Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Preferred Pharmaceuticals Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 5 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,
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: 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.
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- 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 • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • 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/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) (2.2) 2 Tablets: 5 mg, 10 mg, 20 mg, 40 mg Angioedema or history of hereditary or idiopathic angioedema (4) Hypersensitivity (4) Coadministration with aliskire Preberite celoten dokument