BENAZEPRIL HYDROCHLORIDE tablet, coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Aidarex Pharmaceuticals LLC

INN (Tên quốc tế):

BENAZEPRIL HYDROCHLORIDE

Thành phần:

BENAZEPRIL HYDROCHLORIDE 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Benazepril hydrochloride tablets 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, from

Tóm tắt sản phẩm:

Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows: 30 TABLET in a BOTTLE (53217-190-30) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Repackaged by Aidarex Pharmaceutical, LLC Corona, CA 92880

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
AIDAREX PHARMACEUTICALS LLC
----------
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, FILM COATED 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)
( 2.3)
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 hydrochloride 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 liv