DESCRIPTION
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.
|
AVAPRO® (irbesartan) is an angiotensin
II receptor (AT 1 subtype) antagonist.
Irbesartan is a non-peptide compound, chemically
described as a 2-butyl-3-[[ 29-( 1H-tetrazol-5-yl) [1, 19-biphenyl]-4-yl]
methyl]1,3-diazaspiro[4,4] non-1-en-4-one.
Its empirical formula is C25H28N6O.
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.
|
|
