Seroquel Xr
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Uses
SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR in schizophrenia was established in one 6- week and one maintenance trial in adults with schizophrenia as well by extrapolation from three 6-week trials in adults with schizophrenia treated with SEROQUEL [see Clinical Studies (14.1)].
SEROQUEL XR is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of SEROQUEL XR in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder as well by extrapolation from two 12-week monotherapy and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder treated with SEROQUEL [see Clinical Studies (14.2)].
SEROQUEL XR is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of SEROQUEL XR was established in one 8-week trial in adults with bipolar I or II disorder as well as extrapolation from two 8-week trials in adults with bipolar I or II disorder treated with SEROQUEL [see Clinical Studies (14.2)].
SEROQUEL XR is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with SEROQUEL. The effectiveness of monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].
SEROQUEL XR is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of SEROQUEL XR as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3)].
History
There is currently no drug history available for this drug.
Other Information
SEROQUEL XR (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated.
Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths.
Each 50 mg tablet contains 58 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 173 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate equivalent to 400 mg quetiapine.
Sources
Seroquel Xr Manufacturers
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Physicians Total Care, Inc.
![Seroquel Xr (Quetiapine Fumarate) Tablet, Extended Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Seroquel Xr | Physicians Total Care, Inc.
SEROQUEL XR tablets should be swallowed whole and not split, chewed or crushed.
It is recommended that SEROQUEL XR be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].
2.1 SchizophreniaDose Selection—SEROQUEL XR should be administered once daily, preferably in the evening. The recommended initial dose is 300 mg/day. Patients should be titrated within a dose range of 400 mg/day – 800 mg/day depending on the response and tolerance of the individual patient [see Clinical Studies (14.1)]. Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—A maintenance trial in adult patients with schizophrenia treated with SEROQUEL XR has shown this drug to be effective in delaying time to relapse in patients who were stabilized on SEROQUEL XR at doses of 400 mg/day to 800 mg/day for 16 weeks. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].
2.2 Bipolar DisorderBipolar Mania
Usual Dose for Acute Monotherapy or Adjunct Therapy (with lithium or divalproex)
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL XR should be administered once daily in the evening starting with 300 mg on Day 1 and 600 mg on Day 2. SEROQUEL XR can be adjusted between 400 mg and 800 mg beginning on Day 3 depending on the response and tolerance of the individual patient.
Recommended Dosing ScheduleDay
Day 1
Day 2
Day 3
SEROQUEL XR
300 mg
600 mg
400 mg to 800 mg
Depressive Episodes Associated with Bipolar Disorder
Usual Dose—SEROQUEL XR should be administered once daily in the evening to reach 300 mg/day by Day 4.
Recommended Dosing ScheduleDay
Day 1
Day 2
Day 3
Day 4
SEROQUEL XR
50 mg
100 mg
200 mg
300 mg
Maintenance Treatment for Bipolar I Disorder
Maintenance Treatment—Maintenance of efficacy in bipolar I disorder was demonstrated with SEROQUEL (administered twice daily totaling 400 mg/day to 800 mg/day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Major Depressive Disorder, Adjunctive Therapy with AntidepressantsDose Selection—SEROQUEL XR in a dose range of 150 mg/day to 300 mg/day was demonstrated to be effective as adjunctive therapy to antidepressants. Begin with 50 mg once daily in the evening. On Day 3, the dose can be increased to 150 mg once daily in the evening. There were dose-dependent increases in adverse reactions in the recommended dose range of 150 mg/day to 300 mg/day. Doses above 300 mg/day were not studied [see Clinical Studies (14.3)].
2.4 Dosing in Special PopulationsConsideration 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 Use in Specific Populations (8.5, 8.7) and Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on SEROQUEL XR 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the response and tolerance of the individual patient.
Patients with hepatic impairment should be started on SEROQUEL XR 50 mg/day. The dose can be increased daily in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerance of the patient.
The elimination of quetiapine was enhanced in the presence of phenytoin. Higher maintenance doses of quetiapine may be required when it is coadministered with phenytoin and other enzyme inducers such as carbamazepine and phenobarbital [see Drug Interactions (7.1)].
2.5 Re-initiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting therapy of patients who have been off SEROQUEL XR for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL XR for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.6 Switching Patients from SEROQUEL Tablets to SEROQUEL XR TabletsPatients who are currently being treated with SEROQUEL (immediate release formulation) may be switched to SEROQUEL XR at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients from other antipsychotics to SEROQUEL XR, or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients from depot antipsychotics, if medically appropriate, initiate SEROQUEL XR therapy in place of the next scheduled injection. The need for continuing existing extrapyramidal syndrome medication should be re-evaluated periodically.
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Astrazeneca Pharmaceuticals Lp
Seroquel Xr | Astrazeneca Pharmaceuticals Lp
2.1 Important Administration InstructionsSEROQUEL XR tablets should be swallowed whole and not split, chewed or crushed.
It is recommended that SEROQUEL XR be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].
SEROQUEL XR should be administered once daily, preferably in the evening.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum SEROQUEL XR dose for each approved indication is displayed in Table 1 below. 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 (14.1, 14.2 and 14.3)].
Table 1: Recommended Dosing for SEROQUEL XRIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia- Adults
Day 1: 300 mg/day
Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day
400-800 mg/day
800 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
Day 5: 400 mg/day
400-800 mg/day
800 mg/day
Schizophrenia Maintenance-Monotherapy-Adults
n/a
400-800 mg/day
800 mg/day
Bipolar I Disorder manic or mixed-Acute monotherapy or adjunct to lithium or divalproex-Adults
Day 1: 300 mg/day
Day 2: 600 mg/day
Day 3: between 400 and 800 mg/day
400-800 mg/day
800 mg/day
Bipolar I Disorder, manic -Acute monotherapy -Children and Adolescents (10 to 17 years)
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
Day 5: 400 mg/day
400-600 mg/day
600 mg/day
Bipolar Disorder, Depressive Episodes-Adults
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance- Adjunct to lithium or divalproex-Adults
n/a
400-800 mg/day
800 mg/day
Major Depressive Disorder- Adjunctive Therapy with Antidepressants-Adults
Day 1: 50 mg/day
Day 2: 50 mg/day
Day 3: 150 mg/day
150-300 mg/day
300 mg/day
n/a-not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1, 14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration 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 Use in Specific Populations (8.5, 8.7) and Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on SEROQUEL XR 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.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on SEROQUEL XR 50 mg/day. The dose can be increased daily in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsSEROQUEL XR 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 XR should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersSEROQUEL XR 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 tolerance of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL XR should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough 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 XR for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL XR for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching Patients from SEROQUEL Tablets to SEROQUEL XR TabletsPatients who are currently being treated with SEROQUEL (immediate release formulation) may be switched to SEROQUEL XR at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.
2.9 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients from other antipsychotics to SEROQUEL XR, or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients from depot antipsychotics, if medically appropriate, initiate SEROQUEL XR therapy in place of the next scheduled injection. The need for continuing existing extrapyramidal syndrome medication should be re-evaluated periodically.
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Tya Pharmaceuticals
Seroquel Xr | Tya Pharmaceuticals
2.1 Important Administration InstructionsSEROQUEL XR tablets should be swallowed whole and not split, chewed or crushed.
It is recommended that SEROQUEL XR be taken without food or with a light meal (approximately 300 calories) [see ]. Clinical Pharmacology (12.3)
SEROQUEL XR should be administered once daily, preferably in the evening.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum SEROQUEL XR dose for each approved indication is displayed in Table 1 below. 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 ( , and )]. 14.114.214.3
Table 1: Recommended Dosing for SEROQUEL XRIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia- Adults
Day 1: 300 mg/day
Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day
400-800 mg/day
800 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
Day 5: 400 mg/day
400-800 mg/day
800 mg/day
Schizophrenia Maintenance-Monotherapy-Adults
n/a
400-800 mg/day
800 mg/day
Bipolar I Disorder manic or mixed-Acute monotherapy or adjunct to lithium or divalproex-Adults
Day 1: 300 mg/day
Day 2: 600 mg/day
Day 3: between 400 and 800 mg/day
400-800 mg/day
800 mg/day
Bipolar I Disorder, manic -Acute monotherapy -Children and Adolescents (10 to 17 years)
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
Day 5: 400 mg/day
400-600 mg/day
600 mg/day
Bipolar Disorder, Depressive Episodes-Adults
Day 1: 50 mg/day
Day 2: 100 mg/day
Day 3: 200 mg/day
Day 4: 300 mg/day
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance- Adjunct to lithium or divalproex-Adults
n/a
400-800 mg/day
800 mg/day
Major Depressive Disorder- Adjunctive Therapy with Antidepressants-Adults
Day 1: 50 mg/day
Day 2: 50 mg/day
Day 3: 150 mg/day
150-300 mg/day
300 mg/day
n/a-not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment Maintenance Treatment[see Clinical Studies ( , )]. 14.114.2
2.3 Dose Modifications in Elderly PatientsConsideration 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 When indicated, dose escalation should be performed with caution in these patients. [see Use in Specific Populations ( , ) and ]. 8.58.7Clinical Pharmacology (12)
Elderly patients should be started on SEROQUEL XR 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.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on SEROQUEL XR 50 mg/day. The dose can be increased daily in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsSEROQUEL XR 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 XR should be increased by 6 fold [see Clinical Pharmacology and Drug Interactions )]. (12.3)7.1
2.6 Dose Modifications when used with CYP3A4 InducersSEROQUEL XR 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 tolerance of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL XR should be reduced to the original level within 7-14 days [see Clinical Pharmacology and Drug Interactions ]. (12.3)(7.1)
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough 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 XR for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL XR for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching Patients from SEROQUEL Tablets to SEROQUEL XR TabletsPatients who are currently being treated with SEROQUEL (immediate release formulation) may be switched to SEROQUEL XR at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.
2.9 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients from other antipsychotics to SEROQUEL XR, or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients from depot antipsychotics, if medically appropriate, initiate SEROQUEL XR therapy in place of the next scheduled injection. The need for continuing existing extrapyramidal syndrome medication should be re-evaluated periodically.
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