Select therapeutic use:
Indications for ORAP:
Motor and phonic tics of Tourette's disorder unresponsive to standard treatment that severely compromise development or daily life function.
Initially 1–2mg/day in divided doses; may increase every other day to max 0.2mg/kg per day not to exceed 10mg/day.
<12yrs: not recommended. ≥12yrs: Initially 0.05mg/kg once daily at bedtime; may increase every third day to max 0.2mg/kg, not to exceed 10mg/day.
Simple tics or tics not associated with Tourette's disorder. Drugs that may cause tics (eg, pemoline, methylphenidate, amphetamines) or prolong the QT interval (eg, phenothiazines, tricyclic antidepressants, antiarrhythmics, dofetilide, sotalol, quinidine, other Class IA or III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, tacrolimus, ziprasidone, others). Congenital long QT syndrome. History of cardiac arrhythmias. Hypokalemia. Hypomagnesemia. Severe CNS depression or comatose states. Concomitant CYP3A4 inhibitors (eg, macrolides antibiotics, azole antifungals, protease inhibitors, nefazodone, zileuton, fluvoxamine, sertraline), citalopram, escitalopram.
Renal or hepatic impairment. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. History of seizures or EEG abnormalities. Monitor ECG at baseline and periodically (esp. during dose adjustment). Correct hypokalemia before starting. Avoid abrupt cessation. May have tumorigenic potential. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. May be potentiated by CYP1A2 inhibitors. Potentiates CNS depression with alcohol, analgesics, other CNS depressants. Caution with anticonvulsants. Avoid grapefruit juice.
Sedation, anticholinergic effects, extrapyramidal symptoms, tardive dyskinesia, ECG changes, neuroleptic malignant syndrome, hyperpyrexia; leukopenia/neutropenia.