BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tablet, coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

INN (Mezinárodní Name):

BENAZEPRIL HYDROCHLORIDE

Složení:

BENAZEPRIL HYDROCHLORIDE 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Benazepril hydrochloride 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 drugs, f

Přehled produktů:

Product: 63629-2672 NDC: 63629-2672-3 100 TABLET, COATED in a BOTTLE NDC: 63629-2672-4 90 TABLET, COATED in a BOTTLE NDC: 63629-2672-1 30 TABLET, COATED in a BOTTLE NDC: 63629-2672-2 60 TABLET, COATED in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENAZEPRIL HYDROCHLORIDE TABLETS USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENAZEPRIL
HYDROCHLORIDE TABLETS USP.
BENAZEPRIL HYDROCHLORIDE 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 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 tablets USP 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions leading to discontinuation were
headache (0.6%) (5.6) and cough (5.7)
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA,
PHARMACOVIGILANCE at 1-866-832-8537 or
[e-mail]; or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DRUG INTERACTIONS
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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.
2
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)
2
Tablets: 5 mg, 10 mg, 20 mg, 40 mg
Angioedema or history of hereditary or idiopathic ang