CAPTOPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

CAPTOPRIL

Composition:

CAPTOPRIL 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets 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 are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does n

Product summary:

Captopril Tablets, USP are available containing 12.5 mg or 25 mg of captopril, USP. The 12.5 mg tablets are white, oval-shaped tablets, partially bisected on both sides debossed with M to the left of the partial bisect and C1 to the right of the partial bisect on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-863-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 25 mg tablets are white, round tablets debossed with M over C2 on one side of the tablet and a quadrisect score on the other side. They are available as follows: NDC 51079-864-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Captopril tablets, USP may exhibit a slight sulfurous odor. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12253 R1 9/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPTOPRIL- CAPTOPRIL TABLET
MYLAN INSTITUTIONAL INC.
----------
WARNING: FETAL TOXICITY
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.
DESCRIPTION
Captopril is 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 217.29)
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. 160 mg/mL), methanol, and ethanol and
sparingly soluble in chloroform and
ethyl acetate.
Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or
100 mg of captopril and the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, crospovidone,
microcrystalline cellulose and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of captopril has not yet been fully
elucidated. Its beneficial 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 hydrolase. This inhibition has been
demonstrated in both he