Product Description
Description: Rosvamac F Tablets contain Rosuvastatin and Fenofibrate which are synthetic lipid-altering agents.
Pharmaceutical Dosage Form: Tablet
Route of Administration: Oral
Composition: Each film coated tablet contains:
Rosuvastatin Calcium IP
Eq. to Rosuvastatin 10 mg
Fenofibrate (Micronised) IP 160 mg
Excipients q.s.
Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide IP
Mechanism of Action: Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action of Rosuvastatin is the liver, the target organ for cholesterol lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα). Through activation of PPARα, fenofibrate increases the lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apo protein CIII. Activation of PPARα also induces an increase in the synthesis of Apo proteins AI and AII. The above stated effects of fenofibrate on lipoproteins lead to a reduction in very low and low density fractions (VLDL and LDL) containing Apo protein B and an increase in the high density lipoprotein fraction (HDL) containing Apo protein AI and AII.
Indications: Rosvamac F is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, Familial Hypercholesterolemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia, Homozygous Familial Hypercholesterolemia, slow the progression of atherosclerosis, Prevention of Cardiovascular Disease
Dosage: As directed by the physician.
Storage: Store at a temperature not exceeding 25°C, protected from light & moisture.
Presentation: 10X10 Tablets
Side effects:
Headache
Dizziness
Constipation
Nausea
Abdominal
Pain
Myalgia
Asthenia
Contraindications: Rosvamac F is contraindicated in patients with a known hypersensitivity to any component of this product, active liver disease, severe renal dysfunction, including those receiving dialysis, myopathy, receiving concomitant ciclosporin, receiving concomitant combination of sofosbuvir/velpatasvir/voxilaprevir, pre-existing gallbladder disease, pregnancy and nursing mothers.
Drug Interactions: Rosvamac F can cause drug interaction with following drugs:
Transporter protein inhibitors
Ciclosporin
Protease inhibitors
Gemfibrozil and other lipid-lowering products
Ezetimibe
Antacid
Erythromycin
Cytochrome P450 enzymes
Glitziness
