VALSARTAN- valsartan tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Bryant Ranch Prepack

INN (Nama Internasional):

VALSARTAN

Komposisi:

VALSARTAN 160 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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,

Ringkasan produk:

Product: 71335-0553 Product: 71335-0600 NDC: 71335-0600-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0600-2 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0600-3 28 TABLET, FILM COATED in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

VALSARTAN- VALSARTAN TABLET, FILM COATED
BRYANT RANCH PREPACK
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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._
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INDICATIONS AND USAGE
Valsartan tablets are 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
* 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
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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 Actavis at
1-800-272-5525 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.G O V/MEDWATCH.
DRUG INTERACTIONS
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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