QUETIAPINE FUMARATE: Package Insert and Label Information

QUETIAPINE FUMARATE- quetiapine fumarate tablet, extended release
REMEDYREPACK INC.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)] . Quetiapine Extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

Suicidal Thoughts and Behavior

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2)] .

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.2)]

Quetiapine Extended-release tablets are not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4)].

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 were 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)].

2.3 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 Use in Specific Populations ( 8.5, 8.7) and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.

Elderly patients should be started on quetiapine extended-release tablets 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 Patients

Patients with hepatic impairment should be started on quetiapine extended-release tablets 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 Inhibitors

Quetiapine Extended-release tablets 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 quetiapine extended-release tablets should be increased by 6-fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].

2.6 Dose Modifications when used with CYP3A4 Inducers

Quetiapine Extended-release tablets 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 to 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 quetiapine extended-release tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].

2.7 Re-initiation 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 quetiapine extended-release tablets for more than one-week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine extended-release tablets for less than one-week, gradual dose escalation may not be required and the maintenance dose may be re-initiated.

2.8 Switching Patients from Quetiapine Tablets to Quetiapine Extended-Release Tablets

Patients who are currently being treated with quetiapine tablets (immediate release formulation) may be switched to quetiapine extended-release tablets at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.

2.9 Switching from Antipsychotics

There are no systematically collected data to specifically address switching patients from other antipsychotics to quetiapine extended-release tablets, 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 quetiapine extended-release tablets 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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