Because of its association
with life threatening hepatic
failure, CYLERT should not ordinarily be considered as first
therapy for ADHD
(see INDICATIONS AND USAGE).
Since CYLERTs marketing in 1975, 13 cases of
failure have been reported to the FDA. While the absolute
number of reported
cases is not large, the rate
of reporting ranges from 4 to 17 times the rate expected in
the general population. This estimate may be conservative
because of under reporting and because the long latency
between initiation of CYLERT treatment and the occurrence
of hepatic failure
may limit recognition
of the association. If only a por-tion of actual
cases were recognized and reported, the risk
could be substantially higher.
Of the 13 cases reported as of May 1996, 11
resulted in death
or liver transplantation, usually within four weeks of the
onset of signs and symptoms of liver
failure. The ear-liest onset of hepatic
abnormalities occurred six months after initiation of CYLERT.
Although some reports described dark urine
malaise, and gastrointestinal
symp-toms), in other reports it was not clear if any prodromal
symptoms preceded the onset of jaundice. It is also not clear
if the recom-mended baseline
testing are predictive of these instances of acute
liver failure. CYLERT
should be dis-continued if clinically significant
is observed during its use (see PRECAUTIONS).
CYLERT (pemoline) is a central
stimulant. Pemoline is structurally dissimilar to the amphetamines
It is an oxazolidine compound
and is chemically identified as 2-amino-S-phenyl-2-oxazolin4-one.
Pemoline is a white, tasteless, odorless powder, relatively insoluble
(less than 1 mg/mL) in water, chloroform, ether, acetone, and benzene;
its solubility in
95% ethyl alcohol
is 2.2 mg/mL.
CYLERT (pemoline) is supplied as tablets containing 18.75 mg, 37.5
mg or 75 mg of pemoline
for oral administration.
CYLERT is also available as chewable tablets containing 37.5 mg
18.75 mg tablet: corn
starch, gelatin, lactose,
polyethylene glycol and
37.5 mg tablet: corn
starch, FD& C Yellow
No. 6. gelatin, lactose, magnesium hydroxide, polyethylene
glycol and talc.
37.5 mg chewable tablet:
FD& C Yellow No. 6, magnesium hydroxide, magnesium
stearate, mannitol, Polyethylene glycol, povidone, talc and artificial
75 mg tablet: corn
starch, gelatin, iron
oxide, lactose, magnesium
hydroxide, polyethylene glycol