Lexxel (Enalapril Maleate-Felodipine) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

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High blood pressure facts

High blood pressure (hypertension) is designated as either essential (primary) hypertension or secondary hypertension and is defined as a consistently elevated blood pressure exceeding 140/90 mm Hg.
High blood pressure is called "the silent killer" because it often causes no symptoms for many years, even decades, until it finally damages certain critical organs.
Poorly controlled high blood pressure ultimately can cause damage to blood vessels in the eye, thickening of the heart muscle and heart attacks, hardening of the arteries (arteriosclerosis), kidney failure, and strokes.
Most antihypertensive medications can be used alone or in combination. Some are used only in combination. Some are preferred over others in certain specific medical situations. And some are not to be used (contraindicated) in other situations.
Several classes of antihypertensive medications are available, including ACE i...

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LEXXEL®
(enalapril maleate-felodipine ER) Tablets

USE IN PREGNANCY

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, LEXXEL should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

DRUG DESCRIPTION

LEXXEL (enalapril maleate-felodipine ER) is a combination product, consisting of an outer layer of enalapril maleate surrounding a core tablet of an extended-release felodipine formulation.

Enalapril 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-[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 structural formula illustration

Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.

Felodipine, a calcium channel blocker, is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4- (2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5- pyridinedicarboxylate. Its empirical formula is C₁₈H₁₉C_l2NO₄ and its structural formula is:

Felodipine structural formula illustration

Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture; however, S-felodipine is the more biologically active enantiomer.

LEXXEL (enalapril maleate-felodipine) is available for oral use as tablets containing 5 mg of enalapril maleate and 5 mg of felodipine as an extended release formulation.

Inactive ingredients include: propyl gallate, polyoxyl 40 hydrogenated castor oil, cellulose compounds, lactose, aluminum silicate, sodium stearyl fumarate, carnauba wax, and black iron oxide. The tablets are imprinted with an ink of synthetic black iron oxide which contains pharmaceutical glaze in SD-45, n-butyl alcohol, propylene glycol, isopropyl alcohol, ammonium hydroxide, and methyl alcohol.

What are the possible side effects of enalapril and felodipine (Lexxel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects: