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CAPOTEN ® (captopril tablets)
USE IN PREGNANCY
When used in pregnancy
during the second and third trimesters, ACE inhibitors can cause
injury and even death
to the developing fetus.
When pregnancy
is detected, CAPOTEN should be discontinued as soon as possible.
See WARNINGS: Fetal/Neonatal
Morbidity and Mortality.
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- CAPOZIDE ® 25/15
- CAPOZIDE ® 25/25
- CAPOZIDE ® 50/15
- CAPOZIDE ® 50/25
(captopril and hydrochlorothiazide
tablets, USP)
DESCRIPTION
CAPOZIDE (captopril and hydrochlorothiazide
tablets, USP) for oral administration
combines two antihypertensive
agents: CAPOTEN (captopril) and hydrochlorothiazide. Captopril, the first
of a new class of antihypertensive
agents, is a specific competitive inhibitor
of angiotensin I-converting
enzyme (ACE), the enzyme responsible
for the conversion of angiotensin
I to angiotensin II. Hydrochlorothiazide
is a benzothiadiazide (thiazide) diuretic-antihypertensive. CAPOZIDE tablets
are available in four combinations of captopril
with hydrochlorothiazide: 25 mg
with 15 mg, 25 mg with 25 mg, 50
mg with 15 mg, and 50 mg
with 25 mg. Inactive ingredients: microcrystalline
cellulose, colorant (FD&
C Yellow No. 6), lactose, magnesium
stearate, pregelatinized starch,
and stearic acid. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline;
hydrochlorothiazide is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Captopril is a white to off-white
crystalline powder
that may have a slight sulfurous odor; it is soluble
in water (approx. 160 mg/mL),
methanol, and ethanol and
sparingly soluble in chloroform
and ethyl acetate. Hydrochlorothiazide
is a white crystalline
powder slightly soluble
in water but freely soluble
in sodium hydroxide
solution.
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