March 21, 2017

Pemoline tablets or chewable tablets

What are pemoline tablets or chewable tablets?

PEMOLINE (Cylert®) is a stimulant. Pemoline treated attention-deficit hyperactivity disorder (ADHD). It has been prescribed for other purposes. Federal law prohibits giving this medication to any person other than the person for whom it was prescribed. Do not share this medicine with anyone else.

NOTE: This drug is discontinued in the United States. Pemoline was removed from the U.S. drug market due to the possibility of liver toxicity. You cannot get this medication in the U.S. as of November 2005. Ask your health care provider regarding alternative medical treatments.

What should my health care professional know before I take pemoline?

They need to know if you have any of these conditions:

  • regularly drink alcohol-containing beverages

  • kidney disease

  • liver disease

  • psychotic or mental illness, depressed mood, or suicidal thoughts

  • recent weight loss

  • seizure disorder

  • Tourette's syndrome

  • an unusual or allergic reaction to pemoline, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Take pemoline tablets by mouth. Follow the directions on the prescription label. If you are taking the chewable tablets, they work best if you chew them before swallowing. Swallow the tablets or chewed tablets with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed.

Remember: The prescription for pemoline is only for the person for whom it was prescribed. Never share or give your prescription to anyone else.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Pemoline has been prescribed for children 6 years of age and older for the treatment of attention-deficit disorder.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with pemoline?

  • amphetamine or dextroamphetamine

  • bupropion

  • caffeine

  • lithium

  • medicines for the treatment of mental conditions or depression

  • medicines for the treatment of colds or weight loss

  • modafinil

  • seizure (convulsion) or epilepsy medicine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking pemoline?

The use of pemoline needs careful supervision. Visit your prescriber or health care professional for regular checks on your progress. You will need to receive blood tests twice monthly to monitor the medication's effects on your liver.

It may be the third or fourth week after you start therapy before you see the full effect of pemoline. Your prescriber or health care professional may want you to stop taking pemoline after a while to see if there is still a need for you to take it. Do not stop taking except on your prescriber's advice. Tell your prescriber or health care professional if you feel a need to take more tablets than prescribed, or to take them more often.

Decreased appetite is a common side effect when starting this medicine. Eating small, frequent meals or snacks can help. Talk to your prescriber if you continue to have poor eating habits. Height, weight and growth of a child taking this medication will be monitored closely.

Take your daily dose in the morning to prevent trouble sleeping at night. Avoid drinks that contain caffeine and try to stick to a regular bedtime every night.

Do not take this medicine with other non-prescription medicines, especially cold and allergy medicines or weight-loss aides, without asking your prescriber or health care professional for advice.

Pemoline can hide signs that you are tired, reduce your coordination, or make you dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Older adults may be more sensitive to these effects.

If you are going to have surgery or other medical procedures, tell your prescriber, surgeon, or health care professional that you are taking pemoline.

What side effects may I notice from taking pemoline?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Symptoms of liver trouble such as:

  • dark yellow or brown urine

  • severe nausea or vomiting

  • unusual tiredness or weakness

  • yellowing of the eyes or skin

Other rare side effects to report to your prescriber or health care professional as soon as possible:

  • changes in vision or eye movements

  • confusion

  • depressed mood or sadness

  • fever

  • hallucinations (seeing and hearing things that are not really there)

  • rapid heart beat or palpitations

  • seizures (convulsions)

  • skin rash, itching, or hives

  • trembling, twitching

  • uncontrollable movements, especially of face, tongue, lips, arms or legs

  • unusual behavior or mood swings

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

Less Common or Rare:

  • a sense of well being

  • dizziness or lightheadedness

  • stomach-ache

More Common, especially in the first few weeks of treatment:

  • decreased appetite or loss of appetite

  • headache

  • mild stomach upset

  • nervousness, restlessness, or difficulty sleeping

  • weight loss

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature below 30 degrees C (86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.


March 21, 2017


U.S. FDA-approved Package Insert