Seroquel
Quetiapine · Tablet, Film Coated · Oral
Uses
1 INDICATIONS AND USAGE SEROQUEL XR is an atypical antipsychotic indicated for the treatment of:
• Schizophrenia (1.1)
• Bipolar I disorder, manic, or mixed episodes (1.2)
• Bipolar disorder, depressive episodes (1.2)
• Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR 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 (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1) ]. 1.2 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. 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 - 17 years) with manic episodes associated with bipolar I disorder treated with SEROQUEL [see Clinical Studies (14.2) ]. 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 and supported by two 8-week trials in adults with bipolar I or II disorder treated with SEROQUEL [see Clinical Studies (14.2) ]. 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 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) 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 (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.
Dosage and administration
• Swallow tablets whole and do not split, chew or crush (2.1)
• Take without food or with a light meal (approx. 300 calories) (2.1)
• Administer once daily, preferably in the evening (2.1)
• Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration, and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 )
• Hepatic Impairment: Lower starting dose (50 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia - Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Schizophrenia - Adolescents (13 to 17 years) (2.2) 50 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder manic or mixed - Acute monotherapy or adjunct to lithium or divalproex - Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder, manic Acute monotherapy - Children and Adolescents (10 to 17 years) (2.2) 50 mg/day 400-600 mg/day 600 mg/day Bipolar Disorder, Depressive Episodes - Adults (2.2) 50 mg/day 300 mg/day 300 mg/day Major Depressive Disorder, Adjunctive Therapy with Antidepressants - Adults (2.2) 50 mg/day 150-300 mg/day 300 mg/day 2.1 Important Administration Instructions 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 (12.3) ]. SEROQUEL XR should be administered once daily, preferably in the evening. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum SEROQUEL XR 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 SEROQUEL XR 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 400-800 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 400-800 mg/day 800 mg/day Schizophrenia Maintenance - Monotherapy - Adults Not applicable 400-800 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 400-800 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 400-600 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 400-800 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 150-300 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 SEROQUEL XR 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 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 tolerability of the patient. 2.5 Dose Modifications when used with CYP3A4 Inhibitors SEROQUEL XR 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 XR 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 SEROQUEL XR 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 tolerance of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL XR should be reduced to the original level within 7-14 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 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 re-initiated.
Dosage forms and strengths
• 50 mg extended-release tablets are peach, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 50” on one side and plain on the other side
• 150 mg extended-release tablets are white, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 150” on one side and plain on the other side
• 200 mg extended-release tablets are yellow, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 200” on one side and plain on the other side
• 300 mg extended-release tablets are pale yellow, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 300” on one side and plain on the other side
• 400 mg extended-release tablets are white, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 400” on one side and plain on the other side Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg (3)
Contraindications
Hypersensitivity to quetiapine or to any excipients in the SEROQUEL XR formulation. Anaphylactic reactions have been reported in patients treated with SEROQUEL XR. Known hypersensitivity to SEROQUEL XR or any components in the formulation. (4)
Warnings and precautions
• Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3)
• Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring (5.4)
• Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5) ∘ Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes ∘ Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment ∘ Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended
• Tardive Dyskinesia: Discontinue if clinically appropriate (5.6)
• Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7)
• Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.9)
• Leukopenia, Neutropenia, and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue SEROQUEL XR at the first sign of a decline in WBC in absence of other causative factors (5.10)
• 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 (5.11)
• Anticholinergic (antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, or constipation (5.20) 5.1 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. Analysis of 17 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 XR is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning ]. 5.2 Suicidal Thoughts and Behaviors in Adolescents and Young Adults 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. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 2.
Side effects
The following adverse reactions are discussed in more detail in other sections of the labeling:
• Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]
• Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ]
• Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3) ]
• Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ]
• Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5) ]
• Tardive dyskinesia [see Warnings and Precautions (5.6) ]
• Hypotension [see Warnings and Precautions (5.7) ]
• Falls [see Warnings and Precautions (5.8) ]
• Increases in blood pressure (children and adolescents) [see Warnings and Precautions (5.9) ]
• Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions (5.10) ]
• Cataracts [see Warnings and Precautions (5.11) ]
• QT Prolongation [see Warnings and Precautions (5.12) ]
• Seizures [see Warnings and Precautions (5.13) ]
• Hypothyroidism [see Warnings and Precautions (5.14) ]
• Hyperprolactinemia [see Warnings and Precautions (5.15) ]
• Potential for cognitive and motor impairment [see Warnings and Precautions (5.16) ]
• Body temperature regulation [see Warnings and Precautions (5.17) ]
• Dysphagia [see Warnings and Precautions (5.18) ]
• Discontinuation Syndrome [see Warnings and Precautions (5.19) ]
• Anticholinergic (antimuscarinic) Effects [see Warnings and Precautions, (5.20) ] Most common adverse reactions (incidence ≥5% and twice placebo): Adults: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion (6.1) Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1) To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma at 1-888-864-2308 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults The information below is derived from a clinical trial database for SEROQUEL XR consisting of approximately 3400 patients exposed to SEROQUEL XR for the treatment of Schizophrenia, Bipolar Disorder, and Major Depressive Disorder in placebo-controlled trials. This experience corresponds to approximately 1020.1 patient-years. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, body weights, laboratory analyses, and ECG results. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, an adverse reaction of the type listed. Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials: Schizophrenia: There were no adverse reactions leading to discontinuation that occurred at an incidence of ≥2% for SEROQUEL XR in schizophrenia trials. Bipolar I Disorder, Manic or Mixed Episodes: There were no adverse reactions leading to discontinuation that occurred at an incidence of ≥2% for SEROQUEL XR in the bipolar mania trial. Bipolar Disorder, Depressive Episode: In a single clinical trial in patients with bipolar depression, 14% (19/137) of patients on SEROQUEL XR discontinued due to an adverse reaction compared to 4% (5/140) on placebo. Somnolence 2 was the only adverse reaction leading to discontinuation that occurred at an incidence of ≥2% in SEROQUEL XR in the bipolar depression trial. MDD, Adjunctive Therapy: In adjunctive therapy clinical trials in patients with MDD, 12.1% (76/627) of patients on SEROQUEL XR discontinued due to adverse reaction compared to 1.9% (6/309) on placebo. Somnolence 2 was the only adverse reaction leading to discontinuation that occurred at an incidence of ≥2% in SEROQUEL XR in MDD trials. ______________ 2 Somnolence combines adverse reaction terms somnolence and sedation. Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials: In short-term placebo-controlled studies for schizophrenia the most commonly observed adverse reactions associated with the use of SEROQUEL XR (incidence of 5% or greater) and observed at a rate on SEROQUEL XR at least twice that of placebo were somnolence (25%), dry mouth (12%), dizziness (10%), and dyspepsia (5%). Adverse Reactions Occurring at an Incidence of 2% or More Among SEROQUEL XR Treated Patients in Short-Term, Placebo-Controlled Trials. Table 12 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy of schizophrenia (up to 6 weeks) in 2% or more in patients treated with SEROQUEL XR (doses ranging from 300 to 800 mg/day) where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients. Table 12: Adverse Reactions in 6-Week Placebo-Controlled Clinical Trials for the Treatment of Schizophrenia Preferred Term SEROQUEL XR (N=951) Placebo (N=319) Somnolence Somnolence combines adverse reaction terms somnolence and sedation. 25% 10% Dry Mouth 12% 1% Dizziness 10% 4% Extrapyramidal Symptoms Extrapyramidal symptoms include the terms: cogwheel rigidity, drooling, dyskinesia dystonia, extrapyramidal disorder, hypertonia, movement disorder, muscle rigidity, parkinsonism, parkinsonian gait, and tardive dyskinesia.
Drug interactions
• Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one‑sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 )
• Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) ( 2.6 , 7.1 , 12.3 )
• Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5‑fold within 7-14 days of discontinuation of CYP3A4 inducers ( 2.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on Quetiapine The risks of using SEROQUEL XR in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of SEROQUEL XR, caution should be used when it is taken in combination with other centrally acting drugs. Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype of CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). Dose adjustment of quetiapine will be necessary if it is co-administered with potent CYP3A4 inducers or inhibitors. CYP3A4 inhibitors: Coadministration of ketoconazole, a potent inhibitor of cytochrome CYP3A4, resulted in significant increase in quetiapine exposure. The dose should be reduced to one‑sixth of the original dose in patients coadministered with a strong CYP3A4 inhibitor [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. CYP3A4 inducers: Coadministration of quetiapine and phenytoin, a CYP3A4 inducer increased the mean oral clearance of quetiapine by 5-fold. Increased doses of SEROQUEL XR up to 5-fold may be required to maintain control of symptoms of schizophrenia in patients receiving quetiapine and phenytoin, or other known potent CYP3A4 inducers [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) ]. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL XR should be reduced to the original level within 7-14 days [see Dosage and Administration (2.6) ]. Anticholinergic Drugs: Concomitant treatment with quetiapine and other drugs with anticholinergic activity can increase the risk for severe gastrointestinal adverse reactions related to hypomotility. SEROQUEL should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects [see Warnings and Precautions (5.20) ] . The potential effects of several concomitant medications on quetiapine pharmacokinetics were studied [see Clinical Pharmacology (12.3) ] . 7.2 Effect of Quetiapine on Other Drugs Because of its potential for inducing hypotension, SEROQUEL XR may enhance the effects of certain antihypertensive agents. SEROQUEL XR may antagonize the effects of levodopa and dopamine agonists. There are no clinically relevant pharmacokinetic interactions of Seroquel on other drugs based on the CYP pathway. Seroquel and its metabolites are non-inhibitors of major metabolizing CYP’s (1A2, 2C9, 2C19, 2D6, and 3A4).
Use in specific populations
• Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including SEROQUEL XR, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ Risk Summary Neonates exposed to antipsychotic drugs, including SEROQUEL XR, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ) . Overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to antipsychotics, including, SEROQUEL XR during pregnancy (see Clinical Considerations ) . In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or fetal risk There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including SEROQUEL XR, during the third trimester of pregnancy. These symptoms varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. Doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the MRHD, for schizophrenia of 800 mg/day based on mg/m 2 body surface area. However, there was evidence of embryo-fetal toxicity, including delays in skeletal ossification at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and at approximately 1-2 times the MRHD (all doses tested) in rabbits. In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD. 8.2 Lactation Risk Summary Limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. There are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. There is no information on the effects of quetiapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SEROQUEL XR and any potential adverse effects on the breastfed child from SEROQUEL XR or from the mother’s underlying condition.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including SEROQUEL XR, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ Risk Summary Neonates exposed to antipsychotic drugs, including SEROQUEL XR, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ) . Overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to antipsychotics, including, SEROQUEL XR during pregnancy (see Clinical Considerations ) . In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or fetal risk There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including SEROQUEL XR, during the third trimester of pregnancy. These symptoms varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. Doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the MRHD, for schizophrenia of 800 mg/day based on mg/m 2 body surface area. However, there was evidence of embryo-fetal toxicity, including delays in skeletal ossification at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and at approximately 1-2 times the MRHD (all doses tested) in rabbits. In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD.
Pediatric use
8.4 Pediatric Use Safety and effectiveness of SEROQUEL XR is supported by studies of SEROQUEL for schizophrenia in adolescent patients 13 - 17 years of age and in bipolar mania in children and adolescent patients 10 - 17 years of age [see Clinical Studies ( 14.1 and 14.2 )]. In general, the adverse reactions observed in children and adolescents during the clinical trials with SEROQUEL were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. Orthostatic hypotension occurred more frequently in adults (4-7%) compared to children and adolescents (<1%) [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ]. Bipolar Depression The effectiveness of SEROQUEL XR for the treatment of bipolar depression in patients under the age of 18 years has not been established. One 8-week trial was conducted to evaluate the safety and efficacy of SEROQUEL XR in the treatment of bipolar depression in pediatric patients 10 - 17 years of age. The primary objective of the study was to evaluate whether SEROQUEL XR at a dose of 150 to 300 mg/day demonstrated superior efficacy (as measured by change in CDRS-R total score from baseline to end of 8 weeks) compared to placebo in children and adolescents 10 - 17 years of age with bipolar depression. A total of 193 patients with bipolar depression were randomized to placebo or SEROQUEL XR. The primary results of this study did not show a difference between SEROQUEL XR and placebo in decreasing depression symptoms in children and adolescents with bipolar disorder. In this study, patients treated with SEROQUEL XR exhibited metabolic changes, weight gain, increases in blood pressure and increases in heart rate [see Warnings and Precautions ( 5.5 , 5.9 ) and Adverse Reactions (6.1) ]. Some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 - 17 years of age) and adults. When adjusted for weight, the AUC and C max of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. The pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see Clinical Pharmacology (12.3) ]. Schizophrenia The efficacy and safety of SEROQUEL XR in the treatment of schizophrenia in adolescents aged 13 - 17 years is supported by one 6-week, double-blind, placebo-controlled trial with SEROQUEL [see Indications and Usage (1.1) , Dosage and Administration (2.2) , Adverse Reactions (6.1) , and Clinical Studies (14.1) ]. Safety and effectiveness of SEROQUEL XR in pediatric patients less than 13 years of age with schizophrenia have not been established. The safety and effectiveness of SEROQUEL XR in the maintenance treatment of schizophrenia has not been established in patients less than 18 years of age. Bipolar Mania The efficacy and safety of SEROQUEL XR in the treatment of bipolar mania in children and adolescents ages 10-17 years is supported by one 3-week, double-blind, placebo‑controlled trial with SEROQUEL [see Indications and Usage (1.2) , Dosage and Administration (2.2) , Adverse Reactions (6.1) , and Clinical Studies (14.2) ]. Safety and effectiveness of SEROQUEL XR in pediatric patients less than 10 years of age with bipolar mania have not been established. The safety and effectiveness of SEROQUEL XR in the maintenance treatment of bipolar disorder has not been established in patients less than 18 years of age.
Geriatric use
8.5 Geriatric Use Sixty-eight patients in clinical studies with SEROQUEL XR were 65 years of age or over. In general, there was no indication of any different tolerability of SEROQUEL XR in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to SEROQUEL XR, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ].
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 events. 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 drug’s known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and anticholinergic toxicity including coma and delirium. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose [see Warnings and Precautions (5.12) ]. 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. 10.2 Management of Overdosage Establish and maintain an airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. Appropriate supportive measures are the mainstay of management. For the most up-to-date information on the management of Seroquel XR overdosage, contact a certified Regional Poison Control Center (1-800-222-1222). SEROQUEL XR overdose may lead to gastric bezoar formation and appropriate diagnostic imaging is recommended to further guide patient management. Routine gastric lavage may not be effective in the removal of the bezoar due to gum like sticky consistency of the mass. Endoscopic pharmacobezoar removal has been performed successfully.
Description
(quetiapine) is an atypical antipsychotic 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 42 H 50 N 6 O 4 S 2
• C 4 H 4 O 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 XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. structural formula
Mechanism of action
12.1 Mechanism of Action The mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2A (5HT 2A ) antagonism. The active metabolite, N-desalkyl quetiapine (norquetiapine), has similar activity at D 2 , but greater activity at 5HT 2A receptors, than the parent drug (quetiapine).
How supplied
• 50 mg Tablets (NDC 61269-270-60) 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.
• 150 mg Tablets (NDC 61269-271-60) 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.
• 200 mg Tablets (NDC 61269-272-60) 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.
• 300 mg Tablets (NDC 61269-273-60) 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.
• 400 mg Tablets (NDC 61269-274-60) 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. Store SEROQUEL XR at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SEROQUEL XR. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. SEROQUEL XR is not approved for elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.2) ]. Neuroleptic Malignant Syndrome (NMS) Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see Warnings and Precautions (5.4) ]. Hyperglycemia and Diabetes Mellitus Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5) ]. Hyperlipidemia Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5) ]. Weight Gain Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5) ]. Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls) especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions (5.7) ]. Increased Blood Pressure in Children and Adolescents Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment [see Warnings and Precautions (5.9) ]. Leukopenia/Neutropenia Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking SEROQUEL XR. Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require SEROQUEL XR to be stopped and/or treatment to be given [see Warnings and Precautions (5.10) ]. Interference with Cognitive and Motor Performance Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely [see Warnings and Precautions (5.16) ]. Heat Exposure and Dehydration Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.17) ]. Concomitant Medication As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs [see Drug Interactions (7.1) ]. Pregnancy Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with SEROQUEL XR. Advise patients that SEROQUEL XR may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SEROQUEL XR during pregnancy [see Use in Specific Populations (8.1 ) ] . Infertility Advise females of reproductive potential that SEROQUEL XR may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3) ] . Need for Comprehensive Treatment Program SEROQUEL XR is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of SEROQUEL XR have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful.
Label text from the FDA structured product label by H2-Pharma, LLC (revised Apr 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Quetiapine Fumarate in 21 products
Seroquel NDC products (21)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0310-0272 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0274 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0275 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0278 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0279 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0281 | Quetiapine Fumarate 150 mg/1 Tablet, Extended Release | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0282 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0283 | Quetiapine Fumarate 300 mg/1 Tablet, Extended Release | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0284 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | AstraZeneca Pharmaceuticals LP | NDA |
| 0310-0271 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | AstraZeneca Pharmaceuticals LP | NDA |
| 61269-274 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | H2-Pharma, LLC | NDA |
| 61269-273 | Quetiapine Fumarate 300 mg/1 Tablet, Extended Release | H2-Pharma, LLC | NDA |
| 61269-272 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | H2-Pharma, LLC | NDA |
| 61269-271 | Quetiapine Fumarate 150 mg/1 Tablet, Extended Release | H2-Pharma, LLC | NDA |
| 61269-270 | Quetiapine Fumarate 50 mg/1 Tablet, Extended Release | H2-Pharma, LLC | NDA |
| 61269-255 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
| 61269-254 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
| 61269-253 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
| 61269-252 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
| 61269-251 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
| 61269-250 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | H2-Pharma, LLC | NDA |
Frequently asked questions
What is Seroquel used for?
1 INDICATIONS AND USAGE SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: • Schizophrenia (1.1) • Bipolar I disorder, manic, or mixed episodes (1.2) • Bipolar disorder, depressive episodes (1.2) • Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR…
What are the side effects of Seroquel?
The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] • Cerebrovascular adverse reactions, including stroke in elderly patients with… See the full label for the complete list.
Who makes Seroquel?
Seroquel is listed by 2 labelers in the FDA NDC directory, including AstraZeneca Pharmaceuticals LP, H2-Pharma, LLC.