Cylert, Pemoline Pharmacology

Pemoline

Brand Name: Cylert

Outside U.S., Brand Names also known as: Betanamin; Tradon

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Cylert patient information (in plain English)

Description

Pemoline belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat children with attention-deficit hyperactivity disorder (ADHD).

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Pharmacology

Pemoline has a pharmacological activity similar to that of other known central nervous system stimulants; however, it has minimal sympathomimetic effects. Although studies indicate that pemoline may act in animals through dopaminergic mechanisms, the exact mechanism and site of action of the drug in man is not known.

Peak serum levels of the drug occur within 2 to 4 hours after ingestion of a single dose. Multiple dose studies in adults at several dose levels indicate that steady state is reached in approximately 2 to 3 days.

Pemoline has a gradual onset of action. Using the recommended schedule of dosage titration, significant clinical benefit may not be evident until the third or fourth week of drug administration.

Indications and Usage

Pemoline is indicated in Attention Deficit Disorder (ADD) with hyperactivity as an integral 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, emotional lability, 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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Contraindications

Pemoline is contraindicated in patients with known hypersensitivity or idiosyncrasy to the drug. Pemoline should not be administered to patients with impaired hepatic function.

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Warnings

Suppression of growth (height/weight) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored. Some doctors recommend drug-free periods during treatment with pemoline.

Pemoline is not recommended for children less than 6 years since its safety and efficacy in this age group have not been established.

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Precautions

Clinical experience suggests that in psychotic children, administration of pemoline may exacerbate symptoms of behavior disturbance and thought disorder.

Pemoline should be administered with caution to patients with significantly impaired renal function.

Liver function tests should be performed prior to and periodically during therapy with pemoline.

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Long-term effects of pemoline in children have not been established.

CNS stimulants, including pemoline, have been reported to precipitate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette'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 pemoline (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 of the behavioral characteristics.

Pregnancy and Withdrawl: Safety for use during pregnancy and nursing has not been established. Although CNS stimulants are seldom indicated after puberty, it should be kept in mind that pemoline should not be used during pregnancy or in women who may become pregnant.

Interference with Cognitive or Motor Performance: Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.

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Drug Interactions

The interaction of pemoline with other drugs has not been studied in humans. Patients who are receiving pemoline concurrently with other drugs, especially drugs with CNS activity, should be monitored carefully.

Decreased seizure threshold has been reported in patients receiving pemoline concomitantly with antiepileptic medications.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions including liver conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE IF YOU EXPERIENCE yellowing of the skin or eyes, dark urine or pale stools, or unusual tiredness.

Common side effects include: difficulty sleeping or drowsiness, dizziness, headache, nausea, stomach pain, or loss of appetite.

Physical/Psychological Dependence:
The pharmacologic similarity of pemoline to other psychostimulants with known dependence liability suggests that psychological and/or physical dependence might also occur with pemoline. There have been isolated reports of transient psychotic symptoms occurring in adults following the long-term misuse of excessive oral doses of pemoline. Pemoline should be given with caution to emotionally unstable patients who may increase the dosage on their own initiative.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects: Abdominal pain; convulsions (seizures); headache; mental depression; nausea; unusual behavior; unusual tiredness or weakness; vomiting.

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Overdose

Signs and Symptoms

Symptoms of overdose may include vomiting, tremors, muscle twitching, convulsions, hallucinations, confusion, sweating, headache, and rapid pulse.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

The treatment for an acute overdosage of pemoline is essentially the same as that for an overdosage of any CNS stimulant. Management is primarily symptomatic and may include induction of emesis or gastric lavage, sedation, and other appropriate supportive measures.

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Dosage

It may take 3-4 weeks for this medicine to reach its full effect. Do not exceed the recommended dosage or take this medicine for longer than prescribed.

Follow the directions for using this medicine provided by your doctor.
Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
If you miss a dose of this medicine, and you take 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

The dose of pemoline will be different for different patients.

Children 6 years of age and over: To start, 37.5 milligrams (mg) every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 112.5 mg a day.

Children up to 6 years of age: Use and dose must be determined by the doctor.

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How Supplied

Cylert 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 of pemoline.

Cylert Patient Information Sheet

Last updated: 03/2003

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

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Pemoline

Brand Name: Cylert