VALSARTAN tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Tillgänglig från:

Northwind Pharmaceuticals, LLC

INN (International namn):

VALSARTAN

Sammansättning:

VALSARTAN 80 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

1.1 Hypertension Valsartan 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 the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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 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’s Joint National Committee

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

VALSARTAN- VALSARTAN TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, LLC
----------
VALSARTAN
BOXED WARNING
WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue valsartan 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 & USAGE
1.1 Hypertension
Valsartan 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 the class to
which valsartan principally
belongs. There are no controlled trials in hypertensive patients
demonstrating risk reduction with
valsartan 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 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’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 also have been
seen regularly.
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