CAPTOPRIL- captopril tablet CAPTOPRIL tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Captopril (UNII: 9G64RSX1XD) (Captopril - UNII:9G64RSX1XD)

Tilgængelig fra:

Camber Pharmaceuticals, Inc.

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, USP 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. Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets, USP 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. Diabetic Nephropathy: Captopril tablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria ˃500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril decreases 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, 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 ).

Produkt oversigt:

12.5 mg tablets in bottles of 100 (NDC 31722-141-01) and 1,000 (NDC 31722-141-10), 25 mg tablets in bottles of 100 (NDC 31722-142-01) and 1,000 (NDC 31722-142-10), 50 mg tablets in bottles of 100 (NDC 31722-143-01) and 1,000 (NDC 31722-143-10), and 100 mg tablets in bottles of 100 (NDC 31722-144-01) and 1,000 (NDC 31722-144-10). The 12.5 mg tablet is white to off white, round, uncoated tablets, debossed with "C" above the bisect and "32" below the bisect on one side and plain on other side. The 25 mg tablet is white to off white, round, uncoated tablets, debossed with Quadrasect on one side and "C33" on other side. The 50 mg tablet is white to off white, capsule shaped, uncoated tablets, debossed with "C" before the bisect and "34" after the bisect on one side and plain on other side. The 100 mg tablet is white to off white, capsule shaped, uncoated tablets, debossed with "C" before the bisect and "35" after the bisect on one side and plain on other side. All captopril tablets are white to off-white and may exhibit a slight sulfurous odor. Store at 20° to 25°C (68° to 77°F) F); Excursions permitted to 15°C to 30°C (59° to 86°F) See USP Controlled Room Temperature]. Keep bottles tightly closed (protect from moisture). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. CAPTOPRIL TABLETS, USP 12.5 mg, 25 mg, 50 mg AND 100 mg Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: CorePharma, LLC. 215 Wood Ave, Middlesex, NJ 08846 Revised March 2021 Rev: 6

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CAPTOPRIL- CAPTOPRIL TABLET
CAMBER PHARMACEUTICALS, INC.
----------
CAPTOPRIL TABLETS, USP 12.5 MG, 25 MG, 50 MG AND 100 MG
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL 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
(MW 217.29) and has the following structural formula:
C H
NO S
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 tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and
100 mg of
Captopril. In addition, each tablet contains the following inactive
ingredients: colloidal
silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF,
magnesium
stearate NF and microcrystalline cellulose NF.
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
9
15
3
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 conver