Qutero

Qutero Dosage/Direction for Use

quetiapine

Manufacturer:

Hetero Labs

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
Schizophrenia: Adults: Quetiapine should be administered twice daily, with or without food. Quetiapine should generally be administered with an initial dose of 25 mg bid, with increases in increments of 25-50 mg bid or tid on the second and third day, as tolerated, to a target dose range of 300 to 400 mg daily by the fourth day, given bid or tid. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady state for quetiapine would not be achieved for approximately 1-2 days. When dosage adjustments are necessary, dose increments/decrements of 25-50 mg bid are recommended.
Antipsychotic efficacy was demonstrated in a dose range of 150 to 750 mg/day. The safety and efficacy doses above 800 mg/day have not been evaluated.
Adolescents (13-17 years): Quetiapine should be administered twice daily. However, Quetiapine may be administered three times daily where needed. The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After day 5, the dose should be adjusted within the recommended dose range of 400 mg/day to 800 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day.
Maintenance Treatment: It is recommended that responding patients be continued on Quetiapine, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Re-initiation of Treatment in Patients Previously Discontinued: When restarting therapy of patients who have been off quetiapine for more than one week, the initial titration schedule should be followed.
Acute manic episodes associated with bipolar I disorder: Adults: Quetiapine should be administered twice daily, with or without food. As monotherapy or as adjunct therapy to mood stabilizers (lithium or divalproex), 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 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.
Children and Adolescents (10 to 17 years): Quetiapine should be administered twice daily. However, based on response and tolerability quetiapine may be administered three times daily where needed. The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After day 5, the dose should be adjusted within the recommended dose range of 400 to 600 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day.
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.
Maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex: Adults: Maintenance of efficacy in Bipolar I Disorder was demonstrated with quetiapine (administered twice daily totalling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, continued on the same dose on which they were stabilized during the stabilization phase.
Children and Adolescents (10 to 17 years): While there is no body of evidence available to answer the question of how long the patient treated with quetiapine should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Preventing recurrence in bipolar disorder: For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at the same dose. The dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 300 to 800 mg/day administered twice daily. It is important that the lowest effective dose is used for maintenance therapy.
Elderly: As with other antipsychotics, quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient.
Pediatric Use: Schizophrenia: Safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established.
Maintenance: The safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age.
The safety and effectiveness of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients.
Bipolar Mania: The efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with Bipolar I disorder was demonstrated.
Safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established.
Bipolar Depression: Safety and effectiveness of quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established.
Renal impairment: Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment: Quetiapine is extensively metabolised by the liver. Therefore, quetiapine should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with known hepatic impairment should be started with 25 mg/day. The dosage should be increased daily with increments of 25 - 50 mg/day until an effective dosage, depending on the clinical response and tolerability of the individual patient.
Mode of administration: Oral route of administration.
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