pemoline

Generic name: pemoline [ PEH-moe-leen ]
Brand name: Cylert
Drug class: CNS stimulants

What is pemoline?

Pemoline was withdrawn from the U.S. market in 2005.

Pemoline stimulates the central nervous system (brain and nerves). The exact way that pemoline work is unknown.

Pemoline is used to treat attention deficit hyperactivity disorder (ADHD).

Pemoline may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about pemoline?

Pemoline was withdrawn from the U.S. market in 2005.

In rare cases, pemoline has caused severe liver damage resulting in death or liver transplant. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage. Before taking pemoline, you will be required to discuss with your doctor the risks and benefits of this medicine and to sign an informed consent stating that you understand these risks and benefits. Also, your doctor will need to monitor your liver function with blood tests before starting therapy with pemoline, and every two weeks thereafter.

Use caution when driving, operating machinery, or performing other hazardous activities. Pemoline may cause dizziness or impair your ability to concentrate. If you experience dizziness or impaired concentration, avoid these activities.

Who should not take pemoline?

Before taking this medication, tell your doctor if you have

• liver disease,

• kidney disease,

• seizures or epilepsy,

• Tourette's syndrome, or

• a history of drug or alcohol abuse.

You may not be able to take pemoline or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pemoline is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. Do not take pemoline without first talking to your doctor if you are pregnant.

It is also not known whether pemoline passes into breast milk. Do not take pemoline without first talking to your doctor if you are breast-feeding a baby.

The safety and effectiveness of pemoline for use by children younger than 6 years of age have not been established.

How should I take pemoline?

Take this medication exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.

Take each dose with a full glass of water.

Pemoline is usually taken once a day in the morning. Follow your doctor's instructions.

In rare cases, pemoline has caused severe liver damage resulting in death or liver transplant. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage. Before taking pemoline, you will be required to discuss with your doctor the risks and benefits of this medicine and to sign an informed consent stating that you understand these risks and benefits. Also, your doctor will need to monitor your liver function with blood tests before starting therapy with pemoline, and every two weeks thereafter.

Store pemoline at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pemoline overdose include agitation, vomiting, tremors (shaking), muscle twitches, seizures, confusion, hallucinations, sweating, flushing, headache, fast or irregular heartbeat, large pupils, and dryness of the mouth and eyes.

What should I avoid while taking pemoline?

Use caution when driving, operating machinery, or performing other hazardous activities. Pemoline may cause dizziness or impair your ability to concentrate. If you experience dizziness or impaired concentration, avoid these activities.

Pemoline side effects

If you experience any of the following serious side effects, stop taking pemoline and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• liver damage (nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine)

• seizures;

• unusual behavior, confusion, or hallucinations; or

• unusual movements of the tongue, lips, face, or arms and legs.

Other, less serious side effects may be more likely to occur. Continue to take pemoline and talk to your doctor if you experience

• insomnia (difficulty sleeping);

• nervousness, headache, or drowsiness;

• mild depression; or

• nausea, decreased appetite, or weight loss.

Pemoline is habit forming and may cause drug dependence. Do not stop taking it suddenly.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Pemoline dosing information

Usual Adult Dose for Attention Deficit Disorder:

Pemoline was voluntarily withdrawn from the U.S. market by the manufacturers in October, 2005 due to a conclusion by the FDA that the overall risk of liver toxicity from pemoline products outweighs the benefits of this drug. The following dosage information applies to when the drug was available in the U.S.

Initial dose: 37.5 mg orally every morning.
Maintenance dose: May increase by 18.75 mg a day at one week intervals, up to a maximum of 112.5 mg/day. The effective dose range is 56.25 to 75 mg for most patients.

Usual Pediatric Dose for Attention Deficit Disorder:

Pemoline was voluntarily withdrawn from the U.S. market by the manufacturers in October, 2005 due to a conclusion by the FDA that the overall risk of liver toxicity from pemoline products outweighs the benefits of this drug. The following dosage information applies to when the drug was available in the U.S.

<6 years: Safety and efficacy have not been established.
>=6 years:
Initial dose: 37.5 mg orally every morning.
Maintenance dose: May increase by 18.75 mg a day at one week intervals, up to a maximum of 112.5 mg/day. The effective dose range is 56.25 to 75 mg for most patients.

What other drugs will affect pemoline?

Before taking pemoline, tell your doctor if you take any medicine to control a seizure disorder. There may be an increased risk of seizures when pemoline is taken with antiepileptic medications.

Drugs other than those listed here may also interact with pemoline. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Further information

• Your pharmacist has more information about pemoline written for health professionals that you may read.

What does my medication look like?

Pemoline was withdrawn from the U.S. market in 2005.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.02. Revision Date: 2/22/07 2:32:18 PM.