BENAZEPRIL HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Eon Labs, Inc.

INN (Algemene Internationale Benaming):

BENAZEPRIL HYDROCHLORIDE

Samenstelling:

BENAZEPRIL HYDROCHLORIDE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Benazepril hydrochloride tablets, USP 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,

Product samenvatting:

Benazepril Hydrochloride Tablets, USP, for oral administration, are packaged with a desiccant and available as 5 mg Yellow-orange, round, biconvex, film-coated tablets, debossed “E ” over “5” on one side and plain on the other side and supplied as: NDC 0185-0505-09 bottles of 90 NDC 0185-0505-01 bottles of 100 NDC 0185-0505-05 bottles of 500 10 mg Orange, round, biconvex, film-coated tablets, debossed “E ” over “53” on one side and plain on the other side and supplied as: NDC 0185-0053-09 bottles of 90 NDC 0185-0053-01 bottles of 100 NDC 0185-0053-05 bottles of 500 20 mg Pink, round, biconvex, film-coated tablets, debossed “E ” over “82” on one side and plain on the other side and supplied as: NDC 0185-0820-09 bottles of 90 NDC 0185-0820-01 bottles of 100 NDC 0185-0820-05 bottles of 500 40 mg Red, round, biconvex, film-coated tablets, debossed “E ” over “48” on one side and plain on the other side and supplied as: NDC 0185-0048-09 bottles of 90 NDC 0185-0048-01 bottles of 100 NDC 0185-0048-05 bottles of 500 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
EON LABS, 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
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DOSAGE FORMS AND STRENGTHS
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(3)
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 Sandoz Inc. at
1-800-525-8747 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch.
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)
Coadministration with aliskiren in patients w