VALSARTAN tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Cardinal Health

ИНН (Международная Имя):

VALSARTAN

состав:

VALSARTAN 80 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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,

Обзор продуктов:

Valsartan Tablets USP, 80 mg are pale red colored, round, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '8' on other side. Overbagged with 10 tablets per bag, NDC 55154-4676-0 Valsartan Tablets USP, 160 mg are grey-orange colored, ovaloid, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '67' on other side. Overbagged with 10 tablets per bag, NDC 55154-4678-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

VALSARTAN- VALSARTAN TABLET, FILM COATED
CARDINAL HEALTH
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
Valsartan is an angiotensin II receptor blocker (ARB) indicated for:
•
•
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DOSAGE AND ADMINISTRATION
INDIC ATIO N
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 to 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 to 160 mg total)
---
Heart Failure (2.3)
40 mg twice daily
40 to 160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction (2.4)
20 mg twice daily
20 to 160 mg twice daily
160 mg twice daily
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg (scored), 80 mg, 160 mg, and 320 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component; Do not coadminister aliskiren
with valsartan tablets in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
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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, arthralgia, back pain, fatigue and
hyperkalemia (6.1)
POST-MYOCARDIAL INFARCTION: Most common adverse reactions which caused
patients to discontinue therapy are
hypotension, cough and increased blood creatinine (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA,
INC. AT 1-866-850-2876 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AS SOON AS POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELO