BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Golden State Medical Supply, Inc.

INN (Tên quốc tế):

BENAZEPRIL HYDROCHLORIDE

Thành phần:

BENAZEPRIL HYDROCHLORIDE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 tablets are contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide tablets are 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 tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepri

Tóm tắt sản phẩm:

Benazepril hydrochloride and hydrochlorothiazide tablets 5 mg/6.25 mg are available for administration as white to off-white, round tablets, scored and engraved “APO” on one side, “5” over bisect “6.25” on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-403-01) Benazepril hydrochloride and hydrochlorothiazide tablets 10 mg/12.5 mg are available for administration as light pink, round, scored tablets, engraved “APO” on one side, “10” over bisect “12.5” on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-404-01) Benazepril hydrochloride and hydrochlorothiazide tablets 20 mg/12.5 mg are available for administration as greyish-violet, round, scored tablets, engraved “APO” on one side, “20” over bisect “12.5” on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-405-01) Benazepril hydrochloride and hydrochlorothiazide tablets 20 mg/25 mg are available for administration as reddish brown, round, scored tablets, engraved “APO” on one side, “20” over bisect “25” on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-406-01) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg Rev. 13 September 2020 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS
5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG AND 20 MG/25 MG
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE
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
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 g/mol.
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 formula is
24
28
2
5
Its molecular formula is C
H
ClN
O
S
, and its molecular weight is 297.74 g/mol.
Hydrochlorothiazide is a thiazide diuretic.
Benazepril hydrochloride and hydrochlorothiazide tablets are a
combination of benazepril
hydrochloride, USP and hydrochlorothiazide, USP. The tablets are
formulated for oral administration
with a combination of 5, 10, or 20 mg of benaze