BENAZEPRIL HYDROCHLORIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

benazepril hydrochloride (UNII: N1SN99T69T) (benazepril - UNII:UDM7Q7QWP8)

Dostupné s:

Rebel Distributors Corp.

INN (Mezinárodní Name):

benazepril hydrochloride

Složení:

benazepril hydrochloride 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Benazepril hydrochloride tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride 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 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.

Přehled produktů:

Benazepril Hydrochloride Tablets are available as: 5 mg: yellow-orange, round, biconvex, film coated tablets, debossed “E” over “5” on one side and plain on the other. 10 mg: orange, round, biconvex, film coated tablets, debossed “E” over “53” on one side and plain on the other. 20 mg: pink, round, biconvex, film coated tablets, debossed “E” over “82” on one side and plain on the other. 40 mg: red, round, biconvex, film coated tablets, debossed “E” over “48” on one side and plain on the other. Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets. Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from 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 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320 OS8016 Rev. 01/09 MF0005REV01/09 MG #17815

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP.
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BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG AND 40 MG
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 tablets
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:
Its molecular 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.
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
lactose monohydrate,
microcrystalline cellulose, pregelatinized starch, hydrogenated castor
oil, crospovidone, colloidal
silicon dioxide, zinc stearate, hypromellose, titanium dioxide,
polyethylene glycol 400 and polysorbate
80. The 5 MG and 10 MG tablets also contain D&C yellow No. 10 and FD&C
yellow No. 6. The 20 MG
tablets also contain FD&C red No. 40 and FD&C yellow No. 6. The 40 MG
tablets also contain FD&C
red No. 40.
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 co