VALSARTAN tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Physicians Total Care, Inc.

INN (আন্তর্জাতিক নাম):

VALSARTAN

রচনা:

VALSARTAN 80 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Valsartan tablets USP 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 USP. 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, Det

পণ্য সারাংশ:

Valsartan tablets USP, 80 mg are available as pink, film-coated, unscored, round, convex tablets, debossed "7432" on one side and "TV" on the other side. Bottles of 30    NDC 54868-6458-0 Valsartan tablets USP, 160 mg are available as orange, film-coated, unscored, oval-shaped tablets, debossed "7433" on one side and "TEVA" on the other side. Bottles of 30    NDC 54868-6452-0 Valsartan tablets USP, 320 mg are available as brown, film-coated, unscored, oval-shaped tablets, debossed "7434" on one side and "TEVA" on the other side. Bottles of 30    NDC 54868-6453-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

VALSARTAN- VALSARTAN TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS USP SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN TABLETS USP.
VALSARTAN TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
INDICATIONS AND USAGE
Valsartan tablets USP 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
DO SE
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
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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
Treatment of HYPERTENSION, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarcti