Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1090
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CYLERT (Tablet)
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CYLERT (pemoline) is administered as a single oral
dose each morning. The recommended starting dose is 37.5 mg/day. This daily
dose should be gradually increased by 18.75 mg at one week intervals until
the desired clinical response is obtained. The effective daily dose for most
patients will range from 56.25 to 75 mg. The maximum recommended daily
dose of pemoline is 112.5 mg. Clinical improvement
with CYLERT is gradual. Using the recommended schedule of dosage titration,
significant benefit may not be evident until the third or fourth week of drug
administration. Because CYLERT provides an observable symptomatic benefit,
patients who fail to show substantial clinical benefit within 3 weeks of completing
dose titration,should be withdrawn from CYLERT therapy. Where possible, drug administration should be interrupted occasionally
to determine if there is a recurrence of behavioral symptoms sufficient to
require continued therapy.
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CYLERT (pemoline) is contraindicated in patients with
known hypersensitivity or idiosyncrasy to the drug. CYLERT should not be
administered to patients with impaired hepatic function (see BOXED
WARNING and ADVERSE REACTIONS).
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| dailymed-instance:boxedWarn... |
Because of its association
with life threatening hepatic failure, CYLERT should not ordinarily be considered
as first line drug therapy for ADHD (see INDICATIONS AND USAGE). Because
CYLERT provides an observable symptomatic benefit, patients who fail to show
substantial clinical benefit within 3 weeks of completing dose titration,
should be withdrawn from CYLERT therapy. Since CYLERT's marketing in 1975,
15 cases of acute hepatic 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 portion of actual cases
were recognized and reported, the risk could be substantially higher. Of the 15 cases
reported as of December 1998, 12 resulted in death or liver transplantation,
usually within four weeks of the onset of signs and symptoms of liver failure.
The earliest onset of hepatic abnormalities occurred six months after initiation
of CYLERT. Although some reports described dark urine and nonspecific prodromal
symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other
reports it was not clear if any prodromal symptoms preceded the onset of jaundice. Treatment
with CYLERT should be initiated only in individuals without liver disease
and with normal baseline liver function tests. It is not clear if baseline
and periodic liver function testing are predictive of these instances of acute
liver failure; however it is generally believed that early detection of drug-induced
hepatic injury along with immediate withdrawal of the suspect drug enhances
the likelihood for recovery. Accordingly, the following liver monitoring
program is recommended: Serum ALT (SGPT) levels should be determined at baseline,
and every two weeks thereafter. If CYLERT therapy is discontinued and then
restarted, liver function test monitoring should be done at baseline and reinitiated
at the frequency above. CYLERT should be discontinued if serum ALT (SGPT) is increased
to a clinically significant level, or any increase���2 times the upper
limit of normal, or if clinical signs and symptoms suggest liver failure (see
PRECAUTIONS). The
physician who elects to use CYLERT should obtain written informed consent
from the patient prior to initiation of CYLERT therapy (see PATIENT INFORMATION/CONSENT
FORM).
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| dailymed-instance:overdosag... |
Signs and symptoms of acute overdosage, resulting
principally from overstimulation of the central nervous system and from excessive
sympathomimetic effects, may include the following: vomiting, agitation,
tremors, hyperreflexia, muscle twitching, convulsions (may be followed by
coma), euphoria, confusion, hallucinations, delirium, sweating, flushing,
headache, hyperpyrexia, tachycardia, hypertension and mydriasis. Consult
with a Certified Poison Control Center regarding treatment
for up to date guidance and advice. Treatment consists of appropriate supportive
measures. The patient must be protected against self-injury and against external
stimuli that would aggravate overstimulation already present. Gastric contents
may be evacuated by gastric lavage. Other measures to detoxify the gut include
administration of activated charcoal and a cathartic. Chlorpromazine has
been reported in the literature to be useful in decreasing CNS stimulation
and sympathomimetic effects. Efficacy of peritoneal
dialysis or extracorporeal hemodialysis for CYLERT overdosage has not beenestablished.
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| dailymed-instance:genericMe... |
pemoline
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| dailymed-instance:fullName |
CYLERT (Tablet)
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| dailymed-instance:adverseRe... |
The following are adverse reactions in decreasing
order of severity within each category associated with CYLERT:<br/>Hepatic: There have been reports of hepatic dysfunction,
ranging from asymptomatic reversible increases in liver enzymes to hepatitis,
jaundice and fatal hepatic failure, in patients taking CYLERT (see BOXED WARNING and PRECAUTIONS).<br/>Hematopoietic: There have been isolated reports of aplastic anemia.<br/>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.<br/>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.<br/>Genitourinary: A case of elevated acid phosphatase in association
with prostatic enlargement has been reported in a 63 year old male who was
treated with CYLERT for sleepiness. The acid phosphatase normalized with
discontinuation of CYLERT and was again elevated with rechallenge.<br/>Miscellaneous: Suppression of growth has been reported with the
long-term use of stimulants in children. (See WARNINGS.) Skin rash has been reported with CYLERT. If adverse reactions are of a significant or protracted nature,
dosage should be reduced or the drug discontinued.
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| dailymed-instance:indicatio... |
CYLERT (pemoline) is indicated in Attention Deficit
Hyperactivity Disorder (ADHD). Because of its association with life threatening
hepatic failure, CYLERT should not ordinarily be considered as first line
therapy for ADHD (see BOXED WARNING). CYLERT (pemoline) therapy should be part of a total treatment
program which typically includes other remedial measures (psychological, educational,
social) for a stabilizing effect in children with a behavioral syndrome characterized
by the following group of developmentally inappropriate symptoms: moderate
to severe distractibility, short attention span, hyperactivity, emotionallability, and impulsivity. The diagnosis of this syndrome should not be made
with finality when these symptoms are only of comparatively recent origin.
Nonlocalizing (soft) neurological signs, learning disability, and abnormal
EEG may or may not be present, and a diagnosis of central nervous system dysfunction
may or may not be warranted.
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CYLERT
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