VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated VALSARTAN AND HYDROCHLOROTHIAZIDE tablet

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:

Macleods Pharmaceuticals Limited

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 320 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

Product summary:

Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. Strengths are available as follows. 80/12.5 mg Tablet - Light orange, oval shaped biconvex film coated tablets debossed with "L16" on one side and plain on other side. Bottles of 90 NDC 33342-074-10 Bottles of 1000 NDC 33342-074-44 160/12.5 mg Tablet - Dark red, oval shaped biconvex film coated tablets debossed with "L17" on one side and plain on other side. Bottles of 90 NDC 33342-075-10 Bottles of 500 NDC 33342-075-15 160/25 mg Tablet - Brown orange, oval shaped biconvex film coated tablets debossed with "L18" on one side and plain on other side. Bottles of 90 NDC 33342-076-10 Bottles of 500 NDC 33342-076-15 320/12.5 mg Tablet - Pink, oval shaped biconvex film coated tablets debossed with "L19" on one side and plain on other side. Bottles of 90 NDC 33342-077-10 Bottles of 500 NDC 33342-077-15 320/25 mg Tablet - Yellow, oval shaped biconvex film coated tablets debossed with "L20" on one side and plain on other side. Bottles of 90 NDC 33342-078-10 Bottles of 500 NDC 33342-078-15 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
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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._
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 DEATH
TO THE DEVELOPING FETUS. (5.1)
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 :
• In patients not adequately controlled with monotherapy (1)
• As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1)
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and
myocardial infarctions.
DOSAGE AND ADMINISTRATION
• Dose once daily. Titrate as needed to a maximum dose of 320/25mg
(2)
• May be used as add-on/switch therapy for patients not adequately
controlled on any of the components
(valsartan or HCTZ) (2)
• May be substituted for titrated components (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5,
320/25 (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