Quetiapine 400 mg Tablet, Extended Release, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Atypical Antipsychotic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Quetiapine is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves), bipolar disorder (a disease that causes depression, mania, and other abnormal moods) and major depressive disorder. Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Quetiapine is approved to treat schizophrenia, bipolar disorder (both manic episodes and depressive episodes), and — in the extended-release form only — as an add-on to an antidepr...
- It depends on the form. If you're taking the regular tablet, you can take it with or without food — no restrictions. But if you're on the extended-release tablet, you should take i...
- Does it matter if I take quetiapine with food?
- Sleepiness is actually one of the most common side effects — in some studies, more than half of patients reported it. Quetiapine blocks histamine receptors in the brain, which has...
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Supplement & herbal interactions
Some supplements/herbs that may interact with Quetiapine — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII B1QE5P712K
Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
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UNII 39J80LT57T
Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.308 | $18.48 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.5937 | $35.62 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2745 | $16.47 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quetiapine 400 mg 00904-6805-61 | Major | 1 tablet | $0.308 | AB | Availability likely | — |
| Quetiapine 400 mgthis 29300-0312-16 | Unichem | 60 tablets | $0.308 | AB | Availability likely | — |
| Quetiapine 400 mg 33342-0137-09 | Macleods | 60 tablets | $0.308 | AB | Availability likely | — |
| Quetiapine 400 mg 68001-0602-06 | BluePoint | 60 tablets | $0.308 | AB | Availability likely | — |
| Quetiapine Fumarate 400 mg 16729-0097-12 | Accord | 60 tablets | $0.323 | AB | Availability likely | +5% |
| Quetiapine Extended Release 400 mg 71093-0139-02 | ACI | 60 tablets | $0.323 | AB | Availability likely | +5% |
| Seroquel Xr 400 mg 00310-0284-60 | AstraZeneca | 60 tablets | $23.975 | AB | Availability likely | +7684% |
| Quetiapine 400 mg 43547-0023-06 | Solco | 60 tablets | — | AB | FDA listed | — |
| Quetiapine Extended Release 400 mg 50228-0384-05 | ScieGen | 500 tablets | — | AB | FDA listed | — |
| Quetiapine Fumarate 400 mg 50742-0639-10 | Ingenus | 1000 tablets | — | AB | FDA listed | — |
| Quetiapine Extended Release 400 mg 51407-0803-60 | Golden | 60 tablets | — | AB | FDA listed | — |
| Seroquel Xr 400 mg 61269-0274-60 | H2-Pharma, | 60 tablets | — | AB | FDA listed | — |
| Quetiapine 400 mg 63629-5944-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Quetiapine Fumarate 400 mg 65862-0877-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Quetiapine 400 mg 68180-0616-01 | Lupin | 100 tablets | — | AB | FDA listed | — |
| Quetiapine 400 mg 70518-4437-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Quetiapine 400 mg 71335-2641-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Quetiapine Fumarate ER 400 mg 72189-0483-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Quetiapine Fumarate ER 400 mg 72189-0642-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Quetiapine 400 mg 70518-4700-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 29300-0312-16 You're viewing this | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-312-16) | 2022-09-12 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] . Quetiapine extended release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.
These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.2) ] .
Quetiapine extended-release tablets are not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed 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.
Quetiapine extended-release tablets are not approved for elderly patients with dementia-related psychosis. ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. ( 5.2 ) Monitor for worsening and emergence of suicidal thoughts and behaviors.
( 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Quetiapine 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 )
1.1Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine tablets [see Clinical Studies (14.1) ] .
1.2Bipolar Disorder Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 - 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine tablets [see Clinical Studies (14.2) ] .
Quetiapine extended-release tablets are indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of quetiapine extended-release tablets was established in one 8-week trial in adults with bipolar I or II disorder and supported by two 8 week trials in adults with bipolar I or II disorder treated with quetiapine tablets [see Clinical Studies (14.2) ] . Quetiapine extended-release tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.
Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with quetiapine tablets. The effectiveness of monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2) ] .
1.3Adjunctive Treatment of Major Depressive Disorder (MDD) Quetiapine extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine extended-release tablets as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3) ] .
1.4Special 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 ▾
2 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
2.1Important Administration Instructions Quetiapine extended-release tablets should be swallowed whole and not split, chewed, or crushed. It is recommended that quetiapine extended-release tablets be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3) ]. Quetiapine extended-release tablets should be administered once daily, preferably in the evening.
2.2Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine extended-release tablets dose for each approved indication is displayed in Table 1 below. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies ( 14.1 , 14.2 and 14.3 )] . Table 1: Recommended Dosing for Quetiapine Extended-Release Tablets I ndication I nitial Dose and Titration R ecommended 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) monotherapy 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 )].
2.3Dose 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 pa…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 50 mg extended-release tablets are peach film-coated, capsule-shaped, biconvex, intagliated tablet with "74" on one side and "U" on the other side 150 mg extended-release tablets are white film-coated, capsule-shaped, biconvex, intagliated tablet with "72" on one side and "U" on the other side 200 mg extended-release tablets are yellow film-coated, capsule-shaped, biconvex, intagliated tablet with "73" on one side and "U" on the other side 300 mg extended-release tablets are pale yellow film-coated, capsule-shaped, biconvex, intagliated tablet with "75" on one side and "U" on the other side 400 mg extended-release tablets are white film-coated, capsule-shaped, biconvex, intagliated tablet with "77" on one side and "U" on the other side Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets. Known hypersensitivity to quetiapine or any components in the formulation. ( 4 )
⚠️ Warnings and Cautions ▾
5 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 quetiapine extended-release tablets 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 )
5.1Increased 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.
Quetiapine extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning ] .
5.2Suicidal 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 st…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Unichem Pharmaceuticals (USA), Inc., at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 quetiapine extended-release tablets consisting of approximately 3400 patients exposed to quetiapine extended-release tablets 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 quetiapine extended-release tablets 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 quetiapine extended-release tablets 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 quetiapine extended-release tablets discontinued due to an adverse reaction compared to 4% (5/140) on placebo.
Somnolence was the only adverse reaction leading to discontinuation that occurred at an incidence of ≥2% in quetiapine extended-release tablets in the bipolar depression t…
🔄 Drug Interactions ▾
7 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 )
7.1Effect of Other Drugs on Quetiapine The risks of using quetiapine extended-release tablets in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine extended-release tablets, 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 quetiapine extended-release tablets 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 quetiapine extended-release tablets 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.
Quetiapine tablets 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) ] .
7.2Effect of Quetiapine on Other Drugs Because of its potential for inducing hypotension, quetiapine extended-release tablets may enhance the effects of certain antihypertensive agents. Quetiapine extended-release tablets may antagonize the effects of levodopa and dopamine agonists. There are no clinically relevant pharmacokinetic interactions of quetiapine tablets on other drugs based on the CYP pathway.
Quetiapine tablets and its metabolites are non-inhibitors of major metabolizing CYP's (1A2, 2C9, 2C19, 2D6, and 3A4).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, 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 quetiapine, 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, quetiapine extended-release tablets 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 quetiapine, 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 antips…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, 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 quetiapine, 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, quetiapine extended-release tablets 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 quetiapine, 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 exp…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of quetiapine extended-release tablets is supported by studies of quetiapine tablets 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 quetiapine tablets 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 quetiapine extended-release tablets 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 quetiapine extended-release tablets in the treatment of bipolar depression in pediatric patients 10 - 17 years of age.
The primary objective of the study was to evaluate whether quetiapine extended-release tablets 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 quetiapine extended-release tablets. The primary results of this study did not show a difference between quetiapine extended-release tablets and placebo in decreasing depression symptoms in children and adolescents with bipolar disorder.
In this study, patients treated with quetiapine extended-release tablets 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 quetiapine extended-release tablets in the treatment of schizophrenia in adolescents aged 13 - 17 years is supported by one 6-week, double-blind, placebo-controlled trial with quetiapine tablets [see Indications and Usage (1.1) , Dosage and Administration (2.2) , Adverse Reactions (6.1) , and Clinical Studies (14.1) ] .
Safety and effectiveness of quetiapine extended-release tablets in pediatric patients less than 13 years of age with schizophrenia have not been established. The safety and effectiveness of quetiapine extended-release tablets 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 quetiapine extended-release tablets 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 quetiapine tablets [see Indications and Usage (1.2) , Dosage and Administration (2.2) , Adverse Reactions (6.1) , and Clinical Studies (14.2) ].
Safety and effectiveness of quetiapine extended-release tablets in pediatric patients less than 10 years of age with bipolar mania have not been established. The safety and effectiveness of quetiapine extended-release tablets in the maintenance treatment of bipolar disorder has not been established in patients less than 18 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Sixty-eight patients in clinical studies with quetiapine extended-release tablets were 65 years of age or over. In general, there was no indication of any different tolerability of quetiapine extended-release tablets in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine extended-release tablets, 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 OVERDOSAGE
10.1Human 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.
10.2Management 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 quetiapine extended-release tablets overdosage, contact a certified Regional Poison Control Center (1-800-222-1222). Quetiapine extended-release tablets 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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).
12.2Pharmacodynamics Quetiapine and its metabolite norquetiapine have affinity for multiple neurotransmitter receptors with norquetiapine binding with higher affinity than quetiapine in general. The Ki values for quetiapine and norquetiapine at the dopamine D 1 are 428/99.8 nM, at D 2 626/489nM, at serotonin 5HT 1A 1040/191 nM at 5HT 2A 38/2.9 nM, at histamine H 1 4.4/1.1 nM, at muscarinic M 1 1086/38.3 nM, and at adrenergic α 1 b 14.6/46.4 nM and, at α 2 receptors 617/1290 nM, respectively. Quetiapine and norquetiapine lack appreciable affinity to the benzodiazepine receptors.
Effect on QT Interval In clinical trials quetiapine was not associated with a persistent increase in QT intervals. However, the QT effect was not systematically evaluated in a thorough QT study. In post marketing experience, there were cases reported of QT prolongation in patients who overdosed on quetiapine [see Overdosage (10.1) ] , in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval.
12.3Pharmacokinetics Adults Following multiple dosing of quetiapine up to a total daily dose of 800 mg, administered in divided doses, the plasma concentration of quetiapine and norquetiapine, the major active metabolite of quetiapine, were proportional to the total daily dose. Accumulation is predictable upon multiple dosing. Steady-state mean C max and AUC of norquetiapine are about 21-27% and 46-56%, respectively, of that observed for quetiapine.
Elimination of quetiapine is mainly via hepatic metabolism. The mean-terminal half-life is approximately 7 hours for quetiapine and approximately 12 hours for norquetiapine within the clinical dose range. Steady-state concentrations are expected to be achieved within two days of dosing.
Quetiapine extended-release tablets are unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. Children and Adolescents At steady state, the pharmacokinetics of the parent compound, in children and adolescents (10-17 years of age), were similar to adults. However, when adjusted for dose and weight, AUC and C max of the parent compound were 41% and 39% lower, respectively, in children and adolescents than in adults.
For the active metabolite, norquetiapine, AUC and C max were 45% and 31% higher, respectively, in children and adolescents than in adults. When adjusted for dose and weight, the pharmacokinetics of the metabolite, norquetiapine, was similar between children and adolescents and adults [see Use in Specific Populations (8.4) ] . Absorption Quetiapine reaches peak plasma concentrations approximately 6 hours following administration.
Quetiapine extended-release tablets dosed once daily at steady state has comparable bioavailability to an equivalent total daily dose of quetiapine tablets administered in divided doses, twice daily. A high-fat meal (approximately 800 to 1000 calories) was found to produce statistically significant increases in the quetiapine extended-release tablets C max and AUC of 44% to 52% and 20% to 22%, respectively, for the 50 mg and 300 mg tablets. In comparison, a light meal (approximately 300 calories) had no significant effect on the C max or AUC of quetiapine.
It is recommended that quetiapine extended-release tablets be taken without food or with a light meal [see Dosage and Administration (2.1) ] . Distribution Quetiapine is widely distributed throughout the body with an apparent volume of distribution of 10±4 L/kg. It is 83% bound to plasma…
🧬 Mechanism of Action ▾
12.1Mechanism 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 / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine Extended-Release Tablets USP, 50 mg: Peach film-coated, capsule-shaped, biconvex, intagliated tablet with "74" on one side and "U" on the other side and are supplied in bottles of 60 tablets (NDC 29300-308-16). Quetiapine Extended-Release Tablets USP, 150 mg: White film-coated, capsule-shaped, biconvex, intagliated tablet with "72" on one side and "U" on the other side and are supplied in bottles of 60 tablets (NDC 29300-309-16). Quetiapine Extended-Release Tablets USP, 200 mg: Yellow film-coated, capsule-shaped, biconvex, intagliated tablet with "73" on one side and "U" on the other side and are supplied in bottles of 60 tablets (NDC 29300-310-16).
Quetiapine Extended-Release Tablets USP, 300 mg: Pale yellow film-coated, capsule-shaped, biconvex, intagliated tablet with "75" on one side and "U" on the other side and are supplied in bottles of 60 tablets (NDC 29300-311-16). Quetiapine Extended-Release Tablets USP, 400 mg: White film-coated, capsule-shaped, biconvex, intagliated tablet with "77" on one side and "U" on the other side and are supplied in bottles of 60 tablets (NDC 29300-312-16). Store quetiapine extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 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 USP is a white to off-white crystalline powder which is moderately soluble in water.
Quetiapine extended-release tablets USP are 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 quetiapine extended-release tablets USP are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate.
The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg 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 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine.
Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine.
Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING 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 quetiapine extended-release tablets. 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.
Quetiapine extended-release tablets are 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 quetiapine extended-release tablets. 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 quetiapine extended-release tablets to be stopped and/or treatment to be given [see Warnings and Precautions (5.10) ] .
Interference with Cognitive and Motor Performance Patients should be adv…
💬 Medication Guide ▾
MEDICATION GUIDE Quetiapine (kwe tye' a peen) Extended-Release Tablets Read this Medication Guide before you start taking quetiapine extended-release tablets 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 quetiapine extended-release tablets? Quetiapine extended-release tablets may cause serious side effects, including: risk of death in the elderly with dementia: Medicines like quetiapine extended-release tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine extended-release tablets are not 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).
Talk to your or your family member's, healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 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. H o w 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. C all 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 your 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 members 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 are quetiapine extended-release tablets? Quetiapine extended-release tablets are a pres…