BENAZEPRIL HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Zydus Pharmaceuticals (USA) Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Benazepril Hydrochloride Tablets, 5 mg are light yellow, round, biconvex, film-coated tablets imprinted with "B1" in black ink on one side and plain on other side and are supplied as follows: NDC 68382-169-16 in bottle of 90 tablets NDC 68382-169-01 in bottle of 100 tablets NDC 68382-169-10 in bottle of 1000 tablets Benazepril Hydrochloride Tablets, 10 mg are white to off-white, round, biconvex, film- coated tablets imprinted with "B2" in black ink on one side and plain on other side and are supplied as follows: NDC 68382-170-16 in bottle of 90 tablets NDC 68382-170-01 in bottle of 100 tablets NDC 68382-170-10 in bottle of 1000 tablets NDC 68382-170-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Benazepril Hydrochloride Tablets, 20 mg are white to off-white, round, biconvex, film-coated tablets imprinted with "B3" in black ink on one side and plain on other side and are supplied as follows: NDC 68382-171-16 in bottle of 90 tablets NDC 68382-171-01 in bottle of 100 tablets NDC 68382-171-10 in bottle of 1000 tablets NDC 68382-171-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Benazepril Hydrochloride Tablets, 40 mg are white to off-white, round, biconvex, film-coated tablets imprinted with "B4" in black ink on one side and plain on other side and are supplied as follows: NDC 68382-172-16 in bottle of 90 tablets NDC 68382-172-01 in bottle of 100 tablets NDC 68382-172-10 in bottle of 1000 tablets NDC 68382-172-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage: Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. (USP)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
_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 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 patients 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)
Coadministration 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.
(5.6)
ADVERSE REACTIONS