CAPTOPRIL tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Legacy Pharmaceutical Packaging

DCI (Denominação Comum Internacional):

CAPTOPRIL

Composição:

CAPTOPRIL 12.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Hypertension : Captopril tablets USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/ agranulocytosis (see WARNINGS ). Captopril 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 is 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. Heart Failure : 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 not require the presen

Resumo do produto:

Captopril Tablets USP 12.5 mg tablets in bottles of 60 NDC 68645-160-59  25 mg tablets in bottles of 60 NDC 68645-161-59  50 mg tablets in bottles of 60 NDC 68645-162-59 100 mg tablets in bottles of 60 NDC 68645-163-59 12.5 mg tablet is white, flat bevelled-edge round with a bisect bar on one side and W 902 on the other side;  25 mg Captopril tablet is a white, flat bevelled-edge round with a quadrisect bar on one side and W 903 on the other side; 50 mg Captopril tablet is a white, flat bevelled-edge round with a bisect bar on one side and W 904 on the other side;  100 mg Captopril tablet is a white, flat bevelled-edge round with a bisect bar on one side and W 905 on the other side. All captopril tablets are white and may exhibit a slight sulfurous odor. Dispense in a tight container as defined in the USP. Manufactured by: Wochardt Limited Mumbai, India Package by: Legacy Pharmaceutical Packaging Earth City, MO Distributed by: Wal-Mart Bentonville, AR 72716 Do not store above 30°C (86°F) Keep bottles tightly closed (protect from moisture). WARNING: KEEP OUT OF THE REACH OF CHILDREN Tamper Evident: Do Not Use this product if the bottle seal is not intact CHILD-RESISTANT: Tighten cap on bottle after use. Do not store above 30o C (86o F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense contents in a tight container. Take charge of your health by taking your medication properly.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CAPTOPRIL- CAPTOPRIL TABLET
LEGACY PHARMACEUTICAL PACKAGING
----------
CAPTOPRIL TABLETS, USP
RX ONLY
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, captopril tablets
USP should be discontinued as soon as possible. SEE WARNINGS:
FETAL/NEONATAL MORBIDITY
AND MORTALITY .
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. Molecular
formula C H NO S [MW 217.29] and has the following structural formula:
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 scored 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:
microcrystalline cellulose, corn starch,
anhydrous lactose, colloidal silicon dioxide, talc and palmitic 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 retent