CAPTOPRIL tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Wockhardt USA LLC.

INN (International Name):

CAPTOPRIL

Sammensætning:

CAPTOPRIL 12.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Captopril Tablets USP 12.5 mg tablets in bottles of 100 (NDC 64679-902-01) and 1000 (NDC 64679-902-02), 25 mg tablets in bottles of 100 (NDC 64679-903-01) and 1000 (NDC 64679-903-02), 50 mg tablets in bottles of 100 (NDC 64679-904-01) and 1000 (NDC 64679-904- 02), and 100 mg tablets in bottles of 100 (NDC 64679-905-01) Bottle contains desiccant. The 12.5 mg tablet is white, flat bevelled-edge round with a bisect bar on one side and 'W' on the other side; the 25 mg Captopril tablet is a white, flat bevelled-edge round with 902 a quadrisect bar on one side and 'W' on the other side; the 50 mg Captopril tablet is a                                                    903 white, flat bevelled-edge round with a bisect bar on one side and 'W' on the other side;                                                                                                      904 the 100 mg Captopril tablet is a white, flat bevelled-edge round with a bisect bar on one side and 'W' on the other side.               905 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).

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CAPTOPRIL- CAPTOPRIL TABLET
WOCKHARDT USA LLC.
----------
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, which may have
a characterstic, sulfide-like odor.
Melts in the range of 104°C to 110°C. 0.3 g soluble in 10mLof water,
methanol, ethanol and
chloroform.
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,
9
15
3
thereby contributing to sodium and fluid retention.
Captopril prevents the conversion of angiotensin I t