BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

ANI Pharmaceuticals, Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Benazepril hydrochloride and hydrochlorothiazide tablets USP 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 benazepril hydrochloride

Tuoteyhteenveto:

Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP are available in four different strengths: 5 mg/6.25 mg: White, capsule shaped, film-coated tablet, scored on one side and debossed “AN 14” on the other side. Each tablet contains 5 mg of benazepril hydrochloride USP and 6.25 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-414-01). 10 mg/12.5 mg: Purple, capsule shaped, film-coated tablet, scored on one side and debossed “AN 15” on the other side. Each tablet contains 10 mg of benazepril hydrochloride USP and 12.5 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-415-01). 20 mg/12.5 mg: Pink, capsule shaped, film-coated tablet, scored on one side and debossed “AN 16” on the other side. Each tablet contains 20 mg of benazepril hydrochloride USP and 12.5 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-416-01). 20 mg/25 mg: Red, capsule shaped, film-coated tablet, scored on one side and debossed “AN 17” on the other side. Each tablet contains 20 mg of benazepril hydrochloride USP and 25 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-417-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10559 Rev 09/22

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
ANI PHARMACEUTICALS, INC.
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP
COMBINATION TABLETS
5 MG/6.25 MG
10 MG/12.5 MG
20 MG/12.5 MG
20 MG/25 MG
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 empirical 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
24
28
2
5
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
Its empirical formula is C H ClN O S , and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP 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
benazepril hydrochlor