Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Bryant Ranch Prepack
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
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, f
Product: 63629-2672 NDC: 63629-2672-3 100 TABLET, COATED in a BOTTLE NDC: 63629-2672-4 90 TABLET, COATED in a BOTTLE NDC: 63629-2672-1 30 TABLET, COATED in a BOTTLE NDC: 63629-2672-2 60 TABLET, COATED in a BOTTLE
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BENAZEPRIL HYDROCHLORIDE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENAZEPRIL HYDROCHLORIDE TABLETS USP. 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 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 USP 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 • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS The most common adverse reactions leading to discontinuation were headache (0.6%) (5.6) and cough (5.7) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS • • • • 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) (2.3) 2 Tablets: 5 mg, 10 mg, 20 mg, 40 mg Angioedema or history of hereditary or idiopathic ang Baca dokumen lengkap