Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. Q-PIN can be administered with or without food.
Adults: For the treatment of schizophrenia: Q-PIN should be administered twice daily. The total daily dose for the first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg/day. Depending on the response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day.
For the treatment of manic episodes associated with bipolar disorder: Q-PIN should be administered twice daily. As monotherapy or as adjunct therapy to mood stabilizers, the total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg per day by Day 6 should be in increments of no greater than 200 mg per day.
The dose may be adjusted depending on response and tolerability of the individual patient, within the range of 200 to 800 mg per day. The usual effective dose is in the range of 400 to 800 mg per day.
For the treatment of depressive episodes associated with bipolar disorder: Q-PIN should be administered once daily at bedtime. Q-PIN should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Q-PIN can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8.
Antidepressant efficacy was demonstrated with Q-PIN at 300 mg and 600 mg; however no additional benefit was seen in the 600 mg group.
Elderly: As with other antipsychotics, Q-PIN should be used with caution in the elderly, especially during the initial dosing period. Elderly patients should be started on Q-PIN 25 mg/day. The dose should be increased daily, in increments of 25 to 50 mg, to an effective dose. The rate of dose titration of Q-PIN may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the response and tolerability of the individual patient.
Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.
Children and adolescents: The safety and efficacy of Q-PIN have not been evaluated in children and adolescents.
Renal impairment: Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment: Quetiapine is extensively metabolised by the liver. Therefore, Q-PIN should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with known hepatic impairment should be started with 25 mg/day. The dosage should be increased daily with increments of 25 - 50 mg/day until an effective dosage, depending on the response and tolerability of the individual patient.