CAPTOPRIL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Health Packaging

INN (Medzinárodný Name):

CAPTOPRIL

Zloženie:

CAPTOPRIL 12.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 not require the presence of

Prehľad produktov:

Captopril Tablets, USP are available as follows: 12.5 mg - White, Round Tablets; Debossed "W-7" on one side and Scored on the other side. Unit dose packages of 30 (3 x 10) NDC 60687-304-21 25 mg - White, Round Tablets; Debossed "WW 172" on one side and Quadrisect Scored on the other side. Unit dose packages of 30 (3 x 10) NDC 60687-315-21 All Captopril Tablets, USP are white and may exhibit a slight sulfurous odor. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CAPTOPRIL- CAPTOPRIL TABLET
AMERICAN HEALTH PACKAGING
----------
CAPTOPRIL TABLETS, USP
RX ONLY
8430421/0320F
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 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:
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
(derived from potato), starch (derived from corn), and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
The mechanism of action of captopril tablets 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 tablets prevent