BENAZEPRIL HYDROCHLORIDE tablet, coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

INN (Alþjóðlegt nafn):

BENAZEPRIL HYDROCHLORIDE

Samsetning:

BENAZEPRIL HYDROCHLORIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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 63187-500-30 bottle of 30 tablets (with desiccant) NDC 63187-500-60 bottle of 60 tablets (with desiccant) NDC 63187-500-90 bottle of 90 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 63187-499-30 bottle of 30 tablets (with desiccant) NDC 63187-499-60 bottle of 60 tablets (with desiccant) NDC 63187-499-90 bottle of 90 tablets (with desiccant) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP). You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Version: 01/2014 07713-01

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
PROFICIENT RX LP
----------
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 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.
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
24
28
2
5
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 substance, angiotensin II.
Angiotensin II also
s