SIMVASTATIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Simvastatin tablets USP are indicated: Simvastatin is contraindicated in the following conditions: Risk Summary Discontinue simvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Simvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see CLINICAL PHARMACOLOGY (12.1)] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenit

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: NDC 71205-809-30                Bottles of 30 NDC 71205-809-60                Bottles of 60 NDC 71205-809-90                Bottles of 90 *The 5 mg strength of Simvastatin Tablets USP is no longer being marketed 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
PROFICIENT RX LP
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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 an HMG-CoA reductase inhibitor indicated:
(1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg (3)
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
o
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:
o
o
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
_Important Dosage and Administration Information_ : (1)
o
o
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Take simvastatin tablets USP orally once daily in the evening.
Maximum recommended dosage is simvastatin tablets USP 40 mg once
daily. simvastatin
tablets USP 80 mg daily dosage 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 req
                                
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