CAPTOPRIL- captorpil tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Rebel Distributors Corp

DCI (Dénomination commune internationale):

CAPTOPRIL

Composition:

CAPTOPRIL 25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 presence

Descriptif du produit:

Captopril Tablets USP 25 mg tablets in bottles of 180 (NDC 42254-335-78). 50 mg tablets in bottles of 90 (NDC 42254-353-90). Bottle contains desiccant. The 25 mg Captopril tablet is a white, flat bevelled-edge round with a quadrisect bar on one side and ‘W’ over 903 on the other side. The 50 mg Captopril tablet is a white, flat bevelled-edge round with a bisect bar on one side and ‘W’ over 904 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. Storage Do not store above 30°C (86°F) Keep bottles tightly closed (protect from moisture).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CAPTOPRIL- CAPTORPIL TABLET
REBEL DISTRIBUTORS CORP
----------
CAPTOPRIL TABLETS, USP
Rx only
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL TABLETS, USP 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. 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
plasma globulin substrate to produce angiotensin I, a relatively
inactive decapeptide. Angiotensin I is
9
15
3
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 angioten