PRAVASTATIN SODIUM tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Major Pharmaceuticals

INN (שם בינלאומי):

PRAVASTATIN SODIUM

הרכב:

PRAVASTATIN SODIUM 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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: In patients with clinically evident CHD, pravastatin sodium is indicated to: Pravastatin sodium tablets are indicated: Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). Hypersensitivity to any component of this medication. Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.2) ]. Atherosclerosis is a chronic process and di

leaflet_short:

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: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5891-61 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: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5892-61 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: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5893-61 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
MAJOR PHARMACEUTICALS
----------
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:
7.
8.
9.
10.
11.
12.
Limitations of use:
2.
DOSAGE AND ADMINISTRATION
5.
6.
7.
8.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
5.
6.
7.
8.
WARNINGS AND PRECAUTIONS
3.
4.
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)
Pravastatin sodium has not been studied in _Fredrickson_ Types I and V
dyslipidemias. (1.3)
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