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NoGeneric NameCategoryIndicationsDosageAdverse ReactionContraindicationsInteractionsPrescribing RestrictionsPrecautionsBrandFUKKM System/GroupMDCNEMLMethod of Purchase
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12-deoxy-2-[18F] fluoro-D-glucose [18F] FDG InjectionA*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 seizuresThe 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 knownIt 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 onlyPatients 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 RadiopharmaceuticalsV09IX04-000-P30-02-XXXNoLP
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2Abacavir Sulphate 300mg tabletA*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 doseNausea, 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 recommendedHypersensitivity, lactic acidosis/ severe hepatomegaly with steatosis, elevated serum lipids and blood glucose, immune reconstitution syndrome, opportunistic infections, transmission of infection, myocardial infarctionAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AF06-183-T10-01-XXXYesLP
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3Abacavir Sulphate 600mg and Lamivudine 300mg TabletA*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 recommendedHypersensitivity, 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 impairmentCo-trimoxazole, methadone, ribavirinNoneClose 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/minAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AR02-964-T10-01-XXXYesGovernment Contract
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4Abemaciclib 100mg Film Coated TabletsA*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 occursDiarrhoea, 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 Inducersi. 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 onlyDiarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicityYularebAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE50-000-T32-02-xxxNoLP
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5Abemaciclib 150mg Film Coated TabletsA*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 occursDiarrhoea, 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 Inducersi. 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 onlyDiarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicityYularebAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE50-000-T32-03-xxxNoLP
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6Abemaciclib 50mg Film Coated TabletsA*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 occursDiarrhoea, 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 Inducersi. 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 onlyDiarrhoea, neutropenia, Interstitial Lung Disease (ILD)/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicityYularebAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE50-000-T32-01-xxxNoLP
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7Abiraterone Acetate 250mg tabletA*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 dailyPeripheral 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 restrictionsHypertension, 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 interactionZytigaAntineoplastic and Immunomodulating Agents > Endocrine TherapyL02BX03-000-T10-01-XXXYesGovernment Contract
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8Abiraterone Acetate 500 mg TabletA*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 dailyPeripheral 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 restrictionsHypertension, 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 interactionAntineoplastic and Immunomodulating Agents > Endocrine TherapyL02BX03-000-T32-02-xxxYesLP
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9Acalabrutinib 100mg Film Coated TabletA*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 dailyUpper 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 malignancyHypersensitivity 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 wortTo be prescribed by Haematologists onlyHaemorrhage, infections, cytopenias, secondary primary malignancies, and atrial fibrillationAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01EL02-000-T32-01-xxxNoLP
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10Acetazolamide 250mg TabletBReduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma250mg 1-4 times a day, the dosage being titrated according to patient responseNausea, 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 glaucomaHypokalaemia, 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 glaucomaAspirin, cyclosporin, digitalis , digoxin, lithium, phenytoin, quinidine, topiramateNoneCaution 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 aspirinDiamoxSensory Organs > OphthalmologicalsS01EC01-000-T10-01-XXXYesAPPL
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11Acetazolamide 500mg InjectionBReduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucomaAdult : 250-1000mg per 24hours, usually in divided doses for amounts over 250mg dailyNausea, 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 glaucomaHypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivity, Addison's disease, chronic non-congestive angle-closure galucomaAspirin, cyclosporin, digitalis, digoxin, lithium, phenytoin, quinidine, topiramateNoneNot 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, diabetesSensory Organs > OphthalmologicalsS01EC01-000-P40-01-XXXYesLP
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12Acetylcysteine 200mg/ml InjectionA*Antidote for paracetamol poisoningDiluted 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 hourAnaphylactic reactions, urticaria, angioedema, bronchospasm, nausea, vomiting, tachycardia, dizziness, feverHypersensitivity to acetylcysteine products, children under 2 years of ageCarbamazepine : increased risk of subtherapeutic carbamazepine levels. Nitroglycerin : enhanced hypotension and nitroglycerin-induced headache. Penicillin G, tetracycline : loss of antibiotic efficacyNoneAsthma, history of bronchospasm and risk of anaphylactoid reactions and history of peptic ulcerationVarious > All Other Therapeutic ProductsV03AB23-520-P30-01-XXXYesGovernment Contract
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13Acetylsalicylic Acid 100 mg & Glycine 45 mg TabletBi) Prevention of myocardial infarct, stroke, vascular occlusion and deep vein thrombosis. ii) Transient ischaemic attacks1 tablet dailyNausea, vomiting, dyspepsia, GI ulceration, haematemesis, malaena. Occasionally hepatotoxicityBleeding disorders. Hypersensitivity to salicylateAlcohol, dipyridamole, metoclopramide, metoprolol, carbonic anhydrase inhibitors, corticosteroids, coumarin anticoagulants, sulphonylureas, methotrexate, phenytoin, valproic acid, probenecid, sulphinpyrazoneNoneDyspepsia, gastric mucosal lesions, haemorrhagic disorders, gout, intolerant to aspirin, renal or hepatic impairment, asthma and G6PD deficiencyCardiprinBlood and Blood Forming Organs > Antithrombotic AgentsB01AC06-259-T10-01-XXXNoGovernment Contract
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14Acetylsalicylic Acid 150mg Dispersible TabletCInitial 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 stroke150mg to be taken daily. Dose to be individualised. Use in children under 16 years old is not recommendedGastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances; prolonged bleeding time, rhinitis, urticaria and epigastric discomfort; angioedema, salicylism, tinnitus, bronchospasmGastric 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, lactationAcetazolamide, 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 spironolactoneNoneRenal 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, elderlyNervous System > AnalgesicsN02BA01-000-T40-03-XXXYesLP
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15Acetylsalicylic Acid 300 mg Soluble TabletCInitial 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 recommendedGastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances, prolonged bleeding time, rhinitis, urticaria and epigastric discomfort, angioedema, salicylism, tinnitus; bronchospasmGastric 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, lactationAcetazolamide, 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 spironolactoneNoneRenal 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, elderlyNervous System > AnalgesicsN02BA01-000-T40-01-XXXYesAPPL
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16Acetylsalicylic Acid 75mg Dispersible TabletCInitial 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 strokeDose to be individualised. 150mg to be taken daily. Use in children under 16 years old is not recommendedGastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances; prolonged bleeding time, rhinitis, urticaria and epigastric discomfort; angioedema, salicylism, tinnitus; bronchospasmGastric 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, lactationAcetazolamide, 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.NoneRenal 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, elderlyNervous System > AnalgesicsN02BA01-000-T40-02-XXXYesLP
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17Acitretin 10mg CapsuleA*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 therapiesADULT: 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 periodsSymptoms 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.NoneLong-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolismDermatologicals > AntipsoriaticsD05BB02-000-C10-01-XXXNoLP
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18Acitretin 25 mg CapsuleA*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 therapiesADULT: 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 periodsSymptoms 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.NoneLong-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolismDermatologicals > AntipsoriaticsD05BB02-000-C10-02-XXXNoLP
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19Acriflavine 0.1% CreamC+Infected skin, lesions, cuts, abrasions, wounds and burns.Apply undiluted three times daily to the affected part .Hypersensitivity to acriflavine compoundHypersensitivity to acriflavine compound.Not knownNoneProlonged application, may stain skin, hair & fabric.Dermatologicals > Antiseptics and DisinfectantsD08AA03-000-G10-01-xxxYesLP
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20Acriflavine 0.1% LotionC+Infected skin, lesions, cuts, abrasions, wounds and burns.Apply undiluted three times daily to the affected part .Hypersensitivity to acriflavine compoundHypersensitivity to acriflavine compound.Not knownNoneProlonged application, may stain skin, hair & fabric.-Dermatologicals > Antiseptics and DisinfectantsD08AA03-000-L60-01-XXXYesAPPL
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21Actinomycin D (Dactinomycin) 500 mcg/ml InjectionAi) For solid tumours ii) Gestational trophoblastic diseasei) 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 daysMyelosuppression, nausea, vomiting, mucositis, alopecia, rash, radiation recall reactions, hepatitis. Malaise, fatigue, fever, myalgia, gastrointestinal, haematologic and dermatologic effectsPregnancy, lactation, chickenpox and shingles or herpes zoster infection.Live vaccines may result in an increase risk of infection, radiation therapy, possibly reduced absorption of phenytoinNoneAvoid extravasation, severe soft tissue damage. Concomitant radiation therapy may exaggerate dactinomycin toxicityCosmegenAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01DA01-110-P40-01-XXXYesLP
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22Acyclovir (Aciclovir) 200mg TabletA/KKi) Treatment of Herpes simplex & Varicella zoster infections ii) Prophylaxis of Herpes simplex infections in immune-compromised patientsIndication (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 acyclovirIncreased mean half-life & plasma concentration with probenecidNonePatients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactationZoviraxAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AB01-000-T10-01-XXXYesAPPL
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23Acyclovir (Aciclovir) 200mg/5 ml SuspensionA*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 dailySkin rashes, GI effects, fatigue NPRA Safety Alert 1. 6 July 2026 Risk of Acute Generalised Exanthematous Pustulosis (AGEP)Patients known to be hypersensitivity to acyclovirIncreased mean half-life & plasma concentration with probenecidNonePatients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactationZoviraxAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AB01-000-L80-01-XXXYesLP
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24Acyclovir (Aciclovir) 250mg InjectionA*i)Treatment of Herpes simplex & Varicella zoster infections ii)Prophylaxis of Herpes simplex infections in immune-compromised patientsADULT: 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 acyclovirIncreased mean half-life & plasma concentration with probenecidNoneIn patients receiving Zovirax IV at higher doses, specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairmentZoviraxAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AB01-000-P4-001-XXXYesAPPL
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25Acyclovir (Aciclovir) 3% Eye OintmentA*Only for the treatment of herpes simplex keratitisApply 1 cm 5 times daily. Continue for at least 3 days after healingLocal irritation and inflammation reported , vision abnormalitiesHypersensitivity to acyclovirNot knownNoneNot knownZoviraxSensory Organs > OphthalmologicalsS01AD03-000-G51-01-XXXYesLP
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26Acyclovir (Aciclovir) 5% CreamA*Herpes simplex infections of the skin, including initial and recurrent labial and genital herpes simplex infectionsApply every 4 hours for 5 - 10 daysTransient burning or stinging or erythema, mild drying or flaking of the skinHypersensitivity to acyclovir or valacyclovirNot knownNoneApplication to mucous membranes, pregnancy, lactation. Should not be used in the eyesDermatologicals > Antibiotics and Chemotherapeutics for Dermatological UseD06BB03-000-G10-01-XXXNoLP
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27Acyclovir (Aciclovir) 800 mg TabletA/KKi)Treatment of Herpes simplex & Varicella zoster infections ii)Prophylaxis of Herpes simplex infections in immune-compromised patientsIndication (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 acyclovirIncreased mean half-life & plasma concentration with probenecidNonePatients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactationZoviraxAntiinfectives for Systemic Use > Antivirals for Systemic UseJ05AB01-000-T10-02-XXXYesLP
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28Adalimumab 40mg InjectionA*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 therapiesi)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 infectionsHypersensitivity to adalimumab or any component of the formulation, severe infectionAnakinra, abatacept, live vaccine, leflunomide, topical tacrolimus, trastuzumabNoneReactivation 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 & lactationHumira, Amgetiva (biosimilar)Antineoplastic and Immunomodulating Agents > ImmunosuppressantsL04AB04-000-P50-01-XXXYesGovernment Contract
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29Adapalene 0.1% CreamA*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 bedtimeErythema, scaling, dryness, pruritus, burning sensationHypersensitivity to adapalene or any of its componentsMethotrexateNoneAvoid 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 sunlampsDifferinDermatologicals > Anti-acne PreparationsD10AD03-000-G10-01-XXXNoLP
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30Adapalene 0.1% GelA/KKTreatment for acne vulgaris where comedones, papules and pustules predominateApply once daily to the affected areas after washing at bedtimeErythema, scaling, dryness, pruritus, burning sensationHypersensitivity to adapalene or any of its componentsMethotrexateNoneAvoid 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 sunlampsDifferinDermatologicals > Anti-acne PreparationsD10AD03-000-G30-01-XXXNoLP
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31Adenosine 3 mg/ml InjectionBRapid conversion of paroxysmal supraventricular tachycardia to sinus rhythmADULT: 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 bolusFacial 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 tasteBradycardia, 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 actionNoneAvoid 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 anginaAdenocorCardiovascular System > Cardiac TherapyC01EB10-000-P30-01-XXXYesLP
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32Adrenaline Acid Tartrate (Epinephrine) 1 mg/ml InjectionBCardiopulmonary resuscitation1 mg by intravenous injection repeated every 3-5 minutes according to responseHypertension, arrhythmias, nausea, vomiting, headache, shortness of breath, sneezingCardiac 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 stageBeta-blocking,alpha-adrenergic blockers agents,antihistamines,tricyclic antidepressants carvedilol, chlorpromazine, halothane, moclobemide, rocuronium, selegiline, timolol,methyldopa, diuretics, oxytoxic drugsNoneElderly 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 TherapyC01CA24-123-P30-01-XXXYesAPPL
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33Afatinib Dimaleate 30mg Film-Coated TabletA*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.GiotrifAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE13-253-T32-02-XXXYesLP
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34Afatinib Dimaleate 40mg Film-Coated TabletA*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.GiotrifAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE13-253-T32-03-XXXYesLP
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35Aflibercept 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 onlyEndophthalmitis, increase in intraocular pressure. Pregnancy and lactation. NPRA Safety Alert (14 Dec 2016) -Risk of Osteonecrosis of the Jaw (ONJ) in Cancer PatientsEyleaSensory Organs > OphthalmologicalsS01LA05-000-P30-01-XXXNoGovernment Contract
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36Agomelatine 25mg TabletA*Major depressionThe 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), oestrogenSNoneUse 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 > PsychoanalepticsN06AX22-000-T10-01-XXXNoGovernment Contract
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37Albendazole 200mg TabletC+i) Single or mixed infestations of intestinal parasites ii) Strongyloides infectioni)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 daysGastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicityPatients 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.NoneDiscontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesionsZentelAntiparasitic Products, Insecticides and Repellents > AnthelminticsP02CA03-000-T10-01-XXXYesAPPL
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38Albendazole 200mg/5 ml SuspensionC+i) Single or mixed infestations of intestinal parasites ii) Strongyloides infectioni)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 daysGastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicityPatients 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 effectsNoneDiscontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesionsAntiparasitic Products, Insecticides and Repellents > AnthelminticsP02CA03-000-L80-01-XXXYesAPPL
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39Alcohol 70% SolutionC+Use as antiseptic and disinfectantApply to the skin undiluted or when neededMental impairment, gastrointestinal disturbances, severe effects include respiratory depression, coma and deathNot knownChlorpropamide, metronidazole, cefoperazone, cefoperazone/sulbactam and cefotaximeNonePregnancy, nursing mothers, elderly-Dermatologicals > Antiseptics and DisinfectantsD08AX08-000-L99-01-XXXYesLP
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40Alectinib 150mg Hard CapsuleA*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 HypertriglyceridaemiaHypersensitivity to alectinib or to any of the excipientsCYP3A inducers, CYP3A inhibitors, medicinal products that increase gastric pH, substrate of P-gp, BCRP substrates, CYP substratesTo be prescribed by Oncologist onlyInterstitial lung disease (ILD)/pneumonitis, hepatotoxicity, severe myalgia and creatine phosphokinase (CPK) elevation, bradycardia, hemolytic anemia, photosensitivity, women of child-bearing potential, lactose intolerance, sodium contentAlecensaAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XE36-110-C11-01-XXXNoLP
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41Alendronate Sodium 70mg and Cholecalciferol 5600 IU TabletA*i) Osteoporosis in postmenopausal women with a history of vertebral fracture and whom oestrogen replacement therapy is contraindicated ii) Male Osteoporosis1 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.NoneReview 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 lactationFosamax PlusMusculo-skeletal System > Drugs for Treatment of Bone DiseasesM05BB03-972-T10-02-XXXNoGovernment Contract
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42Alendronate Sodium 70mg TabletA*, A/KKKategori preskriber A*: Osteoporosis (Male) Kategori preskriber A/KK: Indicated for the treatment of osteoporosis in high-risk postmenopausal women70 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 breakfastOesophageal reactions, abdominal pain,musculoskeletal pain,headache,diarrhoea,constipationHypersensitivity to alendronate products, hypocalcaemia, esophageal abnormalities, inability to stand or sit upright for 30 minutesConcurrent use with aspirin and mesalamine may result in gastrointestinal distress. Concurrent use with calcium and antacids may result in reduced alendronate absorptionNoneReview 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 therapyFosamaxMusculo-skeletal System > Drugs for Treatment of Bone DiseasesM05BA04-520-T10-01-XXXNoLP
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43Alfacalcidol 0.25mcg CapsuleA/KKi) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalaciaInitial 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/protocolHypercalcaemia-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 consideredHypercalcaemia, 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, phenobarbitoneNonePregnancy, 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-alphaAlimentary Tract and Metabolism > VitaminsA11CC03-000-C10-01-XXXNoAPPL
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44Alfacalcidol 1mcg CapsuleA/KKi) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalaciaInitial 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/protocolHypercalcaemia-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 consideredHypercalcaemia, 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,NonePregnancy, 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-alphaAlimentary Tract and Metabolism > VitaminsA11CC03-000-C10-02-XXXNoLP
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45Alfacalcidol 2 mcg/ml InjectionA*i) Chronic kidney disease mineral bone disorder ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalaciaInitial 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/protocolHypercalcaemia, nausea, vomiting, polydipsia, polyuriaHypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol productsAntiepileptics, diuretics, barbituratesNoneTake care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration.One-AlphaAlimentary Tract and Metabolism > VitaminsA11CC03-000-P30-01-XXXNoLP
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46Alfacalcidol 2mcg/ml DropsA*i) Neonatal hypocalcemia ii) Osteoporosis iii) Hypoparathyroidism and pseudohypoparathyroidism iv) Rickets and osteomalaciaNEONATES : 0.1 mcg/kg/day Dosing is individualised based on serum calcium level and according to product insert/protocolHypercalcaemia-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 consideredHypercalcaemia, 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.NoneTake care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titrationOne-AlphaAlimentary Tract and Metabolism > VitaminsA11CC03-000-D50-01-XXXNoLP
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47Alfentanil HCl 0.5 mg/ml InjectionA*For use as short acting narcotic analgesic in short procedures and day-care surgical proceduresInitial dose: 20 - 40 mcg/kg. Supplemental dose: 15 mcg/kg or infusion 0.5 - 1.0 mcg/kg/minTacycardia, bradyarrhythmia, cardiac dysrhythmia, hypertension, hypotension, respiratory depression, apnoea, muscular rigidity, dizziness, nausea, CNS disturbances, vomiting and constipationHypersensitivity 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 raisedDiltiazem, 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 depressantsNoneContinuous 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 machineryRapifenNervous System > AnestheticsN01AH02-110-P30-01-XXXNoLP
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48Alfuzosin HCl 10mg TabletA*Treatment of functional symptoms related with benign prostatic hypertrophy (BPH)10 mg once a day pre bedGastrointestinal disturbances, vertigo, malaise, dizziness, headache. Rarely orthostatic hypotension, syncope, tachycardia, palpitations, chest pain, asthenia, drowsiness, oedema, flushing, dry mouth, rash, pruritisOrthostatic 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 inhibitorsNoneElderly, coronary insufficiency, discontinue in the event of recurrence or exacerbation of angina, may impair ability to drive or operate machineryXatral XLGenito Urinary System and Sex Hormones > UrologicalsG04CA01-110-T10-01-XXXNoGovernment Contract
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49Alglucosidase alfa 5 mg/ml InjectionA*Infantile-onset Pompe disease20 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.UnknownNonePatients with an acute underlying illness, immunogenicity, pregnancy, nursing mothersAlimentary Tract and Metabolism > Other Alimentary Tract and Metabolism ProductsA16AB07-000-P40-01-XXXNoLP
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50Alkaline Nasal DoucheBTo remove nasal plugTo be diluted with an equal volume of warm water before useExcessive use can be toxic due to its absorptionNot knownNot knownNoneEpistaxis, not to be used in cranial surgery or trans nasal neuro surgical procedureRespiratory System > Nasal PreparationsR01A000-999-L50-01-XXXNoLP
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51Allopurinol 100 mg TabletA/KKi) 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 leukaemiaInitial 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 functionHypersensitivity to allopurinol, pregnancy, lactation, acute gout, asymptomatic hyperuricaemiaOral 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 pregnancyZyloricMusculo-skeletal System > Antigout PreparationsM04AA01-000-T10-02-XXXYesLP
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52Allopurinol 300 mg TabletA/KKi) 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 leukaemiaInitial 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 functionHypersensitivity to allopurinol, pregnancy, lactation, acute gout, asymptomatic hyperuricaemiaOral 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 pregnancyZyloricMusculo-skeletal System > Antigout PreparationsM04AA01-000-T10-01XXXYesAPPL
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53All-Trans Retinoic Acid (Tretinoin) 10 mg CapsuleA*Acute promyelocytic leukaemiaInduction: 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 protocolsHeadache, 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 cholesterolHypersensitivity to retinoids, pregnancy and lactationConcurrent 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 thrombosisNoneAvoid 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 syndromeVesanoidAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL01XX14-000-C10-01-XXXYesLP
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54Alprazolam 0.25mg TabletA/KKAnxiety disorders0.25 - 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 childrenDrowsiness, 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, sedationHypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depressionKetoconazole, 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.NoneAvoid 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 dependenceXanaxNervous System > PsycholepticsN05BA12-000-T10-01-XXXNoLP
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55Alprazolam 0.5mg TabletAAnxiety disorders0.25 - 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 childrenDrowsiness, 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, sedationHypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depressionKetoconazole, 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.NoneAvoid 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 dependenceXanaxNervous System > PsycholepticsN05BA12-000-T10-02-XXXNoLP
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56Alprazolam 1mg TabletAAnxiety disorders0.25 - 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 childrenDrowsiness, 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, sedationHypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depressionKetoconazole, 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.NoneAvoid 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 dependenceXanaxNervous System > PsycholepticsN05BA12-000-T10-03-XXXNoLP
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57Alprostadil 500 mcg/ml InjectionA*For treatment of congenital heart diseases which are ductus arteriosus dependent0.05 - 0.1 mcg/kg/min by continuous IV infusion, then decreased to lowest effective doseBradycardia, fever, hypotension, tachycardia, neonatal apnoea, seizuresNeonates with respiratory distress syndromeHeparinNoneConcurrent anticoagulants, neonates with bleeding tendencies, spinal cord injuryProstin VRCardiovascular System > Cardiac TherapyC01EA01-000-P30-01-XXXNoGovernment Contract
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58Alteplase 50 mg per vial InjectionA*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 AgentsB01AD02-000-P40-01-XXXYesGovernment Contract
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59Amantadine HCl 100mg CapsuleBParkinson's diseaseInitial 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 dayOedema 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 disturbancesHypersensitivity to amantadine products, pregnancy, lactation, epilepsy, history of gastric ulceration, severe renal impairmentAlcohol, methyldopa, metoclopramide, domperidone, antipsychotic, antimuscarinics. Enhances the adverse effects of antimuscarinics and levodopa. Central nervous system stimulants, drugs that raise urinary pHNoneSeizure disorder, psychiatry disorder, recurrent eczema, gastric ulceration. Patients with cardiovascular or liver disease, impaired renal function. Elderly. Withdrawal of the drug should be gradualSymmetrelNervous System > Anti-parkinson DrugsN04BB01-110-C10-01-XXXNoLP
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60Amikacin 125 mg/ml InjectionAInfections due to susceptible organismsADULT: (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/dayOtotoxicity, 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 blockersNoneRenal 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.AmikinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01GB06-183-P30-03-XXXYesAPPL
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61Amikacin 250mg/ml InjectionAInfections due to susceptible organismsADULT: (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/dayOtotoxicity, 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 blockersNoneRenal 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.AmikinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01GB06-183-P30-02-XXXYesAPPL
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62Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg TabletBi) Diuretic as an adjunct to the management of oedematous states ii) Hypertensioni) Initially 1 - 2 tab daily adjusted according to response. Max : 4 tabs daily. ii) 1 -2 tabs daily as a single or divided doseHeadache, 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.NoneDiabetes 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 TabletCardiovascular System > DiureticsC03EA01-900-T10-01-XXXNoAPPL
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63Amino Acids & Glucose with Electrolytes InjectionASource of amino acids, carbohydrate and electrolytes in patients needing IV nutritionDose to be individualised. ADULT usual requirement for amino acid 1-2 g/kg/day, carbohydrate 4-6 g/kg/dayHyperammonemia, encephalopathy, cholestasis, thrombophlebitisPatients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysisNot knownNoneLiver disease, renal impairmentBlood and Blood Forming Organs > Blood Substitutes and Perfusion SolutionsB05BA10-910-P30-03-XXXNoLP
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64Amino Acids InjectionASource of amino acids in patients needing IV nutritionDose to be individualised. ADULT usually 500-2000 ml by IV. ADULT usual requirement for amino acid: 1-2 g/kg/dayGastrointestinal upset, flushing, sweating, thrombophlebitisPatients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysisNot knownNoneLiver disease, renal impairmentBlood and Blood Forming Organs > Blood Substitutes and Perfusion SolutionsB05BA01-910-P30-01-XXXNoAPPL
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65Amino Acids with Electrolytes InjectionASource of amino acids and electrolytes in patients needing IV nutritionDose to be individualised. ADULT usual requirement for amino acid 1-2 g/kg/dayGastrointestinal upset, flushing, sweating, thrombophlebitisPatients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysisNot knownNoneLiver disease, renal impairment-Blood and Blood Forming Organs > Blood Substitutes and Perfusion SolutionsB05BA10-910-P30-02-XXXNoLP
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66Amino Acids, Glucose and Lipid with Electrolytes InjectionASource of amino acids, carbohydrate, lipid and electrolytes in patients needing IV nutritionDose 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/dayGastrointestinal upset, flushing, sweating, thrombophlebitisPatients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysisNot knownNoneLiver disease, renal impairment-Blood and Blood Forming Organs > Blood Substitutes and Perfusion SolutionsB05BA10-910-P30-01-XXXNoLP
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67Amino Acids, Glucose and Lipid without Electrolytes InjectionASource 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, thrombophlebitisPatients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysisNot knownNoneLiver disease, renal impairment-Blood and Blood Forming Organs > Blood Substitutes and Perfusion SolutionsB05BA10-910-P30-04-XXXNoLP
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68Aminophylline 25mg/ml InjectionBReversible airways obstruction, acute severe brochospasmAdult: 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 dermatitisHypersensitivity to theophylline or derivatives, hypersensitivity to ethylenediamineAzole antifungals, ciprofloxacin, clarithromycin, erythromycin : increased risk of theophylline toxicity. Caffeine : increased caffeine level. Halothane : increased risk of arrthmiaNoneShould 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 DiseasesR03DA05-000-P30-01-XXXYesAPPL
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69Amiodarone 200 mg TabletA*Arrhythmias200 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 TransplantationCardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunctionAntiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetics, ciclosporinNoneAcute 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 TransplantationCardiovascular System > Cardiac TherapyC01BD01-110-T10-01-XXXYesLP
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70Amiodarone 50 mg/ml InjectionA*, A/KKCategory 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 TransplantationCardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunctionAntiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetic, ciclosporinCategory 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 TransplantationCardiovascular System > Cardiac TherapyC01BD01-110-P30-01-XXXYesLP
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71Amisulpride 100mg TabletA*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 predominatePredominantly 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 gainHypersensitivity to amisulpride, pheochromocytoma, prolactinomas and breast cancer, pregnancy, lactation, children under 15 years of ageAmiodarone; 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)NoneRenal 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 pressureSolianNervous System > PsycholepticsN05AL05-000-T10-01-XXXNoGovernment Contract
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72Amisulpride 400mg TabletA*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 predominatePredominantly 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 gainHypersensitivity to amisulpride, pheochromocytoma, prolactinomas and breast cancer, pregnancy, lactation, children under 15 years of ageAmiodarone; 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)NoneRenal 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 pressureSolianNervous System > PsycholepticsN05AL05-000-T10-02-XXXNoGovernment Contract
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73Amitriptyline HCl 25 mg TabletBi) Depression ii) Nocturnal enuresis where organic pathology has been excludedi) 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 depressionHypersensitivity to drug/class. Immediate recovery phase after myocardial infarction, heart block, mania. MAOI use within the last 14 daysBarbiturate, 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, clonidineNoneCardiac 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, anaesthesiaLaroxylNervous System > PsychoanalepticsN06AA09-110-T10-01-XXXYesLP
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74Amlodipine 10 mg and Valsartan 160 mg TabletA/KKEssential hypertension in patients whose blood pressure is not adequately controlled by monotherapyDoses 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 mgNasopharyngitis, 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 AngioedemaPregnancy and lactation, hypersensitivity to amlodipine, valsartan, or any component of the productPotassium supplement. Potassium-sparing diuretic, potassium containing salt substitutes or other drugs that may increase potassium levelNoneRisk 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 AngioedemaExforgeCardiovascular System > Agents Acting on the Renin-angiotensin SystemC09DB01-935-T10-03-XXXNoLP
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75Amlodipine 10 mg TabletBHypertension5 mg once daily. Max: 10 mg once dailyHeadache, dizziness, gingival hyperplasia, tachycardia, peripheral oedemaHypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failureCyclosporin, sildenafil, vardenafil, CYP3A4 inducers, CYP3A4 inducers(fluconazole, itraconazole, ketoconazole)NoneAngina (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 TabletCardiovascular System > Calcium Channel BlockersC08CA01-000-T10-02-XXXYesAPPL
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76Amlodipine 5 mg and Valsartan 160 mg TabletA/KKEssential hypertension in patients whose blood pressure is not adequately controlled by monotherapyDoses 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 mgNasopharyngitis, 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 AngioedemaPregnancy and lactation, hypersensitivity to amlodipine, valsartan or any component of the productPotassium Supplement. Potassium-sparing diuretic, potassium containing salt substitutes or other drugs that may increase potassium levelNoneRisk 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 AngioedemaExforgeCardiovascular System > Agents Acting on the Renin-angiotensin SystemC09DB01-935-T10-02-XXXNoLP
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77Amlodipine 5 mg TabletBHypertension5 mg once daily. Max: 10 mg once dailyHeadache, dizziness, gingival hyperplasia, tachycardia, peripheral oedemaHypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failureCyclosporin, sildenafil, vardenafil, CYP3A4 inducers, CYP3A4 inducers(fluconazole, itraconazole, ketoconazole).NoneAngina (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 TabletCardiovascular System > Calcium Channel BlockersC08CA01-000-T10-01-XXXYesAPPL
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78Amorolfine 5% Nail LacquerA*Fungal nail infectionsApply 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 sensationHypersensitivity to amorolfineNot knownNoneAvoid contact with eyes, previous hypersensitivity or intolerance to other topical antifungal agentsLocerylDermatologicals > Antifungals for Dermatological UseD01AE16-110-L50-01-XXXNoLP
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79Amoxicillin (Amoxycillin) & Clavulanate 228 mg/5 ml SyrupA/KKInfections caused by susceptible organismsMild 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 doseDiarrhoea, pseudomembraneous colitis, indigestion, GI upsets, increased liver enzymeHypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunctionAminoglycosides, anticoagulants, probenecid, allopurinol, oral contraceptiveNoneCaution 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 MeningitisAugmentinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR02-961-F21-02-XXXYesLP
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80Amoxicillin (Amoxycillin) 1g & Clavulanate 200mg InjectionA, A/KKPrescriber 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 facilityCHILD 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 hourlyDiarrhoea, pseudomembraneous colitis, GI upsets, increased liver enzyme, urticaria and erythematous multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemiaHypersensitivity to penicillins, possible cross sensitivity with other ‚-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunctionAminoglycosides, anti-coagulants, oral contraceptives, methotrexateIndication (i): No prescribing restriction Indication (ii): Administered as a single stat dose prior to hospital transferPregnancy, breast-feeding, renal or liver failure, pseudomembranous colitis NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic MeningitisAugmentinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR02-961-P40-02-XXXYesGovernment Contract
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81Amoxicillin (Amoxycillin) 250mg CapsuleBInfections caused by susceptible strains of gram positive and gram negative organismsADULT: 250 - 500 mg 3 times daily. CHILD: 20 - 40 mg/kg/day in divided doses 8 hourlyDiarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundiceHypersensitivity to penicillinsAminoglycosides, oral contraceptivesNoneHypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic MeningitisAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CA04-012-C10-01-XXXYesAPPL
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82Amoxicillin (Amoxycillin) 250mg/5mL Oral SolutionBInfections caused by susceptible strains of gram positive and gram negative organismsCHILD less than 10 years: 125 - 250 mg 8 hourly. CHILD less than 20 kg: 20 - 40 mg/kg/day in 3 - 4 divided dosesDiarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundiceHypersensitivity to penicillinsAminoglycosides, oral contraceptivesNoneHypersensitivity 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 UseJ01CA04-012-L80-01-XXXYesLP
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83Amoxicillin (Amoxycillin) 500mg & Clavulanate 125mg TabletA/KKInfections 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 disturbancesHypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillin-associated cholestatic jaundice/hepatic dysfunctionAminoglycosides, anticoagulants, probenecid, allopurinol, oral contraceptive.NoneRenal or hepatic impairment. Patients on anticoagulation therapy. Prolonged use. Pregnancy. NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic MeningitisAugmentinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR02-961-T10-02-XXXYesAPPL
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84Amoxicillin (Amoxycillin) 500mg and Clavulanate 100mg InjectionAInfections caused by susceptible organisms. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection and osteomyelitisCHILD 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 hourlyDiarrhoea, pseudomembraneous colitis, gastrointestinal upsets, increased liver enzyme, urticaria and erythematous multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemiaHypersensitivity to penicillins, possible cross sensitivity with other beta-lactams. History of penicillin-associated cholestatic jaundice or hepatic dysfunctionAminoglycosides, anti-coagulants, oral contraceptives, methotrexateNonePregnancy, breast-feeding, renal or liver failure, pseudomembranous colitis NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic MeningitisAugmentinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR02-961-P40-01-XXXYesLP
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85Amoxicillin (Amoxycillin) 500mg CapsuleBInfections caused by susceptible strains of gram positive and gram negative organismsADULT: 250 - 500 mg 3 times daily. CHILD: 20 - 40 mg/kg/day in divided doses 8 hourlyDiarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundiceHypersensitivity to penicillinsAminoglycosides, oral contraceptivesNoneHypersensitivity to cephalosporins, renal or hepatic impairment, superinfection NPRA Safety Alert 1. 29 May 2024 Risk of Aseptic MeningitisAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CA04-012-C10-02-XXXYesLP
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86Amoxicillin (Amoxycillin) Trihydrate 125 mg/5 ml SyrupBInfections caused by susceptible strains of gram positive and gram negative organismsCHILD less than 10 years: 125 - 250 mg 8 hourly. CHILD less than 20 kg: 20 - 40 mg/kg/day in 3 - 4 divided dosesDiarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundiceHypersensitivity to penicillinsAminoglycosides, oral contraceptivesNoneHypersensitivity 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 UseJ01CA04-012-F10-01-XXXYesAPPL
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87Amphotericin B 50 mg Injection (Conventional)ASystemic fungal infectionsADULT: 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 recommendedFever, headache, anorexia, weight loss, GI disturbances, malaise, epigastric pain, dyspepsia, generalized pain, anaemia, abnormal renal function. Rarely cardiovascular toxicity, haematologic reactions, neurologic reactions, liver failureHypersensitivityCorticosteroids, nephrotoxic antibiotics and antineoplasticsNoneAvoid rapid infusion, renal impairment. Hepatic & renal function tests, blood count & plasma electrolyte monitoring are required. Pregnancy, lactationAntiinfectives for Systemic Use > Antimycotics for Systemic UseJ02AA01-801-P40-01-XXXYesAPPL
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88Ampicillin Sodium & Sulbactam Sodium 250 mg/5 ml SuspensionATreatment of susceptible bacterial infectionsADULT: 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 superinfectionHistory of allergic reaction to any penicillinsIf applied concomitantly, probenecid may reduce the distribution and diffusion of ampicillin Allopurinol run a higher risk of developing rashes.NoneOvergrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapyUnasyn Susp.Antiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR01-961-F21-01-XXXNoLP
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89Ampicillin Sodium & Sulbactam Sodium 375 mg TabletA/KKTreatment of susceptible bacterial infectionsADULT: 375-750mg twice daily CHILDREN AND INFANTS: 25-50mg/kg/day in 2 divided doses, if ≥ 30kg use an adult doseGI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfectionHistory of allergic reaction to any penicillinsAllopurinol, Anticoagulants, Bacteriostatic drugs, Estrogen-containing oral contraceptives, Methotrexate, ProbenecidNoneOvergrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapyUnasynAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR01-961-T10-01-XXXNoGovernment Contract
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90Ampicillin Sodium 1g & Sulbactam Sodium 500mg InjectionATreatment of susceptible bacterial infectionsADULT: 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 hourBlood 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 penicillinsAlloprinol, Aminoglycosides, Bacteriostatic drugs (Cloramphenicol, erythromycin, sulphonamides and tetracyclines), Mthotrexate, ProbenecidNoneOvergrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapyUnasyn 1.5gAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR01-961-P40-02-XXXNoGovernment Contract
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91Ampicillin Sodium 500 mg InjectionBTreatment of susceptible bacterial infections (non beta-lactamase-producing organisms); meningitis250 - 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 doseGI disturbances, skin rashes, pruritis, urticartia, fever, anaphylaxis, blood disorders, superinfectionHypersensitivity to penicillinsExcretion impaired by probenecid. Increased risk of skin rashes with allopurinol. May decrease effectiveness of oral contraceptives and atenololNoneHypersensitivity to cephalosporins. Chronic treatment requires assessment of renal, hepatic& haematopoietic functions. Renal impairment, lymphatic leukaemiaPenbritinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CA01-520-P40-01-XXXYesAPPL
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92Ampicillin Sodium 500mg & Sulbactam Sodium 250mg InjectionATreatment of susceptible bacterial infectionsADULT: 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 hourlyGI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfectionHistory of allergic reaction to any penicillinsConcurrent use with oral contraceptives may result in decreased contraceptive effectivenessNoneOvergrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapyUnasyn 750 mgAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CR01-961-P40-01-XXXNoLP
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93Ampicillin Trihydrate 125 mg/5 ml SuspensionBTreatment 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 dailyDiarrhoea, indigestion, nausea, vomiting, occasionally rashesHypersensitivity to penicillinsBacteriostatic drugs, anticoagulantsNoneHypersensitivity to cephalosporins. Severe renal dysfunction, hepatic and hematolgic system.PenbritinAntiinfectives for Systemic Use > Antibacterials for Systemic UseJ01CA01-012-F21-01-XXXYesLP
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94Anastrozole 1 mg TabletA*Hormonal therapy in breast cancer in post-menopausal women if failed /contraindicated with Tamoxifen1 mg dailyHot flashes, asthenia, peripheral oedema, vaginal bleeding, deep vein thrombosis, arthralgia, backpain, cough, dypsnea, headache, nausea, rash, hypercholesterolaemia NPRA Safety Alert 1. 29 Nov 2021 - DepressionHypersensitivity 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 densityArimidexAntineoplastic and Immunomodulating Agents > Endocrine TherapyL02BG03-000-T10-01-XXXYesLP
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95Anidulafungin 100mg InjectionA*Treatment of invasive candidiasis, including candidemia in adults when intolerance or resistance to Amphotericin B or FluconazoleLoading 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, pruritusHypersensitivity to anidulofungin or other antifungals of echinocandin class eg caspofunginCiclosporine; Anidulafungin steady state AUC may be slightly increased. No dosage adjustment is needed. Antifungal agents: Antifungal agents may diminish the therapeutic effectNoneInsufficiently 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.EraxisÆAntiinfectives for Systemic Use > Antimycotics for Systemic UseJ02AX06-000-P30-01-XXXYesGovernment Contract
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96Anifrolumab 300mg/2ml Concentrate for Solution for InfusionA*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 reactionHypersensitivity to the active substance or to any of the excipientsNo 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 onlyHypersensitivity, infections, immunisations, malignancySAPHNELOAntineoplastic and Immunomodulating Agents > ImmunosuppressantsL04AA51-000-P33-01-xxxNoLP
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97Anti Rhd Immunoglobulin InjectionBPrevention 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 traumai) 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 elevationRh(D)-positive motherLive virus vaccines-Never administer to infant. IgA deficiency. Hypersensitivity to thiomersal or human IgAntiinfectives for Systemic Use > Immune Sera and ImmunoglobulinsJ06BB01-000-P30-01-XXXYesAPPL
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98Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) InjectionA*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 treatment10 - 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/daySevere 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 testingAtgamAntineoplastic and Immunomodulating Agents > Antineoplastic AgentsL04AA03-000-P30-01-XXXNoGovernment Contract
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99Antirabies Immunoglobulin InjectionBTreatment of rabies, post-exposureHuman 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, neuropathySevere febrile infection, acute disease, progressive chronic disease, hypersensitivity to any of the ingredients of the vaccineCorticosteroids and immunosuppressantNoneAllergy to neomycin. Prior systemic reaction to human immunoglobulin preparation, isolated immunoglobulin A deficiencyImogam RabiesAntiinfectives for Systemic Use > Immune Sera and ImmunoglobulinsJ06BB05-000-P30-01-XXXYesLP