BENAZEPRIL HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AvKARE

INN (Διεθνής Όνομα):

BENAZEPRIL HYDROCHLORIDE

Σύνθεση:

BENAZEPRIL HYDROCHLORIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Benazepril 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 d

Περίληψη προϊόντος:

Benazepril HCl tablets, USP, 5 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with "51" on one side and "A"on the other side. They are available as follows: NDC 42291-160-90 Bottles of 90 NDC 42291-160-01 Bottles of 100 NDC 42291-160-50 Bottles of 500 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: NDC 42291-161-90 Bottles of 90 NDC 42291-161-01 Bottles of 100 NDC 42291-161-50 Bottles of 500 Benazepril HCl tablets, USP, 20 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with "53" on one side and "A" on the other side. They are available as follows: NDC 42291-162-90 Bottles of 90 NDC 42291-162-01 Bottles of 100 NDC 42291-162-18 Bottles of 180 NDC 42291-162-50 Bottles of 500 Benazepril HCl tablets, USP, 40 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with "54" on one side and "A" on the other side. They are available as follows: NDC 42291-163-90 Bottles of 90 NDC 42291-163-01 Bottles of 100 NDC 42291-163-18 Bottles of 180 NDC 42291-163-50 Bottles of 500 Storage: Store at 20º to 25°C (68° to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
BENAZEPRIL HYDROCHLORIDE TABLETS, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENAZEPRIL HCL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BENAZEPRIL HCL TABLETS.
BENAZEPRIL HCL 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 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) (2.2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 5 mg, 10 mg, 20 mg, 40 mg (3)
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 common adverse rea