Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
Hisun Pharmaceuticals USA, Inc.
SIMVASTATIN
SIMVASTATIN 10 mg
ORAL
PRESCRIPTION DRUG
Simvastatin tablets USP 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): In adults with primary hyperlipidemia. 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: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Simvastatin tablets are contraindicated in the following conditions: - Concomitant use of strong CYP3A4 inhibitors (sel
Simvastatin Tablets USP are supplied as follows: Storage Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.
Abbreviated New Drug Application
SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED HISUN PHARMACEUTICALS USA, INC. ---------- 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 RECENT MAJOR CHANGES Dosage and Administration ( 2.1) ..............................................................................................7/2023 INDICATIONS AND USAGE Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) 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): In adults with primary hyperlipidemia. 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: Primary dysbetalipoproteinemia. Hypertriglyceridemia. DOSAGE AND ADMINISTRATION _Important Dosage and Administration Information: _( 2.1) Take simvastatin tablets USP orally once daily in the evening. Maximum recommended dosage is simvastatin tablets USP 40 mg once daily. An 80 mg daily dosage of simvastatin tablets USP 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 USP 40 mg daily, prescribe alternative LDL- Lees het volledige document