Posology : מינונים

4.2 Posology And Method Of Administration Usual Dose:
FANAPT tablets must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg orally twice daily. Dose increases to reach the target range of 6-12 mg twice daily (12_24 mg/day) may be made with daily dosage adjustments not to exceed 2 mg twice daily (4 mg/day). The maximum recommended dose is 12 mg twice daily (24 mg/day). FANAPT tablets doses above 24 mg/day have not been systematically evaluated in the clinical trials. Efficacy was demonstrated with FANAPT tablets in a dose range of 6 to 12 mg twice daily. Prescribers should be mindful of the fact that patients need to be titrated to an effective dose of FANAPT tablets. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require similar titration. Prescribers should also be aware that some adverse effects associated with FANAPT tablets use are dose related.
FANAPT tablets can be administered without regard to meals.


Dosage in Special Populations
Dosage adjustments are not routinely indicated on the basis of age, gender, race, or renal impairment status [see Use in Specific Populations (9.6, 9.7)].


Dosage adjustment for patients taking FANAPT tablets concomitantly with potential CYP2D6 inhibitors: FANAPT tablets dose should be reduced by one-half when administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine or paroxetine. When the CYP2D6 inhibitor is withdrawn from the combination therapy, FANAPT tablets dose should then be increased to where it was before [see Drug Interactions (8)].
Dosage adjustment for patients taking FANAPT tablets concomitantly with potential CYP3A4 inhibitors: FANAPT tablets dose should be reduced by one-half when administered concomitantly with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, FANAPT tablets dose should be increased to where it was before [see Drug Interactions (8)].
Dosage adjustment for patients taking FANAPT tablets who are poor metabolizers of CYP2D6: FANAPT tablets dose should be reduced by one-half for poor metabolizers of CYP2D6 [see Clinical Pharmacology, Pharmacokinetics (13)].
Hepatic Impairment: A study in mild and moderate liver impairment has not been conducted. FANAPT is not recommended for patients with hepatic impairment. [see Use in Specific Populations (9.7)].
Maintenance Treatment
Although there is no body of evidence available to answer the question of how long the patient treated with FANAPT should be maintained, it is generally recommended that responding patients be continued beyond the acute response.
Patients should be periodically reassessed to determine the need for maintenance treatment.

Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address reinitiation of treatment, it is recommended that the initiation titration schedule be followed whenever patients have had an interval off FANAPT tablets of more than 3 days.
Switching from Other Antipsychotics
There are no specific data to address how patients with schizophrenia can be switched from other antipsychotics to FANAPT or how FANAPT can be used concomitantly with other antipsychotics. Although immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.