CAPTOPRIL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

INN (국제 이름):

CAPTOPRIL

구성:

CAPTOPRIL 25 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 d

제품 요약:

NDC: 63629-1338-1: 100 Tablets in a BOTTLE NDC: 63629-1338-2: 30 Tablets in a BOTTLE NDC: 63629-1338-3: 90 Tablets in a BOTTLE NDC: 63629-1338-4: 60 Tablets in a BOTTLE NDC: 63629-1338-5: 120 Tablets in a BOTTLE NDC: 63629-1338-6: 10 Tablets in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CAPTOPRIL- CAPTOPRIL TABLET
BRYANT RANCH PREPACK
----------
CAPTOPRIL TABLETS, USP
REV. 11/19
RX 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. SEEWARNINGS: 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
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