KETIPINOR TABLET 25 MG [SIN13767P]

Product Info

KETIPINOR TABLET 25 MG

[SIN13767P]

4.1 Therapeutic indications

• Treatment of schizophrenia.

• Treatment of acute manic episodes associated with bipolar I disorder. Ketipinor has not been demonstrated to prevent recurrence of manic or depressive episodes.

• Depressive episodes associated with bipolar disorder.

• Maintenance treatment of bipolar I disorder as adjunct therapy to lithium or valproate.

4.2 Dosage and method of administration

Adults

For the treatment of schizophrenia:

KETIPINOR 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:

KETIPINOR should be administered twice daily, with or without food.
As monotherapy or as adjunct 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 per 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 KETIPINOR 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:

KETIPINOR should be administered once daily at bedtime, with or without food.

KETIPINOR should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). KETIPINOR 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 (See section 4.8 “Undesirable effects” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For the maintenance treatment of bipolar I disorder as adjunct therapy to lithium or valproate:

Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or valproate. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase.

Children and adolescents
The safety and efficacy of quetiapine have not been evaluated in children and adolescents.

Elderly
As with other antipsychotics, KETIPINOR should be used with caution in the elderly, especially during the initial dosing period. Elderly patients should be started on KETIPINOR 25 mg/day. The dose should be increased daily, in increments of 25 – 50 mg to an effective dose, which is likely to be lower than in younger patients. Note: the mean plasma clearance of quetiapine was reduced by 30–50% in elderly subjects when compared to younger patients.

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, and therefore should be used with caution in patients with known hepatic impairment.
Patients with renal or hepatic impairment should be started on KETIPINOR 25 mg/day. The dosage should be increased daily with increments of 25 to 50 mg/day until an effective dosage, depending on the clinical response and tolerability of the individual patient.

4.3 Contra-indications

• Hypersensitivity to the active substance or to any of the excipients of the product.

• Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone (see also section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).