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

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February 9, 2012

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High Blood Pressure »

What is high blood pressure?

High blood pressure (HBP) or hypertension means high pressure (tension) in the arteries. Arteries are vessels that carry blood from the pumping heart to all the tissues and organs of the body. High blood pressure does not mean excessive emotional tension, although emotional tension and stress can temporarily increase blood pressure. Normal blood pressure is below 120/80; blood pressure between 120/80 and 139/89 is called "pre-hypertension", and a blood pressure of 140/90 or above is considered high.

The top number, the systolic blood pressure, corresponds to the pressure in the arteries as the heart contracts and pumps blood forward into the arteries. The bottom number, the diastolic pressure, represents the pressure in the arteries as the heart relaxes after the contraction. The diastolic pressure reflects the lowest pressure to which the arteries are exposed.

An elevation of the systolic and/or diastolic blood pressure increas...

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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: