Label: ENALAPRIL MALEATE tablet
- NDC Code(s): 50228-228-01, 50228-228-10, 50228-229-01, 50228-229-10, view more
- Packager: ScieGen Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 17, 2025
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BOXED WARNING
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WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.- When pregnancy is detected, discontinue enalapril as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (See WARNINGS, Fetal Toxicity.)
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DESCRIPTION
Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described ...
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CLINICAL PHARMACOLOGY
Mechanism of Action - Enalapril, after hydrolysis to enalaprilat, inhibits angiotensinconverting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the ...
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SPL UNCLASSIFIED SECTIONHeart Failure, Mortality Trials - In a multicenter, placebo-controlled clinical trial, 2,569 patients with all degrees of symptomatic heart failure and ejection fraction ≤35 percent were ...
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INDICATIONS AND USAGE
Hypertension - Enalapril maleate tablets, USP are indicated for the treatment of hypertension. Enalapril maleate tablets, USP are effective alone or in combination with other ...
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CONTRAINDICATIONS
Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting ...
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WARNINGS
Anaphylactoid and Possibly Related Reactions - Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin ...
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SPL UNCLASSIFIED SECTIONAnaphylactoid Reactions during Desensitization - Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid ...
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PRECAUTIONS
General - Aortic Stenosis/Hypertrophic Cardiomyopathy - As with all vasodilators, enalapril should be given with caution to patients with obstruction in the outflow tract of the left ...
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Drug Interactions
Neprilysin Inhibitors - Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see - WARNINGS). Dual Blockade of the Renin-Angiotensin System ...
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Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no evidence of a tumorigenic effect when enalapril was administered for 106 weeks to male and female rats at doses up to 90 mg/kg/day or for 94 weeks to male and female mice at doses up ...
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Pregnancy
Nursing Mothers - Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should ...
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ADVERSE REACTIONS
Enalapril maleate has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril maleate has been found to be generally well ...
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SPL UNCLASSIFIED SECTIONEnalapril Maleate - (n = 673) Incidence - (discontinuation) Placebo - (n = 339) Incidence - Body As A Whole - Orthostatic Effects Syncope Chest Pain ...
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Pediatric Patients
The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients. Clinical Laboratory Test Findings - Serum Electrolytes - Hyperkalemia (see P ...
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OVERDOSAGE
Limited data are available in regard to overdosage in humans. Single oral doses of enalapril above 1,000 mg/kg and ≥1,775 mg/kg were associated with lethality in mice and rats, respectively ...
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DOSAGE AND ADMINISTRATION
Hypertension - In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate. The diuretic should ...
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HOW SUPPLIED
Enalapril maleate tablets, USP are supplied as follows: 2.5 mg tablets: White, round, biconvex tablet, debossed with “333” on one side and plain with a bisect on the other side; supplied ...
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Enalapril Maleate Tablets USP 2.5 mg-Container Label
Each tablet contains: 2.5 mg enalapril maleate. Manufactured for: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
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Enalapril Maleate Tablets USP 5 mg-Container Label
Each tablet contains: 5 mg enalapril maleate. Manufactured for: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
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Enalapril Maleate Tablets USP 10 mg-Container Label
Each tablet contains: 10 mg enalapril maleate. Manufactured for: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
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Enalapril Maleate Tablets USP 20 mg-Container Label
Each tablet contains:20 mg enalapril maleate. Manufactured for: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
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INGREDIENTS AND APPEARANCEProduct Information