Posology : מינונים

4.2   Posology and method of administration
Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.
Seroquel XR should be administered once daily, without food (Seroquel XR should be administrated at least one hour before a meal). The tablets should be swallowed whole and not split, chewed or crushed.

Adults:
For the treatment of schizophrenia and manic episodes associated with bipolar disorder The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2.
The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily. The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerability of the patient. For maintenance therapy in schizophrenia no dosage adjustment is necessary.
For the treatment of depressive episodes associated with bipolar disorder Seroquel XR should be administered at evening. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended daily dose is 300 mg. Depending on the patient’s response Seroquel XR maybe titrated up to 600 mg daily. Antidepressant efficacy was demonstrated at 300 mg and 600 mg/day; however, no additional benefit was seen in the 600 mg group above 300 mg daily during short-term treatment (see section 5.1).
In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered. When treating depressive episodes in bipolar disorder, treatment should be prescribed by physicians experienced in treating bipolar disorder.
For preventing recurrence in bipolar disorder
For prevention of recurrence of manic, depressive or mixed episodes in bipolar disorder, patients who have responded to Seroquel XR for acute treatment of bipolar disorder should continue on Seroquel XR at the same dose. The dose may be adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day. It is important that the lowest effective dose is used for maintenance therapy.
For add-on treatment of major depressive episodes in MDD:
Seroquel XR should be administered once daily in the evening. The daily dose at the start of therapy is 50 mg on Day 1 and 2, and 150 mg on Day 3 and 4. Antidepressant effect was seen at 150 and 300 mg/day in short-term trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see section 5.1 Pharmacodynamic properties) and at 50 mg/day in short-term monotherapy trials.
There is an increased risk of adverse events at higher doses. Clinicians should therefore ensure that the lowest effective dose, starting with 50 mg/day, is used for treatment. The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.

Switching from Seroquel immediate-release tablets:
For more convenient dosing, patients who are currently being treated with divided doses of immediate release Seroquel tablets may be switched to Seroquel XR at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.

Elderly:
As with other antipsychotics and antidepressant, Seroquel XR should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration of Seroquel XR may need to be slower, and the daily therapeutic dose lower, than that used in younger patients. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients. Elderly patients should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.

In elderly patients with major depressive episodes MDD, dosing should begin with 50 mg/day on Days 1-3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8. The lowest effective dose, starting from 50 mg/day should be used. Based on individual patient evaluation, if dose increase to 300 mg/day is required this should not be prior to Day 22 of treatment.

Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.

Paediatric population:
The safety and efficacy of Seroquel XR 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 metabolized by the liver. Therefore, Seroquel XR should be used with caution in patients with known hepatic impairment, especially during the initial dosing period.
Patients with hepatic impairment should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.