BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated

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:

H.J. Harkins Company, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). In using benazepril hydrochloride and hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. 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 hydrochlorothiazi

Product summary:

Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 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 0185-0124-01 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 0185-0204-01 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. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS8023 Rev. 10/11 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444 MF0124REV07/11 MG #18758

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE - BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH
TO THE DEVELOPING
FETUS. When pregnancy is detected, benazepril hydrochloride and
hydrochlorothiazide should be
discontinued as soon as possible. See WARNINGS, FETAL/NEONATAL
MORBIDITY AND MORTALITY.
DESCRIPTION
Benazepril hydrochloride 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 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.
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
24
28
2
5
7
8
3
4
2
hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of hydrochlorothiazide
USP. The inactive ingredients of
the tablets are colloidal sil