ACEON®
(perindopril erbumine) Tablets
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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, ACEON® Tablets should be discontinued
as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
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DESCRIPTION
ACEON® (perindopril erbumine) Tablets is the tert-butylamine
salt of perindopril, the ethyl ester of a non-sulfhydryl
angiotensin-converting enzyme (ACE) inhibitor. Perindopril
erbumine is chemically described as (2S,3a S,7µS)-1-[(S)-N-[(S)-1-Carboxy-butyl]alanyl]hexahydro-2-indolinecarboxylic
acid, 1-ethyl ester, compound with tert-butylamine (1:1).
Its molecular formula is C19H32N2O5C4H11N.
Perindopril erbumine is a white, crystalline powder with
a molecular weight of 368.47 (free acid) or 441.61 (salt
form). It is freely soluble in water (60% w/w), alcohol
and chloroform.
Perindopril is the free acid form of perindopril erbumine,
is a pro-drug and metabolized in vivo by hydrolysis of
the ester group to form perindoprilat, the biologically
active metabolite.
ACEON® Tablets is available in 2 mg, 4
mg and 8 mg strengths for oral administration. In addition
to perindopril erbumine, each tablet contains the following
inactive ingredients: colloidal silica (hydrophobic),
lactose, magnesium stearate and microcrystalline cellulose.
The 4 and 8 mg tablets also contain iron oxide.
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