VALSARTAN tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

A-S Medication Solutions

INN (Mezinárodní Name):

VALSARTAN

Složení:

VALSARTAN 80 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year 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 Education

Přehled produktů:

Product: 50090-2518 NDC: 50090-2518-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-2518-1 90 TABLET, FILM COATED in a BOTTLE Product: 50090-2550 NDC: 50090-2550-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-2550-1 90 TABLET, FILM COATED in a BOTTLE Product: 50090-2877 NDC: 50090-2877-1 90 TABLET, FILM COATED in a BOTTLE NDC: 50090-2877-0 30 TABLET, FILM COATED in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

VALSARTAN - VALSARTAN TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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_.
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 DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.1) 4/2021
Dosage and Administration (2.1, 2.3) 4/2021
INDICATIONS AND USAGE
Valsartan is an angiotensin II receptor blocker (ARB) indicated for:
Hypertension, to lower blood pressure in adults and children 1 year
and older. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions (1.1)
Heart failure (NYHA class II to IV), to reduce hospitalization for
heart failure in adults (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 in adults (1.3)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
DOSE RANGE*
Hypertension Adults (2.2)
80 to 160 mg once daily
80 to 320 mg once daily
1 to 16 years (2.3)
1 mg/kg once daily
Up to 40 mg daily
1 to 4 mg/kg once daily
Up to 160 mg daily
Heart Failure (2.4)
40 mg twice daily
40 to 160 mg twice daily
Post-Myocardial Infarction
(2.5)
20 mg twice daily
20 to 160 mg twice daily
* As tolerated by patient
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
Observe for signs and symptoms of hypotension (5.2)
Monitor r