Rozavel 10 | Rosuvastatin

Product Composition:

• Rosuvastatin

Precautions:

• Patients w/ predisposing factors for myopathy (e.g. untreated hypothyroidism, renal impairment), history of chronic liver disease and alcoholism. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue treatment if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy. Lactation Contraindicated

Indications:

• Hyperlipidaemias, Primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, homozygous familial hypercholesterolaemia, Stroke prevention

Contraindications:

• Severe renal impairment, active liver disease, unexplained persistent elevations of serum transaminases; hypersensitivity. Pregnancy, lactation.

Dosage:

• Adult: PO: Dose range: 5-40 mg once daily. Initially 5-10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily. Daily dose can be increased after further 4 weeks to 40 mg only in severe hypercholesterolaemia with high cardiovascular risk and under specialist supervision. Elderly initially 5 mg once daily. HoFH: Starting dose 20 mg. Child: Heterozygous familial hypercholesterolaemia: >10 yr Initially, 5 mg once daily, may be adjusted at intervals of at least 4 wk. Max: 20 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg Rosuvastatin can be taken with or without food, at any time of day. Renal impairment: CrCl (ml/min) 30-60Initially, 5 mg once daily to max 20 mg once daily <30 Contraindicated.

Common Side Effects:

• >10% Myalgia (3-13%) 1-10% Arthralgia (10%),Diabetes mellitus, new onset (3%),Pharyngitis (9%),Headache (6%),Asthenia (up to 5%),Dizziness (4%),CPK increased (3%),Nausea (3%),Abdominal pain (2%),ALT increased (2%),Constipation (2%),Flulike illness (2%),UTI (2%) <1% Jaundice,Myopathy,Rhabdomyolysis Potentially Fatal: Rhabdomyolysis with acute renal failure.

Mode Of Action:

• Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. It increases the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL. It also decreases apolipoprotein B, triglycerides and increases HDL.

Interaction:

• May increase serum levels of warfarin and oral contraceptives. May increase serum levels w/ itraconazole, HIV protease inhibitors. May decrease serum levels w/ erythromycin and antacids. May increase risk of myopathy w/ fenofibrate, niacin. Potentially Fatal: Increased risk of rhabdomyolysis w/ gemfibrozil and ciclosporin.

Pregnancy Interaction:

• Pregnancy Category – X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.