PRAVASTATIN SODIUM- pravastatin sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PRAVASTATIN SODIUM

Composition:

PRAVASTATIN SODIUM 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Tablets USP are 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. Pravastatin Sodium Tablets USP are indicated: - as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein chol

Product summary:

Pravastatin Sodium Tablets USP are supplied as: 10 mg tablets: Pink, unscored, round tablet, debossed “TEVA” on one side and “771” on the other side in bottles of 90 (NDC 665-90) and 1000  (NDC 42291-665-10). 20 mg tablets : Light-yellow, unscored, round tablet, debossed “TEVA” on one side and “7201” on the other side in bottles of 90 (NDC 42291-667-90) and 1000 (NDC 42291-667-10). 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side in bottles of 90 (NDC 42291-668-90)and (NDC 42291-668-10) 1000. 80 mg tablets: Off-white to mottled grey, unscored, oval-shaped tablet, debossed “TEVA” on one side and “7270” on the other side in bottles of 45 (NDC 42291-669-45) ,90 (NDC 42291-669-90) and 1000 (NDC 42291-669-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM
TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PRAVASTATIN SODIUM
TABLETS USP.
PRAVASTATIN SODIUM TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin Sodium Tablets USP are 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 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 Tablets USP have 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 10 mg
once daily. (2.2)
Children (ages 8 to 13 years, inclusive): the recommended starting
dose is 20 mg once daily. (2.3)
Adolescents (ages 14 to 18 years): the recommended starting dose is 40
mg once daily. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg, 40 mg, and 80 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4.1, 6.2, 11)
Active liver disease or unexplained, persistent elevations of serum
transaminases. (4.2, 5.2)
Women who are pregnant or may become pregnant. (4.3, 8.1)
Nursing