Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
NuCare Pharmaceuticals, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride (HCl) 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
Benazepril HCl tablets, USP, 10 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side. They are available as follows: Bottles of 30 NDC 68071-3142-3 Bottles of 60 NDC 68071-3142-6 Bottles of 90 NDC 68071-3142-9 Bottles of 120 NDC 68071-3142-2 Storage: Store at 20º to 25°C (68° to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP.
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USEBENAZEPRIL HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE TABLETS, USP 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 (HCL) TABLETS, USP 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) (2.3) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, 20 mg, 40 mg 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 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 The most c Baca dokumen lengkap