Quetiapine Extended Release

QUETIAPINE EXTENDED RELEASE- quetiapine fumarate tablet, film coated, extended release
ScieGen Pharmaceuticals, Inc

1 INDICATIONS AND USAGE

1.1 Schizophrenia

Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see Clinical Studies (14.1)].

1.2 Bipolar Disorder

Quetiapine extended-release tablets are 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 quetiapine extended-release tablets 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. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 to 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine tablets [see Clinical Studies (14.2)].

Quetiapine extended-release tablets are indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of quetiapine extended-release tablets was established in one 8-week trial in adults with bipolar I or II disorder and supported by two 8-week trials in adults with bipolar I or II disorder treated with quetiapine tablets [see Clinical Studies (14.2)].

Quetiapine extended-release tablets are 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 quetiapine tablets. The effectiveness of monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].

1.3 Adjunctive Treatment of Major Depressive Disorder (MDD)

Quetiapine extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine extended-release tablets 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)].

1.4 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Quetiapine extended-release tablets should be swallowed whole and not split, chewed or crushed.

It is recommended that quetiapine extended-release tablets be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].

Quetiapine extended-release tablets should be administered once daily, preferably in the evening.

2.2 Recommended Dosing

The recommended initial dose, titration, dose range and maximum quetiapine extended-release tablets 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 quetiapine extended-release tablets

Indication	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 to 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 to 800 mg/day	800 mg/day
Schizophrenia Maintenance-Monotherapy-Adults	Not applicable	400 to 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 to 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 to 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	Not applicable	400 to 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 to 300 mg/day	300 mg/day

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)].