Enalapril tablet

Enalapril tablet
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2], Amr Marawan, M.D. [3]

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Black Box Warning

USE IN PREGNANCY See full prescribing information for complete Boxed Warning. Condition Name: When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalapril maleate should be discontinued as soon as possible.

Overview

Enalapril tablet is an Angiontensin converting enzyme inhibitor that is FDA approved for the {{{indicationType}}} of hypertension, heart failure, left ventricular dysfunction after myocardial infarction, diabetic nephropathy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Hyperkalemia (1% to 3.8% ), dizziness (4.3% to 7.9% ), increase in serum blood urea nitrogen (0.2% to 11% ), increase in serum creatinine (0.2% to 11% ), fatigue (3% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

<h4>Condition 1</h5>

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Enalapril tablet FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Enalapril tablet Contraindications in the drug label.

Warnings

USE IN PREGNANCY See full prescribing information for complete Boxed Warning. Condition Name: When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalapril maleate should be discontinued as soon as possible.

There is limited information regarding Enalapril tablet Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Enalapril tablet Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Enalapril tablet Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Enalapril tablet Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Enalapril tablet in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Enalapril tablet in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Enalapril tablet during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Enalapril tablet in women who are nursing.

Pediatric Use

• The effects of enalapril maleate as an Antihypertensive have been established in hypertensive pediatric patients age 1 month to 16 years. Use of enalapril maleate in these age groups is supported by evidence from adequate and well-controlled studies of enalapril maleate in pediatric and adult patients as well as by published literature in pediatric patients.

• For pediatric hypertensive patients, the usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients.

• Enalapril maleate is not recommended in neonates and in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2, as no data are available.

Geriatic Use

FDA Package Insert for Enalapril tablet contains no information regarding Geriatrics.

Gender

FDA Package Insert for Enalapril tablet contains no information regarding Gender.

Race

FDA Package Insert for Enalapril tablet contains no information regarding Race.

Renal Impairment

There is no FDA guidance on the use of Enalapril tablet in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Enalapril tablet in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Enalapril tablet in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Enalapril tablet in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Enalapril tablet Administration in the drug label.

Monitoring

There is limited information regarding Enalapril tablet Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Enalapril tablet and IV administrations.

Overdosage

There is limited information regarding Enalapril tablet overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Enalapril tablet Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Enalapril tablet Mechanism of Action in the drug label.

Structure

There is limited information regarding Enalapril tablet Structure in the drug label.

Pharmacodynamics

There is limited information regarding Enalapril tablet Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Enalapril tablet Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Enalapril tablet Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Enalapril tablet Clinical Studies in the drug label.

How Supplied

There is limited information regarding Enalapril tablet How Supplied in the drug label.

Storage

There is limited information regarding Enalapril tablet Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Enalapril tablet Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Enalapril tablet interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Enalapril tablet Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Enalapril tablet Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.