BENAZEPRIL HYDROCHLORIDE tablet coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Sammensetning:

BENAZEPRIL HYDROCHLORIDE 5 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
TEVA PHARMACEUTICALS USA, 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 TEVA USA,
PHARMACOVIGILANCE at 1-888-838-2872 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 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.
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)
Coad