A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lexxel Online, Description, Chemistry, Ingredients - Enalapril Maleate-Felodipine
Lexxel Online, Description, Chemistry, Ingredients - Enalapril Maleate-Felodipine
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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.
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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.
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 C18H19Cl2NO4.
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 is available for oral use in two tablet combinations
of enalapril maleate with felodipine as an extended-release formulation: LEXXEL
5-2.5, containing 5 mg of enalapril maleate and 2.5 mg of felodipine ER and
LEXXEL 5-5, containing 5 mg of enalapril maleate and 5 mg of felodipine ER.
Inactive ingredients include: propyl gallate, polyoxyl 40 hydrogenated
castor oil, cellulose compounds, lactose, aluminum silicate, sodium stearyl
fumarate, carnauba wax, and iron oxides. The tablets are imprinted with an ink
of synthetic red iron oxide (LEXXEL 5-2.5) or synthetic black iron oxide (LEXXEL
5-5) which contains pharmaceutical glaze in SD-45, n-butyl alcohol, propylene
glycol, isopropyl alcohol, ammonium hydroxide, and simethicone (LEXXEL 5-2.5)
and methyl alcohol (LEXXEL 5-5).
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