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Seroquel XR

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Seroquel XR

Indications
Dosage
How Supplied

INDICATIONS

Schizophrenia

SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR in schizophrenia was established in one 6week 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].

Bipolar Disorder

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].

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].

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].

Adjunctive Treatment of Major Depressive Disorder (MDD)

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].

DOSAGE AND ADMINISTRATION

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].

Schizophrenia

Dose 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]. 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].

Bipolar Disorder

Bipolar 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 Schedule

Day 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 Schedule

Day 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].

Major Depressive Disorder, Adjunctive Therapy with Antidepressants

Dose 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].

Dosing in Special Populations

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 Use In Specific Populations and CLINICAL PHARMACOLOGY]. 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].

Re-initiation of Treatment in Patients Previously Discontinued

Although 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.

Switching Patients from SEROQUEL Tablets to SEROQUEL XR Tablets

Patients 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.

Switching from Antipsychotics

There 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.

HOW SUPPLIED

Dosage Forms And Strengths

50 mg extended-release tablets 150 mg extended-release tablets 200 mg extended-release tablets 300 mg extended-release tablets 400 mg extended-release tablets

Storage And Handling

50 mg Tablets (NDC 0310-0280) peach, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 50” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.

150 mg Tablets (NDC 0310-0281) white, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 150“ on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.

200 mg Tablets (NDC 0310-0282) yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 200” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.

300 mg Tablets (NDC 0310-0283) pale yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 300” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.

400 mg Tablets (NDC 0310-0284) white, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 400” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.

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

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Rev. 5/2011

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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