PRAVASTATIN SODIUM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

제공처:

Zydus Pharmaceuticals USA Inc.

INN (국제 이름):

PRAVASTATIN SODIUM

구성:

PRAVASTATIN SODIUM 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablet, USP is indicated to: -   reduce the risk of myocardial infarction (MI). -   reduce the risk of undergoing myocardial revascularization procedures. -   reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. In patients with clinically evident CHD, pravastatin sodium tablet is indicated to: -   reduce the risk of total mortality by reducing coronary death. -   reduce the risk of MI. -   reduce the risk of undergoing myocardial revascularization procedures. -  

제품 요약:

Pravastatin Sodium Tablets USP, 10 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC46' on one side and plain on the other side and are supplied as follows: NDC 68382-070-16 in bottles of 90 tablets NDC 68382-070-05 in bottles of 500 tablets Pravastatin Sodium Tablets USP, 20 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC45' on one side and plain on the other side and are supplied as follows: NDC 68382-071-16 in bottles of 90 tablets NDC 68382-071-05 in bottles of 500 tablets NDC 68382-071-10 in bottles of 1000 tablets Pravastatin Sodium Tablets USP, 40 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC44' on one side and plain on the other side and are supplied as follows: NDC 68382-072-16 in bottles of 90 tablets NDC 68382-072-05 in bottles of 500 tablets Pravastatin Sodium Tablets USP, 80 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC43' on one side and plain on the other side and are supplied as follows: NDC 68382-073-16 in bottles of 90 tablets NDC 68382-073-05 in bottles of 500 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PRAVASTATIN SODIUM
TABLETS.
PRAVASTATIN SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
INDICATIONS AND USAGE
Pravastatin sodium tablet, USP is an HMG-CoA reductase inhibitor
(statin) indicated as an adjunctive
therapy to diet to:
Reduce the risk of MI, revascularization, and cardiovascular mortality
in hypercholesterolemic patients
without clinically evident CHD. (1.1)
Reduce the risk of total mortality by reducing coronary death, MI,
revascularization, stroke/TIA, and the
progression of coronary atherosclerosis in patients with clinically
evident CHD. (1.1)
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase
HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. (1.2)
Reduce elevated serum TG levels in patients with hypertriglyceridemia.
(1.2)
Treat patients with primary dysbetalipoproteinemia who are not
responding to diet. (1.2)
Treat children and adolescent patients ages 8 years and older with
heterozygous familial
hypercholesterolemia after failing an adequate trial of diet therapy.
(1.2)
Limitations of use:
Pravastatin sodium tablet, USP has not been studied in _Fredrickson
_Types I and V dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
Adults: the recommended starting dose is 40 mg once daily. Use 80 mg
dose only for patients not
reaching LDL-C goal with 40 mg. (2.2)
Significant renal impairment: the recommended starting dose is
pravastatin 10 mg once daily. (2.3)
Children (ages 8 to 13 years, inclusive): the recommended starting
dose is 20 mg once daily. (2.4)
Adolescents (ages 14 to 18 years): the recommended starting dose is 40
mg once daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg