BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis US LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION) . Benazepril HCl and Hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril HCl 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 HCl and Hydrochlorothiazide is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril HCl and Hydrochlorothiazide is contraindicated in combination with a neprilysin (e.g., sacubitril). Do not administer Benazepril HCl and Hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan a neprilysin inhibitor (see WARN

Product summary:

Benazepril HCl USP and Hydrochlorothiazide USP is available in tablets of three different strengths: Benazepril HCl Hydrochlorothiazide Tablet Color 10 mg 12.5 mg light pink 20 mg 12.5 mg grayish violet 20 mg 25 mg red Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets. The National Drug Codes for the various packages are: Dose Bottle of 100 Tablet Imprint 10/12.5 NDC 0574-0227-01 452 20/12.5 NDC 0574-0229-01 453 20/25 NDC 0574-0228-01 454 Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side. Storage: Do not store above 86°F (30°C). Protect from moisture and light. Dispense in a tight, light‑resistant container (USP). Distributed By: PadagisTM Allegan, MI 49010 www.padagis.com 37Y00 RC J5 Rev 11-22 Manufactured for: Validus Pharmaceuticals LLC Parsippany, NJ 07054 © 2022 Validus Pharmaceuticals LLC 60160-04 November 2022

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
PADAGIS US LLC
----------
BENAZEPRIL HCL USP AND HYDROCHLOROTHIAZIDE USP TABLETS
COMBINATION TABLETS
10 MG/12.5 MG
20 MG/12.5 MG
20 MG/25 MG
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HCL 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 empirical formula is C
H
N O ·HCl, and its molecular weight is 460.96.
24
28
2
5
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:
Its empirical formula is C H ClN O S , and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
Benazepril HCl and Hydrochlorothiazide is a combination of benazepril
and
hydrochlorothiazide USP. The tablets are formulated for oral
administration with a
combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of
hydrochlorothiazide
USP. The inactive ingredients of the tablets are