FrenvasTM is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3- hydroxy- 3- methyl- glutaryl- coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised primarily through the high affinity LDL receptor. FrenvasTM lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. FrenvasTM reduces LDL production and the number of LDL particles. FrenvasTM produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles
FrenvasTM 10 mg film coated tablet contains 10 mg Atorvastatin Calcium USP. FrenvasTM 20 mg film coated tablet contains 20 mg Atorvastatin Calcium USP.
• 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.
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.
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.
• 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.
The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, or niacin (nicotinic acid). These risks may also occur when combining these drugs with Atorvastatin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives and or hypoglycemic agents. Caution should also be exercised when Atorvastatin is administered with inhibitors of P450 3A4 (macrolide antibiotics and azole antifungals). The effect of inducers of cytochrome P450 3A4 (rifampicin or phenytoin) on Atorvastatin is unknown. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin. No interaction was found with cimetidine.
Specific treatment is not available for Atorvastatin overdosage. If an overdose occur, the patient should betreated symptomatically and supportive measures instituted, as required. Liver function tests and serum CPK levels should be monitored. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance Atorvastatin clearance
Store below 25◦C. Protect from light and moisture. Keep all medicines out of the reach of children.
FrenvasTM 10 mg: Each box contains 2 Alu-Alu blister packs of 14 film coated tablets. FrenvasTM 20 mg: Each box contains 3 Alu-Alu blister packs of 7 film coated tablets.