IRBESARTAN tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)

Предлага се от:

DIRECTRX

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. 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

Каталог на резюме:

Irbesartan USP is available as white to off-white film coated, oval tablets, debossed on one side with “ML 94”, “ML 95” and “ML 96” respectively for 75 mg, 150 mg and 300 mg tablets and plain on the other side. (see Table below). Unit-of-use bottles contain 30, 90 or 500 tablets and blister packs contain 100 tablets or 90 tablets, as follows: 75 mg 150 mg 300 mg Debossing “ ML 94” “ML 95” “ML 96” Bottle of 30 33342-047-07 33342-048-07 33342-049-07 Bottle of 90 33342-047-10 33342-048-10 33342-049-10 Bottle of 500 33342-047-15 33342-048-15 33342-049-15 Blister of 100 33342-047-12 33342-048-12 --- Blister of 90 --- --- 33342-049-39 Storage Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

IRBESARTAN- IRBESARTAN TABLET
DIRECTRX
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IRBESARTAN
WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue irbesartan tablets as soon
as possible.
• Drugs that act directly on the renin-angiotensin system can cause
injury and death to the
developing fetus [see Warnings and Precautions (5.1)].
1.1 Hypertension
Irbesartan tablets are indicated for the treatment of hypertension, to
lower blood pressure. Lowering
blood pressure lowers the risk of fatal and non-fatal cardiovascular
(CV) events, primarily strokes and
myocardial infarction. These benefits have been seen in controlled
trials of antihypertensive drugs from
a wide variety of pharmacologic classes including this drug.
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 also have been
seen regularly.
Elevated systolic or diastolic pressure causes increased
cardiovascular risk, and the absolute risk
increase per mmHg is greater at higher blood pressures, so that even
modest reductions of se