March 29, 2017
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Epaned

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Epaned

EPANED
(enalapril maleate) Powder for Oral Solution

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue EPANED® as soon as possible. [See WARNINGS AND PRECAUTIONS]
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

EPANED (enalapril maleate) Oral Solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5•C4H4O4, and its structural formula is:

EPANED (enalapril maleate) Structural Formula Illustration

Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.

EPANED Oral Solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium benzoate, sodium citrate, and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. EPANED Oral Solution is clear and colorless.

Last reviewed on RxList: 10/3/2016
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

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