Usual Adult Dose for Tourette's Syndrome

Initial dose: 1 to 2 mg orally per day in divided doses
Maintenance dose: Typically less than 0.2 mg/kg or 10 mg/day, whichever is less
Maximum dose: 10 mg/day

Comments:

• Use should be limited to patients with Tourette's Disorder whose development and/or daily life function is severely compromised by motor and phonic tics. This drug is not indicated for use as first-line therapy or in patients with tics that are merely annoying or cosmetically troublesome.
• Initial doses may be increased every other day if tolerated.
• Patients requiring doses greater than 4 mg/day should undergo CYP 450 2D6 genotyping.

Usual Pediatric Dose for Tourette's Syndrome

12 years and older:

• Initial dose: 0.05 mg/kg orally at bedtime
• Maximum dose: 0.2 mg/kg, not to exceed 10 mg/day

• Use should be limited to patients with Tourette's Disorder whose development and/or daily life function is severely compromised by motor and phonic tics. This drug is not indicated for use as first-line therapy or in patients with tics that are merely annoying or cosmetically troublesome.
• Doses may be increased every 3 days to a maximum of 0.2 mg/kg.
• CYP450 2D6 genotyping should be performed in patients taking greater than 0.05 mg/kg/day.

Renal Dose Adjustments

Use with caution.

Liver Dose Adjustments

Use with caution.

Dose Adjustments

CYP450 2D6 poor metabolizers:
Adults:

• Maximum dose: 4 mg orally per day
• Do not increase doses earlier than every 14 days

• Maximum dose: 0.05 mg/kg/day
• Do not increase doses earlier than every 14 days

• Severe neutropenia (ANC less than 1000/mm3): Discontinue therapy.

• Adults with increases over 0.52 seconds or 25% above baseline; children with increases over 0.47 seconds or 25% above baseline: Stop further dose increases and/or consider dose reductions.

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Therapy should be initiated slowly and gradually.

• A risk/benefit assessment is warranted for this drug, as use could result in serious adverse events (e.g., tardive dyskinesia, neuroleptic malignant syndrome, and sudden, unexpected death due to QT prolongation).
• When determining the initial dose for a patient, consideration should be given to the patient's age, symptom severity, and previous response to other neuroleptic drugs. Patients should be on the lowest possible dose that suppresses symptoms but limits side effects.
• Patients should be evaluated regularly to verify that the lowest possible dose is used.

• Complete Blood Count before and periodically during treatment
• ECGs at baseline and periodically during treatment
• Electrolyte levels periodically, especially in patients with electrolyte disturbances

• Warn patients to avoid abrupt discontinuation of this drug.
• Tell patients to immediately report any signs/symptoms of neutropenia/leukopenia, neuroleptic malignant syndrome, or tardive dyskinesia.
• Patients should be advised to report all concurrent prescription and nonprescription medications or herbal products they are taking.
• Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are known.
• Patients should be advised to speak to a healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.