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LIPITOR Atorvastatin Calcium Tablets Dosage And Administration

Dosage And Administration

Patients should be placed on a standard cholesterol-lowering diet before receiving LIPITOR, and should continue on this diet during treatment with LIPITOR. If appropriate, a program of weight control and physical exercise should be implemented.

Prior to initiating therapy with LIPITOR, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed.

Primary Hypercholesterolemia and Combined (Mixed) Dyslipidemia, Including Familial Combined Hyperlipidemia

The recommended starting dose of LIPITOR is 10 or 20 mg once daily, depending on patient’s LDL-C reduction required. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. Doses can be given at any time of the day with or without food, and should preferably be given in the evening. A significant therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 2-4 weeks. The response is maintained during chronic therapy. Adjustments of dosage, if necessary, should be made at intervals of 2 to 4 weeks. The maximum dose is 80 mg/day.

The dosage of LIPITOR should be individualized according the baseline LDL-C, total-C/HDL-C ratio and/or TG levels to achieve the recommended desired lipid values at the lowest dose needed to achieve LDL-C desired level. Lipid levels should be monitored periodically and, if necessary, the dose of LIPITOR adjusted based on desired lipid levels recommended by guidelines.

Severe Dyslipidemias

In patients with severe dyslipidemias, including homozygous and heterozygous familial hypercholesterolemia and dysbetalipoproteinemia (Type III), higher dosages (up to 80 mg/day) may be required (see WARNINGS AND PRECAUTIONS, Pharmacokinetic Interactions, Muscle Effects; DRUG INTERACTIONS).

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age)

In this population, the recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg/day have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy (see INDICATIONS AND CLINICAL USE and PHARMACOLOGY, Clinical Studies). Adjustments should be made at intervals of 4 weeks or more.

Prevention of Cardiovascular Disease

Clinical trials conducted that evaluated atorvastatin in the primary prevention of myocardial infarction used a dose of 10 mg atorvastatin once daily.

For secondary prevention of myocardial infarction, optimal dosing may range from 10 mg to 80 mg atorvastatin once daily, to be given at the discretion of the prescriber, taking into account the expected benefit and safety considerations relevant to the patient to be treated.

Concomitant Therapy

See DRUG INTERACTIONS.

Dosage in Patients with Renal Insufficiency

(See WARNINGS AND PRECAUTIONS)

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