VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Alembic Pharmaceuticals Limited

INN (International namn):

VALSARTAN

Sammansättning:

VALSARTAN 80 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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 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

Produktsammanfattning:

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 mg/12.5 mg Tablet - Light orange, oval-shaped film coated tablets debossed with ‘L235’ on one side and plain on other side. NDC 46708-453-30 bottle of 30 tablets NDC 46708-453-90 bottle of 90 tablets NDC 46708-453-71 bottle of 500 tablets NDC 46708-453-10 carton of 100 (10 x 10) tablets unit dose 160 mg/12.5 mg Tablet - Dark red, oval-shaped film coated tablets debossed with ‘L236’ on one side and plain on other side. NDC 46708-454-30 bottle of 30 tablets NDC 46708-454-90 bottle of 90 tablets NDC 46708-454-71 bottle of 500 tablets NDC 46708-454-10 carton of 100 (10 x 10) tablets unit dose 160 mg/25 mg Tablet - Brown orange, oval-shaped film coated tablets debossed with ‘L237’ on one side and plain on other side. NDC 46708-455-30 bottle of 30 tablets NDC 46708-455-90 bottle of 90 tablets NDC 46708-455-71 bottle of 500 tablets NDC 46708-455-10 carton of 100 (10 x 10) tablets unit dose 320 mg/12.5 mg Tablet - Pink, oval-shaped film coated debossed with ‘L238’ on one side and plain on other side. NDC 46708-455-30 bottle of 30 tablets NDC 46708-455-90 bottle of 90 tablets NDC 46708-455-71 bottle of 500 tablets NDC 46708-455-10 carton of 100 (10 x 10) tablets unit dose 320 mg/25 mg Tablet - Yellow, oval-shaped film coated debossed with ‘L239’ on one side and plain on other side. NDC 46708-457-30 bottle of 30 tablets NDC 46708-457-90 bottle of 90 tablets NDC 46708-457-71 bottle of 500 tablets NDC 46708-457-10 carton of 100 (10 x 10) tablets unit dose Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
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, USP 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 EVEN
DEATH TO THE DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
Valsartan and hydrochlorothiazide tablets are combination of
valsartan, an angiotensin II receptor blocker
(ARB) and hydrochlorothiazide (HCTZ), a diuretic. (1)
Valsartan and hydrochlorothiazide tablets are indicated for the
treatment of hypertension, to lower blood
pressure: (1)
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. (1)
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) (3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to sulfonamide-derived drugs or any
component: Do not co-administer aliskiren
with valsartan and hydrochlorothiazide tablets in patients with
diabetes (4) (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume-depletion prior to initiati