Pemoline - Guidelines for Using Pemoline - Uses and Benefits

Type of Drug:

Central nervous system stimulant.

How the Pemoline Product Works:

Pemoline stimulates the central nervous system. How it does this is not fully understood.

Uses of The Pemoline:

To aid in treatment of children with behavior problems (attention deficit disorder) characterized by hyperactivity, moderate to severe distractibility, short attention span, impulsive behavior, and extreme mood changes.

Unlabeled Uses: Occasionally doctors may prescribe pemoline for narcolepsy (irresistible periods of sleep lasting less than 15 minutes during normal waking hours) and excessive daytime sleepiness.

Precautions:

• Drug dependence: The similarity of pemoline to other brain stimulants with known dependence liability suggests that psychological and physical dependence might also occur. There have been isolated reports of temporary psychotic symptoms occurring in adults following the long-term misuse of excessive doses. Pemoline should be given with caution to emotionally unstable patients who may increase the dosage on their own initiative.

• CNS stimulants: CNS stimulants, including pemoline, have been reported to precipitate motor and phonic tics, and Tourette syndrome. Therefore, clinical evaluation for tics and Tourette syndrome in children and their families should precede use of stimulant medications.

• Potential liver toxicity: Report any unexplained appetite loss, nausea, vomiting, general body discomfort, weakness, or yellowing of the skin or eyes to your doctor.

• Total treatment program: Pemoline therapy should be part of a total treatment program that includes psychological, educational psychological, educational, and social measures.

• Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits to the mother outweigh the possible hazards to the fetus.

• Breastfeeding: It is not known if pemoline appears in breast milk. Consult your doctor before you begin breastfeeding.

• Children: Safety and effectiveness in children less than 6 years of age have not been established. Pemoline use may worsen symptoms of behavior disturbance and thought disorder in psychotic children. Aggravation of Tourette syndrome and seizure disorders have been reported after starting pemoline therapy. Chronic administration of stimulants to children may be associated with growth inhabiting. Therefore, growth must be monitored during treatment. Long-term effects in children have not been well established. Treatment is not indicated in all cases of attention deficit disorder with hyperactivity. The decision to prescribe pemoline should depend on the assessment of the severity of the child’s symptoms for his or her age, and not depend solely on the presence of one or more of the behavioral characteristics.

• Lab Tests: Lab tests will be required before and during pemoline therapy. Tests may include periodic liver function evaluation.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over-­the-counter or prescription medications or dietary supplements while taking pemoline. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. Decreased seizure thresh­old has been reported in patients also taking anti epileptic medications (eg, phenytoin).

Side Effects:

Every drug is capable of producing side effects. Many pemoline users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

• Digestive Tract: Nausea; stomachache; loss of appetite.

• Nervous System: Sleeplessness; seizures; hallucinations; dizziness; drowsiness; increased irritability; involuntary movements of tongue, face, arms, and legs; Tourette syndrome; depression; headache; abnormal eye movements.

• Other: Rash; yellowing of skin or eyes; dark urine; abnormal liver function tests; weight loss; liver dysfunction.

Guidelines for Use:

• Do not use pemoline until you have discussed with your doctor the risks and benefits of treatment. A written informed consent is required before beginning therapy.
• Dosage is individualized. Take exactly as prescribed. Administer as a single dose each morning.
• Do not stop taking or change the dose unless directed your doctor.
• If a dose is missed, take it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
• Clinical improvement with pemoline is gradual. Significant benefit may not be evident until after 3 to 4 weeks of therapy.
• Because of its association with life-threatening liver failure, pemoline should not ordinarily be considered as first-line drug therapy for attention deficit hyperactivity disorder (ADHD).
• May cause drowsiness or dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity until tolerance is determined.
• Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or are breastfeeding.
• Notify your doctor immediately if you experience darkening of urine, appetite loss, general body discomfort, nausea, vomiting, yellowing of the skin or eyes, or uncontrolled movement.
• Notify your doctor if sleeplessness occurs and is bothersome.
• Chronic use may suppress growth in children.
• Your doctor may interrupt treatment occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
• Pemoline therapy should be stopped if no benefit is noted after 3 weeks of taking the maximum do.
• Lab tests will be required to monitor therapy. Be sure to keep appointments.
• Store at room temperature (59° to 86°F).

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