SIMVOR EZ Tablet
Simvastatin + Ezetimibe
10 mg/20 mg
SUN PHARMACEUTICAL INDUSTRIES LTD.
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | INDIA |
| Agent | Muscat Pharmaceutical Trading L.L.C. |
| Retail Price | 43.00 AED |
Available as:
Indications
SIMVOR EZ Tablet is used for:
Hypercholesterolaemia, Hyperlipidaemias, Hypertriglyceridaemia, Hyperlipoproteinaemia
Adult Dose
Oral
Hypercholesterolaemia, Hyperlipidaemias, Hypertriglyceridaemia, Hyperlipoproteinaemia
Adult: As tablet containing ezetimibe (mg)/simvastatin (mg): 10/10, 10/20, 10/40, 10/80. Usual starting dose: 10/20 mg daily. Dose may range from 10/10 mg daily to 10/80 mg daily.
Simvastatin 80 mg/day should only be used for individuals who have been taking a simvastatin dose of 80 mg for 12 months or longer without evidence of myopathy
Prescribing information advises if patients are taking simvastatin 40 mg/day without meeting their LDL goal to switch to a different statin rather than increase to 80 mg/day
Hepatic impairment
Mild: Dosage adjustment not required
Moderate-to-severe: Not recommended
Child Dose
Heterozygous Familial Hypercholesterolemia
<10 years: Safety and efficacy not established
10-18 years: 10 mg/10 mg/day-10 mg/40 mg/day PO qHS
Simvastatin 80 mg/day should only be used for individuals who have been taking a simvastatin dose of 80 mg for 12 months or longer without evidence of myopathy
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
< 60 10/20 mg in the evening. Higher dose to be used with caution.
Administration
Patient should be placed on standard cholesterol-lowering diet before receiving drug
Administer >2 hr before or >4 hr after bile acid sequestrant (eg, cholestyramine)
Contra Indications
Hypersensitivity, acute liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation. Patients of Chinese descent should not take 80 mg of simvastatin with lipid-modifying dose of niacin-containing products (>1g/day).
Precautions
History of liver disease. Risk of rhabdomyolysis increased in the presence of severe infection, hypotension, major surgical trauma, uncontrolled seizures and severe metabolic, endocrine and electrolyte disorder. Alcoholism; premenarcheal females; child <10 yr.
Pregnancy-Lactation
Pregnancy
Contraindicated in women who are or may become pregnant
Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development
Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy
There are no adequate and well-controlled studies of use with statins during pregnancy; however, there are rare reports of congenital anomalies in infants exposed to statins in utero
Lactation
Unknown if simvastatin excreted in human milk; because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not breastfeed
A decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother
Interactions
Simvastatin may cause slight elevation of serum digoxin. Cholestyramine and colestipol increase bioavailability of simvastatin. Increase in ezetimibe plasma levels with ciclosporin. Increased risk of myopathy when used with ciclosporin, gemfibrozil, danazol, amiodarone and verapamil.
Potentially Fatal: Concurrent use with itraconazole, ketoconazole, niacin, telithromycin, clarithromycin, erythromycin, nefazodone and HIV protease inhibitors may increase the risk of rhabdomyolysis and acute renal failure. Increased risk of hemorrhage with anticoagulants.
Adverse Effects
Side effects of Simvastatin + Ezetimibe :
1-10%
Headache (6.8%)
Upper respiratory tract infection (3.9%)
Myalgia (3.5%)
Increased ALT (4%)
Influenza (2.6%)
Pain in extremity (2.3%)
Mechanism of Action
Simvastatin inhibits the conversion of HMG-CoA to mevalonic acid by blocking the enzyme HMG-CoA reductase, an early and rate limiting step in the biosynthesis of cholesterol. Ezetimibe localises at the brush border of the small intestine where it inhibits the absorption of cholesterol, decreasing the delivery of intestinal cholesterol to the liver. Cholesterol absorption is an active process and ezetimibe inhibits the protein transporters on small intestinal enterocyte brush border that bring about this active transport.
Note
SIMVOR EZ 10 mg/20 mg Tablet manufactured by SUN PHARMACEUTICAL INDUSTRIES LTD.. Its generic name is Simvastatin + Ezetimibe. SIMVOR EZ is availble in United Arab Emirates.
Farmaco UAE drug index information on SIMVOR EZ Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.