BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 mg, 10 mg, 20 mg and 40 mg, 5124, 5125, 5126, 5127, Rx only

/BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 mg, 10 mg, 20 mg and 40 mg, 5124, 5125, 5126, 5127, Rx only
BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 mg, 10 mg, 20 mg and 40 mg, 5124, 5125, 5126, 5127, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 mg, 10 mg, 20 mg and 40 mg, 5124, 5125, 5126, 5127, Rx only

ID:

4bea215c-7140-4209-bc87-04f71058d569

Code:

34391-3

USE IN PREGNANCY


id: 3623fa06-0e6d-40b6-aa0f-ecaaa22eb5d8
displayName: Boxed Warning section
FDA Article Code: 34066-1

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, benazepril hydrochloride should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is C24H28N2O5•HCl M.W. 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: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red.

INDICATIONS AND USAGE


id: 8d408943-6504-4c09-92a0-4d0ff94392fe
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: 1703acec-fd15-41bf-9bf0-8a87169b9468
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product 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.

ADVERSE REACTIONS


id: 8ca4507f-177d-45e3-b7e2-7c65e580d407
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Benazepril hydrochloride has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was comparable in benazepril hydrochloride and placebo patients. The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with benazepril hydrochloride and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%) (see PRECAUTIONS, Cough). The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with benazepril hydrochloride are shown below.

PATIENTS IN U.S. PLACEBO-CONTROLLED STUDIES
BENAZEPRIL HYDROCHLORIDE PLACEBO
(N = 964) (N = 496)
N % N %
Headache 60 6.2 21 4.2
Dizziness 35 3.6 12 2.4
Fatigue 23 2.4 11 2.2
Somnolence 15 1.6 2 0.4
Postural Dizziness 14 1.5 1 0.2
Nausea 13 1.3 5 1.0
Cough 12 1.2 5 1.0
Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients), and rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain):

OVERDOSAGE


id: 97537e83-b14e-4e3c-af89-d0a28890853b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Single oral doses of 3 g/kg benazepril were associated with significant lethality in mice. Rats, however, tolerated single oral doses of up to 6 g/kg. Reduced activity was seen at 1 g/kg in mice and at 5 g/kg in rats. Human overdoses of benazepril have not been reported, but the most common manifestation of human benazepril overdosage is likely to be hypotension. Laboratory determinations of serum levels of benazepril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of benazepril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of benazepril and its metabolites. Benazepril is only slightly dialyzable, but dialysis might be considered in overdosed patients with severely impaired renal function (see WARNINGS). Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of benazepril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of benazepril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat benazepril overdose by infusion of normal saline solution.

HOW SUPPLIED


id: 1702d86c-3093-4295-916c-322f00411525
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Benazepril hydrochloride tablets USP, 5 mg are light yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5124” on the other. Tablets are packaged in

Bottles of 30 NDC 54868-5392-0
Benazepril hydrochloride tablets USP, 10 mg are mustard yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5125” on the other. Tablets are packaged in
Bottles of 30 NDC 54868-5001-0
Bottles of 90 NDC 54868-5001-2
Bottles of 100 NDC 54868-5001-1
Benazepril hydrochloride tablets USP, 20 mg are pink, arc triangle-coated tablets, debossed with the number “93” on one side and “5126” on the other. Tablets are packaged in
Bottles of 30 NDC 54868-5079-0
Bottles of 90 NDC 54868-5079-2
Bottles of 100 NDC 54868-5079-1
Benazepril hydrochloride tablets USP, 40 mg are pink to light red, arc triangle-coated tablets, debossed with the number “93” on one side and “5127” on the other. Tablets are packaged in
Bottles of 30 NDC 54868-5204-0
Bottles of 60 NDC 54868-5204-2
Bottles of 90 NDC 54868-5204-1
Bottles of 100 NDC 54868-5204-3
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS
USA
Sellersville, PA 18960 Rev. M 9/2011 Relabeling and Repackaging by:

Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

PRINCIPAL DISPLAY PANEL


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 19d7c0aa-c36c-4a26-b6e3-43ec4fcafb3e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 29f96002-9e69-40c4-925c-2e1bacfe2a93
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: aa12a8c2-be54-468a-ab8f-00c4beba3137
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4