LOTENSIN- benazepril hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Available from:

Physicians Total Care, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, 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 Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Lotensin is contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Lotensin is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.

Product summary:

Lotensin is available in tablets of 5 mg, 10 mg, 20 mg, and 40 mg, packaged with a desiccant in bottles of 100 tablets. Each tablet is imprinted with LOTENSIN on one side and the tablet strength (“5,” “10,” “20,” or “40”) on the other. The National Drug Codes for the various packages are Storage: Do not store above 30°C (86°F). Protect from moisture. Dispense in tight container (USP). Manufactured by: Novartis Pharmaceuticals Corporation Suffern, New York 10901 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2012-45 January 2012 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

LOTENSIN - BENAZEPRIL HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
LOTENS IN
LOTENS IN
(BENAZEPRIL HYDROCHLORIDE)
TABLETS
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOTENSIN 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. Its chemical name is
3-[[1-(ethoxy-carbonyl)-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 non-sulfhydryl
angiotensin-converting enzyme
inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage
of the ester group.
Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40
mg of benazepril hydrochloride
for oral administration. The inactive ingredients are colloidal
silicon dioxide, crospovidone,
hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets),
hypromellose, iron oxides, lactose,
magnesium stearate (40-mg tablets), microcrystalline cellulose,
polysorbate 80, propylene glycol (5-
mg and 40-mg tablets), starch, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Benazepril and benazeprilat inhibit angiotensin-converting enzyme
(ACE) in human subjects and animals.
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the vasoconstrictor
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2
5
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion by the adrenal cortex.
Inhibition of ACE results in decreased plasma angiotensin II, which
leads to decreased vasopressor
activity and to decreased aldosterone secretion. The latter decrease
may result in a small increase of
serum potassium. Hypertensive patients trea