ENALAPRIL MALEATE ORAL SOLUTION- enalapril maleate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Camber Pharmaceuticals, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Enalapril maleate oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Use ( 8.4) and Clinical Studies ( 14)]. 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 this drug. 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 J

Product samenvatting:

Enalapril maleate oral solution is a ready-to-use oral solution that contains 1 mg/mL of enalapril maleate. It is clear, colorless solution with a strawberry flavor, packaged in a 150 mL white, round high-density polyethylene bottle with a white, polypropylene, child-resistant closure with induction seal FSE. Each bottle contains 150 mL.                              Bottle of 150 mL           NDC 31722-020-15 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ENALAPRIL MALEATE ORAL SOLUTION - ENALAPRIL MALEATE SOLUTION
CAMBER PHARMACEUTICALS, 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)
RECENT MAJOR CHANGES
Contraindications ( 4) 7/2017
INDICATIONS AND USAGE
Enalapril maleate is an angiotensin-converting enzyme inhibitor
indicated for:
• treatment of hypertension in adults and children older than one
month, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and
myocardial infarctions. ( 1.1)
• 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
Hypertension
• Adult: recommended initial dose is 5 mg once daily. Maximum dose
is 40 mg daily. ( 2.1)
• Pediatrics: recommended starting dose is 0.08 mg/kg (up to 5 mg)
once daily. ( 2.1)
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. ( 3)
CONTRAINDICATIONS
• Hypersensitivity related to previous treatment with an ACEI. ( 4)
• Here