Use in Pregnancy
id: 58A54490-1DDF-B984-0D1E-30AC90C3C08A
displayName: BOXED WARNING section
FDA Article Code: 34066-1
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, benazepril hydrochloride tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
id: 4FFBBA3D-97CF-67F8-613B-E50819A37BD4
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-1 H-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 is supplied as 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, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, 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.
INDICATIONS AND USAGE
id: 35BAE516-1AF3-60B2-6F97-B3FBB013D7C5
displayName: INDICATIONS AND USAGE section
FDA Article Code: 34067-9
Benazepril hydrochloride tablets are indicated for the treatment of hypertension. Benazepril hydrochloride tablets may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride tablets, 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 tablets do 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: 394BAB74-F9B6-FF21-29A5-E2AD8C5D608A
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.
ADVERSE REACTIONS
id: B28C7AD6-182B-7B67-4ECB-5EB1865C53B1
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 |
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: 512B64CC-02B8-B894-06E8-523DCA8F0365
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: 675338E2-2381-7EF5-D8BF-FDC34B86DACE
displayName: HOW SUPPLIED section
FDA Article Code: 34069-5
Benazepril hydrochloride 5 mg tablets are white, film-coated tablets, debossed “ETH” on one side and “341” on the other side, packaged as follows: NDC 58177-341-04 bottle of 100 tablets (with desiccant)Benazepril hydrochloride 10 mg tablets are red, film-coated tablets, debossed “ETH” on one side and “342” on the other side, packaged as follows: NDC 58177-342-04 bottle of 100 tablets (with desiccant) NDC 58177-342-08 bottle of 500 tablets (with desiccant)Benazepril hydrochloride 20 mg tablets are gray, film-coated tablets, debossed “ETH” on one side and “343” on the other side, packaged as follows: NDC 58177-343-04 bottle of 100 tablets (with desiccant) NDC 58177-343-08 bottle of 500 tablets (with desiccant)Benazepril hydrochloride 40 mg tablets are blue, film-coated tablets, debossed “ETH” on one side and “344” on the other side, packaged as follows: NDC 58177-344-04 bottle of 100 tablets (with desiccant) NDC 58177-344-08 bottle of 500 tablets (with desiccant)Store at controlled room temperature 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Do not store above 30°C (86°F).Dispense in a tight container (USP).Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63044
