IRBESARTAN- irbesartan tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

REMEDYREPACK INC.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hypertension Irbesartan tablet USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.  Nephropathy in Type 2 Diabetic Patients Irbesartan tablet USP 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, irbesartan tablet USP 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 tablet USP is contraindicated in patients who are hypersensitive to any component of this product.  Do not co-administer aliskiren with irbesartan tablet USP in patients with diabetes (see PRECAUTIONS, Drug Interactions).

Přehled produktů:

Irbesartan Tablets USP, 75 mg are white, capsule shaped, biconvex tablets debossed with '158' on one side and 'H' on the other side. They are supplied in Bottles of 30 tablets (NDC 31722-729-30) Bottles of 90 tablets (NDC 31722-729-90) Bottles of 500 tablets (NDC 31722-729-05) Blister Pack of 12x10's (Alu-PVC) (NDC 31722-729-31) Irbesartan Tablets USP, 150 mg are white, capsule shaped, biconvex tablets debossed with'159' on one side and 'H'  on the other side. They are supplied in Bottles of 30 tablets (NDC 31722-730-30) Bottles of 90 tablets (NDC 31722-730-90) Bottles of 500 tablets (NDC 31722-730-05) Blister Pack of 12x10's (Alu-PVC) (NDC 31722-730-31)Irbesartan Tablets USP, 300 mg are white, capsule shaped, biconvex tablets debossed with '160' on one side and 'H'  on the other side. They are supplied in Bottles of 30 tablets (NDC 31722-731-30) Bottles of 90 tablets (NDC 31722-731-90) Bottles of 500 tablets (NDC 31722-731-05) Blister Pack of 12x10's (Alu-PVC) (NDC 31722-731-31) Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] Manufactured for: Camber Pharmaceuticals, inc. Piscataway,NJ 08854 By:                         Revised:  December 2014

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IRBESARTAN- IRBESARTAN TABLET
REMEDYREPACK INC.
----------
IRBESARTAN TABLETS USP
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 (AT1 subtype) antagonist.
Irbesartan USP is a non-peptide compound, chemically described as a
2-butyl-3 _-[p-(o-1H_-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 USP 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 is available for oral administration in unscored tablets
containing 75 mg, 150 mg, or 300 mg
of Irbesartan USP. Inactive ingredients include: calcium stearate,
carboxy methyl cellulose calcium,
colloidal silicon dioxide, microcrystalline cellulose and povidone.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II is a potent vasoconstrictor formed from angiotensin I
in a reaction catalyzed by
25
28
6
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