SAQUIN SR PROLONGED-RELEASE TABLETS 400MG [SIN16693P]

Product Info

SAQUIN SR PROLONGED-RELEASE TABLETS 400MG

[SIN16693P]

4.1 Therapeutic indications

Saquin SR is indicated for:

• Treatment of Schizophrenia

• Treatment of bipolar disorder:

  • For the treatment of manic episodes associated with bipolar I disorder

  • For the treatment of depressive episodes associated with bipolar disorder

  • For the prevention of recurrence in maintenance treatment of bipolar disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate

• Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Prior to initiating treatment, clinicians should consider the safety profile of quetiapine.

4.2 Posology and method of administration

Posology
SAQUIN SR 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:
SAQUIN SR 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
Saquin SR should be administered once daily in the evening. SAQUIN SR should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). SAQUIN SR 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 in the 600 mg group during short-term treatment.

For preventing recurrence in maintenance treatment of bipolar disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Patients who have responded to SAQUIN SR in monotherapy for acute treatment of bipolar disorder should continue on SAQUIN SR therapy at the same dosing regimen. Saquin SR 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 SAQUIN SR in combination therapy to a mood stabilizer (lithium or valproate) for acute treatment of bipolar disorder should continue on SAQUIN SR therapy at the same dose. The SAQUIN SR 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.
Saquin SR should be administered once daily in the evening. Saquin SR 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) 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 SAQUIN SR after 6 weeks treatment for MDD should have treatment re-evaluated.

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

Elderly:
As with other antipsychotics and antidepressants, Saquin SR should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration of Saquin SR 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 in MDD, dosing should begin with 50 mg/day on Days 1–3, increasing to 100 mg/day on Day 4, 150 mg/day on Day 8 and then up to 300 mg/day depending on clinical response and tolerability.

Children and adolescents:
Saquin SR is not indicated for use in children and adolescents below 18 years of age.

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, SAQUIN SR 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.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.