BENAZEPRIL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril HCl tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Benazepril HCl, USP is contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril HCl, USP is 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 HCl, USP in patients with diabetes. Close

Product summary:

Benazepril HCl tablets, USP, 5 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-751-03 Bottles of 100: NDC 65162-751-10 Bottles of 500: NDC 65162-751-50 Benazepril HCl tablets, USP, 10 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-752-03 Bottles of 100: NDC 65162-752-10 Bottles of 500: NDC 65162-752-50 Benazepril HCl tablets, USP, 20 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-753-03 Bottles of 100: NDC 65162-753-10 Bottles of 500: NDC 65162-753-50 Benazepril HCl tablets, USP, 40 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-754-03 Bottles of 100: NDC 65162-754-10 Bottles of 500: NDC 65162-754-50 Storage: Store at 20º to 25°C (68° to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at (1-877-835-5472) or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gove/medwatch Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 01-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
DIRECT RX
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BENAZEPRIL HYDROCHLORIDE
BOXED WARNING SECTION
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue benazepril hydrochloride 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 SECTION
Benazepril hydrochloride (HCl), USP 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 C24H28N2O5•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 HCl tablets, USP are supplied as white, round, biconvex
tablets containing either 5 mg, 10
mg, 20 mg, or 40 mg of benazepril HCl, USP for oral administration.
The inactive ingredients are
crospovidone, lactose anhydrous, magnesium stearate, microcrystalline
cellulose, pregelatinized corn
starch and talc.
CLINICAL PHARMACOLOGY SECTION
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 latter decrease
may result in a small increase of
serum potassium. Hypertensive patients treated with benazepril HCl
alone for up to 52 weeks had
elevations of serum potassium of up to 0.2 mEq/L. Similar patients
treated with be