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:

Northwind Pharmaceuticals

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 160 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Original Manufacturer Information: 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, 80 mg/12.5 mg are light orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '61' on other side. Bottles of 90 NDC 65862-547-90 Bottles of 1,000 NDC 65862-547-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-547-10 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 90 NDC 65862-548-90 Bottles of 1,000 NDC 65862-548-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-548-10 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. Bottles of 90 NDC 65862-549-90 Bottles of 1,000 NDC 65862-549-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-549-10 Valsartan and Hydrochlorothiazide Tablets USP, 320 mg/12.5 mg are pink colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '64' on other side. Bottles of 90 NDC 65862-550-90 Bottles of 500 NDC 65862-550-05 Valsartan and Hydrochlorothiazide Tablets USP, 320 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '65' on other side. Bottles of 90 NDC 65862-551-90 Bottles of 500 NDC 65862-551-05 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
NORTHWIND PHARMACEUTICALS
----------
VALSARTAN AND HYDROCHLORTHIAZIDE
INDICATIONS AND USAGE
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 Program’s Joint
National Committee on Prevention,
Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic
classes and with different
mechanisms of action, have been shown in randomized controlled trials
to reduce cardiovascular
morbidity and mortality, and it can be concluded that it is blood
pressure reduction, and not some other
pharmacologic property of the drugs, that is largely responsible for
those benefits. The largest and
most consistent cardiovascular outcome benefit has been a reduction in
the risk of stroke, but reductions
in myocardial infarction and cardiovascular mortality have also been
seen regularly.
Elevated systolic or diastolic pressure causes increased
cardiovascular risk, and the absolute risk
increase per mmHg is greater at higher bl