IRBESARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

irbesartan

Composition:

irbesartan 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Irbesartan 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 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 coadminister aliskiren with Irbesartan in patients with diabetes (see PRECAUTIONS: Drug Interactions ).

Product summary:

Irbesartan Tablets USP, 150 mg are white or off-white, capsule-shaped, biconvex , debossed ‘HH’ on one side and ‘330’ on the other side. NDC numbers are supplied as follows: NDC 63187-757-30: bottles of 30 NDC 63187-757-60: bottles of 60 NDC 63187-757-90: bottles of 90 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. You may report side effects to Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN- IRBESARTAN TABLET
PROFICIENT RX LP
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IRBESARTAN TABLETS USP
RX ONLY
WARNING: 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 is available for oral administration in unscored tablets
containing 75 mg, 150 mg, or 300 mg
of irbesartan. Inactive ingredients include: lactose monohydrate,
microcrystalline cellulose,
croscarmellose sodium, hypromellose, 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
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.
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25
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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 re