Rocovas 20 mg Tab

What is Rocovas?

Rocovas contains Rosuvastatin Calcium, a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a cholesterol precursor.

Indications

Primary hyperlipidemia and mixed dyslipidemia (as an adjunct to diet to reduce total-C, LDL-C, ApoB, non-HDL-C and TG, and to increase HDL-C); hypertriglyceridemia; primary dysbetalipoproteinemia (Type III hyperlipoproteinemia); homozygous familial hypercholesterolemia (HoFH); slowing progression of atherosclerosis; heterozygous familial hypercholesterolemia (HeFH) in pediatric patients 10-17 years; risk reduction of myocardial infarction, stroke, and arterial revascularization in patients with multiple risk factors.

Pharmacology

Rosuvastatin increases hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL, and inhibits hepatic synthesis of VLDL, reducing total VLDL and LDL particle numbers.

Dosage & Administration

Pediatric HeFH (10-17 years): 5-20 mg/day, max 20 mg/day. Very high cholesterol/high MI or stroke risk: 40 mg once daily. Homozygous FH: starting dose 20 mg once daily. Asian patients: consider starting at 5 mg once daily. With cyclosporine: limit to 5 mg once daily. With lopinavir/ritonavir or atazanavir/ritonavir: limit to 10 mg once daily. Severe renal impairment (CrCl <30 mL/min, not on dialysis): start at 5 mg once daily, do not exceed 10 mg once daily.

Interaction

Cyclosporine increases exposure (limit to 5 mg once daily). Gemfibrozil combination should be avoided (limit to 10 mg once daily if used together). Lopinavir/ritonavir or atazanavir/ritonavir increase exposure (limit to 10 mg once daily). Coumarin anticoagulants: may prolong INR, monitor closely. Fibrates and niacin may increase risk of skeletal muscle effects.

Contraindications

Hypersensitivity to product components; active liver disease including unexplained persistent transaminase elevations; pregnancy and women who may become pregnant; nursing mothers.

Side Effects

Generally well tolerated. Most frequent: headache, myalgia, constipation, asthenia, abdominal pain, and nausea.

Pregnancy & Lactation

Should be administered to women of childbearing age only when highly unlikely to conceive. Discontinue immediately if pregnancy occurs. Unknown if excreted in human milk; avoid during breastfeeding.

Precautions & Warnings

Use with caution in patients with predisposing factors for myopathy (age >65, inadequately treated hypothyroidism, renal impairment). Risk of myopathy increased with concurrent fibrates, niacin, gemfibrozil, cyclosporine, or protease inhibitor combinations. Discontinue if markedly elevated creatine kinase or myopathy occurs. Liver enzyme tests recommended before therapy, at 12 weeks, and periodically thereafter.

Overdose Effects

No specific treatment; manage symptomatically with supportive measures. Hemodialysis does not significantly enhance clearance.

Therapeutic Class

Statins (HMG-CoA reductase inhibitors).

Storage Conditions

Keep below 30°C, protected from light and moisture. Keep out of the reach of children.