SIMVASTATIN tablet, film coated 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:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

SIMVASTATIN

Composition:

SIMVASTATIN 20 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 is contraindicated in the following conditions: - Concomitant use of strong CYP3A4 inhibitors (select azole a

Product summary:

Simvastatin tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with ‘LL’ on one side and ‘C03’ on the other side. They are supplied as follows: Unit of Use Bottles of 30: NDC 68645-470-54 Simvastatin tablets USP, 40 mg are brick red colored, round shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C04' on the other side. They are supplied as follows: Unit of Use Bottles of 30: NDC 68645-527-54 Storage Store between 20° to 25°C (68° to 77°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
SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
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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, 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 USP are 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_ : (1) (2)
(2)
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 tablets USP 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