Lipitor^®

Abbreviated Prescribing Information¹

Presentation: Lipitor^® (Crystalline Atorvastatin) film-coated tablets are available in blister tabs: 10 mg × 30’s, 20 mg × 30’s, 40 mg × 30’s and 80 mg × 30’s. Indications: Lipitor^® (Crystalline Atorvastatin) is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides to increase HDL-cholesterol in patients with primary hypercholesterolaemia (heterozygous familial and non-familial hypercholesterolaemia), combined (mixed) hyperlipidaemia (Fredrickson types lla and llb), elevated serum triglyceride levels (Fredrickson type IV) and for patients with dysbetalipoproteinaemia (Fredrickson type lll) who do not respond adequately to diet. Reduction of total and LDL-cholesterol in patients with homozygous familial hypercholesterolaemia. Reduction of total and LDL-cholesterol and apolipoprotein B levels in boys and postmenarchal girls, 10–17 yrs, with heterozygous familial hypercholesterolemia when after adequate diet therapy, LDL-cholesterol remains ≥190 mg/dL or ≥160 mg/dL and there is a positive family history of premature CV disease or two or more other CV disease risk factors. For prevention of CV disease without clinically evident coronary heart disease but with multiple risk factors, e.g. age, smoking, HTN, low HDL-C or family history of early coronary heart disease, Lipitor^® is indicated to reduce the risk of MI, stroke, revascularisation procedures and angina. In type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors, e.g. retinopathy, albuminuria, smoking or HTN, Lipitor^® is indicated to reduce the risk of MI and stroke. In patients with clinically evident CHD, Lipitor^® is indicated to reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularisation procedures, hospitalisation for CHF and angina. Dosing: Dose range: 10–80 mg once daily. Doses may be given any time of the day with or without food. Starting and maintenance doses should be individualised according to baseline LDL-cholesterol levels, the goal of therapy and patient response. Contraindications: Hypersensitivity to any component of this medication, active liver disease or elevated serum transaminases >3 times the upper limit of normal. Pregnancy, lactation or of childbearing potential who are not on adequate contraceptive measures. Special precautions: Hepatic effects and skeletal muscle effects, including immune-mediated necrotizing myopathy (IMNM); monitor for creatine phosphokinase and transaminases elevations; haemorrhagic stroke; endocrine dysfunction. Concurrent administration of fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, HIV/HCV protease inhibitors, HCV NS5A/NS5B inhibitors, letermovir or lipid-modifying doses of niacin (≥1 g/day); lowest dose necessary of atorvastatin should be employed. The concurrent use of atorvastatin and fusidic acid is not recommended. Avoid alcohol consumption. Statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. Atorvastatin should be discontinued in case of aggravation of symptoms. Adverse reactions: Nasopharyngitis, hyperglycaemia, pharyngolaryngeal pain, epistaxis, diarrhoea, dyspepsia, nausea, flatulence, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling, abnormal liver function test, increased blood creatine phosphokinase, myasthenia gravis, ocular myasthenia, IMNM.

API-LIPITOR-1223

Full prescribing information is available upon request.

Reference: 1. Malaysia Lipitor^® Prescribing Information dated 20 December 2023.

Market Authorization Holder:
Viatris Sdn. Bhd.
Reg. No: 201801018158 (1280174-H)
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Uptown, 47400 Petaling Jaya, Selangor, Malaysia. Tel: 603-7733 8005

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