BENAZEPRIL HYDROCHLORIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

REMEDYREPACK INC.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics. Benazepril HCl tablets are contraindicated in patients: - who are hypersensitive to benazepril or to any other ACE inhibitor - with a history of angioedema with or without previous ACE inhibitor treatment Benazepril HCl is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril HCl within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2)]. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors; including benazepril HCl tablets in patients with diabetes [see Drug Interactions (7.4)]. Risk Summary Benazepril HCl can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue benazepril HCl as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to benazepril HCl for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occur in neonates with a history of in utero exposure to benazepril HCl, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function . Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. A newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat. The antihypertensive effects of benazepril HCl have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age [see Clinical Pharmacology (12.3)]. The pharmacokinetics of benazepril HCl have been evaluated in pediatric patients 6 to 16 years of age [see Clinical Pharmacology (12.3)]. Infants below the age of 1 year should not be given benazepril HCl because of the risk of effects on kidney development. Safety and effectiveness of benazepril HCl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 mL/min/1.73 m² [see  Dosage and Administration (2.1) and Clinical Pharmacology (12.3)]. Of the total number of patients who received benazepril in U.S. clinical studies of benazepril HCl, 18% were 65 or older while 2% were 75 or older. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Benazepril and benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2)] . ACE inhibitors, including benazepril HCl, as monotherapy, have an effect on blood pressure that is less in Black patients than in non-Blacks.  Dose adjustment of benazepril HCl is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 mL/min. No dose adjustment of benazepril HCl is required in patients with creatinine clearance > 30 mL/min [see  Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Vörulýsing:

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: 70518-3528-00 PACKAGING: 90 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 discontinuation were