SIMVASTATIN- 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:

Camber Pharmaceuticals, Inc.

INN (International Name):

SIMVASTATIN

Composition:

SIMVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Simvastatin tablets 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):   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 following

Product summary:

Simvastatin tablets USP, 5 mg are yellow colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘16’ on other side. They are supplied as follows: Bottles of 30                                            (NDC 31722-510-30) Bottles of 90                                            (NDC 31722-510-90) Bottles of 100                                          (NDC 31722-510-01) Bottles of 1000                                        (NDC 31722-510-10  Simvastatin tablets USP, 10 mg are pink colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘17’ on other side. They are supplied as follows: Bottles of 30                                            (NDC 31722-511-30) Bottles of 90                                            (NDC 31722-511-90) Bottles of 100                                          (NDC 31722-511-01) Bottles of 1000                                        (NDC 31722-511-10) Simvastatin tablets USP, 20 mg are brown colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘18’ on other side. They are supplied as follows: Bottles of 30                                            (NDC 31722-512-30) Bottles of 90                                            (NDC 31722-512-90) Bottles of 100                                          (NDC 31722-512-01) Bottles of 1000                                        (NDC 31722-512-10 Simvastatin  tablets USP, 40 mg are brick red colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘19’ on other side. They are supplied as follows: Bottles of 30                                            (NDC 31722-513-30) Bottles of 90                                            (NDC 31722-513-90) Bottles of 100                                          (NDC 31722-513-01) Bottles of 1000                                        (NDC 31722-513-10)       Simvastatin tablets USP, 80 mg are brick red capsule shaped, film coated tablet, debossed with ‘H’ on one side and ‘20’ on other side. They are supplied as follows: Bottles of 30                                            (NDC 31722-514-30) Bottles of 90                                            (NDC 31722-514-90) Bottles of 100                                          (NDC 31722-514-01) Bottles of 500                                          (NDC 31722-514-05) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.                       

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED
CAMBER 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
Warnings and Precautions ( 5.2) 5/2022
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_)_
o Take simvastatin tablets orally once daily in the evening.
o Maximum recommended dosage is simvastatin tablets 40 mg once daily.
An 80 mg daily dosage of
simvastatin tablets are restricted to patients who have been taking
simvastatin tablets 80 mg daily
chronically (e.g., for 12 months or more) without evidence of muscle
toxicity.
o For patients that require a high-intensity statin or are unable to
achieve their LDL-C goal receiving
simvastatin tablets 40 mg daily, prescribe alternative LDL-C lowering
treatment.
o Assess LDL-C when