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Lipitor

Crystalline Atorvastatin Calcium


1. TRADE NAME(S) OF THE MEDICINAL PRODUCT

LIPITOR


2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: crystalline atorvastatin
The tablets for oral administration contain crystalline atorvastatin calcium equivalent to 10, 20, 40, or 80 mg atorvastatin.


3. PHARMACEUTICAL FORM
Atorvastatin tablets for oral administration contain 10, 20, 40 or 80 mg crystalline atorvastatin.
10mg: White, elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other side.
20mg: White, elliptical, film-coated tablets debossed "20" on one side and "PD 156" on the other side.
40mg: White, elliptical, film-coated tablets debossed "40" on one side and "PD 157" on the other side.
80mg: White, elliptical, film-coated tablets debossed "80" on one side and "PD 158" on the other side.


4. CLINICAL PARTICULARS
4.1 Therapeutic Indications

Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum triglyceride levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.


Atorvastatin is also indicated for the reduction of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia.

 

Prevention of Cardiovascular Disease
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina


In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke


In patients with clinically evident coronary heart disease, atorvastatin is indicated to:

- reduce the risk of non-fatal myocardial infarction,
- reduce the risk of fatal and non-fatal stroke,
- reduce the risk for revascularization procedures,
- reduce the risk of hospitalization for CHF,
- reduce the risk of angina.
(See Section 5.1 Pharmacodynamic Properties)


Pediatric Patients (10-17 years of age)
Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
a. LDL-C remains ≥ 190 mg/dL or
b. LDL-C remains ≥ 160 mg/dL and:
  there is a positive family history of premature cardiovascular disease or
  two or more other CVD risk factors are present in the pediatric patient

 

4.2 Posology and method of administration
General - Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients, and to treat underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with atorvastatin. The dosage range is 10 to 80 mg once daily. Doses may be given any time of the day, with or without food. Starting and maintenance dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly.


Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia - The majority of patients are controlled with 10 mg atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.


Homozygous Familial Hypercholesterolemia - In a compassionate-use study of patients with homozygous familial hypercholesterolemia, most patients responded to 80 mg of atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).


Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age) - The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy (see section 4.1 Therapeutic indications, and section 5.1 Pharmacodynamic properties). Adjustments should be made at intervals of 4 weeks or more.


Use in Patients with Hepatic Insufficiency - (See section 4.3 Contraindications and section 4.4 Special warnings and precautions for use).

 

Use in Patients with Renal Insufficiency - Renal disease has no influence on the plasma concentrations or on the LDL-C reduction with atorvastatin. Thus, no adjustment of the dose is required. (see section 4.4 Special warnings and precautions for use).


Use in the Elderly - No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population (see section 5.2 Pharmacokinetic properties: Special Populations).


Use in Combination with Other Medicinal Compounds - In cases where co-administration of atorvastatin with cyclosporine is necessary, the dose of atorvastatin should not exceed 10 mg (see section 4.4 Special warnings and precautions for use-Skeletal Muscle Effects and section 4.5 Interaction with other medicinal products and other forms of interaction - Transporter Inhibitors).


Use in Children (Homozygous Familial Hypercholesterolemia) - Treatment experience in a pediatric population is limited to doses of atorvastatin up to 80mg/day for one year in 8 patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients.


4.3 Contraindications
Atorvastatin is contraindicated in patients who have:
Hypersensitivity to any component of this medication,
Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal, or who are:
Pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.

 

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