CAPTOPRIL tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
12-10-2012

Aktiivinen ainesosa:

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

Saatavilla:

Bryant Ranch Prepack

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Captopril tablets USP are indicated for the treatment of hypertension. 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. Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in hea

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

                                CAPTOPRIL- CAPTOPRIL TABLET
BRYANT RANCH PREPACK
----------
CAPTOPRIL TABLETS, USP
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
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 prevents the conversion of angiotensin I to angiotensin II
by inhibition of ACE, a
peptidyldipeptide carboxy hydrolase. This inhibition has been
demonstrated in both healthy human
subjects and in animals by showing that the elevation of blood
pressure caused by exogenously
administered angiotensin I was attenua
                                
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