Seroquel XR Tablet 300mg

LUYE PHARMA (SINGAPORE) PTE. LTD.

LUYE PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

TABLET, EXTENDED RELEASE

**Posology and method of administration** SEROQUEL XR should be administered once daily, with or without food. The tablets should be swallowed whole and not split, chewed or crushed. **Adults** **For the treatment of schizophrenia:** The daily dose at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. 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. The safety of doses above 800 mg/day have not been evaluated. **For the treatment of manic episodes associated with bipolar disorder:** SEROQUEL XR should be administered once daily in the evening. The daily dose at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. 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 the treatment of depressive episodes associated with bipolar disorder:** SEROQUEL XR should be administered once daily in the evening. SEROQUEL XR should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). SEROQUEL XR can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8. Antidepressant efficacy was demonstrated with SEROQUEL at 300 mg and 600 mg, however no additional benefit was seen in the 600 mg group during short-term treatment (See _Undesirable effects_ and _Clinical efficacy_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **For preventing recurrence in maintenance treatment of bipolar disorder:** Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase (See _Clinical efficacy_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment (See _Clinical efficacy_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients who have responded to SEROQUEL XR in monotherapy for acute treatment of bipolar disorder should continue on SEROQUEL XR therapy at the same dosing regimen. SEROQUEL XR dose can be re-adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day. Patients who have responded to SEROQUEL XR in combination therapy to a mood stabilizer (lithium or valproate) for acute treatment of bipolar disorder should continue on SEROQUEL XR therapy at the same dose. The SEROQUEL XR dose can be re-adjusted depending on clinical response and tolerability of the individual patient within the dose range of 400 mg to 800 mg/day. **For add-on treatment of major depressive episodes in MDD:** When treating recurrent MDD in patients who are intolerant of, or who have an inadequate response to alternative therapies, treatment should be initiated either by the treating psychiatrist or by the general practitioner after consultation with the psychiatrist. SEROQUEL XR should be administered once daily in the evening. SEROQUEL XR should be administered prior to bedtime. 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 _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) 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. Patients who have not responded to SEROQUEL XR after 6 weeks treatment for MDD should have treatment re-evaluated (See _Clinical efficacy_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Switching from SEROQUEL immediate-release tablets:** For more convenient dosing, patients who are currently being treated with divided doses of immediate release SEROQUEL tablets (SEROQUEL IR, tradename SEROQUEL®) 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, 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 with 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 disorder initial dosing should begin at 50 mg on Days 1–3, the dose can be increased to 100 mg on Day 4, 150 mg on Day 8 and then up to 300 mg depending on clinical response and tolerability (See _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Children and adolescents** SEROQUEL is not indicated for use in children and adolescents below 18 years of age. Data from placebo-controlled clinical trials are set forth in sections _‘Special warnings and special precautions for use’, ‘Undesirable effects’, ‘Pharmacodynamic properties’ and ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **Renal and hepatic impairment** The oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is extensively metabolized by the liver. Therefore, SEROQUEL XR should be used with caution in patients with known hepatic impairment. Patients with hepatic or renal impairment should be started on 50 mg/day. The dose should be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.