BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Доступна с:

Sandoz Inc

ИНН (Международная Имя):

BENAZEPRIL HYDROCHLORIDE

состав:

BENAZEPRIL HYDROCHLORIDE 5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). Benazepril hydrochloride and hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Benazepril hydrochloride and hydrochlorothiazide is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride and hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride and hydrochlorothiazide in patients with diabetes.

Обзор продуктов:

Benazepril Hydrochloride and Hydrochlorothiazide Tablets, USP for oral administration, are available as 5 mg/6.25 mg White to off-white, oblong, film-coated tablets, debossed "E 124" on one side and scored on the other side and supplied as: NDC 0185-0236-01 bottles of 100 10 mg/12.5 mg Pink, oblong, film-coated tablets, debossed "E 204" on one side and scored on the other side and supplied as: NDC 0185-0325-01 bottles of 100 20 mg/12.5 mg Lavender, oblong, film-coated tablets, debossed "E 211" on one side and scored on the other side and supplied as: NDC 0185-0211-01 bottles of 100 20 mg/25 mg Maroon, oblong, film-coated tablets, debossed "E 277" on one side and scored on the other side and supplied as: NDC 0185-0277-01 bottles of 100 Each strength is supplied in bottles that contain a desiccant. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep tightly closed. KEEP OUT OF THE REACH OF CHILDREN. Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev. July 2022 46309876

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
EON LABS, INC.
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE 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
Benazepril hydrochloride, USP is a white to off-white crystalline
powder, soluble (>100
mg/mL) in water, in ethanol, and in methanol. Benazepril
hydrochloride's chemical name
is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-
tetrahydro-2-oxo-1_H_-1-
(3S)-benzazepine-1-acetic acid monohydrochloride; its structural
formula is:
Its molecular formula is C
H
N O •HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl
angiotensin-
converting enzyme inhibitor. Benazepril is converted to benazeprilat
by hepatic cleavage
of the ester group.
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline
powder. It is slightly soluble in water; freely soluble in sodium
hydroxide solution, in _n_-
butylamine, and in dimethylformamide; sparingly soluble in methanol;
and insoluble in
ether, in chloroform, and in dilute mineral acids.
Hydrochlorothiazide's chemical name is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide; its structural
24
28
2
5
formula is:
Its molecular formula is C H ClN O S and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
The tablets are a combination of benazepril hydrochloride and
hydrochlorothiazide, USP.
They are formulated for oral administration with a combination of 5
mg, 10 mg, or 20
mg of benazepril hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of
hydrochlorothiazide,
USP. The inactive ingredients of the tablets are colloidal silicon
dioxide, crospovidon