VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan and hydrochlorothiazide 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 hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide 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 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Bl

Product summary:

Valsartan and Hydrochlorothiazide Tablets, USP are available containing 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg or 320 mg/25 mg of valsartan, USP and hydrochlorothiazide, USP. The 80 mg/12.5 mg tablets are orange, film-coated, round, unscored tablets, debossed with M on one side of the tablet and V21 on the other side. They are available as follows: NDC 0378-6321-77 bottles of 90 tablets The 160 mg/12.5 mg tablets are orange, film-coated, round, unscored tablets, debossed with M on one side of the tablet and V22 on the other side. They are available as follows: NDC 0378-6322-77 bottles of 90 tablets The 160 mg/25 mg tablets are orange, film-coated, oval, unscored tablets, debossed with M on one side of the tablet and V23 on the other side. They are available as follows: NDC 0378-6323-77 bottles of 90 tablets The 320 mg/12.5 mg tablets are orange, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V24 on the other side. They are available as follows: NDC 0378-6324-77 bottles of 90 tablets The 320 mg/25 mg tablets are beige, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V25 on the other side. They are available as follows: NDC 0378-6325-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS.
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Valsartan and hydrochlorothiazide tablets are the combination tablet
of valsartan, an angiotensin II
receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic.
Valsartan and hydrochlorothiazide
tablets 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 HCTZ): 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25
mg, 320 mg/12.5 mg, 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 tablets
were headache and dizziness. The only adverse experience that occurred
in ≥ 2% of patients treated with
valsartan and hydrochlorothiazide tablets and at a higher incidence
than placebo was nasopharyngitis
(2.4% vs. 1.9%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AND
HYDROCHLOROTHIAZIDE
TABLETS AS SOON AS POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEAT