VALSARTAN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Tilgjengelig fra:

Alembic Pharmaceuticals Limited

INN (International Name):

VALSARTAN

Sammensetning:

VALSARTAN 40 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection,

Produkt oppsummering:

Valsartan is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below. Valsartan tablets USP, 40 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L128 and breakline on one side and 40 on the other side. NDC46708-044-30    bottle of 30 tablets NDC 46708-044-90    bottle of 90 tablets NDC 46708-044-71    bottle of 500 tablets NDC 46708-044-91  bottle of 1000 tablets NDC 46708-044-10    cartons of 100 (10X10 unit-dose blisters)    Valsartan tablets USP,  80 mg: Pink colored, oval shaped, biconvex, film coated tablets, debossed with L129 on one side and 80 on the other side. NDC 46708-045-30    bottle of 30 tablets NDC 46708-045-90   bottle of 90 tablets NDC 46708-045- 71 bottle of 500 tablets NDC 46708-045-91  bottle of 1000 tablets NDC 46708-045-10   cartons of 100 (10X10 unit-dose blisters)    Valsartan tablets USP, 160 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L130 on one side and 160 on the other side. NDC 46708-046-30    bottle of 30 tablets NDC 46708-046-90   bottle of 90 tablets NDC 46708-046- 71 bottle of 500 tablets NDC 46708-046-91  bottle of 1000 tablets NDC 46708-046-10   cartons of 100 (10X10 unit-dose blisters)  Valsartan tablets USP, 320 mg: Purple colored, oval shaped, biconvex, film coated tablets, debossed with L127 on one side and 320 on the other side. NDC 46708-047-30    bottle of 30 tablets NDC 46708-047-90   bottle of 90 tablets NDC 46708-047- 71 bottle of 500 tablets NDC 46708-047- 91 bottle of 1000 tablets   Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VALSARTAN - VALSARTAN TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN
TABLETS.
VALSARTAN TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN TABLETS AS SOON AS
POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN
DEATH TO THE DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
Valsartan tablets is an angiotensin II receptor blocker (ARB)
indicated for: (1)
Treatment of HYPERTENSION, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal
and nonfatal cardiovascular events, primarily strokes and myocardial
infarctions (1.1)
Treatment of HEART FAILURE (NYHA class II-IV); valsartan tablets
significantly reduced hospitalization for
heart failure (1.2)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
DOSE RANGE
TARGET
MAINTENANCE
DOSE*
Adult Hypertension (2.1)
80 or 160 mg once daily
80 to 320 mg once daily
---
Pediatric Hypertension (6-
16 years) (2.2)
1.3 mg/kg once daily (up
to 40 mg total)
1.3 to 2.7 mg/kg once daily (up
to 40-160 mg total)
---
Heart Failure (2.3)
40 mg twice daily
40 to 160 mg twice daily
160 mg twice daily
* as tolerated by patient (2)
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component; Do not coadminister aliskiren
with valsartan tablets in patients
with diabetes (4) (4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension (5.2)
Monitor renal function and potassium in susceptible patients (5.3,
5.4)
ADVERSE REACTIONS
HYPERTENSION: Most common adverse reactions are headache, dizziness,
viral infection, fatigue and
abdominal pain (6.1)
HEART FAILURE: Most common adverse reactions are dizziness,
hypotension, diarrhea