PRAVASTATIN SODIUM- pravastatin sodium tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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. In patients with clinically evident CHD, pravastatin sodium 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. - reduce the risk of strok

Περίληψη προϊόντος:

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 1,000 (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 1,000 (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 1,000 (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 1,000 (NDC 60505-1323-7) Store at 20° to 25°C (68° to 77°F); excursions permitted from 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
REMEDYREPACK 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
Dosage and Administration
Patients with Renal Impairment (2.3) 7/2016
Contraindications
Pregnancy (4.3), Lactation (4.4) 7/2016
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 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 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 AN