QUETIAPINE SANDOZ 25 MG TABLETS [SIN13838P]

Product Info

QUETIAPINE SANDOZ 25 MG TABLETS

[SIN13838P]

4.1 Therapeutic indications

• Treatment of schizophrenia.

• Treatment of acute manic episodes associated with bipolar I disorder.

• Treatment of depressive episodes associated with bipolar disorder.

• Preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate.

4.2 Posology and method of administration
Quetiapine should be administered with or without food.

Adults
For the treatment of schizophrenia:
Quetiapine should be administered twice daily, with or without food.

The total daily dose for the first 4 days of therapy is 50 mg Quetiapine (Day 1), 100 mg Quetiapine (Day 2), 200 mg Quetiapine (Day 3) and 300 mg Quetiapine (Day 4).

From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg Quetiapine per day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range of 150 to 750 mg Quetiapine per day.

For the treatment of manic episodes associated with bipolar disorder:
Quetiapine 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 Quetiapine (Day 1), 200 mg Quetiapine (Day 2), 300 mg Quetiapine (Day 3) and 400 mg Quetiapine (Day 4). Further dosage adjustments up to 800 mg Quetiapine per day by Day 6 should be in increments of no greater than 200 mg Quetiapine 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 Quetiapine per day. The usual effective dose is in the range of 400 to 800 mg Quetiapine 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 Quetiapine 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:
Quetiapine should be administered once daily at bedtime, with or without food.

Quetiapine should be titrated as follows: the daily dose for the first four days of therapy is 50 mg Quetiapine (Day 1), 100 mg Quetiapine (Day 2), 200 mg Quetiapine (Day 3) and 300 mg Quetiapine (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300 mg and 600 mg however no additional benefit was seen with higher doses (600 mg Quetiapine) group. Effectiveness has not been systematically evaluated in clinical trials for more than 8 weeks (see sections 4.8 and 5.1 – 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 quetiapine in combination therapy with lithium or valproate for acute treatment of bipolar disorder should continue on quetiapine therapy at the same dose. The quetiapine 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 quetiapine for acute treatment of bipolar disorder should continue on quetiapine therapy at the same dosing regimen. The quetiapine 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, quetiapine should be used with caution in elderly patients, especially during the initial phase of treatment. Elderly patients should be started on Quetiapine 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 under 18 years
Quetiapine 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 4.4, 4.8, 5.1 and 5.2 – 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 start with 25 mg quetiapine per day. Depending on clinical response and tolerability of the individual patient, the dose should be increased daily, in increments of 25 to 50 mg quetiapine, to an effective dose.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients of this product.