Benazepril Hydrochloride (Page 5 of 5)

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 is 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 tablets, follow the suspension preparation instructions below to administer benazepril hydrochloride tablets as a suspension.

Treatment with benazepril hydrochloride tablets is not advised for children below the age of 6 years (see PRECAUTIONS, Pediatric Use) and in pediatric patients with glomerular filtration rate <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 <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablet 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, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:

NDC 63187-500-30 bottle of 30 tablets (with desiccant)

NDC 63187-500-60 bottle of 60 tablets (with desiccant)

NDC 63187-500-90 bottle of 90 tablets (with desiccant)

Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:

NDC 63187-499-30 bottle of 30 tablets (with desiccant)

NDC 63187-499-60 bottle of 60 tablets (with desiccant)

NDC 63187-499-90 bottle of 90 tablets (with desiccant)

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight container (USP).

You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Version: 01/2014

07713-01

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 63187-500-30 Rx only

Benazepril
Hydrochloride
Tablets USP

5 mg

30 Tablets

63187-500-30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 63187-499-90 Rx only

Benazepril
Hydrochloride
Tablets USP

10 mg

90 Tablets

63187-499-90
(click image for full-size original)
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-500(NDC:43547-335)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code S;341
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-500-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:63187-500-60 60 TABLET, COATED in 1 BOTTLE None
3 NDC:63187-500-90 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076118 01/01/2014
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-499(NDC:43547-336)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
FD&C RED NO. 40
Product Characteristics
Color RED Score no score
Shape ROUND Size 8mm
Flavor Imprint Code S;342
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-499-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:63187-499-60 60 TABLET, COATED in 1 BOTTLE None
3 NDC:63187-499-90 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076118 01/01/2014
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-499), REPACK (63187-500), RELABEL (63187-499), RELABEL (63187-500)

Revised: 01/2024 Proficient Rx LP

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 © 2024. All Rights Reserved.