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ORAP (pimozide) is indicated for the suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond satisfactorily to standard treatment. ORAP is not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. ORAP should be reserved for use in Tourette's Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics.
Evidence supporting approval of pimozide for use in Tourette's Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older.
DOSAGE AND ADMINISTRATION
The suppression of tics by ORAP requires a slow and gradual introduction of the drug. The patient's dose should be carefully adjusted to a point where the suppression of tics and the relief afforded is balanced against the untoward side effects of the drug.
An ECG should be done at baseline and periodically thereafter, especially during the period of dose adjustment (see WARNINGS and PRECAUTIONS – Laboratory Tests). Periodic attempts should be made to reduce the dosage of ORAP to see whether or not tics persist at the level and extent first identified. In attempts to reduce the dosage of ORAP, consideration should be given to the possibility that increases of tic intensity and frequency may represent a transient, withdrawal-related phenomenon rather than a return of disease symptoms. Specifically, one to two weeks should be allowed to elapse before one concludes that an increase in tic manifestations is a function of the underlying disease syndrome rather than a response to drug withdrawal. A gradual withdrawal is recommended in any case.
Reliable dose response data for the effects of ORAP (pimozide) on tic manifestation in Tourette's Disorder patients below the age of twelve are not available.
Treatment should be initiated at a dose of 0.05 mg/kg preferably taken once at bedtime. The dose may be increased every third day to a maximum of 0.2 mg/kg not to exceed 10 mg/day.
At doses above 0.05 mg/kg/day, CYP 2D6 genotyping should be performed. In poor CYP 2D6 metabolizers, ORAP doses should not exceed 0.05 mg/kg/day, and doses should not be increased earlier than 14 days (see PRECAUTIONS – Pharmacogenomics).
In general, treatment with ORAP should be initiated with a dose of 1 to 2 mg a day in divided doses. The dose may be increased thereafter every other day. Most patients are maintained at less than 0.2 mg/kg/day, or 10 mg/day, whichever is less. Doses greater than 0.2 mg/kg/day or 10 mg/day are not recommended.
At doses above 4 mg/day, CYP 2D6 genotyping should be performed. In poor CYP 2D6 metabolizers, ORAP doses should not exceed 4 mg/day, and doses should not be increased earlier than 14 days (see PRECAUTIONS – Pharmacogenomics).
A chronic study in dogs indicated that pimozide caused gingival hyperplasia when administered for several months at about 5 times the maximum recommended human dose. This condition was reversible after withdrawal.
ORAP® (pimozide) 1 mg tablets are white, oval, scored tablets, debossed “ORAP 1”. They are available in bottles of 100 (NDC 57844-151-01).
ORAP® (pimozide) 2 mg tablets are white, oval, scored tablets, debossed “LEMMON” on one side and “ORAP 2” on the other. They are available in bottles of 100 (NDC 57844-187-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the official compendium.
Pharmacist: Dispense in child-resistant container.
Manufactured for: Gate Pharmaceuticals, Div. of Teva Pharmaceuticals USA Sellersville, PA 18960. Manufactured by: Teva Pharmaceuticals USA, Sellersville, PA 18960. Rev. Aug 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/7/2011
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