LOTENSIN HCT- 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:

Physicians Total Care, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lotensin HCT is 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 Lotensin HCT, 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. Lotensin HCT is contraindicated in patients who are anuric. Lotensin HCT 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. Lotens

Product summary:

Lotensin HCT is available in tablets of four different strengths: Tablets are oblong and scored, with “Lotensin HCT” on one side and appropriate number imprinted on the other side. Storage: Do not store above 30ºC (86ºF). Protect from moisture and light. Dispense in tight, light -resistant container (USP). Manufactured by: Novartis Pharmaceuticals Corporation Suffern, New York 10901 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2012-46 January 2012 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

LOTENSIN HCT - BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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LOTENSIN HCT
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE USP
COMBINATION TABLETS
5 MG/6.25 MG
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 LOTENSIN HCT 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 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
®
24
28
2
5
Its empirical formula is C H ClN O S , and its molecular weight is
297.73. Hydrochloro-thiazide is
a thiazide diuretic.
Lotensin HCT is a combination of benazepril hydrochloride and
hydrochlorothiazide USP. The tablets
are formulated for oral administration with a combination of 5, 10, or
20 mg of benazepril
hydrochloride and 6.25, 12.5, or 25 mg of hydrochlorothiazide USP. The
inactive ingredients of the
tablets are cellulose compound