Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Apotex Corp
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE - BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED APOTEX CORP ---------- 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 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 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 (3) CONTRAINDICATIONS Angioedema or history of hereditary or idiopathic angioedema (4) Hypersensitivity (4) Co-administration with aliskiren in patients with diabetes (4) WARNINGS AND PRECAUTIONS Angioedema: Discontinue benazepril hydrochloride tablets 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) AD Läs hela dokumentet