CAPTOPRIL tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Solco Healthcare US, LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Hypertension: 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. 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

Ringkasan produk:

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, oval, flat, beveled-edge tablets, debossed with "S1" on one side and partial bisected on both sides. They are available as follows: NDC 43547-363-10 bottles of 100 tablets NDC 43547-363-11 bottles of 1,000 tablets The 25 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S2" on one side and quadrisected on the other side. They are available as follows: NDC 43547-364-10 bottles of 100 tablets NDC 43547-364-11 bottles of 1,000 tablets The 50 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S3" on one side and bisected on the other side. They are available as follows: NDC 43547-365-10 bottles of 100 tablets NDC 43547-365-11 bottles of 1,000 tablets The 100 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S4" on one side and bisected on the other side. They are available as follows: NDC 43547-366-10 bottles of 100 tablets NDC 43547-366-11 bottles of 1,000 tablets Captopril tablets, USP may exhibit a slight sulfurous odor. Bottles contain silica gel desiccants. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CAPTOPRIL- CAPTOPRIL TABLET
SOLCO HEALTHCARE US, LLC
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CAPTOPRIL TABLETS, USP
FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
•
•
To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US,
LLC at 1-
866257-2597 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
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
[MW 217.29] and has the following structure:
C H
NO S
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: lactose monohydrate,
corn starch,
microcrystalline cellulose and stearic acid.
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.
9
15
3
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