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:

Medsource Pharmaceuticals

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Sammensetning:

BENAZEPRIL HYDROCHLORIDE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Benazepril hydrochloride tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride in patients with diabetes.

Produkt oppsummering:

Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows: NDC 43547-335-10 bottle of 100 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows: NDC 43547-336-10 bottle of 100 tablets (with desiccant) NDC 43547-336-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows: NDC 43547-337-10 bottle of 100 tablets (with desiccant) NDC 43547-337-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows: NDC 43547-338-10 bottle of 100 tablets (with desiccant) NDC 43547-338-50 bottle of 500 tablets (with desiccant) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Version: 05/2015 07713-02

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
MEDSOURCE PHARMACEUTICALS
----------
BENAZEPRIL HYDROCHLORIDE TABLETS, USP, FILM COATED FOR ORAL USE
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE
TABLETS AS SOON AS
POS S IBLE.
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 benazepril
3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-
propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-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.
Benazepril hydrochloride, USP is supplied as film-coated tablets
containing 5 mg, 10 mg, 20 mg, and 40
mg of benazepril hydrochloride for oral administration. The inactive
ingredients are carnauba wax,
colloidal silicon dioxide, crospovidone, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
pregelatinized starch, titanium dioxide,
and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum
lake. The 20 mg tablet also
contains black iron oxide and yellow iron oxide. The 40 mg tablet also
contains FD&C Blue No. 2
aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20
mg and 40 mg meet USP
Dissolution Test 2.
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
24
28
2
5
substance, angiotensin II. An