BENAZEPRIL HYDROCHLORIDE tablet, coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Sammensetning:

BENAZEPRIL HYDROCHLORIDE 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, 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 hydrochloride 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. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with a history of angioe

Produkt oppsummering:

Benazepril hydrochloride tablets USP, 5 mg are light yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5124” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 10 mg are mustard yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5125” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 20 mg are pink, arc triangle-coated tablets, debossed with the number “93” on one side and “5126” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 40 mg are pink to light red, arc triangle-coated tablets, debossed with the number “93” on one side and “5127” on the other. Tablets are packaged in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 9/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BENAZEPRIL HYDROCHLORIDE - BENAZEPRIL HYDROCHLORIDE TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
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BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 MG, 10 MG, 20 MG AND 40 MG
5124
5125
5126
5127
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 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. 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
C
H N O •HCl M.W. 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.
Benazepril hydrochloride 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, hypromellose, iron oxide yellow, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, povidone,
pregelatinized starch, starch, titanium
dioxide, and triacetin. Additionally, the 5 mg strength contains talc,
the 20 mg strength contains iron
oxide black and iron oxide red, and the 40 mg strength contains iron
oxide red.
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
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion by the adrenal cortex.
24
28
2
5
Inhibition of ACE results in decreased plasma angiotensin II, which
leads to decreased vasopressor
activity and