CAPTOPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, 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, 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 thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Captopril Tablets, USP 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 not require

Product summary:

Captopril Tablets, USP are available as follows: 25 mg - White, Round Tablets; Debossed "WW 172" on one side and Quadrisect Scored on the other side. 50 mg - White, Oblong Tablets; Debossed "WW 173" on one side and Scored on the other side. All Captopril Tablets, USP are white and may exhibit a slight sulfurous odor. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised January 2012 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPTOPRIL - CAPTOPRIL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
CAPTOPRIL TABLETS, USP
REV. 01/12
RX ONLY
USE IN PREGNANCY
WARNING: FETAL TOXICITY
·WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL 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 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 and has the
following structural formula:
MW=217.29 C H NO S
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.
Each tablet, for oral administration, contains 12.5 mg, 25 mg, 50 mg,
or 100 mg of captopril. In addition,
each tablet contains the following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide,
microcrystalline cellulose, sodium starch glycolate, starch, 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
9
15
3
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