BENAZEPRIL (Page 2 of 2)

DOSAGE AND ADMINISTRATION

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 PRECAUTIONS).

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 WARNINGS). 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 Pharmacodynamics). 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 PRECAUTIONS, Pediatric Use) 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 m2 (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 WARNINGS).

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.

HOW SUPPLIED

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 65162-751-03

Bottles of 100: NDC 65162-751-10

Bottles of 500: NDC 65162-751-50

10 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side)

Bottles of 30: NDC 65162-752-03

Bottles of 100: NDC 65162-752-10

Bottles of 500: NDC 65162-752-50

20 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side)

Bottles of 30: NDC 65162-753-03

Bottles of 100: NDC 65162-753-10

Bottles of 500: NDC 65162-753-50

40 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side)

Bottles of 30: NDC 65162-754-03

Bottles of 100: NDC 65162-754-10

Bottles of 500: NDC 65162-754-50

Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature)

Dispense in tight container (USP).

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by
Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 12-2009

BENAZEPRIL 20MG LABEL
(click image for full-size original)

BENAZEPRIL
benazepril hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-259(NDC:65162-753)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
Product Characteristics
Color white Score no score
Shape ROUND (BICONVEX) Size 8mm
Flavor Imprint Code 53;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-259-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:16590-259-60 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:16590-259-90 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076820 02/02/2010
Labeler — STAT RX USA LLC (786036330)

Revised: 03/2010 STAT RX USA LLC

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.