PRAVASTATIN SODIUM tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aphena Pharma Solutions - Tennessee, Inc.

INN (nemzetközi neve):

PRAVASTATIN SODIUM

Összetétel:

PRAVASTATIN SODIUM 40 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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: - high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1 - a s an adjunct to diet for the treatment of patients with ele

Termék összefoglaló:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Pravastatin Sodium Tablets, USP 10 mg are available for oral administration as light pink, round, unscored tablets, imprinted “APO” on one side and “PRA” over “10” on the other side. They are supplied as follows: Bottles of 90 (NDC 60505-0168-9) Bottles of 100 (NDC 60505-0168-1) Bottles of 500 (NDC 60505-0168-5) Bottles of 1000 (NDC 60505-0168-7) Pravastatin Sodium Tablets, USP 20 mg are available for oral administration as off-white to light yellow, round, unscored tablets, imprinted “APO” on one side and “PRA” over “20” on the other side. They are supplied as follows: Bottles of 90 (NDC 60505-0169-9) Bottles of 100 (NDC 60505-0169-1) Bottles of 500 (NDC 60505-0169-5) Bottles of 1000 (NDC 60505-0169-7) Pravastatin Sodium Tablets, USP 40 mg are available for oral administration as light green, round, unscored tablets, imprinted “APO” on one side and “PRA” over “40” on the other side. They are supplied as follows: Bottles of 90 (NDC 60505-0170-9) Bottles of 100 (NDC 60505-0170-1) Bottles of 500 (NDC 60505-0170-5) Bottles of 1000 (NDC 60505-0170-7) Pravastatin Sodium Tablets, USP 80 mg are available for oral administration as off-white to light yellow, round, unscored tablets, imprinted "APO" on one side and "PRA" over "80" on the other side. They are supplied as follows: Bottles of 90 (NDC 60505-1323-9) Bottles of 100 (NDC 60505-1323-1) Bottles of 500 (NDC 60505-1323-5) Bottles of 1000 (NDC 60505-1323-7) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PRAVASTATIN SODIUM.
PRAVASTATIN SODIUM TABLETS, USP
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin sodium 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 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 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 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, 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 mothers. (4.4, 8.3)
WARNINGS AND PRECAUTIONS
Skeletal muscle effects