mg/kg body weight daily. Slow IV infusion (over at least 4 hours) diluted in 250 - 500 ml Normal Saline. For Graft versus host disease treatment:40 mg/kg/day | Severe and unremitting thrombocytopenia or leucopenia, generalized rash, tachycardia, dyspnoea, hypotension, anaphylaxis. | Hypersensitivity, acute viral illness. | Live vaccines, increased risk of infection. | - | Perform test dose, prophylactic platelet transfusion before and after infusion. Sodium and fluid overload. Monitor for allergic reactions and serum sickness Monitor for signs of leukopenia, thrombocytopenia or concurrent infection. Perform skin testing | Atgam | Antineoplastic and Immunomodulating Agents > Antineoplastic Agents | L04AA03-000-P30-01-XXX | No | Government Contract | |||||||||||
100 | 99 | Antirabies Immunoglobulin Injection | B | Treatment of rabies, post-exposure | Human rabies immunoglobulin: 20 iu/kg; half by IM and half by infiltration around the wound. Equine rabies immunoglobulin: 40iu/kg of body weigth in adults and children. Note: Please refer to package insert for recommendations by the manufacturer. | Minor local reactions, systemic reactions, hypersensitivity reaction, neuropathy | Severe febrile infection, acute disease, progressive chronic disease, hypersensitivity to any of the ingredients of the vaccine | Corticosteroids and immunosuppressant | None | Allergy to neomycin. Prior systemic reaction to human immunoglobulin preparation, isolated immunoglobulin A deficiency | Imogam Rabies | Antiinfectives for Systemic Use > Immune Sera and Immunoglobulins | J06BB05-000-P30-01-XXX | Yes | LP |