Cholestad

Cholestad

simvastatin

Manufacturer:

Berlin

Distributor:

Littman
Full Prescribing Info
Contents
Simvastatin.
Action
Antihyperlipidemic.
Simvastatin is a lipid-lowering agent, reduces elevated total cholesterol, LDL cholesterol. Marked responses are seen within 2 weeks and maximum therapeutic responses occur within 4-6 weeks. The response is maintained during continuation of therapy.
Indications/Uses
Coronary Heart Disease: In patients with coronary heart disease, simvastatin is indicated to reduce the risks of coronary death, nonfatal myocardial infarction, stroke and transient ischemic attacks (TIA).
Hyperlipidemia: Adjunct to diet to reduce elevated total-C, LDL-C, Apo B and TG and to slightly increase HDL-C in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia when response to diet and other nonpharmacological measures are inadequate. Simvastatin therefore, lowers the LDL-C/HDL-C and the total-C/HDL-C ratios.
Dosage/Direction for Use
Coronary Heart Disease: Starting Dose: 10-20 mg/day given as a single dose in the evening.
Hyperlipidemia: Starting Dose: 10 mg/day given as a single dose in the evening.
Adjustments of dosage if required, should be made at intervals of not less than 4 weeks to maximum of 80 mg/day.
Concomitant Therapy: Cholestad may be combined with bile acid sequestrants.
Contraindications
Hypersensitivity to any component of Cholestad. Active liver disease or unexplained persistent elevations of serum transaminases. No combination with mibefradil.
Use in Children: Cholestad is not recommended for use in children.
Use in Pregnancy & Lactation: Cholestad is not recommended for use in pregnancy and lactation.
Special Precautions
Muscle Effects: Simvastatin and other inhibitors of HMG-CoA reductase occasionally causes myopathy, which is manifested as muscle pain or weakness with grossly elevated creatine kinase (CK) >10 times the upper limit of normal (ULN).
Myopathy Caused by Drug Interactions: The incidence and severity of myopathy are increased by concomitant use of HMG-CoA reductase inhibitors with drugs that can cause myopathy when given alone eg, gemfibrozil, fibrates.
Simvastatin and HMG-CoA reductase inhibitors eg, cyclosporins, mibefradil, itraconazole, ketoconazole and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin are metabolized by the cytochrome P-450 isoform 3A4.
Certain drugs that have a significant inhibitory effect at the therapeutic doses on this metabolic pathway can substantially raise the plasma levels of HMG-CoA reductase inhibitors and thus increase the risk of myopathy. Patients starting therapy with Simvastatin should be advised of the risk of myopathy and told to report promptly.
Hepatic Effect: If the transaminase levels show evidence of progression particularly if they rise to 3 times the ULN and are persistent, Cholestad should be discontinued. It is recommended that liver function tests be performed before treatment begins and periodically thereafter. Patients titrated to the 80-mg dose should receive an additional test at 3 months. Cholestad should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Use In Pregnancy & Lactation
Cholestad is not recommended for use in pregnancy and lactation.
Side Effects
Abdominal pain, constipation and flatulence. Asthenia and headache, myopathy, nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesis, peripheral neuropathy, vomiting and anemia. Rarely, rhabdomyolysis and hepatitis/jaundice, angioedema, lupus-like syndrome, polymyalgia, rheumatics, vasculitis, thrombocytopenia, eosinophilia, increased ESR, arthritis, arthralgia, photosensitivity, fever, flushing, dyspnea and malaise.
Drug Interactions
The risk of rhabdomyolysis is increased by the concomitant use of simvastatin with drugs that have a significant inhibitory effect on cytochrome P-450 3A4 at therapeutic doses (eg, cyclosporins, mibefradil, itraconazole, ketoconazole, erythromycin and nefazodone) or with fibric acid derivatives or niacin. Simvastatin potentiated the effect of anticoagulants eg, warfarin.
Storage
Store at temperatures not exceeding 30°C.
Shelf-Life: 24 months.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Tab 20 mg x 100's. 40 mg x 100's.
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