País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
Micro Labs Limited
SIMVASTATIN
SIMVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
Simvastatin tablets are indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. Simvastatin tablets are contraindicated in th
Simvastatin Tablets USP, 5 mg are light yellow colored, oblong shaped, biconvex, film-coated tablets, engraved with ‘5’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-005-30 unit of use bottles of 30 NDC 42571-005-60 unit of use bottles of 60 NDC 42571-005-90 unit of use bottles of 90 NDC 42571-005-05 unit of use bottles of 500 NDC 42571-005-10 bottles of 1000. Simvastatin Tablets USP, 10 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘10’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-010-30 unit of use bottles of 30 NDC 42571-010-60 unit of use bottles of 60 NDC 42571-010-90 unit of use bottles of 90 NDC 42571-010-05 unit of use bottles of 500 NDC 42571-010-10 bottles of 1000. Simvastatin Tablets USP, 20 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘20’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-020-30 unit of use bottles of 30 NDC 42571-020-60 unit of use bottles of 60 NDC 42571-020-90 unit of use bottles of 90 NDC 42571-020-05 unit of use bottles of 500 NDC 42571-020-10 bottles of 1000. Simvastatin Tablets USP, 40 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘40’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-040-30 unit of use bottles of 30 NDC 42571-040-60 unit of use bottles of 60 NDC 42571-040-90 unit of use bottles of 90 NDC 42571-040-05 unit of use bottles of 500 NDC 42571-040-10 bottles of 1000. Simvastatin Tablets USP, 80 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘80’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-080-30 unit of use bottles of 30 NDC 42571-080-60 unit of use bottles of 60 NDC 42571-080-90 unit of use bottles of 90 NDC 42571-080-05 unit of use bottles of 500 NDC 42571-080-10 bottles of 1000. Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature] Dispense in tightly-closed container.
Abbreviated New Drug Application
SIMVASTATIN - SIMVASTATIN TABLET MICRO LABS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIMVASTATIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMVASTATIN TABLETS. SIMVASTATIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: ( 1) To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. DOSAGE AND ADMINISTRATION _Important Dosage and Administration Information: ( 2.1)_ Take simvastatin tablets orally once daily in the evening. Maximum recommended dosage is simvastatin tablets 40 mg once daily. An 80 mg daily dosage of simvastatin tablets is restricted to patients who have been taking simvastatin 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving simvastatin tablets 40 mg daily, prescribe alternative LDL-C lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating, and adjust the dosage if necessary. _Adults:_Recommended dosage is 20 mg to 40 mg once daily. ( 2.2 Llegiu el document complet