API

Rosuvastatin (10mg)

Drug classification

Lipid-lowering agent; specific subclass: HMG-CoA reductase inhibitor (statin).

Dosage form

Film-coated oral tablet containing 10 mg of rosuvastatin.

API strength per dosage

Dose

Rosuvastatin 10 mg is typically started once daily for adults with hyperlipidemia or mixed dyslipidemia; adjust based on response and guidelines. Lower starting doses are recommended for Asian patients, those with renal impairment, or risk factors for myopathy. Not routinely used in children under 10 years. Contraindicated in active liver disease. Always individualize dosing.

Mechanism of action

Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol biosynthesis. This decreases intrahepatic cholesterol, upregulates LDL receptors on hepatocytes, and enhances clearance of low-density lipoprotein (LDL) cholesterol from plasma, resulting in reduced total and LDL cholesterol levels.

Indications

Treatment of High cholesterol Prevention of heart attack and stroke

Side effects

Muscle pain Weakness Headache Abdominal pain Dizziness Joint pain Nausea

Pregnancy category

Rosuvastatin is contraindicated in pregnancy due to potential fetal harm; discontinue immediately if pregnancy occurs. Use effective contraception during treatment.

Precautions

Assess liver function before and during therapy, monitor for muscle pain or weakness, check creatine kinase if myopathy suspected, use caution in renal impairment, avoid in active liver disease, monitor lipid levels regularly, consider drug interactions, advise on potential for diabetes risk, avoid in pregnancy and lactation.

Contraindications

Hypersensitivity to rosuvastatin, active liver disease, unexplained persistent elevations of serum transaminases, pregnancy, breastfeeding, severe renal impairment, concomitant use with cyclosporine.