SIMVASTATIN- simvastatin tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Micro Labs Limited

INN（国际名称）:

SIMVASTATIN

组成:

SIMVASTATIN 5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 th

產品總結:

Simvastatin Tablets USP, 5 mg are light yellow colored, oblong shaped, biconvex, film-coated tablets, engraved with ‘5’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-005-30    unit of use bottles of 30 NDC 42571-005-60    unit of use bottles of 60 NDC 42571-005-90    unit of use bottles of 90 NDC 42571-005-05    unit of use bottles of 500 NDC 42571-005-10    bottles of 1000. Simvastatin Tablets USP, 10 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘10’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-010-30    unit of use bottles of 30 NDC 42571-010-60    unit of use bottles of 60 NDC 42571-010-90    unit of use bottles of 90 NDC 42571-010-05    unit of use bottles of 500 NDC 42571-010-10    bottles of 1000. Simvastatin Tablets USP, 20 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘20’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-020-30    unit of use bottles of 30 NDC 42571-020-60    unit of use bottles of 60 NDC 42571-020-90    unit of use bottles of 90 NDC 42571-020-05    unit of use bottles of 500 NDC 42571-020-10    bottles of 1000. Simvastatin Tablets USP, 40 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘40’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-040-30    unit of use bottles of 30 NDC 42571-040-60    unit of use bottles of 60 NDC 42571-040-90    unit of use bottles of 90 NDC 42571-040-05    unit of use bottles of 500 NDC 42571-040-10    bottles of 1000. Simvastatin Tablets USP, 80 mg are white to off white oblong shaped, biconvex, film-coated tablets, engraved with ‘80’ on one face and ‘SVT’ on the other. They are supplied as follows: NDC 42571-080-30    unit of use bottles of 30 NDC 42571-080-60    unit of use bottles of 60 NDC 42571-080-90    unit of use bottles of 90 NDC 42571-080-05    unit of use bottles of 500 NDC 42571-080-10    bottles of 1000.   Storage   Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]   Dispense in tightly-closed container.

授权状态:

Abbreviated New Drug Application

产品特点

SIMVASTATIN - SIMVASTATIN TABLET
MICRO LABS LIMITED
----------
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
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 tablets orally once daily in the evening.
Maximum recommended dosage is simvastatin tablets 40 mg once daily. An
80 mg daily dosage of
simvastatin tablets 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 40 mg daily, prescribe alternative LDL-C lowering
treatment.
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating, and adjust the dosage if
necessary.
_Adults:_Recommended dosage is 20 mg to 40 mg once daily. ( 2.2