CAPTOPRIL tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AMICI PHARMACEUTICALS LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Captopril tablets 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 digital

Resumo do produto:

Captopril Tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of captopril, USP. The 12.5 mg tablets are white to off-white, arc diamond shaped tablets with bisect on one side and “131” on the other side. They are available as follows: Bottles of 100 Tablets                                     NDC 69292-522-01 Bottles of 1000 Tablets                                   NDC 69292-522-10 The 25 mg tablets are white to off-white, arc diamond shaped tablets with quadrisect on one side and “132” on the other side. They are available as follows: Bottles of 100 Tablets                                     NDC 69292-524-01 Bottles of 1000 Tablets                                   NDC 69292-524-10 The 50 mg tablets are white to off-white, arc diamond shaped tablets with bisect on one side and “133” on the other side. They are available as follows: Bottles of 100 Tablets                                     NDC 69292-526-01 Bottles of 1000 Tablets                                   NDC 69292-526-10 The 100 mg tablets are white to off-white, capsule shaped tablets with bisect on one side and “134” on the other side. They are available as follows: Bottles of 100 Tablets                                     NDC 69292-528-01 Bottles of 500 Tablets                                     NDC 69292-528-50 Bottles contain a desiccant-charcoal canister. All captopril tablets are white and may exhibit a slight sulfurous odor.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CAPTOPRIL- CAPTOPRIL TABLET
AMICI PHARMACEUTICALS LLC
----------
CAPTOPRIL TABLETS, USPRX ONLY
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: corn starch, lactose
monohydrate,
microcrystalline cellulose and stearic acid.
MECHANISM OF ACTION
The mechanism of action of captopril tablets have 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 the conversion of angiotensin I to
angiotensin II by inhibition of
ACE, a peptidyldipeptide carboxy hydrolase. This inhibition has been
demonstrated in
both healt