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ORAP (PIMOZIDE): PRESCRIBING INFORMATION
Orap (Pimozide) is an orally active antipsychotic agent of the diphenyl-butylpiperidine series. The formula of pimozide is 1-[1-[4,4-bis(4-fluorophenyl) butyl]-4piperidinyl]-1,3-dihydro-2H-benzimidazole-2-one.
The solubility of pimozide in water is less than 0.01 mg / ml; it is slightly soluble in most organic solvents.
Each Orap tablet contains 1 mg, 2 mg, 4 mg or 10 mg of pimozide and the following inactive ingredients: microcrystalline cellulose, calcium stearate, lactose anhydrous and
Orap clinical pharmacology
INDICATIONS AND USAGE
Pimozide (Orap) tablets 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.
USE IN SPECIFIC POPULATIONS
Orap use in specific populations
Orap drug interactions
Orap adverse reactions
In general, the signs and symptoms of overdosage with Orap would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) electrocardiographic abnormalities, 2) severe extrapyramidal reactions, 3) hypotension, 4) a comatose state with respiratory depression.
In the event of overdosage, gastric lavage, establishment of a patent airway and, if necessary, mechanically-assisted respiration are advised. Electrocardiographic monitoring should commence immediately and continue until the ECG parameters are within the normal range. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine.
Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered. Because of the long half-life of pimozide, patients who take an overdose should be observed for at least 4 days. As with all drugs, the physician should consider contacting a poison control center for additional information on the treatment of overdose.
DOSAGE AND ADMINISTRATION
Orap dosage and administration
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.
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.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container as defined in the official compendium.
Pharmacist: Dispense in child-resistant container.
Manufactured and distributed by Gate Pharmaceuticals, Teva Pharmaceuticals, Janssen companies and its divisions.
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