AVALIDE®
(irbesartan-hydrochlorothiazide)
Tablets
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, AVALIDE should be discontinued
as soon as possible.(See WARNINGS: Fetal/Neonatal
Morbidity and Mortality.)
DESCRIPTION
AVALIDE®* (irbesartan-hydrochlorothiazide)
Tablets is a combination of an angiotensin II receptor antagonist
(AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide
(HCTZ).
Irbesartan is a non-peptide compound, chemically described
as a 2-butyl-3-[[2'-(1H-tetrazol-5-yl) [1, 1'-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.
Hydrochlorothiazide is 6-chloro-3, 4-dihydro- 2H-1,2,4-benzo-thiadiazine-7-sulfonamide
1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its
structural formula is: Hydrochlorothiazide is a white, or
practically white, crystalline powder with a molecular weight
of 297.7. Hydrochlorothiazide is slightly soluble in water
and freely soluble in sodium hydroxide solution.
AVALIDE is available for oral administration in tablets
containing 150 mg or 300 mg of irbesartan combined with
12.5 mg of hydrochlorothiazide. Inactive ingredients include:
lactose monohydrate, microcrystalline cellulose, pregelatinized
starch, croscarmellose sodium, ferric oxide red, ferric
oxide yellow, silicon dioxide, and magnesium stearate.
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