"CYLERT® Tablets [ci'lert] (Pemoline)
WARNINGS
Decrements in the predicted growth (i.e., weight gain and/or height) rate have
been reported with the long term use of stimulants in children. Therefore,
patients requiring long-term therapy should be carefully monitored.
PRECAUTIONS
General: Clinical experience suggests that in psychotic children,
administration of CYLERT may exacerbate symptoms of behavior disturbance and
thought disorder.
CYLERT should be administered with caution to patients with significantly
impaired renal function.
Laboratory Tests:
Liver function test should be performed prior
to and periodically during therapy with CYLERT. The drug should be
discontinued if abnormalities are revealed and confirmed by follow-up tests.
(See "ADVERSE REACTIONS" section regarding reports of abnormal liver
function tests, hepatitis and jaundice.)
Pediatric Use: Safety and effectiveness in children below the age
of 6 years have not been established.
Long-term effects of CYLERT in children have not been established (See
"WARNINGS" section).
CNS stimulants, including pemoline (CYLERT), have been reported to
precipitate motor and phonic tics and Tourette's syndrome. Therefore, clinical
evaluation for tics and Tourettte's syndrome in children and their families
should precede use of stimulant medications.
Drug treatment is not indicated in all cases of ADD with hyperactivity and
should be considered only in light of complete history and evaluation of the
child. The decision to prescribe CYLERT (pemoline) should depend on the
physician's assessment of the chronicity and severity of the child's symptoms
and their appropriateness for his/her age. Prescription should not depend
solely on the presence of one or more the behavioral characteristics.
ADVERSE REACTIONS
The following are adverse reactions in decreasing order of severity within
each category associated with CYLERT:
Hepatic: There have been reports of hepatic dysfunction including
elevated liver enzymes, hepatitis and jaundice in patients taking CYLERT.
Hematopoietic: There have been isolated reports of aplastic anemia.
Miscellaneous: Supression of growth has been reported with the long-term
use of stimulants in children. (See "WARNINGS" section.) Skin rash
has been reported with CYLERT.
Central Nervous System: The following CNS effects have been reported
with the use of CYLERT: convulsive seizures; literature reports indicate that
CYLERT may precipitate attacks of Gilles de la Tourette syndrome;
hallucinations; dyskinetic movements of the tongue, lips, face and
extremities; abnormal oculomotor function including nystagmus and oculogyric
crisis; mild depression; dizziness; increased irritability; headache; and
drowsiness.
Insomnia is the most frequently reported side effect of CYLERT; it
usually occurs early in therapy prior to an optimum therapeutic response. In
the majority of cases it is transient in nature or responds to a reduction in
dosage.
Gastrointestinal: Anorexia and weight loss may occur during the first
weeks of therapy. In the majority of cases it is transient in nature; weight
gain usually resumes within three to six months.
Nausea and stomach ache have also been reported.
DRUG ABUSE AND DEPENDENCE
Controlled Substance: CYLERT is subject to control under DEA schedule
IV."
In most people the effects of these stimulant drugs are
short-lived and there is often a letdown or "crash" after they wear
off. During this "crash" the patient can feel very depressed,
sleepy, and sluggish. Furthermore, and very much unlike the other
drugs discussed so far in this chapter, stimulant drugs have the potential to
induce "tolerance." People who abuse amphetamines and other
stimulants--usually in attempts to lose weight or stay awake for prolonged
periods--often find that a dose that had worked for a while is suddenly
ineffective and they need a higher dose. They then become "tolerant"
to the higher dose and have to increase the dose again. Soon, the person is
addicted to the drug. Stopping it suddenly leads to a severe withdrawal
reaction characterized by bad depression and extreme fatigue. Suicides
have been reported in people who suddenly stop taking amphetamines.
The patient must understand
that he will probably become addicted to the medication and that he should
never stop taking it abruptly."
"Some health professionals fear that these medications may end up
being over prescribed. Dr. Carl Kline, an expert in the field of learning
disabilities from the University of British Columbia, has this to say,
'It
is my belief that if these drugs were outlawed, children would not be at all
deprived of essential medication, but that doctors would be forced to make
more accurate diagnoses and seek better means of handling the hyperactive
behavior of a certain small percentage of their little patients.'"
Do these drugs make a difference in the long-term
outcome of the minimal brain dysfunction? The above referenced
book goes on to say...
"Until recently, the most important question concerning Ritalin or
Amphetamine administration has not been asked. Do these drugs make a
difference in the long-term outcome of the minimal brain dysfunction? A
comprehensive examination of this subject carried out at the Montreal
Children's Hospital discovered a startling fact. At the end of five years,
hyperkinetic children who received drugs (either Ritalin or Chloropromazine)
did not differ significantly from children who had not received. Although it
appeared that hyperactive kids treated with Ritalin were initially more
manageable, the degree of improvement and emotional adjustment was essentially
identical at the end of five years to that seen in a group of kids who had
received no medication at all.