IRBESARTAN tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

LUPIN LIMITED

INN (Међународно име):

IRBESARTAN

Састав:

IRBESARTAN 75 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Irbesartan Tablets USP are indicated for the treatment of hypertension. It 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 reduces 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 is contraindicated in patients who are hypersensitive to any component of this product. Do not co-administer aliskiren with irbesartan in patients with diabetes (see PRECAUTIONS: Drug Interactions ).

Резиме производа:

Irbesartan Tablets USP, 75 mg are white to off-white, oval shaped, uncoated tablets, debossed with ‘LU’ on one side and ‘M11’ on the other side, which are supplied as follows: NDC 68180-410-06 Bottle of 30s NDC 68180-410-09 Bottle of 90s Irbesartan Tablets USP, 150 mg are white to off-white, oval shaped, uncoated tablets, debossed with ‘LU’ on one side and ‘M12’ on the other side, which are supplied as follows: NDC 68180-411-06 Bottle of 30s NDC 68180-411-09 Bottle of 90s NDC 68180-411-02 Bottle of 500s Irbesartan Tablets USP, 300 mg are white to off-white, oval shaped, uncoated tablets, debossed with ‘LU’ on one side and ‘M13’ on the other side, which are supplied as follows: NDC 68180-412-06 Bottle of 30s NDC 68180-412-09 Bottle of 90s NDC 68180-412-02 Bottle of 500s Storage Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

IRBESARTAN- IRBESARTAN TABLET
LUPIN LIMITED
----------
IRBESARTAN TABLETS USP
RX ONLY
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: FETAL TOXICITY.
DESCRIPTION
Irbesartan is an angiotensin II receptor (AT subtype) antagonist.
Irbesartan 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.
Its empirical formula is C
H N O, and the structural formula:
Irbesartan is a white to off-white crystalline powder with a molecular
weight of 428.5. It is a nonpolar
compound with a partition coefficient (octanol/water) of 10.1 at pH of
7.4. Irbesartan 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. Inactive ingredients include: colloidal
silicon dioxide, crospovidone,
magnesium stearate, mannitol, povidone and sodium lauryl sulphate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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 receptor than for the AT receptor