SIMVASTATIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Available from:

Hisun Pharmaceuticals USA, Inc.

INN (International Name):

SIMVASTATIN

Composition:

SIMVASTATIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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-