Source: FDA, National Drug Code (US) Revision Year: 2021
AVAPRO (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan 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 C25H28N6O, 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, film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
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AVAPRO 75 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2871” on the other. AVAPRO 150 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2872” on the other. AVAPRO 300 mg is a white to off-white, biconvex oval, film-coated, tablet debossed with a heart on one side and “2873” on the other. |
| How Supplied | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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AVAPRO (irbesartan) is available as white to off-white, biconvex oval, film-coated tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain 30 or 90 film-coated tablets as follows:
sanofi-aventis U.S. LLC, Bridgewater, NJ 08807 |
| Drug | Countries | |
|---|---|---|
| AVAPRO | Australia, Japan, United States |
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