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Seroquel

Seroquel

INDICATIONS

Schizophrenia

SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies].

Bipolar Disorder

SEROQUEL is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [see Clinical Studies].

SEROQUEL is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies].

SEROQUEL is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies].

Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder

Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.

DOSAGE AND ADMINISTRATION

Important Administration Instructions

SEROQUEL can be taken with or without food.

Recommended Dosing

The recommended initial dose, titration, dose range and maximum SEROQUEL dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies].

Table 1: Recommended Dosing for SEROQUEL

Indication Initial Dose and Titration Recommended Dose Maximum Dose
Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25– 50 mg twice a day, in intervals of not less than 2 days.
150-750 mg/day 750 mg/day
Schizophrenia-Adolescents (13-17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-800 mg/day. Based on response and tolerability, may be administered three times daily.
400-800 mg/day 800 mg/day
Schizophrenia-Maintenance N/A1 400– 800 mg/day 800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400– 800 mg/day 800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day. Based on response and tolerability, may be administered three times daily.
400-600 mg/day 600 mg/day
Bipolar Depression-Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day 300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400-800 mg/day 800 mg/day
1. N/A Not applicable

Maintenance Treatment for Schizophrenia and Bipolar I Disorder

Maintenance TreatmentPatients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies].

Dose Modifications in Elderly Patients

Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY]. When indicated, dose escalation should be performed with caution in these patients.

Elderly patients should be started on SEROQUEL 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.

Dose Modifications in Hepatically Impaired Patients

Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day -50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

Dose Modifications when used with CYP3A4 Inhibitors

SEROQUEL dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of SEROQUEL should be increased by 6 fold [see CLINICAL PHARMACOLOGY and DRUG INTERACTIONS].

Dose Modifications when used with CYP3A4 Inducers

SEROQUEL dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL should be reduced to the original level within 7-14 days [see CLINICAL PHARMACOLOGY and DRUG INTERACTIONS].

Reinitiation of Treatment in Patients Previously Discontinued

Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off SEROQUEL for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.

Switching from Antipsychotics

There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to SEROQUEL, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate SEROQUEL therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.

HOW SUPPLIED

Dosage Forms And Strengths

  • 25 mg tablets are peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '25' on one side and plain on the other side,
  • 50 mg tablets are white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '50' on one side and plain on the other side
  • 100 mg tablets are yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and '100' on one side and plain on the other side
  • 200 mg tablets are white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '200' on one side and plain on the other side
  • 300 mg tablets are white, capsule-shaped, biconvex, film coated tablets, intagliated with 'SEROQUEL' on one side and '300' on the other side
  • 400 mg tablets are yellow, capsule-shaped, biconvex, film coated tablets, intagliated with 'SEROQUEL' on one side and '400' on the other side

Storage And Handling

25 mg Tablets (NDC 0310-0275) peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '25' on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

50 mg Tablets (NDC 0310-0278) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '50' on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

100 mg Tablets (NDC 0310-0271) yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and '100' on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

200 mg Tablets (NDC 0310-0272) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '200' on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

300 mg Tablets (NDC 0310-0274) white, capsule-shaped, biconvex, film coated tablets, intagliated with 'SEROQUEL' on one side and '300' on the other side, are supplied in bottles of 60 tablets, and hospital unit dose packages of 100 tablets.

400 mg Tablets (NDC 0310-0279) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with 'SEROQUEL' on one side and '400' on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP].

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Revised: October 2013

Last reviewed on RxList: 11/8/2013
This monograph has been modified to include the generic and brand name in many instances.

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