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Risperidon Depot ISM (Okedi)

Wirkmechanismus

Wie Risperidon

Klinische Studien

  • Vergleichende Bioverfügbarkeit von intramuskulärem Risperidon ISM und oralem Risperidon

Anwendung und Dosierung

Plasmaspiegel

Oral vs. ISM
4-Wochenverlauf

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Figure 3 Mean (±SD) steady-state plasma concentrations versus time profiles for risperidone active moiety after the 4th monthly dose of Risperidone ISM 100 mg (PK population).
Notes: The blue line corresponds to the mean (SD) active moiety plasma concentrations of Risperidone ISM 100 mg. The shaded gray area corresponds to the Cmin ss – C max ss range observed after the 7th once daily dose of oral risperidone 4 mg (steady-state). Dashed black lines represent those C min minus SD at the bottom and C max plus SD at the top, for steady-state oral risperidone.
Abbreviations: C min ss, minimum plasma concentration at steady-state; AUCtau , area under the curve during the dosing interval; Cmax ss, maximum plasma concentration at steady-state.

Figure 2 Mean (±SD) plasma concentrations versus time profiles for risperidone active moiety during oral risperidone 4 mg treatment (7th dose) and after switching to risperidone ISM 100 mg (PK population).
Notes: Once daily oral risperidone 4 mg was administered for 7 days. An intense oral pharmacokinetic (PK) analysis was conducted at study Day 7 (last day of the oral risperidone treatment) including samples at pre-dose (within 0.5 hours relative to the dose time), 1, 2, 3, 4, 6, 8, and 12 hours, post-dose (black line). Twenty-four hours after the last oral risperidone dose (study Day 8), a single intramuscular dose of Risperidone ISM 100 mg was administered and PK samples were obtained at pre-dose and 12 hours post-dose, as well as at Days 10, 15, 22, 29, and 36 (blue line).