CAPTOPRIL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

SANDOZ INC.

INN (Medzinárodný Name):

CAPTOPRIL

Zloženie:

CAPTOPRIL 12.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 dig

Prehľad produktov:

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 0781-8052-01    bottles of 100 tablets NDC 0781-8052-10    bottles of 1000 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 0781-8061-01    bottles of 100 tablets NDC 0781-8061-10    bottles of 1000 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 0781-8075-01    bottles of 100 tablets NDC 0781-8075-10    bottles of 1000 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 0781-8080-01    bottles of 100 tablets Captopril tablets, USP may exhibit a slight sulfurous odor. Bottles contain silica gel desiccants. Store at 20o to 25oC (68o to 77oF), excursions permitted to 15o to 30oC (59o to 86oF). [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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CAPTOPRIL- CAPTOPRIL TABLET
SANDOZ INC.
----------
CAPTOPRIL TABLETS, USP
FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
•
•
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at
1-800-525-8747 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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of captopril has not yet been fully
elucidated. Its beneficial effects in
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
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.
Captopr