BENAZEPRIL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride is indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.  These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Benazepril hydrochloride is indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.  These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of sever

Product summary:

Benazepril Hydrochloride Tablets USP, 5 mg are available as light orange, round, film-coated tablets debossed "696" on one side and plain on the other side containing 5 mg benazepril hydrochloride, packaged in bottles of 100 (NDC 23155-749-01) and 500 (NDC 23155-749-05) tablets. Benazepril Hydrochloride Tablets USP, 10 mg are available as orange, round, film-coated tablets debossed "697" on one side and plain on the other side containing 10 mg benazepril hydrochloride, packaged in bottles of 100 (NDC 23155-750-01) and 500 (NDC 23155-750-05) tablets. Benazepril Hydrochloride Tablets USP, 20 mg are available as peach, round, film-coated tablets debossed "698" on one side and plain on the other side containing 20 mg benazepril hydrochloride, packaged in bottles of 100 (NDC 23155-751-01) and 500 (NDC 23155-751-05) tablets. Benazepril Hydrochloride Tablets USP, 40 mg are available as orange-red, round, film-coated tablets debossed "699" on one side and plain on the other side containing 40 mg benazepril hydrochloride, packaged in bottles of 100 (NDC 23155-752-01) and 500 (NDC 23155-752-05) tablets. Dispense in a tight container as defined in the USP. Use child-resistant closure (as required). Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENAZEPRIL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR USE
BENAZEPRIL HYDROCHLORIDE TABLETS.
BENAZEPRIL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
WARNING-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE AS
SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
Benazepril hydrochloride is an angiotensin-converting enzyme (ACE)
inhibitor indicated for the treatment
of hypertension, to lower blood pressure. Lowering blood pressure
reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
(1)
DOSAGE AND ADMINISTRATION
Adult Patients: Initiate with 10 mg once daily (or 5 mg if patient is
on diuretic). Titrate to 40 mg daily
based on blood pressure response. (2.1)
Pediatric patients age 6 years and above with glomerular filtration
rate (GFR) >30 mL/min/1.73 m :
Initiate with 0.2 mg/kg once daily. Maximum dose is 0.6 mg/kg once
daily.
Renal Impairment: Initiate with 5 mg once daily in patients with GFR
<30 mL/min/1.73 m (serum
creatinine >3 mg/dL) (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, 40 mg
CONTRAINDICATIONS
Angioedema or history of hereditary or idiopathic angioedema (4)
Hypersensitivity (4)
Coadministration with aliskiren in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
Angioedema: Discontinue benazepril hydrochloride and treat
appropriately. (5.2)
Monitor renal function periodically. (5.3)
Monitor blood pressure after initiation. (5.4)
Hyperkalemia: Monitor serum potassium periodically. (5.5)
Hepatic toxicity: Monitor for jaundice or signs of liver fail