Ketipinor

Ketipinor Dosage/Direction for Use

quetiapine

Manufacturer:

Orion Pharma

Distributor:

Apex
Full Prescribing Info
Dosage/Direction for Use
Ketipinor can be administered with or without food.
Usual dose: Ketipinor should generally be administered with an initial dose of 25 mg twice daily, with increases in increments of 25 - 50 mg twice or thrice daily on the 2nd and 3rd day, as tolerated, to a target range of 300 - 400 mg daily by the 4th day, given twice or thrice daily.
Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady state for Ketipinor would not be achieved for approximately 1 - 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 - 50 mg twice daily are recommended.
Antipsychotic efficacy was demonstrated in a dose range of 150 - 750 mg/day. Although it has been reported that doses more than 300 mg/day were not more efficacious than 300 mg/day dose, in some cases, doses in the range of 400 - 500 mg/day appeared to be needed. The safety of doses more than 800 mg/day has not been established.
Maintenance treatment: While the effectiveness of long term use of quetiapine has not been clearly demonstrated, the effectiveness of maintenance treatment is well established for many other antipsychotic drugs. It is recommended that responding patients be continued on Ketipinor at the lowest dose needed to maintain remission. Patients should be periodically reassessed for efficacy and the need for maintenance treatment.
Reinitiation of treatment in patients previous discontinued: It is recommended that when restarting patients who had stopped therapy with Ketipinor for less than 1 week, initiation with Ketipinor is not required and the maintenance dose may be reinitiated. However, for patients who have been off Ketipinor for more than 1 week, the initiation titration schedule should be followed.
Acute Manic Episodes Associated with Bipolar Disorder: As monotherapy or as adjunct therapy to mood stabilizers (lithium or divalproex), total daily dose for the first 4 days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustment up to 800 mg/day by Day 6 should be in increments of no more than 200 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range of 200 - 800 mg/day. The usual effective dose range is 400 - 800 mg/day.
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.
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