Anzitor® 10: Each film coated tablet contains Atorvastatin 10 mg as Atorvastatin Calcium USP.
Anzitor® 20: Each film coated tablet contains Atorvastatin 20 mg as Atorvastatin Calcium USP.
Anzitor® 40: Each film coated tablet contains Atorvastatin 40 mg as Atorvastatin Calcium USP.
Anzitor® 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. Anzitor® 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. Anzitor® reduces LDL production and the number of LDL particles. Anzitor® produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.
Anzitor® is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with:
Patients should be placed on a standard cholesterol lowering diet before receiving Anzitor® and should continue on this diet during treatment with Anzitor®. The usual starting dose for all the indications is 10 mg once daily. The doses 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.
Children: Treatment experience in a paediatric population with dose of Anzitor® up to 80 mg/day is limited. Geriatric (>70 years) use: The safety and efficacy of Anzitor® in this population is as similar as < 70 years of age patients with the dose upto 80 mg/day.
In patients with Renal Insufficiency: No dosage adjustment is required.
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Should an increase in ALT or AST of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of Atorvastatin is recommended. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Skeletal muscle effects: Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Should significant increases in CPK persist, reduction of dose or withdrawal of Atorvastatin is recommended. Rare cases of rhabdomy.