Uses
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Tourette's Syndrome
Suppression of motor and vocal tics of Tourette's syndrome (Gilles de la Tourette's syndrome) in adults and children who have failed to respond adequately to, or who do not tolerate, conventional therapy (e.g., haloperidol). (See Pediatric Use under Cautions.)
Not intended as a treatment of first choice, nor is it intended for suppression of tics that are only annoying or cosmetically troublesome.
Reserve for use in patients whose development and/or daily life function is severely compromised by the presence of motor and vocal tics.
Has been used concomitantly with a stimulant in children with tic disorders (e.g., Tourette's syndrome) and comorbid attention deficit hyperactivity disorder (ADHD)† in whom stimulants alone cannot control tics.
Schizophrenia
Has been used for the symptomatic management of a variety of psychiatric illnesses†, principally schizophrenia†, but other agents generally are preferred.
Dosage and Administration
General
- Perform ECG before initiation of therapy and periodically thereafter, particularly during periods of dosage adjustment. (See Cardiovascular Effects under Cautions.)
Administration
Oral Administration
Administer orally, usually once daily; also may administer in divided doses, particularly if once-daily dosing is not well tolerated.
Some clinicians recommend administration as a single dose at bedtime to minimize adverse effects.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Initiate therapy with low dosage and adjust dosage gradually.
Pediatric Patients
Tourette's Syndrome
Oral
Children <12 years of age†: Reliable dose-response data for drug effects on tic manifestations not available.
Children ≥12 years of age: Initially, 0.05 mg/kg daily, preferably at bedtime. May increase dosage every third day to a maximum of 0.2 mg/kg daily, not to exceed 10 mg daily.
During prolonged maintenance therapy, use lowest possible effective dosage. Once adequate response is achieved, make periodic attempts (e.g., every 6–12 months) to reduce dosage to determine whether initial intensity and frequency of tics persist.
In attempts to reduce dosage, consider possibility that observed increases of tic intensity and frequency may represent a transient, withdrawal-related phenomenon rather than return of the syndrome's symptoms. Allow 1–2 weeks to elapse before concluding that an increase in tic manifestations is a function of the underlying disorder rather than a response to drug withdrawal.
If therapy is to be discontinued, gradually reduce dosage.
Adults
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Tourette's Syndrome
Oral
Initially, 1–2 mg daily in divided doses. May increase dosage every other day according to patient's tolerance and therapeutic response. Some clinicians suggest that dosage be increased at longer intervals (e.g., every 5–7 days) until manifestations decrease by ≥70%, adverse effects occur without symptomatic benefit, or symptomatic benefit and adverse effects occur simultaneously.
If minimal adverse effects occur (e.g., not interfering with functioning) before adequate response is achieved, hold further dosage increase until adverse effects resolve. If adverse effects interfere with functioning but are not severe, can reduce dosage by 1-mg increments at weekly intervals until such effects resolve.
If severe adverse effects occur, immediately reduce dosage by 50% or withhold drug. Once serious adverse effects resolve, can reinstitute with more gradual titration, increasing dosage at intervals ranging from 7–30 days.
Most patients are adequately treated with dosages <0.2 mg/kg daily or 10 mg daily, whichever is less; higher dosages not recommended.
During prolonged maintenance therapy, use lowest possible effective dosage. Once adequate response is achieved, make periodic attempts (e.g., every 6–12 months) to reduce dosage to determine whether initial intensity and frequency of tics persist.
In attempts to reduce dosage, consider possibility that observed increases of tic intensity and frequency may represent a transient, withdrawal-related phenomenon rather than return of the syndrome's symptoms. Allow 1–2 weeks to elapse before concluding that an increase in tic manifestations is a function of the underlying disorder rather than a response to drug withdrawal.
If therapy is to be discontinued, gradually reduce dosage.
Prescribing Limits
Pediatric Patients
Tourette's Syndrome
Oral
Children ≥12 years of age: Maximum 0.2 mg/kg, not exceeding 10 mg daily.
Adults
Tourette's Syndrome
Oral
Dosages >0.2 mg/kg or 10 mg daily not recommended.
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