Classes
DEA Class; Rx
Common Brand Names; Orap
- Antipsychotics, 1st Generation;
Description
Reserved for use for motor and phonic tics of Tourette’s syndrome refractory to standard treatment
As with all antipsychotics, increased mortality risk in elderly patients treated for dementia-related psychosis
Indications
Indicated for the treatment of Tourette’s syndrome or chronic tic disorders† not responding to standard therapy.
Contraindications
Documented hypersensitivity
CNS depression (including coma), neuroleptic malignant syndrome (NMS), poorly controlled seizure disorder
Use as first-line treatment
Tics not associated with Tourette’s
Prolongs QT interval: concurrent QT-prolonging drugs or congenital long QT patients
Concomitant CYP3A4 or CYP2D6 inhibitors
Adverse Effects
- Akinesia (40%)
- Drowsiness (35%)
- EPS (10-15%)
- Sedation (70%)
- Speech disorder (10-15%)
- Visual disturbance (20%)
- Dry mouth (25%)
- Constipation (20%)
- Impotence (10-15%)
- Appetite increase
- Thirst increase
- Dizziness
- Drug-induced tardive dystonia
- Nervousness
- Photosensitivity
- Taste change
- Orthostatic hypotension
- Diminished sweating
- Nasal congestion
- Diarrhea
- Urinary retention
- Retinitis pigmentosa
- Ineffective thermoregulation
- Heatstroke or hypothermia (rare)
- Neuroleptic malignant syndrome (rare)
- Seizure (rare)
- Prolonged QT interval
- Torsades de pointes
- Obstipation (rare)
- Paralytic ileus (rare)
- Agranulocytosis (rare)
Warnings
FDA Warning regarding off-label use for dementia in elderly
Avoid grapefruit juice
Risk of EPS & NMS
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia
If history of clinically significant low WBC or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of a clinically significant decline <1000/mm³ in WBC in absence of other causative factors and continue monitoring WBC until recovery
Pregnancy and Lactation
Pregnancy Category: C
Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation: unknown, avoid
Maximum Dosage
0.2 mg/kg/day PO or 10 mg/day PO, whichever is less.
0.2 mg/kg/day PO or 10 mg/day PO, whichever is less.
0.2 mg/kg/day PO or 10 mg/day PO, whichever is less.
8 to 12 years: Do not exceed 0.2 mg/kg/day or 10 mg/day PO, whichever is less. Published data suggest a maximum of 6 mg/day PO or 0.2 mg/kg/day PO, whichever is less, for children less than 12 years old.
Less than 8 years: Safety and efficacy have not been established.
Not indicated.
How supplied
Pimozide
tablets
- 1mg
- 2mg
