IRBESARTAN tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Bryant Ranch Prepack

INN (Међународно име):

IRBESARTAN

Састав:

IRBESARTAN 150 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Irbesartan tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Irbesartan tablets USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (> 300 mg/day) in patients with type 2 diabetes and hypertension. In this population, irbesartan tablets USP reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY , Clinical Studies ). Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ).

Резиме производа:

Irbesartan tablets USP are available as follows: 75 mg - white to off-white capsule-shaped tablets, one side of the tablet debossed with “TEVA” the other side of the tablet debossed with the number “7464”, in bottles of 30 and 90. 150 mg - white to off-white capsule-shaped tablets, one side of the tablet debossed with “TEVA” the other side of the tablet debossed with the number “7465”, in bottles of 30, 90, and 500. 300 mg - white to off-white capsule-shaped tablets, one side of the tablet debossed with “TEVA” the other side of the tablet debossed with the number “7466”, in bottles of 30, 90, and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 6/2014

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

IRBESARTAN- IRBESARTAN TABLET
BRYANT RANCH PREPACK
----------
IRBESARTAN TABLETS USP
7464
7465
7514
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AS SOON AS
POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS, FETAL TOXICITY.
DESCRIPTION
Irbesartan USP is an angiotensin II receptor (AT subtype) antagonist.
Irbesartan USP is a non-peptide compound, chemically described as a
2-butyl-3-[_p_-(_o_-1_H_-tetrazol-5-
ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
The structural formula is:
C
H N O M.W. 428.5
Irbesartan USP is a white to off-white crystalline powder. It is a
nonpolar compound with a partition
coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan USP is
slightly soluble in alcohol and
methylene chloride and practically insoluble in water.
Irbesartan tablets USP are available for oral administration in
unscored tablets containing 75 mg, 150
mg, or 300 mg of irbesartan USP. Inactive ingredients include:
croscarmellose sodium, magnesium
stearate, microcrystalline cellulose, poloxamer, povidone,
pregelatinized starch, and silicon dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
1
25
28
6
Angiotensin II is a potent vasoconstrictor formed from angiotensin I
in a reaction catalyzed by
angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is
the principal pressor agent of the
renin-angiotensin system (RAS) and also stimulates aldosterone
synthesis and secretion by adrenal
cortex, cardiac contraction, renal resorption of sodium, activity of
the sympathetic nervous system, and
smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and
aldosterone-secreting effects of
angiotensin II by selectively binding to the AT angiotensin II
receptor. There is also an AT receptor
in many tissues, but it is not involved in cardiovascular homeostasis.
Irbesartan is a specific competitive antagonist of AT receptors with a
much greater affinity (more than
8500 fold) for the AT recepto