Label: SEROQUEL - quetiapine fumarate tablet, film coated 

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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 07/10

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    Boxed Warning

    WARNING: 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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SEROQUEL (quetiapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

    SUICIDALITY AND ANTIDEPRESSANT DRUGS

    Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL is not approved for use in patients under ten years of age [see Warnings and Precautions (5.2)].

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  • DESCRIPTION

    11 DESCRIPTION

    SEROQUEL ® (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 C 42H 50N 6O 4S 2•C 4H 4O 4 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 is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.

    Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.


    The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.

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  • CLINICAL PHARMACOLOGY

    12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action

    The mechanism of action of SEROQUEL, as with other drugs having efficacy in the treatment of schizophrenia and bipolar disorder, is unknown. However, it has been proposed that the efficacy of SEROQUEL in schizophrenia and its mood stabilizing properties in bipolar depression and mania are mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT2 with similar receptor affinities may explain some of the other effects of SEROQUEL.

    SEROQUEL’s antagonism of histamine H1 receptors may explain the somnolence observed with this drug.


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  • INDICATIONS & USAGE

    1 INDICATIONS AND USAGE

    1.1 Schizophrenia

    SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6–week trial in adolescents (13–17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]

    1.2 Bipolar Disorder

    SEROQUEL is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [see Clinical Studies (14.2)].
    SEROQUEL is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies (14.2)].

     SEROQUEL is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)]

    1.3 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.


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  • CONTRAINDICATIONS

    4 CONTRAINDICATIONS

    None known
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  • ADVERSE REACTIONS

    6 ADVERSE REACTIONS 6.1 Clinical Study Experience

    Adults

    Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

    The information below is derived from a clinical trial database for SEROQUEL consisting of over 4300 patients. This database includes 698 patients exposed to SEROQUEL for the treatment of bipolar depression, 405 patients exposed to SEROQUEL for the treatment of acute bipolar mania (monotherapy and adjunct therapy), 646 patients exposed to SEROQUEL for the maintenance treatment of bipolar I disorder as adjunct therapy, and approximately 2600 patients and/or normal subjects exposed to 1 or more doses of SEROQUEL for the treatment of schizophrenia.

    Of these approximately 4300 subjects, approximately 4000 (2300 in schizophrenia, 405 in acute bipolar mania, 698 in bipolar depression, and 646 for the maintenance treatment of bipolar I disorder) were patients who participated in multiple dose effectiveness trials, and their experience corresponded to approximately 2400 patient-years. The conditions and duration of treatment with SEROQUEL varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

    Adverse reactions during exposure were obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reaction categories.

    In the tables and tabulations that follow, standard COSTART terminology has been used to classify reported adverse reactions for schizophrenia and bipolar mania. MedDRA terminology has been used to classify reported adverse reactions for bipolar depression.

    The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

    Incidence of Adverse Reactions in Short-Term, Placebo-Controlled Trials in Adults

    Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials:

    Schizophrenia: Overall, there was little difference in the incidence of discontinuation due to adverse reactions (4% for SEROQUEL vs. 3% for placebo) in a pool of controlled trials. However, discontinuations due to somnolence (0.8% SEROQUEL vs. 0% placebo) and hypotension (0.4% SEROQUEL vs. 0% placebo) were considered to be drug related [see Warnings and Precautions (5.8 and 5.16)].

    Bipolar Disorder:

    Mania: Overall, discontinuations due to adverse reactions were 5.7% for SEROQUEL vs. 5.1% for placebo in monotherapy and 3.6% for SEROQUEL vs. 5.9% for placebo in adjunct therapy.

    Depression: Overall, discontinuations due to adverse reactions were 12.3% for SEROQUEL 300 mg vs. 19.0% for SEROQUEL 600 mg and 5.2% for placebo.

    Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials:

    In the acute therapy of schizophrenia (up to 6 weeks) and bipolar mania (up to 12 weeks) trials, the most commonly observed adverse reactions associated with the use of SEROQUEL monotherapy (incidence of 5% or greater) and observed at a rate on SEROQUEL at least twice that of placebo were somnolence (18%), dizziness (11%), dry mouth (9%), constipation (8%), ALT increased (5%), weight gain (5%), and dyspepsia (5%).

    Adverse Reactions Occurring at an Incidence of 1% or More Among SEROQUEL Treated Patients in Short-Term, Placebo-Controlled Trials:

    The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.

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  • OVERDOSAGE

    10 OVERDOSAGE

    10.1 Human Experience

    In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed experienced no adverse reactions or recovered fully from the reported reactions. Death has been reported in a clinical trial following an overdose of 13.6 grams of quetiapine alone. In general, reported signs and symptoms were those resulting from an exaggeration of the drugs known pharmacological effects, ie, drowsiness and sedation, tachycardia and hypotension. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose [seeWarnings and Precautions (5)]. One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first degree heart block. In post-marketing experience, there were cases reported of QT prolongation with overdose. There were also very rare reports of overdose of SEROQUEL alone resulting in death or coma.

    10.2 Management of Overdosage

    In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizure or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with acute overdosage of SEROQUEL. Similarly it is reasonable to expect that the alpha-adrenergic-blocking properties of bretylium might be additive to those of quetiapine, resulting in problematic hypotension.

    There is no specific antidote to SEROQUEL. Therefore, appropriate supportive measures should be instituted. The possibility of multiple drug involvement should be considered. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.


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  • DOSAGE & ADMINISTRATION

    2 DOSAGE AND ADMINISTRATION

    SEROQUEL can be taken with or without food.

    2.1 Schizophrenia

    Adults

    Dose Selection— SEROQUEL should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg - 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for SEROQUEL would not be achieved for approximately 1-2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg - 50 mg divided twice daily are recommended. Most efficacy data with SEROQUEL were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.

    Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of SEROQUEL. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day - 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

    Maintenance Treatment—The effectiveness of SEROQUEL for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with SEROQUEL should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

    Adolescents (13-17 years)

     Dose Selection—SEROQUEL should be administered twice daily. However, based on response and tolerability SEROQUEL may be administered three times daily where needed.

     The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the dose should be adjusted within the recommended dose range of 400 mg/day to 800 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day. Efficacy was demonstrated with SEROQUEL at both 400 mg and 800 mg; however, no additional benefit was seen in the 800 mg group.

    Maintenance Treatment—The effectiveness of SEROQUEL for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with SEROQUEL should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

    2.2 Bipolar Disorder

    Adults

    Acute Treatment of Manic Episodes in Bipolar I Disorder

    Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

    Acute Treatment of Depressive Episodes in Bipolar Disorder

    Dose Selection—SEROQUEL should be administered once daily at bedtime to reach 300 mg/day by Day 4.

    Recommended Dosing Schedule
    Day Day 1 Day 2 Day 3 Day 4

    SEROQUEL

    50 mg

    100 mg

    200 mg

    300 mg

    In these clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with SEROQUEL at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.

    Maintenance Treatment of Bipolar I Disorder

    Maintenance of efficacy in bipolar I disorder was demonstrated with SEROQUEL (administered twice daily totaling 400 to 800 mg per 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 [see Clinical Studies (14.2)].

     Children and Adolescents (10 to 17 years)

     Acute Treatment of Manic Episodes in Bipolar I Disorder

     

    Dose Selection—SEROQUEL should be administered twice daily. However, based on response and tolerability SEROQUEL may be administered three times daily where needed.

     The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the dose should be adjusted within the recommended dose range of 400 to 600 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day. Efficacy was demonstrated with SEROQUEL at both 400 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.

     Maintenance Treatment of Bipolar I Disorder

     The effectiveness of SEROQUEL for longer than 3 weeks has not been evaluated in controlled clinical trials of children and adolescents. While there is no body of evidence available to answer the question of how long the patient treated with SEROQUEL should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

    2.3 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 Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.

    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.

    2.4 Reinitiation of Treatment in Patients Previously Discontinued

    Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off SEROQUEL, titration of SEROQUEL is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off SEROQUEL for more than one week, the initial titration schedule should be followed.

    2.5 Switching from Antipsychotics

    There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to SEROQUEL, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate SEROQUEL therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.

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  • HOW SUPPLIED

    16 HOW SUPPLIED/STORAGE AND HANDLING

    25 mg Tablets (NDC 0310-0275) peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘25’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets.

    50 mg Tablets (NDC 0310-0278) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘50’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets.

    100 mg Tablets (NDC 0310-0271) yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and ‘100’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

    200 mg Tablets (NDC 0310-0272) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

    300 mg Tablets (NDC 0310-0274) white, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘300’ on the other side, are supplied in bottles of 60 tablets, and hospital unit dose packages of 100 tablets.

    400 mg Tablets (NDC 0310-0279) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘400’ on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets.

    Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].


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  • MEDICATION GUIDE

    SPL MEDGUIDE SECTION

    Medication Guide

    SEROQUEL (SER-oh-kwell)

    (quetiapine fumarate)

    Tablets

    Read this Medication Guide before you start taking SEROQUEL and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

    What is the most important information I should know about SEROQUEL?

    Serious side effects may happen when you take SEROQUEL, including

    • Risk of death in the elderly with dementia: Medicines like SEROQUEL can raise the risk of death in elderly people who have lost touch with reality due to confusion and memory loss (dementia). SEROQUEL is not approved for treating psychosis in the elderly with dementia.

    • Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

      1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

      2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.

      3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

        • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

        • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

        • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

    • thoughts about suicide or dying

    • attempts to commit suicide

    • new or worse depression

    • new or worse anxiety

    • feeling very agitated or restless

    • panic attacks

    • trouble sleeping (insomnia)

    • new or worse irritability

    • acting aggressive, being angry, or violent

    • acting on dangerous impulses

    • an extreme increase in activity and talking (mania)

    • other unusual changes in behavior or mood

    What else do I need to know about antidepressant medicines?

    • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

    • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

    • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

    • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

    • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

    What is SEROQUEL?

    • SEROQUEL is a prescription medicine used to treat schizophrenia in people age 13 or older.

    • SEROQUEL is a prescription medicine used to treat bipolar disorder, including:

      • depressive episodes associated with bipolar disorder in adults

      • manic episodes associated with bipolar I disorder alone or with lithium or divalproex in adults

      • long-term treatment of bipolar I disorder with lithium or divalproex in adults

    • SEROQUEL is used to treat manic episodes associated with bipolar I disorder in children ages 10 to 17 years.

    SEROQUEL has not been studied in patients younger than 10 years of age.

    What should I tell my healthcare provider before taking SEROQUEL?

    Before taking SEROQUEL, tell your healthcare provider if you have or have had:

    • diabetes or high blood sugar in you or your family: your healthcare provider should check your blood sugar before you start SEROQUEL and also during therapy

    • high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL- cholesterol

    • low or high blood pressure

    • low white blood cell count

    • cataracts

    • seizures

    • abnormal thyroid tests

    • high prolactin levels

    • heart problems

    • liver problems

    • any other medical condition

    • pregnancy or plans to become pregnant. It is not known if SEROQUEL will harm your unborn baby

    • breast-feeding or plans to breast-feed. It is not known if SEROQUEL will pass into your breast milk. You and your healthcare provider should decide if you will take SEROQUEL or breast-feed. You should not do both.

    Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, non-prescription medicines, herbal supplements and vitamins.

    SEROQUEL and other medicines may affect each other causing serious side effects. SEROQUEL may affect the way other medicines work, and other medicines may affect how SEROQUEL works.

    Especially tell your healthcare provider if you take or plan to take medicines for:

    • depression

    • high blood pressure

    • Parkinson’s disease

    • trouble sleeping

    Also tell your healthcare provider if you take or plan to take any of these medicines:

    • phenytoin, divalproex or carbamazepine (for epilepsy)

    • barbiturates (to help you sleep)

    • rifampin (for tuberculosis)

    • glucocorticoids (steroids for inflammation)

    • thioridazine (an antipsychotic)

    • ketoconazole, fluconazole or itraconazole (for fungal infections)

    • erythromycin (an antibiotic)

    • protease inhibitors (for HIV)

    This is not a complete list of medicines that can affect or be affected by SEROQUEL. Your doctor can tell you if it is safe to take SEROQUEL with your other medicines. Do not start or stop any medicines while taking SEROQUEL without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

    Tell your healthcare provider if you are having a urine drug screen because SEROQUEL may affect your test results. Tell those giving the test that you are taking SEROQUEL.

    How should I take SEROQUEL?

    • Take SEROQUEL exactly as your healthcare provider tells you to take it. Do not change the dose yourself.

    • Take SEROQUEL by mouth, with or without food.

    • If you feel you need to stop SEROQUEL, talk with your healthcare provider first.

    If you suddenly stop taking SEROQUEL, you may experience side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.

    • If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.

    • If you take too much SEROQUEL, call your healthcare provider or poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

    What should I avoid while taking SEROQUEL?

    Do not drive, operate machinery, or do other dangerous activities until you know how SEROQUEL affects you. SEROQUEL may make you drowsy.

    • Avoid getting over-heated or dehydrated.

      • Do not over-exercise.

      • In hot weather, stay inside in a cool place if possible.

      • Stay out of the sun. Do not wear too much or heavy clothing.

      • Drink plenty of water.

    • Do not drink alcohol while taking SEROQUEL. It may make some side effects of SEROQUEL worse.

    What are possible side effects of SEROQUEL?

    Serious side effects have been reported with SEROQUEL including:

    Also, see “What is the most important information I should know about SEROQUEL?” at the beginning of this Medication Guide

    • Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Stop SEROQUEL and call your healthcare provider right away.

    • High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take SEROQUEL. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start SEROQUEL and during therapy.

    Call your healthcare provider if you have any of these symptoms of high blood sugar while taking SEROQUEL:

    • feel very thirsty

    • need to urinate more than usual

    • feel very hungry

    • feel weak or tired

    • feel sick to your stomach

    • feel confused, or your breath smells fruity

    • High cholesterol and triglyceride levels in the blood (fat in the blood): Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported in clinical trials with SEROQUEL. You may not have any symptoms, so your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking SEROQUEL and during therapy.

    • Increase in weight (weight gain): Weight gain has been seen in patients who take SEROQUEL so you and your healthcare provider should check your weight regularly.

    • Tardive dyskinesia: Tell your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking SEROQUEL. Tardive dyskinesia may also start after you stop taking SEROQUEL.

    • Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.

    • Increases in blood pressure: reported in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before starting SEROQUEL and during therapy.

    • Low white blood cell count

    • Cataracts

    • Seizures

    • Abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.

    • Increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.

    • Increases in liver enzymes: Your healthcare provider may do blood tests to check your liver enzyme levels.

    • Long lasting and painful erection

    • Difficulty swallowing

    Common possible side effects with SEROQUEL include:

    Adults:

    • drowsiness

    • dry mouth

    • dizziness

    • weakness

    • weight gain

    • abdominal pain

    • constipation

    • sore throat

    • sluggishness

    • upset stomach

    • weight gain

    • a sudden drop in blood pressure upon standing

    • adnormal liver tests

    Children and Adolescents:

    • drowsiness

    • fatigue

    • nausea

    • dry mouth

    • weight gain

    • dizziness

    • increased appetite

    • vomiting

    • rapid heart rate

    These are not all the possible side effects of SEROQUEL. For more information, ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store SEROQUEL?

    • Store SEROQUEL at room temperature, between 59°F to 86°F (15°C to 30°C).

    • Keep SEROQUEL and all medicines out of the reach of children.

    General information about SEROQUEL

    Do not take SEROQUEL unless your healthcare provider has prescribed it for you for your condition. Do not share SEROQUEL with other people, even if they have the same condition. It may harm them.

    This Medication Guide provides a summary of important information about SEROQUEL. For more information about SEROQUEL, talk with your healthcare provider or pharmacist or call 1-800-236-9933. You can ask your healthcare provider for information about SEROQUEL that is written for health professionals.

    What are the ingredients in SEROQUEL

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  • PRINCIPAL DISPLAY PANEL

    image of labelimage of label

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  • INGREDIENTS AND APPEARANCE
    SEROQUEL 
    quetiapine fumarate tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49999-951(NDC:0310-0272)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    HYPROMELLOSE  
    POLYETHYLENE GLYCOL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape ROUND (biconvex) Size 11mm
    Flavor Imprint Code SEROQUEL;200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49999-951-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020639 07/08/2010
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    Name Address ID/FEI Business Operations
    Astrazeneca Pharmaceuticals LP 054743190 repack
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