Benazepril Hydrochloride and Hydrochlorothiazide (Page 5 of 6)

OVERDOSAGE

No specific information is available on the treatment of overdosage with Benazepril HCl and Hydrochlorothiazide; treatment should be symptomatic and supportive. Therapy with Benazepril HCl and Hydrochlorothiazide should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.

Single oral doses of 1 g/kg of benazepril caused reduced activity in mice, and doses of 3 g/kg were associated with significant lethality. Reduction of activity in rats was not seen until they had received doses of 5 g/kg, and doses of 6 g/kg were not lethal. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.

Data from human overdoses of benazepril are scanty, but the most common manifestation of human benazepril overdosage is likely to be hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

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. Benazeprilat 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.

DOSAGE AND ADMINISTRATION

Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg.

Switch Therapy: A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with Benazepril HCl and Hydrochlorothiazide. The usual recommended starting dose is 10/12.5 mg once daily to control blood pressure.

Replacement Therapy: The combination may be substituted for the titrated individual components.

HOW SUPPLIED

Benazepril HCl USP and Hydrochlorothiazide USP is available in tablets of three different strengths:

Benazepril HCl	Hydrochlorothiazide	Tablet Color
10 mg	12.5 mg	light pink
20 mg	12.5 mg	grayish violet
20 mg	25 mg	red

Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.

The National Drug Codes for the various packages are:

Dose	Bottle of 100	Tablet Imprint
10/12.5	NDC 0574-0227-01	452
20/12.5	NDC 0574-0229-01	453
20/25	NDC 0574-0228-01	454

Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.

Storage: Do not store above 86°F (30°C). Protect from moisture and light. Dispense in a tight, light‑resistant container (USP).

Distributed By:

Padagis_TM

Allegan, MI 49010

www.padagis.com

37Y00 RC J5 Rev 11-22

Manufactured for:

Validus Pharmaceuticals LLC

Parsippany, NJ 07054

© 2022 Validus Pharmaceuticals LLC

60160-04

November 2022

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Benazepril HCl and Hydrochlorothiazide Tablets 10 mg/12.5mg

100 TABLETS

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/12.5 mg

100 TABLETS

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.