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
PRINCIPAL DISPLAY PANEL — 10 mg
NDC 63187-499-90 Rx only
Benazepril
Hydrochloride
Tablets USP
10 mg
90 Tablets
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BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride tablet, coated | ||||||||||||||||||||||||||||||
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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
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