CAPTOPRIL tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Major Pharmaceuticals

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Hypertension: Captopril tablets, USP, are indicated for the treatment of hypertension. In using captopril tablets, USP, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets, USP may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets, USP are effective alone and in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Heart Failure: Captopril tablets, USP are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril i

ملخص المنتج:

Captopril tablets, USP are available containing 12.5 mg and 25 mg of captopril, USP. The 12.5 mg tablets are white to off-white, oval shaped, flat beveled edged uncoated tablets having break line on both sides and one side debossed with “C” on one side of the break line and “1” on other side of the break line (bisect). They are available as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7105-61 The 25 mg tablets are white to off-white, round, flat beveled edged, uncoated tablets debossed with “2” over “C” one side and quadrisect score on the other side. They are available as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7106-61 All captopril tablets, USP are white to off-white and may exhibit a slight sulfurous odor. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep bottles tightly closed (protect from moisture). All trademarks are the properties of their respective owners. Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807. Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Made in India. Issued: 10/2018

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CAPTOPRIL- CAPTOPRIL TABLET
MAJOR PHARMACEUTICALS
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CAPTOPRIL TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Captopril tablets, USP are a specific competitive inhibitor of
angiotensin I-converting
enzyme (ACE), the enzyme responsible for the conversion of angiotensin
I to
angiotensin II.
Captopril is designated chemically as
1-[(2S)-3-mercapto-2-methylpropionyl] -L-proline
[MW 217.28] and has the following structure:
Captopril USP is a white to off-white crystalline powder that may have
a slight sulfurous
odor; it is soluble in water (approx. 126 mg/mL), methanol, and
ethanol and sparingly
soluble in chloroform and ethyl acetate.
Captopril tablets, USP are available in potencies of 12.5 mg, 25 mg,
50 mg, and 100 mg
as scored tablets for oral administration.
Inactive ingredients: microcrystalline cellulose, lactose,
crospovidone, colloidal silicon
dioxide and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of captopril has not yet been fully
elucidated. Its beneficial
WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL TABLETS AS SOON
AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL
TOXICITY
effects in hypertension and heart failure appear to result primarily
from suppression of
the renin-angiotensin-aldosterone system. However, there is no
consistent correlation
between renin levels and response to the drug. Renin, an enzyme
synthesized by the
kidneys, is released into the circulation where it acts on a plasma
globulin substrate to
produce angiotensin I, 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 sodium and fluid
retention.
Captopril prevents the conversion of angiotensin I to angiotensin II
by inhibition of ACE,
a peptidyldipeptide carboxy