BENAZEPRIL HYDROCHLORIDE- 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:

Mylan Pharmaceuticals Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 5 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 are available containing 5 mg, 10 mg, 20 mg or 40 mg of benazepril hydrochloride, USP. The 5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 441 on the other side. They are available as follows: NDC 0378-0441-01 bottles of 100 tablets The 10 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 443 on the other side. They are available as follows: NDC 0378-0443-01 bottles of 100 tablets The 20 mg tablets are white, film-coated, round, unscored tablets debossed with M over 444 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0444-01 bottles of 100 tablets The 40 mg tablets are white, film-coated, oval, unscored tablets debossed with M 447 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0447-01 bottles of 100 tablets 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 using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
MYLAN 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
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
TABLETS 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions leading to discontinuation were
headache (0.6%) and cough (0.5%) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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.
2
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)
2
Tablets: 5 mg, 10 mg, 20 mg, 40 mg
Angioedema or history of hereditary or idiopathic angioedema (4)
Hypersensitivity (4)
Coadmini