BENAZEPRIL HYDROCHLORIDE tablet, coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

REMEDYREPACK INC.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows: NDC 43547-335-10 bottle of 100 tablets (with desiccant) 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: NDC 43547-336-10 bottle of 100 tablets (with desiccant) NDC 43547-336-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows: NDC 43547-337-10 bottle of 100 tablets (with desiccant) NDC 43547-337-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows: NDC 43547-338-10 bottle of 100 tablets (with desiccant) NDC 43547-338-50 bottle of 500 tablets (with desiccant) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Revised: 12/2015 07713-04

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
REMEDYREPACK INC.
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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 liver failure