Benazepril Hydrochloride Tablets, USP, film coated for oral use

/Benazepril Hydrochloride Tablets, USP, film coated for oral use
Benazepril Hydrochloride Tablets, USP, film coated for oral use2018-09-06T09:12:40+00:00

Prescription Drug Name:

Benazepril Hydrochloride Tablets, USP, film coated for oral use

ID:

be41d21c-4747-47bb-b4b7-bbfabcd7a9b1

Code:

34391-3

WARNING: FETAL TOXICITY


id: 06f2eaec-5150-46d6-9ffc-e96af7cb2439
displayName: Boxed Warning section
FDA Article Code: 34066-1

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


id: 4d830dba-c299-4a13-9e4b-008895bf470f
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 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 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.

INDICATIONS AND USAGE


id: e17cab44-aad0-461d-b0b7-61a1b2838dd2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: 4ba8d982-284f-4072-b913-e1202dcb5aa8
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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.

ADVERSE REACTIONS


id: 987eb8cf-8225-45eb-af3a-b5aebf7c37d5
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Benazepril hydrochloride tablets have 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 tablets 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 tablets 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 tablets are shown below.

Patients in U.S. Placebo-Controlled Studies
Benazepril Hydrochloride Tablets

(N=964)

Placebo

(N=496)

N % N %
Headache 60 6.2 21 4.2
Dizziness 35 3.6 12 2.4
Somnolence 15 1.6 2 0.4
Postural Dizziness 14 1.5 1 0.2
Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients or with less than 1% difference in incidence between benazepril or placebo treatment), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):

OVERDOSAGE


id: 36296b3d-e206-4bfc-98cf-866bdc53e928
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, which can be associated with electrolyte disturbances and renal failure. 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. If ingestion is recent, activated charcoal should be considered. Gastric decontamination (e.g., vomiting, gastric lavage) may be considered in individual cases, in the early period after ingestion. Patients should be closely monitored for blood pressure and clinical symptoms. Supportive management should be employed to ensure adequate hydration and to maintain systemic blood pressure. In the case of marked hypotension, physiological saline solution should be administered intravenously; depending on the clinical situation the use of vasopressors (e.g., catecholamines i.v.) may be considered.

HOW SUPPLIED


id: 1c2b8bf0-e6fa-4d66-8963-cca401f6a3ba
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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 63187-393-30 bottle of 30 tablets (with desiccant)
NDC 63187-393-60 bottle of 60 tablets (with desiccant)
NDC 63187-393-90 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
Linhai, Zhejiang 317024, China
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Version: 01/2014 07713-01

PRINCIPAL DISPLAY PANEL – 20 mg 90 tablet text


id: 7ed1d464-3554-466b-ac12-ead3fde17af0
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 63187-393-90     Rx only Benazepril

Hydrochloride

Tablets USP 20 mg 90 Tablets