(enalapril) Powder for Oral Solution
- When pregnancy is detected, discontinue EPANED™ as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See WARNINGS AND PRECAUTIONS]
EPANED (Enalapril Maleate) Powder for Oral Solution 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-[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:
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.
Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor.
EPANED Powder for Oral Solution is a kit consisting of 1 bottle containing a dry powder blend of enalapril maleate, USP, mannitol, and colloidal silicon dioxide and 1 bottle of Ora-Sweet SF diluent for reconstitution resulting in a 1 mg/mL EPANED oral solution. The Ora-Sweet SF diluent contains: purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, and flavoring. Buffered with citric acid and sodium citrate. Preserved with methylparaben (0.03%), propylparaben (0.008%), and potassium sorbate (0.1%).
Last reviewed on RxList: 8/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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