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Atorvastatin Calcium Trihydrate 40 mg

Atorvastatin Calcium Trihydrate

Short Description

Atorvastatin Calcium Trihydrate contains Atorvastatin calcium trihydrate (equivalent to Atorvastatin) as active ingredient is available in film coated caplet 40 mg.

Indications

Atorvastatin Calcium Trihydrate is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein

B and triglycerides in patients with primary hypercholesterolemia, combined (mixed) hyperlipidemia, and heterozygous and homozygous familial

hypercholesterolemia when response to diet and other non pharmacological measures are inadequate.


Prevention of cardiovascular complication :

  • In hypertensive patient (40 years or older) and dyslipidemia with at least 3 risk factors for future cardiovascular events such as left ventricular hypertrophy (LVH), ECG abnormalities, non-insulin dependent diabetes mellitus (NIDDM), peripheral vascular disease, post-history of cerebrovascular events including transient ischemic attack (TIA) 3 months previously, microalbuminuria/proteinuria, smoking (regular smoker within the last year of 20 cigarettes or cigars/week), TC/HDL-C ratio 6, and history of coronary artery disease event in a first degree relative before age 55 (males) or 60 (females), Atorvastatin Calcium Trihydrate is indicated to reduce the risk of fatal coronary heart disease and nonfatal myocardial infarction, stroke, revascularization procedures and angina pectoris.

Pediatric patients (10 – 17 years of age) :

Atorvastatin Calcium Trihydrate is indicated as an adjunct to diet to reduce total-C, LDL-C and apo-B levels in boys and postmenarchal girls,

10 – 17 years, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present :

  1. LDL-C remains • 190 mg/dl or

  2. LDL-C remains • 160 mg/dl and;

  • there is a positive family history of premature cardiovascular disease or

  • two or more other cardiovascular disease (CVD) risk factors are present in the pediatric patient.

Specification

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 usual starting dose is 10 mg once a day. The dosage range is 10 to 80 mg once a daily. Doses may be given any time of the day, with or without food. Starting and maintenance dosage should be individualized according to baseline LDLC 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 2 weeks, and the maximum response is usually achieved within 4 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.

  • 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 INDICATIONS). Adjustments should be made at intervals of 4 weeks or more.

  • Use in patients with hepatic insufficiency : See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS in the insert.

  • Use in patients with renal insufficiency : Renal disease has no influence on the plasma concentrations or on the LDL-C reduction of Atorvastatin. Thus, no adjustment of the dose is required (see WARNINGS AND PRECAUTIONS in the insert).

  • Use in children : Treatment experience in a pediatric population is limited to doses of Atorvastatin up to 80 mg/day for one year in 8 patients with homozygous familial hypercholesterolemia. No clinical or biochemical abnormalities were reported in these patients.

  • Use in elderly : No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population.

  • 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.

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