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)
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
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
in unscored tablets containing 75 mg, 150 mg, or 300 mg
of irbesartan. Inactive ingredients include: lactose, microcrystalline
sodium, poloxamer 188, silicon
dioxide and magnesium