Active Ingredient: Ziprasidone
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 40 milligrams ziprasidone, 2 times daily to meals.
The recommended dose in acute treatment of schizophrenia is 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
It is of particular importance not to exceed the maximum dose as the safety profile above 160 mg/day has not been confirmed and ziprasidone is associated with dose-related prolongation of the QT interval.
In maintenance treatment of schizophrenia patients, ziprasidone should be administered at the lowest effective dose; in many cases, a dose of 20 mg twice daily may be sufficient.
A lower starting dose is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.
It should be taken with food.
For:
Regimen A: Oral, 20 milligrams ziprasidone, one dose, over the duration of 1 day. Afterwards, in case that patient weight is ≥ 45 kg, oral, between 120 milligrams ziprasidone and 160 milligrams ziprasidone, divided daily, 2 doses in total.
Regimen B: Oral, 20 milligrams ziprasidone, one dose, over the duration of 1 day. Afterwards, in case that patient weight is ≤ 45 kg, oral, between 60 milligrams ziprasidone and 80 milligrams ziprasidone, divided daily, 2 doses in total.
The recommended dose, in acute treatment of bipolar mania, in paediatric patients (age 10 to 17 years) is a single dose of 20 mg on day 1, with food. Ziprasidone should subsequently be administered with food in two daily divided doses, and should be titrated over 1-2 weeks to a target range of 120-160 mg/day for patients weighing ≥45 kg, or to a target range of 60-80 mg/day for patients weighing <45 kg. Subsequent dosing should be adjusted on the basis of individual clinical status within the range of 80-160 mg/day for patients weighing ≥45 kg, or 40-80 mg/day for patients weighing <45 kg. Asymmetric dosing, with morning doses 20 mg or 40 mg less than evening doses, was permitted in the clinical trial.
It is of particular importance not to exceed the weight-based maximum dose as the safety profile above the maximum dose (160 mg/day for children ≥45 kg and 80 mg/day for children <45 kg has not been confirmed and ziprasidone is associated with dose-related prolongation of the QT interval.
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