In the U.S.—

In Canada—

• Stimulant, central nervous system

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

Pemoline increases attention and decreases restlessness in children who are overactive, cannot concentrate for very long or are easily distracted, and are emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Rarely, pemoline has caused serious liver problems. You and your doctor should talk about the good this medicine will do as well as the risks of using it. In addition, you will be asked to sign an informed consent form stating that you understand and agree to accept the risk of liver problems.

Pemoline is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.; Available in Canada only through a special access program).
• Chewable tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pemoline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pemoline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pemoline has not been shown to cause birth defects or other problems in humans. However, studies in animals given large doses of pemoline have shown that pemoline causes an increase in stillbirths and decreased survival of the offspring after birth.

Breast-feeding—It is not known whether pemoline passes into breast milk.

Children—Slowed growth rate in children who received medicines like pemoline for a long period of time has been reported. Some doctors recommend medicine-free periods during treatment with pemoline to help prevent slowed growth.

Pemoline may make behavior worse in children with serious mental illness.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pemoline, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet)—Using these medicines with pemoline may cause severe nervousness, irritability, trouble in sleeping, or possibly irregular heartbeat or seizures

• Anticonvulsants (medicine to control seizures)—Pemoline may increase the chance of having seizures; your doctor may change the dose of your anticonvulsant medicine

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Taking pemoline while you are taking or within 2 weeks of taking an MAO inhibitor may result in sudden extremely high blood pressure or fever, irregular heartbeat, or seizures

• Drug abuse or dependence (or history of)—Dependence on pemoline may develop

• Gilles de la Tourette's syndrome or other tics or
• Liver disease or
• Mental illness (severe)—Pemoline may make the condition worse

• Kidney disease—Higher blood levels of pemoline may occur, increasing the chance of side effects

For patients taking the chewable tablet form of this medicine:

• These tablets must be chewed before swallowing. Do not swallow whole.

Sometimes this medicine must be taken for 3 to 4 weeks before improvement is noticed.

Take pemoline only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Dosing—

The dose of pemoline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pemoline. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral or chewable dosage forms (tablets):
  • 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.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible and go back to your regular dosing schedule. If you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. In addition, you must have your blood tested every other week to see if this medicine is affecting your liver.

Dark urine or yellow eyes or skin may be a sign of a serious unwanted effect on your liver. Check with your doctor immediately if you develop dark urine or yellow eyes or skin.

This medicine may cause some people to become dizzy or less alert than they are normally. Make sure you know how you react to this medicine before you ride a bicycle or do anything else that could be dangerous if you are dizzy or are not alert.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on pemoline are:

• a strong desire or need to continue taking the medicine.
• a need to increase the dose to receive the effects of the medicine.
• withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after the medicine is stopped.

If you take this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Pemoline may cause some serious side effects, including liver problems. Also, medicines like pemoline, when used for a long time, have been reported to slow the growth rate of children. Some doctors recommend medicine-free periods during treatment with pemoline. Pemoline may also cause unwanted effects on behavior in children with severe mental illness.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if either of the following side effects occurs:

• Rare
  • Dark urine;  yellow eyes or skin 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Convulsions (seizures);  hallucinations (seeing, hearing, or feeling things that are not there);  nausea and vomiting;  shortness of breath, troubled breathing, wheezing, or tightness in chest;  skin rash;  sores, ulcers, or white spots on lips or in mouth;  swollen or painful glands;  uncontrolled movements of eyes, tongue, lips, face, arms, or legs;  unusual bleeding or bruising;  unusual tiredness;  vocal sounds you cannot control 
  
  

• Symptoms of overdose
  • Agitation;  confusion;  convulsions (seizures)—may be followed by coma;  false sense of well-being;  fast heartbeat;  hallucinations (seeing, hearing, or feeling things that are not there);  headache (severe);  high blood pressure;  high fever;  large pupils;  muscle trembling or twitching;  restlessness;  sweating;  vomiting 
  
  

This medicine may also cause the following side effects that your doctor will watch for:

• Rare
  • Liver problems;  slow growth in children  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Loss of appetite;  trouble in sleeping ;  weight loss 
  
  

• Less common
  • Dizziness;  drowsiness;  headache;  increased irritability;  mental depression;  stomachache 
  
  

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 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.