Simvastatin (Simvastatin)

Trade Name : Simvastatin

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 10 mg/1

SIMVASTATIN HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Simvastatin (Simvastatin) which is also known as Simvastatin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Simvastatin (Simvastatin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

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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 tablets can be started simultaneously with diet.
Simvastatin tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Limitations of Use
Simvastatin tablets have not been studied in Fredrickson Types I and V dyslipidemias. ()

Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. ()
Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. ()
Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. ()
Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. ()
Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (, )

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Dose range is 5 to 40 mg/day. ()
Recommended usual starting dose is 10 or 20 mg once a day in the evening. ()
Recommended starting dose for patients at high risk of CHD is 40 mg/day. ()
Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80 mg dose of simvastatin tablets should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. ()
Patients who are currently tolerating the 80 mg dose of simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction. ()
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80 mg dose of simvastatin tablets, patients unable to achieve their LDL-C goal utilizing the 40 mg dose of simvastatin tablets should not be titrated to the 80 mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering. ()
Adolescents (10 to 17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day. ()

Tablets: 5 mg; 10 mg; 20 mg; 40 mg; 80 mg ()

Simvastatin tablets are contraindicated in the following conditions:

Concomitant administration of strong CYP3A4 inhibitors. (, )
Concomitant administration of gemfibrozil, cyclosporine, or danazol. (, )
Hypersensitivity to any component of this medication. (, )
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (, )
Women who are pregnant or may become pregnant. (, )
Nursing mothers. (, )

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Patients should be advised of the increased risk of myopathy including rhabdomyolysis with the 80 mg dose. ()
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain medicines. Predisposing factors include advanced age (u2265 65), female gender, uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. (, , , )
Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. See Drug Interaction table. ()
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. ()

Most common adverse reactions (incidence u2265 5.0%) are: upper respiratory infection, headache, abdominal pain, constipation, and nausea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions Associated With Increased Risk of Myopathy/Rhabdomyolysis
2.3
2.4
4
5.1
7.1
7.2
7.3
12.3

5.1n- 7.2n- 7.4
Coumarin anticoagulants: Concomitant use with simvastatin prolongs INR. Achieve stable INR prior to starting simvastatin. Monitor INR frequently until stable upon initiation or alteration of simvastatin therapy. ()

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Severe renal impairment: patients should be started at 5 mg/day and be closely monitored. (, )

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.

Simvastatin, USP is a lipid-lowering agent that is derived synthetically from a fermentation product of After oral ingestion, simvastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding u03b2-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, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1-[1u03b1,3u03b1,7u03b2,8u03b2(2n ,4n ),-8au03b2]]. Its structural formula is:
CHO M.W. 418.57
Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.
Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, titanium dioxide and triacetin. Additionally, the 5 mg, 10 mg, 20 mg, and 80 mg strengths contain: iron oxide yellow; and the 5 mg and 80 mg strengths contain: iron oxide black.

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Simvastatin tablets USP are supplied as follows:
5 mg: Light-yellow, round, convex, film-coated tablets, debossed u201c7152u201d on one side and u201cTVu201d on the other side. They are supplied as follows:
NDCn- NDC
10 mg: Light-pink, round, convex, film-coated tablets, debossed u201c7153u201d on one side and u201cTVu201d on the other side. They are supplied as follows:
NDCn- NDCn- NDC
20 mg: Tan, round, convex, film-coated tablets, debossed u201c7154u201d on one side and u201cTVu201d on the other side. They are supplied as follows:n
NDCn- NDCn- NDC
40 mg: Red, round, convex, film-coated tablets, debossed u201c7155u201d on one side and u201cTVu201d on the other side. They are supplied as follows:n
NDCn- NDCn- NDC
80 mg: Brick-red, capsule-shaped, film-coated tablets, debossed u201c7156u201d on one side and u201cTVu201d on the other side. They are supplied as follows:
NDCn- NDCn- NDC
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.
Patients should be advised about substances they should not take concomitantly with simvastatin []. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking simvastatin tablets.

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Simvastatin (Simvastatin)

Trade Name : Simvastatin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Simvastatin (Simvastatin)

Trade Name : Simvastatin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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