ENALAPRIL MALEATE ORAL SOLUTION- enalapril maleate solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)

Հասանելի է:

Bionpharma Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Enalapril maleate oral solution is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In these patients, enalapril maleate oral solution increases survival and decreases the frequency of hospitalization. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate oral solution decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. Enalapril is contraindicated in patients with: - a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor. [see Warnings and Precautions ( 5.2)] - hereditary or idiopathic angioedema. [see Warnings and Precautions ( 5.2)] Do not co-administer aliskiren with enalapril in patients with diabetes [see Drug Interactions ( 7.2)] . Enalapril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2)] . Risk Summary Enalapril 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 enalapril as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. 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 Adverse reactions in the fetus or in neonates with a history of in utero exposure to enalapril maleate. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, 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 oligohydraminos may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to enalapril for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs in neonates with a history of in utero exposure to enalapril, 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. Risk Summary Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for severe adverse reactions in the breastfed infant, including hypotension, hyperkalemia, and renal impairment, advise women not to breastfeed during treatment with enalapril. Neonates with a history of in utero exposure to enalapril maleate If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Enalapril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure. Pediatric patients with heart failure or asymptomatic left ventricular dysfunction  Safety and effectiveness of enalapril have not been established in pediatric patients with heart failure or asymptomatic left ventricular dysfunction. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. 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. ACE inhibitors, including enalapril, as monotherapy have an effect on blood pressure that is less in black patients than in non-blacks. Use a lower initial dose of enalapril in patients undergoing hemodialysis and in patients whose eGFR is ≤ 30 mL/min [see Clinical Pharmacology ( 12.3)] .

Ապրանքի ամփոփագիր:

Enalapril maleate oral solution is a ready-to-use solution that contains 1 mg/mL of enalapril maleate, USP. It is a clear, colorless oral solution with a mixed berry flavor, packaged in a 150 mL, white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and placed in a carton with tamper-evident seal. Each bottle contains 150 mL. NDC 69452-237-46 Store refrigerated (2° to 8°C/36° to 46°F) in a tightly closed container. Protect from freezing and excessive heat. Patients may store enalapril maleate oral solution at room temperature (20° to 25°C/68° to 77°F) for up to 60 days.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ENALAPRIL MALEATE ORAL SOLUTION- ENALAPRIL MALEATE SOLUTION
BIONPHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENALAPRIL MALEATE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ENALAPRIL
MALEATE ORAL SOLUTION.
ENALAPRIL MALEATE ORAL SOLUTION
INITIAL U.S. APPROVAL: 1985
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE ORAL
SOLUTION 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
Enalapril is an angiotensin-converting enzyme inhibitor indicated for:
treatment of symptomatic heart failure. ( 1.2)
treatment of asymptomatic left ventricular dysfunction, to decrease
the rate of development of overt
heart failure and reduce hospitalization for heart failure. ( 1.3)
DOSAGE AND ADMINISTRATION
Heart Failure: Initiate at 2.5 mg twice daily. Titrate up to 20 mg
twice daily as tolerated. ( 2.2)
Asymptomatic Left Ventricular Dysfunction: Initiate at 2.5 mg twice
daily. Titrate up to 10 mg twice daily. (
2.3)
Enalapril maleate oral solution is a ready-to-use solution intended
for oral use only.
DOSAGE FORMS AND STRENGTHS
Enalapril maleate oral solution is a ready-to-use oral solution: 1
mg/mL enalapril maleate, USP. ( 3)
CONTRAINDICATIONS
Hypersensitivity related to previous treatment with an ACEI. ( 4)
Hereditary or idiopathic angioedema. ( 4)
Do not co-administer aliskiren in patients with diabetes. ( 4)
In combination with a neprilysin inhibitor. ( 4)
WARNINGS AND PRECAUTIONS
Angioedema and Anaphylactoid Reactions. ( 5.2)
Impaired Renal Function: Assess renal function. ( 5.5)
Hyperkalemia. ( 5.6)
ADVERSE REACTIONS
The most common adverse reactions for patients treated for heart
failure (>6%) were hypotension and
dizziness. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIONPHARMA INC. AT
1-888-235-BION O