SEROQUEL XR TABLET 50MG

ASTRAZENECA UK LIMITED (MANUFACTURE, QC TESTING, PACKING, FINAL RELEASE) - UNITED KINGDOMASTRAZENECA PHARMACEUTICALS LP (MANUFACTURE, QC TESTING AND RELEASE OF BULK PRODUCT) (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Jul 29, 2008
Approval ID: 3b03afcdeba7b1f2
Company: ASTRAZENECA UK LIMITED (MANUFACTURE, QC TESTING, PACKING, FINAL RELEASE) - UNITED KINGDOMASTRAZENECA PHARMACEUTICALS LP (MANUFACTURE, QC TESTING AND RELEASE OF BULK PRODUCT) (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: 3b03afcdeba7b1f2
Drug Name: SEROQUEL XR TABLET 50MG
Product Name: SEROQUEL XR TABLET 50MG
Approval Number: SIN13502P
Approval Date: 2008-07-29
Registrant: LUYE PHARMA (SINGAPORE) PTE. LTD.
Licence Holder: LUYE PHARMA (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, EXTENDED RELEASE
Dosage: 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.
Route Of Administration: ORAL
Indication Info: Therapeutic indications SEROQUEL XR is indicated for the treatment of schizophrenia. SEROQUEL XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on SEROQUEL XR. SEROQUEL XR is indicated for bipolar disorder: <ul class="dash"> <li>manic episodes associated with bipolar I disorder</li> <li>depressive episodes associated with bipolar disorder</li> <li>preventing recurrence in maintenance treatment of bipolar disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate.</li> </ul> SEROQUEL XR is indicated for use as add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Prior to initiating treatment, clinicians should consider the safety profile of SEROQUEL XR.
Contraindications: Contraindications SEROQUEL XR is contraindicated in patients who are hypersensitive to any component of this product.
Atc Code: N05AH04
Atc Item Name: quetiapine
Pharma Manufacturer Name: LUYE PHARMA (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/luye-pharma-singapore-pte-ltd

Active Ingredients

Quetiapine fumarate 57.56mg eqv quetiapine

50 mg

Quetiapine fumarate 57.56mg eqv quetiapine

50 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jul 29, 2008

Approval ID

3b03afcdeba7b1f2

Type

Therapeutic

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