CAPTOPRIL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Hikma Pharmaceuticals USA Inc.

INN (mednarodno ime):

CAPTOPRIL

Sestava:

CAPTOPRIL 12.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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, USP 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 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 tablets 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 tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see PRECAUTIONS, Drug Interactions ).

Povzetek izdelek:

Captopril Tablets, USP are available as follows: 12.5 mg - White, Round Tablets; Debossed "W-7" on one side and Scored on the other side.             Bottles of 100 tablets                                      NDC 0143-1171-01                            Bottles of 1000 tablets                                    NDC 0143-1171-10         25 mg - White, Round Tablets; Debossed "WW 172" on one side and Quadrisect Scored on the other side.             Bottles of 100 tablets                                      NDC 0143-1172-01             Bottles of 1000 tablets                                    NDC 0143-1172-10        50 mg - White, Oblong Tablets; Debossed "WW 173" on one side and Scored on the other side.             Bottles of 100 tablets                                      NDC 0143-1173-01             Bottles of 1000 tablets                                    NDC 0143-1173-10            100 mg - White, Oblong Tablets; Debossed "WW 174" on one side and Scored on the other side.             Bottles of 100 tablets                                      NDC 0143-1174-01            All Captopril Tablets, USP are white and may exhibit a slight sulfurous odor. Store at 20° to 25°C (68° to 77°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. Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Revised November 2019

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CAPTOPRIL- CAPTOPRIL TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
CAPTOPRIL TABLETS, USP
REV. 11/19
RX ONLY
WARNING: FETAL TOXICITY
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
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
and has the following structural formula:
MW 217.29
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 or
100 mg of
captopril. In addition, each tablet contains the following inactive
ingredients: anhydrous
lactose, colloidal silicon dioxide, microcrystalline cellulose, sodium
starch glycolate
(derived from potato), starch (derived from corn), and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
The mechanism of action of captopril tablets 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.
Captopril tabl