Active Ingredient: Lurasidone
Lurasidone is indicated for the treatment of schizophrenia in adults and adolescent aged 13 years and over.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 37 milligrams lurasidone, once daily. Afterwards, oral, between 37 milligrams lurasidone and 148 milligrams lurasidone, once daily. The maximum allowed total dose is 148 milligrams lurasidone daily.
The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 148 mg once daily. Dose increase should be based on physician judgement and observed clinical response. The maximum daily dose should not exceed 148 mg.
Patients on doses higher than 111 mg once daily who discontinue their treatment for longer than 3 days should be restarted on 111 mg once daily and up-titrated to their optimal dose. For all other doses patients can be restarted on their previous dose without need for up-titration.
A starting dose of 18.5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors. Dose adjustment of lurasidone may be necessary in combination with mild and moderate CYP3A4 inducers.
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Dosing recommendations for elderly patients with normal renal function (CrCl ≥80 ml/min) are the same as for adults with normal renal function. However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status.
Limited data are available in elderly people treated with higher doses of lurasidone. No data are available in elderly people treated with 148 mg of lurasidone. Caution should be exercised when treating patients ≥65 years of age with higher doses of lurasidone.
For:
In the case that patient age in years is ≥ 13 :
Oral, 37 milligrams lurasidone, once daily. Afterwards, oral, between 37 milligrams lurasidone and 74 milligrams lurasidone, once daily. The maximum allowed total dose is 74 milligrams lurasidone daily.
The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 74 mg once daily. Dose increase should be based on physician judgement and observed clinical response. The maximum daily dose should not exceed 74 mg. In children, lurasidone should be prescribed by an expert in paediatric psychiatry.
A starting dose of 18.5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors. Dose adjustment of lurasidone may be necessary in combination with mild and moderate CYP3A4 inducers.
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
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