Generic

Atorvastatin

Therapeutic Class

Cardiovascular

Pack Size

Frenvas 10 mg tablet: Each box contains 28 tablets (2 X 14’s) in Alu-Alu blister pack.
Frenvas 20 mg tablet: Each box contains 21 tablets (3 X 7’s) in Alu-Alu blister pack.

Indications

Atorvastatin is indicated as an adjunct to diet for the- Reduction of Elevated Total Cholesterol • Reduction of Elevated LDL Cholesterol • Reduction of Elevated Triglyceride (TG) • Increase of HDL Cholesterol FRENVAS reduces the risk of atherosclerosis which is responsible for major vascular events like heart attack, stroke etc.

Therapeutic Class

Cardiovascular

Dosage & Administration

• Patients should be placed on a standard cholesterol lowering diet before receiving Atorvastatin and should continue on this diet during treatment • The usual starting dose for all the indications is 10 mg once daily. The dosage range is 10 to 80 mg once daily. • Doses should be individualized 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. • Doses may be given at any time of day with or without food.

Contraindications

Atorvastatin is contraindicated- • In patients with hypersensitivity to any component of this medication • During pregnancy & breast-feeding and • In women of child-bearing potential not using appropriate contraceptive measures.

Side Effects

Adverse reactions have usually been mild and transient like headache, altered liver function tests and gastro-intestinal effects including abdominal pain, flatulence, diarrhea, nausea and vomiting. Thrombocytopenia, rash and hypersensitivity reactions have been reported rarely. Other side effects include insomnia, angioedema, anorexia, asthenia, paresthesia, peripheral neuropathy, alopecia, pruritus, impotence, chest pain, hypoglycemia and hyperglycemia.

Pregnancy & Lactation

• Pregnancy category X. • Atorvastatin is contraindicated in pregnancy and while breast-feeding. • Women of child bearing potential should use appropriate contraceptive measures. • If the woman becomes pregnant while taking Atorvastatin, it should be discontinued.

Precautions

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine, fibrates, and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

Storage Conditions

Store below 25â—¦C. Protect from light and moisture. Keep all medicines out of the reach of children.