TOURETTE SYNDROME

Your patient presented with Tourette Syndrome and the standard therapy
you prescribed is not working.

What now?

  • ORAP is effective in reducing motor and phonic tics
  • ORAP may enable Tourette Syndrome patients to lead more normal lives
  • ORAP has a pediatric dosage schedule:
    • Initiate ORAP treatment at a dose of 0.05 mg/kg, preferably at bedtime
    • Dose may be increased every third day to a maximum of 0.2 mg/kg, not to exceed 10 mg/day
  • ORAP usage has no weight gain reported

Over 10 years of clinical experience suggests that when standard therapy fails ORAP may produce significantly more improvement of symptoms(i)

Although Tourette Syndrome most often has its onset in patients between the ages of 2 and 15 years, information on the use and efficacy of ORAP in patients less than 12 years of age is limited. A 24-week open-label study in 36 children between the ages of 2 and 12 demonstrated that ORAP has a similar safety profile in this age group as in older patients, and there were no safety findings that would preclude its use in this age group.

Because its use and safety have not been evaluated in other childhood disorders, ORAP is not recommended for use in any condition other than Tourette Syndrome.

ORAP is indicated for the suppression of motor and phonic tics in patients with Tourette Syndrome who have failed to respond satisfactorily to standard therapy. ORAP is not intended as treatment of first choice.

ORAP is intended for use only in Tourette Syndrome patients whose symptoms are severe and who cannot tolerate or do not respond to standard treatment.

Evidence supporting approval of ORAP for use in Tourette Syndrome was obtained in two controlled clinical investigations that enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 years or older.

ORAP is indicated for the suppression of motor and phonic tics in patients with Tourettes Syndrome who have failed to respond satisfactorily to standard therapy. Treatment with ORAP may expose the patient to certain risks. Prescribers are urged to familiarize themselves with the potential risks before prescribing. ORAP is contraindicated in patients with a history of cardiac arrhythmias, congenital long QT syndrome, or concurrent use of certain medication.


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