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Lipitor (Atorvastatin) is an oral drug that lowers the level of cholesterol in the blood.
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| Therapeutic indications |  |
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Hypercholesterolaemia: Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults and children aged 10 years and older with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia when response to diet and other nonpharmacological measures is inadequate. Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios. Lipitor is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol, LDL-cholesterol, and apolipoprotein B in patients with homozygous familial hypercholesterolaemia when response to these measures is inadequate.
Primary prevention in type II diabetes: Lipitor is indicated for reducing the risk of cardiovascular events in diabetic patients with at least 1 additional risk factor, without clinically evident coronary heart disease irrespective of whether cholesterol is raised. See section 5.1.
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| 4.2 Posology and method of administration | |
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The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor. The usual starting dose is 10 mg once a day. Doses should be individualised according to baseline LDL  C
levels, the goal of therapy, and patient response. Adjustment of dosage
should be made at intervals of 4 weeks or more. The maximum dose is 80
mg once a day. For patients taking interacting drugs that increase plasma exposure to atorvastatin, the starting dose should be 10 mg once a day, and a maximum dose of less than 80mg may need to be considered. In some cases a dose reduction, or where not practical, a temporary dose suspension may be considered (see Sections 4.4 and 4.5). Doses above 20mg/day have not been investigated in patients aged <18 years. Doses may be given at any time of day with or without food.
Primary Hypercholesterolaemia and Combined (Mixed) Hyperlipidaemia Adults: The majority of patients are controlled with 10 mg Lipitor once a day. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy. Current consensus guidelines should be consulted to establish treatment goals for individual patients.
Children aged 10-17 years: Doses above 20mg/day have not been investigated.
Heterozygous Familial Hypercholesterolaemia Adults: Patients should be started with Lipitor 10 mg daily. Doses should be individualised and adjusted every 4 weeks to 40 mg daily. Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant (eg, colestipol) may be combined with 40 mg Lipitor.
Children aged 10-17 years: Doses above 20mg/day and combination therapies have not been investigated.
Homozygous Familial Hypercholesterolaemia Adults: In a compassionate-use study of patients with homozygous familial hypercholesterolaemia, most patients responded to a dose of 80 mg of Lipitor (see Section 5.1 Pharmacodynamics). Children: Treatment experience in a paediatric population with doses of Lipitor up to 80 mg/day is limited.
Dosage in Patients With Renal Insufficiency Renal disease has no influence on the plasma concentrations nor lipid effects of Lipitor; thus, no adjustment of dose is required.
Dosage in Patients With Hepatic Dysfunction In patients with moderate to severe hepatic dysfunction, the therapeutic response to Lipitor is unaffected but exposure to the drug is greatly increased. Cmax increases by approximately 16 fold and AUC (0-24) by approximately 11 fold. Therefore, caution should be exercised in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Geriatric Use Adequate treatment experience in adults age 70 or older with doses of Lipitor up to 80 mg/day has been obtained. Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.
Prevention of Cardiovascular disease In the primary prevention trials, the dose was 10mg/day (see section 5.1 for the lipid levels where this dose was found to be effective, patients with higher levels will require conventional measurement and dose titration). |
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