Label: ENALAPRIL MALEATE tablet
- NDC Code(s): 70518-4256-0
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 51672-4245
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 20, 2025
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SPL UNCLASSIFIED SECTIONRx only
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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 maleate 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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DESCRIPTIONEnalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- ...
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CLINICAL PHARMACOLOGYMechanism of Action - Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the ...
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INDICATIONS AND USAGEHypertension - Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially ...
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CONTRAINDICATIONSEnalapril 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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WARNINGSAnaphylactoid and Possibly Related Reactions - Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin ...
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PRECAUTIONSGeneral - 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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ADVERSE REACTIONSEnalapril 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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OVERDOSAGELimited 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. The ...
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DOSAGE AND ADMINISTRATIONHypertension - 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, if ...
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HOW SUPPLIEDEnalapril Maleate Tablets USP, 10 mg are white colored, round, biconvex tablets. One side scored and engraved with "T" above the score and with "10" under the score. The other side plain. They are ...
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SPL UNCLASSIFIED SECTIONRepackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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PRINCIPAL DISPLAY PANELDRUG: Enalapril Maleate - GENERIC: Enalapril Maleate - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-4256-0 - COLOR: white - SHAPE: ROUND - SCORE: Two even pieces - SIZE: 8 mm - IMPRINT: T;10 - PACKAGING: 30 in 1 ...
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INGREDIENTS AND APPEARANCEProduct Information