BENAZEPRIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride tablets 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.

Product summary:

Benazepril hydrochloride 5 mg tablets are light yellow colored, round, film coated, debossed with “RX736” on one side and plain on the other side. They are supplied as follows: NDC 63304-736-30 Bottles of 30 NDC 63304-736-10 Bottles of 1000 NDC 63304-736-77 Blister unit-dose pack of 100 Benazepril hydrochloride 10 mg tablets are dark yellow colored, round, film coated, debossed with “RX737” on one side and plain on the other side. They are supplied as follows: NDC 63304-737-30 Bottles of 30 NDC 63304-737-10 Bottles of 1000 NDC 63304-737-77 Blister unit-dose pack of 100 Benazepril hydrochloride 20 mg tablets are light pink colored, round, film coated, debossed with “RX738” on one side and plain on the other side. They are supplied as follows: NDC 63304-738-30 Bottles of 30 NDC 63304-738-10 Bottles of 1000 NDC 63304-738-77 Blister unit-dose pack of 100 Benazepril hydrochloride 40 mg tablets are dark pink colored, round, film coated, debossed with “RX739” on one side and plain on the other side. They are supplied as follows: NDC 63304-739-30 Bottles of 30 NDC 63304-739-10 Bottles of 1000 NDC 63304-739-77 Blister unit-dose pack of 100 Storage: Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight container (USP). Keep this and all drugs out of the reach of children. To report SUSPECTED ADVERSE REACTIONS, contact Ranbaxy Pharmaceuticals Inc. at 1-888-RANBAXY (726-2299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA January 2015 FDA-08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL 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 benazepril
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 round, film-coated 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, hypromellose,
iron oxide yellow (5 mg and 10
mg), iron oxide red (20 mg and 40 mg), lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol 400, polyethylene glycol 6000,
polysorbate 80, pregelatinized starch,
propylene glycol, talc, titanium dioxide, opacode S-1-17823-black (40
mg tablets only).
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.
Inhibition of ACE results in decreased plasma angiotensin II, which
leads to decreased vasopressor
activity and to decreased aldosterone secretion. The latte