PRAVASTATIN SODIUM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dr.Reddy's Laboratories Limited

INN (Tarptautinis Pavadinimas):

PRAVASTATIN SODIUM

Sudėtis:

PRAVASTATIN SODIUM 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 tablets are 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. • redu

Produkto santrauka:

Pravastatin sodium tablets USP are supplied as:  10 mg tablets: White, round, biconvex coated tablets, debossed ‘RDY’ on one side and ‘229’ on other side and are supplied in bottles of 30, 90, 100 and 500.  Bottles of 30               NDC 55111-229-30 Bottles of 90               NDC 55111-229-90 Bottles of 100              NDC 55111-229-01 Bottles of 500             NDC 55111-229-05         20 mg tablets: White, round, biconvex coated tablets, debossed ‘RDY’ on one side and ‘230’ on other side and are supplied in bottles of 30, 90, 100 and 500. Bottles of 30               NDC 55111-230-30 Bottles of 90               NDC 55111-230-90 Bottles of 100              NDC 55111-230-01 Bottles of 500              NDC 55111-230-05  40 mg tablets: White, round, biconvex coated tablets, debossed ‘RDY’ on one side and ‘231’ on other side and are supplied in bottles of 30, 90, 100 and 500. Bottles of 30               NDC 55111-231-30 Bottles of 90               NDC 55111-231-90 Bottles of 100            NDC 55111-231-01 Bottles of 500            NDC 55111-231-05  80 mg tablets: White, oval, biconvex coated tablets, debossed ‘RDY’ on one side and ‘274’ on other side and are supplied in bottles of 30, 90, 100 and 500. Bottles of 30               NDC 55111-274-30 Bottles of 90               NDC 55111-274-90 Bottles of 100             NDC 55111-274-01 Bottles of 500             NDC 55111-274-05 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]. Keep tightly closed (protect from moisture). Protect from light.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
DR.REDDY'S LABORATORIES LIMITED
----------
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, andcardiovascularmortalityin
hypercholesterolemicpatientswithout
clinicallyevidentCHD. (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 serumTG 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 to18 years):the recommended starting dose is 40
mg once daily.(2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10