VALSARTAN tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Proficient Rx LP

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. 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 Educa

Каталог на резюме:

Valsartan is available as tablets containing valsartan USP 320 mg. All strengths are packaged in bottles as described below. 320 mg tablets are biconvex, oval-shaped and unscored. Tablet Color Deboss NDC 71205-###-##     Side 1 Side 2 Bottle of 30 60 90 320 mg Dark grey-violet L15 -- 301-30 301-60 301-90 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

VALSARTAN- VALSARTAN TABLET, FILM COATED
PROFICIENT RX LP
----------
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
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
. 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)
• Post-myocardial infarction; for the reduction of cardiovascular
mortality in clinically stable patients with
left ventricular failure or left ventricular dysfunction following
myocardial infarction (1.3)
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
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
* as tolerated by patient
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)
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, DIAR