AVAPRO- irbesartan tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

irbesartan (UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)

から入手可能:

Physicians Total Care, Inc.

INN（国際名）:

irbesartan

構図:

irbesartan 150 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. AVAPRO is 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, AVAPRO 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 ). AVAPRO is contraindicated in patients who are hypersensitive to any component of this product.

製品概要:

AVAPRO® (irbesartan) is available as white to off-white biconvex oval tablets, debossed with a heart shape on one side and a portion of the NDC code on the other. Unit-of-use bottles contain 30, 90, or 500 tablets and blister packs contain 100 tablets, as follows: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

認証ステータス:

New Drug Application

製品の特徴

AVAPRO - IRBESARTAN TABLET
PHYSICIANS TOTAL CARE, INC.
----------
AVAPRO
(IRBES ARTAN)
TABLETS
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, AVAPRO should be discontinued as soon as
possible. See WARNINGS:
FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
AVAPRO * (irbesartan) is an angiotensin II receptor (AT subtype)
antagonist.
*Registered trademark
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.
AVAPRO is available for oral administration in unscored tablets
containing 75 mg, 150 mg, or 300 mg
of irbesartan. Inactive ingredients include: lactose, microcrystalline
cellulose, pregelatinized starch,
croscarmellose sodium, poloxamer 188, silicon dioxide, and magnesium
stearate.
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
®
®
1
25
28
6
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.