BENAZEPRIL HYDROCHLORIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

AvPAK

Designació comuna internacional (DCI):

BENAZEPRIL HYDROCHLORIDE

Composición:

BENAZEPRIL HYDROCHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Benazepril HCl 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 a variety

Resumen del producto:

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 50268-109-15 (10 tablets per card, 5 cards per carton) 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 50268-110-15 (10 tablets per card, 5 cards per carton) 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 50268-111-15 (10 tablets per card, 5 cards per carton) 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 50268-112-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose Package. For Institutional Use Only. 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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BENAZEPRIL HCI 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, 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 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
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
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 HCl 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 reactions leading to