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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

SIMVASTATIN

Composition:

SIMVASTATIN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Simvastatin tablet is 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 the

Product summary:

Simvastatin tablets USP 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S 5" on one side and plain on other side. Bottles of 30 Tablets (NDC 43063-008-30) Bottles of 90 Tablets (NDC 43063-008-90) Storage Store at 68°F to 77°F (20°C to 25°C). [See USP Controlled Room Temperature]. "Dispense in tight containers as defined in the USP"

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, 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)
3/2023
Dosage and Administration ( 2.2, 2.3, 2.4)
3/2022
Warnings and Precautions ( 5.2)
5/2022
Warnings and Precautions ( 5.1, 5.3)
3/2022
Contraindications, Pregnancy and Lactation ( 4) Removed
3/2022
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 tablet orally once daily in the evening.
Maximum recommended dosage is simvastatin tablet 40 mg once daily. An
80 mg daily dosage of
simvastatin tablet 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 g