Pemoline (patient information)

IMPORTANT WARNING:
In May 2005, Abbott Laboratories announced that Cylert (pemoline) will no longer be available in the United States and in October 2005, manufacturers of generic pemoline agreed to stop sales and marketing of these products. This action is based on advice from the Food and Drug Administration (FDA). The FDA states that the overall risk of liver toxicity with pemoline outweighs the benefits of the drug. If you are currently taking pemoline, you should call your doctor to discuss switching to another treatment. For more information visit the FDA website.

Pemoline can cause serious and sometimes deadly liver damage. Tell your doctor if your child has or has ever had liver disease. Make sure your child keeps all appointments with the doctor and the laboratory. Your child's doctor will order lab tests before and during treatment to check if pemoline is affecting his/her liver.

If your child experiences any of the following symptoms, call his/her doctor immediately: loss of appetite, excessive tiredness, lack of energy, upset stomach, dark urine, and yellowing of the skin or eyes.

Make sure to read and sign the consent form before your child begins to take pemoline.

Why is this medication prescribed
Pemoline is used to treat attention-deficit disorder in children over the age of six. It should be part of a total treatment program, which typically includes psychological and social counseling.

How should this medicine be used
Pemoline comes as a tablet to take by mouth. It is usually taken once a day. To avoid insomnia and to provide its greatest benefits during waking hours, pemoline should be taken in the morning. Have your child take pemoline exactly as directed. Your child should not take more or less of it or take it more often than prescribed by the doctor.

Continue to give pemoline even if the child appears to be better. Do not stop giving pemoline without talking to your doctor.

Other uses for this medicine
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow
Before giving your child pemoline:


 * tell your doctor and pharmacist if your child is allergic to pemoline or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications your child is taking, especially medications for seizures, and vitamins.
 * in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if your child has or has ever had kidney disease.
 * tell your doctor if your child is pregnant. If your child becomes pregnant while taking pemoline, call your doctor.

What should I do if I forget a dose
Give your child the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not give your child a double dose to make up for a missed one.

Mild side effects
''Pemoline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:''


 * insomnia
 * weight loss
 * upset stomach
 * diarrhea

Severe side effects
If your child experiences any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:


 * hallucinations
 * excitement
 * agitation
 * restlessness
 * fast heartbeat
 * seizures
 * dizziness

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
Keep all appointments with your child's doctor and the laboratory. Your child's doctor will order certain lab tests to check your child's response to pemoline. Regular checkups give the doctor a chance to measure your child's progress.

Do not let anyone else take your child's medication. Ask your pharmacist any questions you have about refilling your child's prescription.