SEROQUEL TABLET 300MG

ASTRAZENECA UK LIMITED - UNITED KINGDOMASTRAZENECA PHARMACEUTICAL CO. LTD (CHINA)🇸🇬 Health Sciences Authority

Approval Date: Feb 26, 2007
Approval ID: 118ee1f618a15f62
Company: ASTRAZENECA UK LIMITED - UNITED KINGDOMASTRAZENECA PHARMACEUTICAL CO. LTD (CHINA)
Type: Therapeutic

Approval Details

Approval Id: 118ee1f618a15f62
Drug Name: SEROQUEL TABLET 300MG
Product Name: SEROQUEL TABLET 300MG
Approval Number: SIN13236P
Approval Date: 2007-02-26
Registrant: LUYE PHARMA (SINGAPORE) PTE. LTD.
Licence Holder: LUYE PHARMA (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Posology and Method of Administration Adults For the treatment of schizophrenia: SEROQUEL should be administered twice daily, with or without food. For the treatment of schizophrenia: 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 clinical 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: SEROQUEL should be administered twice daily, with or without food. 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 clinical 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. The safety of doses above 800 mg/day has not been evaluated in clinical trials. Effectiveness for more than 12 weeks has not been systematically evaluated in clinical trials for monotherapy. Therefore, the physician who elects to use SEROQUEL for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient. For the treatment of depressive episodes associated with bipolar disorder: SEROQUEL should be administered once daily at bedtime, with or without food. SEROQUEL should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). SEROQUEL 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. Effectiveness has not been systematically evaluated in clinical trials for more than 8 weeks (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: Patients who have responded to SEROQUEL in combination therapy with lithium or valproate for acute treatment of bipolar disorder should continue on SEROQUEL therapy at the same dose. The SEROQUEL 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. Patients who have responded to SEROQUEL for acute treatment of bipolar disorder should continue on SEROQUEL therapy at the same dosing regimen. The SEROQUEL 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. Elderly As with other antipsychotics, SEROQUEL should be used with caution in the elderly, especially during the initial dosing period. Elderly patients should be started on SEROQUEL 25 mg/day. The dose should be increased daily, in increments of 25 to 50 mg, to an effective dose, which is likely to be lower than that in younger patients. 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 metabolised by the liver, and therefore should be used with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should be started on SEROQUEL 25 mg/day. The dose should be increased daily, in increments of 25 to 50 mg, to an effective dose.
Route Of Administration: ORAL
Indication Info: Indications SEROQUEL is indicated for the treatment of: <ul> <li>schizophrenia.</li> <li>acute manic episodes associated with bipolar I disorder.</li> <li>depressive episodes associated with bipolar disorder.</li> <li>preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate.</li> </ul>
Contraindications: Contraindications SEROQUEL 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.

Active Ingredients

QUETIAPINE FUMARATE 345 mg EQV QUETIAPINE (Core)

300 mg

QUETIAPINE FUMARATE 345 mg EQV QUETIAPINE (Core)

300 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 26, 2007

Approval ID

118ee1f618a15f62

Type

Therapeutic

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