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BENAZEPRIL

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Overview

What is BENAZEPRIL?

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 CHNO•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 Tablets, USP are supplied as white and round biconvex tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and talc.



What does BENAZEPRIL look like?



What are the available doses of BENAZEPRIL?

Sorry No records found.

What should I talk to my health care provider before I take BENAZEPRIL?

Sorry No records found

How should I use BENAZEPRIL?

Benazepril hydrochloride is indicated for the treatment of hypertension. It 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 ).

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

Hypertension

Adults

The recommended initial dose for patients not receiving a diuretic is 10 mg once-a-day. The usual maintenance dosage range is 20-40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Dosage adjustment should be based on measurement of peak (2-6 hours after dosing) and trough responses. If a once-daily regimen does not give adequate trough response, an increase in dosage or divided administration should be considered. If blood pressure is not controlled with Benazepril hydrochloride alone, a diuretic can be added.

Total daily doses above 80 mg have not been evaluated.

Concomitant administration of Benazepril hydrochloride with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see ).

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of Benazepril hydrochloride. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with Benazepril hydrochloride (see ). Then, if blood pressure is not controlled with Benazepril hydrochloride alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg benazepril hydrochloride should be used to avoid excessive hypotension.

Pediatrics

In children, doses of Benazepril hydrochloride between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure (see ). Based on this, the recommended starting dose of Benazepril hydrochloride in 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.

For pediatric patients who cannot swallow tablets, or for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths for benazepril hydrochloride, follow the suspension preparation instructions below to administer benazepril HCl as a suspension.

Treatment with benazepril hydrochloride is not advised for children below the age of 6 years (see  ) and in pediatric patients with glomerular filtration rate less than 30 mL, as there are insufficient data available to support a dosing recommendation in these groups.

For Hypertensive Patients with Renal Impairment

For patients with a creatinine clearance less than 30 mL/min/1.73 m(serum creatinine greater than 3 mg/dL), the recommended initial dose is 5 mg Benazepril hydrochloride once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg (see ).

Preparation of Suspension (for 150 mL of a 2 mg/mL suspension)

Add 75 mL of Ora-Plus®*oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen Benazepril hydrochloride 20 mg tablets, and shake for at least 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 75 mL of Ora-Sweet®*oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use.

*Ora-Plus® and Ora-Sweet® are registered trademarks of Paddock Laboratories, Inc. Ora-Plus® contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet® contains citric acid, berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.


What interacts with BENAZEPRIL?

Sorry No Records found


What are the warnings of BENAZEPRIL?

Sorry No Records found


What are the precautions of BENAZEPRIL?

Sorry No Records found


What are the side effects of BENAZEPRIL?

Sorry No records found


What should I look out for while using BENAZEPRIL?

Benazepril hydrochloride is contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor.

Benazepril hydrochloride is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment


What might happen if I take too much BENAZEPRIL?

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 ).

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 should I store and handle BENAZEPRIL?

Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009Benazepril Hydrochloride Tablets, USP are supplied as follows:5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side)Bottles of 30:     NDC 65162-751-03Bottles of 100:   NDC 65162-751-10Bottles of 500: NDC 65162-751-5010 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)Bottles of 30:     NDC 65162-752-03Bottles of 100:   NDC 65162-752-10Bottles of 500: NDC 65162-752-5020 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)Bottles of 30:     NDC 65162-753-03Bottles of 100:   NDC 65162-753-10Bottles of 500: NDC 65162-753-5040 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)Bottles of 30:     NDC 65162-754-03Bottles of 100:   NDC 65162-754-10Bottles of 500: NDC 65162-754-50Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)Dispense in tight container (USP). Manufactured by: Hauppauge, NY 11788Distributed by Glasgow, KY 42141Rev. 12-2009


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action

Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.

Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with Benazepril hydrochloride alone for up to 52 weeks had elevations of serum potassium of up to 0.2 mEq/L. Similar patients treated with Benazepril hydrochloride and hydrochlorothiazide for up to 24 weeks had no consistent changes in their serum potassium (see ).

Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. In animal studies, benazepril had no inhibitory effect on the vasopressor response to angiotensin II and did not interfere with the hemodynamic effects of the autonomic neurotransmitters acetylcholine, epinephrine, and norepinephrine.

ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of benazepril hydrochloride remains to be elucidated.

While the mechanism through which benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, benazepril has an antihypertensive effect even in patients with low-renin hypertension (see ).

Pharmacokinetics and Metabolism

Following oral administration of benazepril hydrochloride, peak plasma concentrations of benazepril are reached within 0.5-1.0 hours. The extent of absorption is at least 37% as determined by urinary recovery and is not significantly influenced by the presence of food in the GI tract.

Cleavage of the ester group (primarily in the liver) converts benazepril to its active metabolite, benazeprilat. Peak plasma concentrations of benazeprilat are reached 1-2 hours after drug intake in the fasting state and 2-4 hours after drug intake in the nonfasting state. The serum protein binding of benazepril is about 96.7% and that of benazeprilat about 95.3%, as measured by equilibrium dialysis; on the basis of in vitro studies, the degree of protein binding should be unaffected by age, hepatic dysfunction, or concentration (over the concentration range of 0.24-23.6 µmol/L).

Benazepril is almost completely metabolized to benazeprilat, which has much greater ACE inhibitory activity than benazepril, and to the glucuronide conjugates of benazepril and benazeprilat. Only trace amounts of an administered dose of benazepril hydrochloride can be recovered in the urine as unchanged benazepril, while about 20% of the dose is excreted as benazeprilat, 4% as benazepril glucuronide, and 8% as benazeprilat glucuronide.

The kinetics of benazepril are approximately dose-proportional within the dosage range of 10-80 mg.

In adults,

The kinetics did not change, and there was no significant accumulation during chronic administration (28 days) of once-daily doses between 5 mg and 20 mg. Accumulation ratios based on AUC and urinary recovery of benazeprilat were 1.19 and 1.27, respectively.

Benazepril and benazeprilat are cleared predominantly by renal excretion in healthy subjects with normal renal function. Nonrenal (i.e., biliary) excretion accounts for approximately 11%-12% of benazeprilat excretion in healthy subjects. In patients with renal failure, biliary clearance may compensate to an extent for deficient renal clearance.

In patients with renal insufficiency,

When dialysis was started two hours after ingestion of 10 mg of benazepril, approximately 6% of benazeprilat was removed in 4 hours of dialysis. The parent compound, benazepril, was not detected in the dialysate.

In patients with hepatic insufficiency (due to cirrhosis),

In pediatric patients,

Pharmacodynamics

Single and multiple doses of 10 mg or more of benazepril hydrochloride cause inhibition of plasma ACE activity by at least 80%-90% for at least 24 hours after dosing. Pressor responses to exogenous angiotensin I were inhibited by 60%-90% (up to 4 hours post-dose) at the 10-mg dose.

Hypertension

Adult

Administration of benazepril hydrochloride to patients with mild-to-moderate hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is infrequent, although it can occur in patients who are salt- and/or volume-depleted (see ).

In single-dose studies, benazepril hydrochloride lowered blood pressure within 1 hour, with peak reductions achieved 2-4 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. In multiple-dose studies, once-daily doses of 20-80 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 6 -12 /4-7 mmHg. The trough values represent reductions of about 50% of that seen at peak.

Four dose-response studies using once-daily dosing were conducted in 470 mild-to-moderate hypertensive patients not using diuretics. The minimal effective once-daily dose of benazepril hydrochloride was 10 mg; but further falls in blood pressure, especially at morning trough, were seen with higher doses in the studied dosing range (10-80 mg). In studies comparing the same daily dose of benazepril hydrochloride given as a single morning dose or as a twice-daily dose, blood pressure reductions at the time of morning trough blood levels were greater with the divided regimen.

During chronic therapy, the maximum reduction in blood pressure with any dose is generally achieved after 1-2 weeks. The antihypertensive effects of benazepril hydrochloride have continued during therapy for at least two years. Abrupt withdrawal of benazepril hydrochloride has not been associated with a rapid increase in blood pressure.

In patients with mild-to-moderate hypertension, Benazepril hydrochloride 10-20 mg was similar in effectiveness to captopril, hydrochlorothiazide, nifedipine SR, and propranolol. The antihypertensive effects of Benazepril hydrochloride were not appreciably different in patients receiving high- or low-sodium diets.

In hemodynamic studies in dogs, blood pressure reduction was accompanied by a reduction in peripheral arterial resistance, with an increase in cardiac output and renal blood flow and little or no change in heart rate. In normal human volunteers, single doses of benazepril caused an increase in renal blood flow but had no effect on glomerular filtration rate.

Use of Benazepril hydrochloride in combination with thiazide diuretics gives a blood-pressure-lowering effect greater than that seen with either agent alone. By blocking the renin-angiotensin-aldosterone axis, administration of Benazepril hydrochloride tends to reduce the potassium associated with the diuretic.

Pediatric

In a clinical study of 107 pediatric patients, 7 to 16 years of age, with either systolic or diastolic pressure above the 95th percentile, patients were given 0.1 or 0.2 mg/kg then titrated up to 0.3 or 0.6 mg/kg with a maximum dose of 40 mg once daily. After four weeks of treatment, the 85 patients whose blood pressure was reduced on therapy were then randomized to either placebo or benazepril and were followed up for an additional two weeks. At the end of two weeks, blood pressure (both systolic and diastolic) in children withdrawn to placebo rose by 4 to 6 mmHg more than in children on benazepril. No dose-response was observed for the three doses.

Non-Clinical Toxicology
Benazepril hydrochloride is contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor.

Benazepril hydrochloride is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment

In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see ).

It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.

Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.

The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.

An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established. Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.

Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of this observation is unknown.

Chlorpropamide’s plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

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 Benazepril hydrochloride) may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema:

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 (see

).

Intestinal Angioedema:

Anaphylactoid Reactions During Desensitization:

Anaphylactoid Reactions During Membrane Exposure:

Hypotension

Benazepril hydrochloride can cause symptomatic hypotension. Like other ACE inhibitors, benazepril has been only rarely associated with hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been volume- and/or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume- and/or salt-depletion should be corrected before initiating therapy with Benazepril hydrochloride.

In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia and, rarely, with acute renal failure and death. In such patients, benazepril hydrochloride therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of benazepril or diuretic is increased.

If hypotension occurs, the patient should be placed in a supine position, and, if necessary, treated with intravenous infusion of physiological saline. Benazepril hydrochloride treatment usually can be continued following restoration of blood pressure and volume.

Neutropenia/Agranulocytosis

Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Available data from clinical trials of benazepril are insufficient to show that benazepril does not cause agranulocytosis at similar rates. Monitoring of white blood cell counts should be considered in patients with collagen-vascular disease, especially if the disease is associated with impaired renal function.

Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, Benazepril hydrochloride should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis.

The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE inhibitor exposure.

In addition, use of ACE inhibitors during the first trimester of pregnancy has been associated with a potentially increased risk of birth defects. In women planning to become pregnant, ACE inhibitors (including Benazepril hydrochloride) should not be used. Women of childbearing age should be made aware of the potential risk and ACE inhibitors (including Benazepril hydrochloride) should only be given after careful counseling and consideration of individual risks and benefits.

Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.

If oligohydramnios is observed, benazepril should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Benazepril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers with another ACE inhibitor, but experience is limited.

No teratogenic effects of benazepril hydrochloride were seen in studies of pregnant rats, mice, and rabbits. On a mg/m2 basis, the doses used in these studies were 60 times (in rats), 9 times (in mice), and more than 0.8 times (in rabbits) the maximum recommended human dose (assuming a 50-kg woman). On a mg/kg basis these multiples are 300 times (in rats), 90 times (in mice), and more than 3 times (in rabbits) the maximum recommended human dose.

Hepatic Failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

General

Impaired Renal Function:

Evaluation of the hypertensive patient should always include assessment of renal function (see

).

Hyperkalemia:

Cough:

Impaired Liver Function:

Surgery/Anesthesia:

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 ).

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.

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):

Cardiovascular:

Renal:

Fetal/Neonatal Morbidity and Mortality:

Angioedema:

Dermatologic:

Gastrointestinal:

Hematologic:

Neurologic and Psychiatric:

Other:

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

The following adverse events of unknown frequency have been reported during post-marketing use of benazepril; small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.

Pediatric Patients:

The long-term effects of benazepril on growth and development have not been studied.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen:

Potassium:

Hemoglobin:

Other (causal relationships unknown):

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).