CAPTOPRIL tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bryant Ranch Prepack

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤ 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients. Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decrease the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema). Captopril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril in patients with diabetes (see PRECAUTIONS: Drug Interactions). Captopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer captopril within 36 hours of switching to or from sacubitril/valsartan, a nepriltsin inhibitor (see PRECAUTIONS, Drug Interactions).

Podsumowanie produktu:

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: 63629-8729-1 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CAPTOPRIL- CAPTOPRIL TABLET
BRYANT RANCH PREPACK
----------
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.
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 fluid
retention.