CARPRO  5  Each film coated tablet contains : Rosuvastatin Calcium IP                       5mg

 CARPRO 10 Each film coated tablet contains : Rosuvastatin Calcium IP                      10 mg

 CARPRO 20 Each film coated tablet contains : Rosuvastatin Calcium IP                       20mg

 PHARMACOLOGY

Pharmacotherapeutic Group: Lipid lowering agents

Pharmacodynamic Properties

 Rosuvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. It competitively inhibits HMG-CoA Reductase , the enzyme that catalyzes the conversion of HMG-CoA to Mevalonic acid. This results in the induction of the LDL receptors, leading to lowered LDL-cholesterol concentration. In in vivo and in vitro studies, Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Pharmacokinetic Properties

Absorption: In clinical pharmacology studies in man, peak plasma concentrations of Rosuvastatin were reached 3 to 5 hours following oral dosing. The absolute bioavailability of Rosuvastatin is approximately 20%. Administration of Rosuvastatin with food did not affect the AUC of Rosuvastatin.

Distribution: Mean volume of distribution at steady-state of Rosuvastatin is approximately 134 liters. Rosuvastatin is 88% bound to plasma proteins, mostly albumin.

Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl Rosuvastatin.

Excretion: Following oral administration, Rosuvastatin and its metabolites are primarily excreted in the feces (90%). The elimination half-life (t1/2) of Rosuvastatin is approximately 19 hours.

INDICATIONS

• Hyperlipidemia and Mixed Dyslipidemia
• Hypertriglyceridemia
• Heterozygous Familial Hypercholesterolemia
• Primary Dysbetalipoproteinemia

DOSE:  Once daily, can be taken with or without food.

Pregnancy Category: X

Storage: Store below 25 °C

Missed dose: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

 CONTRAINDICATIONS

• Hypersensitivity
• Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels
• Women who are pregnant or may become pregnant.
• Nursing mothers.

 SPECIAL PRECAUTIONS

• Skeletal muscle effects: Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism , renal impairment
• Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment.

 PRESENTATION

• CARPRO 5 Each box contains: 10 strips X 10 Tabs. ALU-ALU Packing
• CARPRO 10 Each box contains: 10 strips X 10 Tabs. ALU-ALU Packing
• CARPRO 20 Each box contains: 10 strips X 10 Tabs. ALU-ALU Packing