pemoline, Cylert

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NOTE: March 25, 2005, pemoline (Cylert) has been withdrawn from the market because of declining sales.

GENERIC NAME: pemoline


DRUG CLASS AND MECHANISM: Pemoline is an oral drug that is used to treat attention deficit hyperactivity disorder (ADHD) as part of an overall treatment program for children with ADHD. Pemoline has effects that are similar to methylphenidate (Ritalin) which also is used to treat ADHD. Pemoline and methylphenidate both have the ability to stimulate the brain, probably by affecting neurotransmitters, the chemicals in the brain that nerves use to communicate with each other. Although both drugs are considered stimulants, they have different effects on neurotransmitters in the brain. Pemoline was approved for use by the FDA in 1975.



PREPARATIONS: Tablets: 18.75 mg, 37.5 mg and 75 mg. Chewable tablet: 37.5 mg.

STORAGE: Pemoline should be stored below 30°C(86°F).

PRESCRIBED FOR: Pemoline is used as part of a treatment program for children with ADHD. Other FDA unapproved uses include narcolepsy, fatigue, and excessive daytime sleepiness. (Narcolepsy is a chronic disease of the brain and spinal cord most commonly characterized by a recurrent, uncontrollable desire to sleep.)

DOSING: Pemoline should be taken in the morning. It may take up to three weeks to observe an effect. Doses should be reduced if poor kidney function exists.

Careful dosing should be done when pemoline is used because of a serious risk for liver toxicity and/or liver failure. Blood tests are necessary to evaluate patients for liver damage before and during pemoline therapy.

DRUG INTERACTIONS: There are no adequate studies of drug interactions with pemoline. Reports suggest that pemoline may decrease the effectiveness of drugs that are used to manage seizures such as phenytoin (Dilantin) or carbamazepine (Tegretol). It is not clear if there are interactions between pemoline and alcohol.

PREGNANCY: There are no adequate studies of pemoline in pregnant women.

NURSING MOTHERS: It is unknown if pemoline is excreted in breast milk.

SIDE EFFECTS: The most common side effects of pemoline are insomnia and anorexia (decreased appetite). A rapid heart rate may occur if large doses of pemoline are taken. Rash and aplastic anemia have occurred rarely with pemoline. Abdominal discomfort, nausea and diarrhea may occur during therapy with pemoline.

Pemoline may cause serious liver toxicity and/or failure. Blood tests should be done before and during treatment to monitor for liver toxicity. Pemoline may suppress normal growth in children, though this effect has not been established clearly. It also may exacerbate behavioral disturbances and thought disorders in psychotic children. Pemoline, as well as other stimulants, may precipitate motor and vocal tics and Tourette's syndrome, but these side effects are likely to be transient.

Reference: FDA Prescribing Information

Last Editorial Review: 3/29/2005

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