Simchol Tablet
Simvastatin
5mg
Aristo Pharmaceuticals Ltd.
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Available as:
Indications
Simchol Tablet is used for:
Hyperlipidaemias, stroke prevention
Adult Dose
Oral
Hyperlipidaemias, Hypercholesterolemia
Adult: Initially, 10-20 mg once daily.
Patients w/ high CV risk or require a large reduction in cholesterol: Initially, 40 mg once daily. May adjust dose at intervals of at least 4 wk to max 80 mg once daily.
All doses to be taken in the evening.
Patients w/ homozygous familial hypercholesterolaemia:
40 mg once daily in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg and an evening dose of 40 mg.
Cardiovascular risk reduction
Adult: High-risk patients (e.g. patients w/ DM or atherosclerotic CV disease): 20-40 mg once daily. Moderate-risk patients: 10 mg once daily.
Dosage Modifications
Coadministration with dronedarone, verapamil, or diltiazem: Do not exceed 10 mg/day
Coadministration with amiodarone, amlodipine, or ranolazine: Do not exceed 20 mg/day
Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter
80 mg/day should be used only for individuals who have been taking simvastatin 80 mg chronically (eg, >12 months) without evidence of myopathy or rhabdomyolysis
Patients tolerating 80 mg who need to be initiated on an interacting drug that is contraindicated or associated with a maximum dose for simvastatin should be switched to an alternative statin with less potential for drug-drug interactions
Patients unable to achieve their LDL-C goal utilizing 40 mg/day should not be titrated to 80 mg (increased risk for myopathy) but should instead be placed on alternative LDL-C-lowering treatment that provides greater LDL-C lowering
Child Dose
Child
Heterozygous familial hypercholesterolaemia:
10-17 yr Initially, 10 mg once daily May increase at intervals of 4 wk to max 40 mg/day.
All doses to be taken in the evening.
Hypercholesterolemia
<10 years: Safety and efficacy not established
Renal Dose
Renal impairment: Mild to moderate: No dosage adjustment needed. Severe: Initially, 5 mg once daily w/ close monitoring.
Administration
May be taken with or without food.
Contra Indications
Acute liver disease or unexplained persistent elevations of serum transaminases. Patients of Chinese descent should not take simvastatin 80 mg/day w/ lipid-modifying dose of niacin-containing products (≥1 g). Simvastatin 80 mg should not be started in new patients and to those taking lower doses. Concurrent use w/ potent CYP3A4 inhibitors e.g. itraconazole, ketoconazole, posaconazole, clarithromycin, erythromycin, telithromycin, nefazodone, HIV protease inhibitors (e.g. nelfinavir), boceprivir, telaprevir., gemfibrozil, ciclosporin, danazol, grapefruit juice. Pregnancy and lactation.
Precautions
History of liver disease. Increased risk of rhabdomyolysis in severe infection, hypotension, major surgical trauma, uncontrolled seizures or severe metabolic, endocrine and electrolyte disorder. Alcoholism; premenarcheal females; children <10 yr. Discontinue treatment if there is marked or persistent increase in serum-aminotransferase concentrations. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy.
Lactation: Contraindicated; potentially unsafe
Pregnancy-Lactation
Interactions
May increase bleeding risk w/ anticoagulants. Reduced serum levels w/ bosentan, efavirenz and rifampicin. Increased risk of myopathy and rhabdomyolysis w/ colchicine, amiodarone, verapamil and diltiazem. Increased risk of myopathy w/ amlodipine, fusidic acid. Potential reduction of cytotoxic effect of rituximab. Increased hepatotoxicity w/ ezetimibe.
Potentially Fatal: Concurrent use w/ itraconazole, ketoconazole, posaconazole, clarithromycin, erythromycin, telithromycin, nefazodone, niacin, HIV protease inhibitors (e.g. nelfinavir), boceprivir, telaprevir, gemfibrozil, ciclosporin and danazol may increase the risk of myopathy, rhabdomyolysis and acute renal failure.
Adverse Effects
Side effects of Simvastatin :
1-10%
CPK elevation (>3x ULN) (5%),Constipation (2%),Upper respiratory infection (9%),Flatulence (1-2%),Transaminases increased (>3x ULN) (1%),Headache (3-7%),Myalgia (5%),Eczema (5%),Vertigo (5%),Abdominal pain (7%)
<1%
Myalgia,Myopathy,Arthralgia,Arthritis,Eosinophilia,Chills,Angioedema,Rhabdomyolysis,Abdominal pain
Potentially Fatal: Severe rhabdomyolysis with acute renal failure.
Mechanism of Action
Simvastatin, an antilipemic agent is a competitive inhibitor of HMG-CoA reductase, the enzyme that catalyses the early and rate-limiting step in cholesterol biosynthesis reduces total cholesterol, LDL-cholesterol and triglycerides and increases HDL-cholesterol levels.
Note
Simchol 5mg Tablet manufactured by Aristo Pharmaceuticals Ltd.. Its generic name is Simvastatin. Simchol is availble in Nepal.
Farmaco Nepal drug index information on Simchol Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.