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Simvastatin
Overview
What is Simvastatin?
Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of . After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.
Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo--pyran-2-yl)-ethyl]-1-naphthalenyl ester, [-[1α,3α,7β,8β(8aβ]]. The molecular formula of simvastatin is CHO and its molecular weight is 418.57. Its structural formula is:
Simvastatin is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane.
Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hydroxypropyl methylcellulose (hypromellose), lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative.
What does Simvastatin look like?
What are the available doses of Simvastatin?
What should I talk to my health care provider before I take Simvastatin?
How should I use Simvastatin?
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.
The dosage range is 5 to 80 mg/day. In patients with CHD or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. The recommended usual starting dose is 20 to 40 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
What interacts with Simvastatin?
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What are the warnings of Simvastatin?
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What are the precautions of Simvastatin?
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What are the side effects of Simvastatin?
Sorry No records found
What should I look out for while using Simvastatin?
Simvastatin is contraindicated in the following conditions:
What might happen if I take too much Simvastatin?
Significant lethality was observed in mice after a single oral dose of 9 g/m. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools.
A few cases of overdosage with simvastatin have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. Supportive measures should be taken in the event of an overdose. The dialyzability of simvastatin and its metabolites in man is not known at present.
How should I store and handle Simvastatin?
Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces VLDL and TG and increases HDL-C.
Non-Clinical Toxicology
Simvastatin is contraindicated in the following conditions:Drug Interactions:
Simvastatin, like other statins, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of statin activity in plasma. Predisposing factors for myopathy include advanced age (≥65 years), uncontrolled hypothyroidism, and renal impairment.
As with other statins, the risk of myopathy/rhabdomyolysis is dose related.
All patients starting therapy with simvastatin, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected.
Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring. Therapy with simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
Drug Interactions
The risk of myopathy and rhabdomyolysis is increased by high levels of statin activity in plasma. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, the antidepressant nefazodone, or large quantities of grapefruit juice (>1 quart daily). The use of simvastatin concomitantly with these CYP3A4 inhibitors should be avoided. If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin should be suspended during the course of treatment [see
The benefits of the combined use of simvastatin with the following drugs should be carefully weighed against the potential risks of combinations: gemfibrozil, other lipid-lowering drugs (other fibrates or ≥1 g/day of niacin), cyclosporine, danazol, amiodarone, or verapamil.
Caution should be used when prescribing other fibrates or lipid-lowering doses (≥1 g/day) of niacin with simvastatin, as these agents can cause myopathy when given alone.
Prescribing recommendations for interacting agents are summarized in Table 1 [see also
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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