Enalapril tablet
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]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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. See WARNINGS, Fetal / Neonatal Morbidity and Mortality.
|
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. See WARNINGS, Fetal / Neonatal Morbidity and Mortality.
|
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
{{#ask: Page Name::Enalapril tablet |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Enalapril tablet |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.