CAPTOPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPTOPRIL (UNII: 9G64RSX1XD) (CAPTOPRIL - UNII:9G64RSX1XD)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

CAPTOPRIL

Composition:

CAPTOPRIL 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension: Captopril tablets US?are indicated for the Teatment of hypertension. tn using captopril, conslderallon should be gtven to the risk of neutropenia!agranutocytosls (seeWARNINGS). Captoprll maybe used as Initial therapy for patientswilh normal renal function, In whomthe rlskls relatively low. In patients with impaired renal function, particularly those wfth collagen vascular olSeas6, captopril should be reseNed for,hypertenslves who have either develoPed unacceptable side effecls on otherdrugs, orhave failed to responq satislactorily 10drug cOmbinations. Captopril is effective alone and in combination with other antihypertensive agents, ~peclally thiazide-type diuretics. The blood pressure lowering effecls of captoprif and thlazldes are approximalaly a

Product summary:

Captopril Tablets USP 12.5 mg tabtets in blisterpacks 30 (NDC 0615-4519-39). 25 mg tablets In blisterpacks 30(NDC 0615-4520-39). 50 mg tablets In blisterpacks 30 (NDC 0615-4521-39). Bottle contains desiccant. The 12.5 mg tablet is white, flat bevelled-edge round with a bisect bar on one side and W;902 on the other side; the 25mg Captopril tablet is a white, flat vevelled-edge round with a quadrisect bar on one side and W;903 on the other side; the 50mg Captopril tablet is a white, flat vevelled-edge round with a bisect bar on one side and W;904 on the other side.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPTOPRIL- CAPTOPRIL TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
CAPTOPRIL
BOXED WARNING
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, captopriJ tablets USP
should be disconlinued as_.
soon as possible. See
WARNINGS: FelallNeonalal Morbidity and Mortalily.
DESCRIPTION
Captoprills a specific competitive inhibitor of angio!erlSln
I-converting enzyme (ACE), the enzyme
responsible for the conversion of
anglolensln Iloanglolensin II.
eaploprills deslgnaled chemically as
j-[(2S)-3-mercaplo-2-malhylpropionylj-L-prolina. Moler:ular
fonnul. e,H'NO,S [MW 217.29) and
has the follo"NIngstruclural.formula:
Captoprills a white to off-white crystalline powder that may have a
slight sulfurous odor; it is soluble
in waler (approx. 160 m9fml),
malhanol, and alhanol and sparingly soluQleln chIorolonn and alhyl
acelala.
Each scored tablet, for oral administration, contains 12.5 mg, 25 mg,
50 mg or 100 mg of captopril.ln
add~ion, each lablet contains the
following inactive ingredients: microcf)"stalline cellulose,comstarch,
anhydrous ladose,
coHoidalsilicon dioxide, talc andpalmilic acid.
CLINICAL PHARMACOLOGY
Mechanism of Action
ThE"t m~chanism 01 action of captopriJ has not yet been fully
elucidated. lis-beneficial effects In
hypertension and heart failure appear 10
result primarily from suppression of the reninwangiolensln-aJdosterone
system. However, there is no
consistent correlallon between
renin levels and response 10 Ihe drug. Renin, an enzyme synthesized by
Ihe kidneys, is released into the
circulation where it acts on a
plasma globulin $ub~trate to produce angiotensinl, a relatively
inactive decapeptide. AngIotensin I is
then converted by angiotensin
converting enzyme (ACE) to angiotensin II, a potent endogenous
vasoconstrictor substance. Angiotensin
II also stimulates aldosterone
secretion from the adrenal cortex, thereby contributing to sodiumand
fluid retenllon. .
Caplop