Indicated for the treatment of:

Schizophrenia:

• Schizophrenia in adults and adolescents (ages 13-17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials.

Bipolar Disorder:

• Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex, in adult and pediatric patients (ages 10-17 years).

• Monotherapy for the acute treatment of depressive episodes associated with bipolar disorder in adult patients with bipolar I and bipolar II disorder.

• Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex in adult patients. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Seroquel is not approved for the treatment of patients with dementia-related psychosis.

In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects.

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. 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.

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to SEROQUEL, or concerning concomitant administration with antipsychotics.

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.

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.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including SEROQUEL. Rare cases of NMS have been reported with SEROQUEL.

Reported increased blood pressure.

Clinical trials with quetiapine demonstrated dose-related decreases in thyroid hormone levels.

Constipation was a commonly reported adverse event in patients treated with quetiapine and represents a risk factor for intestinal obstruction. Intestinal obstruction has been reported with quetiapine, including fatal reports in patients who were receiving multiple concomitant medications that decrease intestinal motility.

Like other drugs that antagonize dopamine D2 receptors, SEROQUEL elevates prolactin levels in some patients and the elevation may persist during chronic administration.

Acute withdrawal symptoms, such as insomnia, nausea, and vomiting have been described after abrupt cessation of atypical antipsychotic drugs, including SEROQUEL.

Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia, diabetes mellitus, dyslipidemia, and body weight gain.

Atypical antipsychotic drugs, including SEROQUEL, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment.

SEROQUEL should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions which would predispose patients to hypotension (dehydration, hypovolemia and treatment with antihypertensive medications).

Events of leukopenia/neutropenia have been reported temporally related to atypical antipsychotic agents, including SEROQUEL. Agranulocytosis has been reported. Agranulocytosis (defined as absolute neutrophil count <500/mm³) has been reported with quetiapine, including fatal cases and cases in patients without pre-existing risk factors. Possible risk factors for leukopenia/neutropenia include pre existing low white cell count (WBC) and history of drug induced leukopenia/neutropenia.

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs, including quetiapine. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.

As with other antipsychotics, SEROQUEL should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer’s dementia.

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.

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.

The use of quetiapine should be avoided in combination with other drugs that are known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class III antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone).

SEROQUEL should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects.

SEROQUEL may antagonize the effects of levodopa and dopamine agonists.

There are no adequate and well-controlled studies of SEROQUEL use in pregnant women. Animal studies: embryo-fetal toxicity.

Neonates exposed to antipsychotic drugs (including SEROQUEL), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

SEROQUEL was excreted into human milk.

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• Generalized anxiety disorder, dementia, major depressive disorder, obsessive compulsive disorders and psychotic symptoms in patients with parkinson’s disease. GoToSource

• Aggression in autistic spectrum disorder and other pervasive developmental disorders. GoToSource

• Prevention of refractory migraines. GoToSource

• Symptoms of alzheimer’s disease. GoToSource

• Panic attacks and post‑traumatic stress disorder. GoToSource

• Maintenance treatment of schizophrenia. GoToSource

• Monotherapy for maintenance treatment of bipolar disorder. GoToSource

• Use in patients under 10 years of age. GoToSource

• Tourette syndrome. GoToSource

Obesity and hyperlipidemia (elevated lipid/fat levels in blood). GoToSource

Restless legs syndrome. GoToSource

Akathisia (movement disorder). GoToSource

Constipation, postural hypotension and bone marrow suppression. GoToSource

Liver failure. GoToSource

Discontinuation syndrome. GoToSource

Sleep-related eating disorders and somnambulism (sleep walking). GoToSource

New-onset type 2 diabetes. GoToSource

Hypothyroidism (underactive thyroid). GoToSource

Prolonged QT and sudden cardiac death. GoToSource

Increased risk of death in elderly patients with dementia-related psychosis. GoToSource

Stevens-johnson syndrome, toxic epidermal necrolysis and erythroderma (potentially fatal skin reaction). GoToSource

Neuroleptic malignant syndrome (life-threatening neurological disorder). GoToSource

Rhabdomyolysis (breakdown of muscle fibers). GoToSource

Tardive dyskinesia. GoToSource

Manic episodes. GoToSource

Interaction with general anesthesia causing refractory hypotension. GoToSource

Hypocortisolism (adrenal insufficiency). GoToSource

Ischemic strokes. GoToSource 

Leukopenia (decreased number of white blood cells in blood) and neutropenia (low levels of neutrophils in blood). GoToSource

Development of cataracts. GoToSource

Seizures. GoToSource

Hyperprolactinemia (high levels of prolactin in the blood, a hormone secreted by the pituitary gland). GoToSource

Dysphagia (difficulty swallowing). GoToSource

Drug rash with eosinophilia and systemic symptoms (life-threatening, drug-induced hypersensitivity reaction). GoToSource

Edema (swelling). GoToSource 

Suicidality and suicidal ideation. GoToSource

Lawsuits filed for diabetes, neuroleptic malignant syndrome and tardive dyskinesia.