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Benazepril Hcl 10 Mg Tabs 500 By Amneal Pharma.

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Benazepril Hcl 10 Mg Tabs 500 By Amneal Pharma.

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Benazepril Hcl 10 Mg Tabs 500 By Amneal Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10045968/RXD4248431
Size : 500
Selling UoM : EA
NDC: 65162-0752-50
UPC Barcode : 365162752502
Supplier: 0050001208 AMNEAL PHARMACEUTICALS, LLC
Supplier Material : 075250
Generic Code : 016040 BENAZEPRIL HCL ORAL TABLET 10 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

52
tablet , white , round round
DebossedBiconvex

USE IN PREGNANCY

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

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.

Lotensin 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, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide.

INDICATIONS

Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

In using Lotensin, 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 Lotensin 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.

SIDE EFFECTS

Lotensin 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 Lotensin 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 Lotensin and in 3% of patients treated with placebo.

WARNINGS
Anaphylactoid and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Lotensin) may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors. In U.S. clinical trials, symptoms consistent with angioedema were seen in none of the subjects who received placebo and in about 0.5% of the subjects who received Lotensin. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with Lotensin should be discontinued and appropriate therapy instituted immediately Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine injection 1:1000 (0.3 mL to 0.5 mL) should be promptly administered