VALSARTAN tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Amneal Pharmaceuticals LLC

INN (Medzinárodný Name):

VALSARTAN

Zloženie:

VALSARTAN 40 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 Education

Prehľad produktov:

Valsartan tablets, USP are available as tablets containing valsartan, USP 40 mg, 80 mg, 160 mg, or 320 mg. Valsartan tablets USP, 40 mg, are supplied as yellow, oval, film-coated scored tablets debossed with “3” bisect “7” on one side and “AN” on the other side. They are available as follows: Bottles of 30:                                     NDC 65162-837-03 Bottles of 60:                                     NDC 65162-837-06 Bottles of 500:                                   NDC 65162-837-50 Valsartan tablets USP, 80 mg, are supplied as pink, oval, film-coated tablets with beveled edges, debossed with “838” on one side and “AN” on the other side. They are available as follows: Bottles of 90:                                     NDC 65162-838-09 Bottles of 500:                                   NDC 65162-838-50 Bottles of 1,000:                                NDC 65162-838-11 Valsartan tablets USP, 160 mg, are supplied as yellow, oval, film-coated tablets with beveled edges, debossed with “839” on one side and “AN” on the other side. They are available as follows: Bottles of 90:                                     NDC 65162-839-09 Bottles of 500:                                   NDC 65162-839-50 Bottles of 1,000:                                NDC 65162-839-11 Valsartan tablets USP, 320 mg, are supplied as brown, oval, film-coated tablets with beveled edges, debossed with “840” on one side and “AN” on the other side. They are available as follows: Bottles of 90:                                     NDC 65162-840-09 Bottles of 500:                                   NDC 65162-840-50 Bottles of 1,000:                                NDC 65162-840-11 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container with a child-resistant closure as defined in the USP.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

VALSARTAN- VALSARTAN TABLET
AMNEAL PHARMACEUTICALS LLC
----------
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 TABLETS 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)
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
Hypertension, to lower blood pressure in adults and children 6 years
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-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 mg to 160 mg
once daily
80 mg to 320 mg once daily
6 to 16 years (2.3)
1 mg/kg once daily Up to 40 mg daily1 to 4 mg/kg once daily Up to 160
mg daily
Heart Failure (2.4)
40 mg twice daily
40 mg to 160 mg twice daily
Post-Myocardial
Infarction (2.5)
20 mg twice daily
20 mg to 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 co-administer
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