Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
irbesartan (UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N)
Physicians Total Care, Inc.
irbesartan
irbesartan 150 mg
ORAL
PRESCRIPTION DRUG
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.
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].
New Drug Application
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. Прочитайте повний документ