VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Inapatikana kutoka:

Proficient Rx LP

INN (Jina la Kimataifa):

VALSARTAN

Tungo:

VALSARTAN 160 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Valsartan and hydrochlorothiazide 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide 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 1 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 P

Bidhaa muhtasari:

Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan and hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. Strengths are available as follows. Valsartan and Hydrochlorothiazide Tablets USP, 160 mg/12.5 mg are dark red colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with "I" on one side and "62" on other side.          Bottles of 30                                                    NDC 63187-312-30          Bottles of 90                                                    NDC 63187-312-90           Valsartan and Hydrochlorothiazide Tablets USP, 160 mg/25 mg are brown-orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with "I" on one side and "63" on other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in tight container (USP).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND HYDROCHLOROTHIAZIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS, USP.
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
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INDICATIONS AND USAGE
Valsartan and hydrochlorothiazide is the combination tablet of
valsartan, an angiotensin II receptor blocker (ARB) and
hydrochlorothiazide, a diuretic.
Valsartan and hydrochlorothiazide tablets, USP are indicated for the
treatment of hypertension, to lower blood pressure:
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•
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets (valsartan and hydrochlorothiazide): 80 mg/12.5 mg, 160
mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320
mg/25 mg. (3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to any sulfonamide-derived drugs or any
component; Do not coadminister aliskiren with valsartan
and hydrochlorothiazide tablets in patients with diabetes.(4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
THE MOST COMMON REASONS FOR DISCONTINUATION OF THERAPY WITH VALSARTAN
AND HYDROCHLOROTHIAZIDE WERE
HEADACHE AND DIZZINESS. THE ONLY ADVERSE EXPERIENCE THAT OCCURRED IN
≥2% OF PATIENTS TREATED WITH VALSARTAN
AND HYDROCHLOROTHIAZIDE AND AT A HIGHER INCIDENCE THAN PLACEBO WAS
NASOPHARYNGITIS (2.4% VS. 1.9%). (6.1)TO
REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA, INC.
AT 1-866-850-2876 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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When pregnancy is detected, discontinue valsartan and
hydrochlorothiazide as soon as possible. (5.1)
Drugs that act directly on the renin-angiotensin system can cause
injury and death to the developing fetus.