EVIPSYZED 25 QUETIAPINE FUMARATE TABLETS USP 25MG [SIN17066P]

Product Info

EVIPSYZED 25 QUETIAPINE FUMARATE TABLETS USP 25MG

[SIN17066P]

4. Therapeutic indications

Quetiapine is indicated for the treatment of

• Schizophrenia

• acute manic episodes associated with bipolar I disorder.

• 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.

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.

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:

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 (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 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: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (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 in the 600 mg group. Effectiveness has not been systematically evaluated in clinical trials for more than 8 weeks.

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 the elderly, especially during the initial dosing period. 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

Quetiapine 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 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 Quetiapine 25 mg/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.

Contraindications

Quetiapine is contraindicated in patients who are hypersensitive to any component of this product.