Generic Name for ORAP
Pimozide 1mg, 2mg; scored tabs.
Legal Classification:
Rx
Pharmacological Class for ORAP
Antipsychotic.
Manufacturer of ORAP
Gate Pharmaceuticals
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Indications for ORAP
Motor and phonic tics of Tourettes disorder unresponsive to standard treatment that severely compromise development or daily life function.
Adult dose for ORAP
Initially 1–2mg/day in divided doses; may increase every other day to max 0.2mg/kg per day not to exceed 10mg/day.
Children's dosing for ORAP
<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.
Contraindications for ORAP
Simple tics or tics not associated with Tourettes 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.
Warnings/Precautions for ORAP
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.
Interactions for ORAP
See Contraindications. May be potentiated by CYP1A2 inhibitors. Potentiates CNS depression with alcohol, analgesics, other CNS depressants. Caution with anticonvulsants. Avoid grapefruit juice.
Adverse Reactions for ORAP
Sedation, anticholinergic effects, extrapyramidal symptoms, tardive dyskinesia, ECG changes, neuroleptic malignant syndrome, hyperpyrexia; leukopenia/neutropenia.
How is ORAP supplied?
Tabs—100