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ORAP (PIMOZIDE): CONTRAINDICATIONS

Orap is contraindicated in the treatment of simple tics or tics other than those associated with Tourette's Disorder.

Orap (Pimozide) should not be used in patients taking drugs that may, themselves, cause motor and phonic tics (e.g., pemoline, methylphenidate and amphetamines) until such patients have been withdrawn from these drugs to determine whether or not the drugs, rather than Tourette's Disorder, are responsible for the tics.

Because Orap (Pimozide) tablets prolongs the QT interval of the electrocardiogram it is contraindicated in patients with congenital long QT syndrome, patients with a history of cardiac arrhythmias, patients taking other drugs which prolong the QT interval of the electrocardiogram or patients with known hypokalemia or hypomagnesemia.

Pimozide (Orap) is contraindicated in patients with severe toxic central nervous system depression or comatose states from any cause.

Pimozide (Orap) tablets is contraindicated in patients with hypersensitivity to it. As it is not known whether cross-sensitivity exists among the antipsychotics, pimozide should be used with appropriate caution in patients who have demonstrated hypersensitivity to other antipsychotic drugs.

Ventricular arrhythmias have been rarely associated with the use of macrolide antibiotics in patients with prolonged QT intervals, as might be produced by ORAP. Specifically, two sudden deaths have been reported when clarithromycin was added to ongoing pimozide therapy. Furthermore, some evidence suggests that pimozide is metabolized partly by the enzyme system cytochrome P450 3A4 (CYP 3A4). Macrolide antibiotics are inhibitors of CYP 3A4, and thus could potentially impede pimozide metabolism. For these reasons, Orap is contraindicated in patients receiving the macrolide antibiotics clarithromycin, erythromycin, azithromycin, dirithromycin, and troleandomycin.

Concomitant use in patients taking Celexa or Lexapro is contraindicated.

Because azole antifungal agents are also inhibitors of the CYP 3A4 enzymes and thus may likewise impair pimozide metabolism, Orap (Pimozide) is contraindicated in patients receiving the azole antifungal agents itraconazole and ketoconazole.

Similarly, protease inhibitor drugs are also inhibitors of CYP 3A4, and thus Orap (Pimozide) tablets is contraindicated in patients receiving protease inhibitors such as ritonavir, indinavir, saquinovir, and nelfinavir.

Nefazodone is a potent inhibitor of CYP 3A4, and its concomitant use with Pimozide (Orap) is also contraindicated.

Other drugs that are relatively less potent inhibitors of CYP 3A4 should also be avoided, in view of the risks: e.g. zileuton, fluvoxamine.

Concomitant use of pimozide in patients taking sertraline is contraindicated.

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