BENAZEPRIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride tablets are 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. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from

Product summary:

Benazepril Hydrochloride Tablets USP, 40 mg are dark pink, circular, biconvex, beveled edge film-coated tablets debossed with ‘E’ on one side and ‘17’ on the other side. Bottles of 30               NDC 43063-748-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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, FILM COATED
PD-RX 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 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 tablets are 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 patients 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: 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 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 failure. (
5.6)
ADVERSE REACTIONS