Class: Atypical Antipsychotics
VA Class: CN709
Chemical Name: (E)-2-Butenedioate-2-[2-(4-dibenzo[b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol (2:1) (salt)
Molecular Formula: (C21H25N3O2S)2•C4H4O4
CAS Number: 111974-72-2
Brands: Seroquel
Warning(s)
Special Alerts:
[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: , and .
Warning(s)
- Increased Mortality in Geriatric Patients
-
Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., quetiapine, aripiprazole, olanzapine, risperidone) compared with those receiving placebo (2.6%).a 97 98
-
Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).a 97 98
-
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.a 97 98 (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Introduction
Atypical or second-generation antipsychotic agent.1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 21 22 23 26 27 28
Uses for Quetiapine Fumarate
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Schizophrenia
Symptomatic management of schizophrenia.1 2 3 4 5 6 18 22 23 26
Bipolar Disorder
Management (alone or in combination with lithium or divalproex sodium) of acute manic episodes associated with bipolar I disorder.1 a
Quetiapine Fumarate Dosage and Administration
Administration
Oral Administration
Administer orally, generally 2–3 times daily without regard to meals.1 25
When switching from other antipsychotic agents to quetiapine, abrupt discontinuance of previous agent may be acceptable for some patients with schizophrenia, but gradual discontinuance may be appropriate for others.1 In all cases, minimize period of overlapping antipsychotic administration.1
In patients being switched from long-acting (depot) parenteral antipsychotic therapy to oral quetiapine therapy, administer first oral dose in place of next scheduled depot injection of the long-acting preparation.1
Periodically reevaluate need for continuing any existing drug therapy for symptomatic relief of adverse extrapyramidal effects.1
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as quetiapine fumarate; dosage is expressed in terms of quetiapine.1
Reinitiating therapy: In patients previously treated with quetiapine, dosage titration is not necessary if reinitiated after a drug-free period <1 week;1 if reinitiated after a drug-free period >1 week, generally titrate dosage as with initial therapy.1
Adults
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Schizophrenia
Oral
Initially, 25 mg twice daily.1 23
Increase dosage in increments of 25–50 mg 2 or 3 times daily on the second or third day, as tolerated, to a target dosage of 300–400 mg daily in 2 or 3 divided doses by the fourth day.1 23
Make subsequent dosage adjustments at intervals of not less than 2 days, usually in increments or decrements of 25–50 mg twice daily.1 20
Dosages ranging from 150–750 mg daily were effective in clinical trials.1 4 5 6 7 8 11 18 22 Dosages >300 mg daily usually do not result in greater efficacy, but dosages of 400–500 mg daily have been required in some patients.1
Optimum duration of therapy currently not known, but efficacy of maintenance therapy with antipsychotics is well established.1 22 Continue therapy in responsive patients as long as clinically necessary and tolerated but at lowest possible effective dosage; reassess need for continued therapy and optimal dosage periodically (e.g., at least annually).1 22
If discontinuance is considered, precautions include slow, gradual dose reduction over many months, more frequent clinician visits, and use of early intervention strategies.22
Bipolar Disorder
Acute Mania
OralInitially, 100 mg daily in 2 divided doses.1 Increase dosage (in increments of ≤100 mg daily in 2 divided doses) to 400 mg daily on the fourth day of therapy.1 Make subsequent adjustments in increments of ≤200 mg daily to reach a dosage of up to 800 mg daily by the sixth day of therapy.1
Majority of patients respond to 400–800 mg daily.1
Optimum duration not established; efficacy has been demonstrated in two 12-week monotherapy trials and one 3-week adjunct therapy trial.a If used for extended periods, periodically reevaluate long-term risks and benefits for the individual patient.1 a
Prescribing Limits
Adults
Schizophrenia
Oral
Safety of dosages >800 mg daily not established.1
Bipolar Disorder
Acute Mania
OralSafety of dosages >800 mg daily not established.1
Special Populations
Hepatic Impairment
Initially, 25 mg daily; increase dosage by 25–50 mg daily according to clinical response and tolerability until an effective dosage is reached.1
Renal Impairment
No dosage adjustment necessary.1
Patients at Risk of Orthostatic Hypotension
Consider a slower rate of dosage titration and a lower target dosage in geriatric patients and in patients who are debilitated or have a predisposition to hypotensive reactions.1 Adjust dosage with caution.1
Initially, 25 mg twice daily to minimize risk of orthostatic hypotension and associated syncope.1 If hypotension occurs during dosage titration, return to previous dosage in titration schedule.1
Cautions for Quetiapine Fumarate
Contraindications
-
Known hypersensitivity to quetiapine or any ingredient in the formulation.1
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Increased Mortality in Geriatric Patients with Dementia-related Psychosis
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.a 97 98
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.a 97 98 (See Boxed Warning and see Geriatric Use under Cautions.)
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, reported rarely.1
Tardive Dyskinesia
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, reported infrequently.1 Consider discontinuance of quetiapine.1
Hyperglycemia and Diabetes Mellitus
Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents, including quetiapine.1 34 35 36 37 38 39 40 41 42 43 44 45 47 60 61 62 63 67 87 Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).1 34 35 36 37 38 39 40 41 42 43 44 45 If manifestations of hyperglycemia occur in any patient, test for diabetes mellitus.1 34 35 36 37 38 39 40 41 42 43 44 45
General Precautions
Orthostatic Hypotension
Orthostatic hypotension reported.1 Use with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).1 (See Patients at Risk of Orthostatic Hypotension under Dosage and Administration.)
Ocular Effects
Possible lenticular changes; ophthalmologic examination of the lens by methods adequate to detect cataract formation (e.g., slit lamp exam) recommended at initiation of therapy, or shortly thereafter, and at 6-month intervals during chronic therapy.1
Nervous System Effects
Possible risk of seizures; use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).1
Disruption of ability to reduce core body temperature possible; use with caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).1
Somnolence reported.1 Potential impairment of judgment, thinking, or motor skills.1
Endocrine Effects
Hypothyroidism possible.1
Elevated prolactin concentrations reported with some atypical antipsychotic agents; not observed in clinical trials with quetiapine but reported in animals.1
Metabolic Effects
Weight gain possible.1
Increases in cholesterol and triglyceride concentrations possible; weakly related to weight gain.1
Hepatic Effects
Asymptomatic, transient, and reversible increases in serum transaminases (principally ALT) reported; usually occurred within first 3 weeks and resolved despite continued quetiapine therapy.1
Sexual Dysfunction
Priapism possible.1
GI Effects
Esophageal dysmotility and aspiration possible; use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).1
Suicide
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Attendant risk with psychotic illnesses; closely supervise high-risk patients.1 Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.1
Possible Prescribing and Dispensing Precautions
Ensure accuracy of prescription; similarity in spelling of Seroquel (quetiapine) and Serzone (former trade name for nefazodone hydrochloride, an antidepressant agent) may result in errors associated with adverse CNS (e.g., mental status deterioration, hallucination, paranoia, muscle weakness, lethargy, dizziness) and GI (e.g., nausea, vomiting, diarrhea) effects.29 30 31
Specific Populations
Pregnancy
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Category C.1
Lactation
Distributed into milk in animals; not known whether distributed into human milk.1 Women receiving quetiapine should not breast-feed.1
Pediatric Use
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Safety and efficacy not established in children <18 years of age.1
Geriatric Use
No substantial differences in safety relative to younger adults, but factors that decrease pharmacokinetic clearance, increase the pharmacodynamic response, or cause poorer tolerance or orthostasis may be present.1 (See Patients at Risk of Orthostatic Hypotension under Dosage and Administration.)
Possible increased risk of death in geriatric patients with dementia-related psychosis.a 97 98 Substantial (1.6- to 1.7-fold) increase in mortality rate reported in geriatric patients with dementia who received atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) for treatment of behavioral disorders; most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).a 97 98
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.a 97 98 (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Hepatic Impairment
Increased plasma concentrations expected in patients with hepatic impairment; dosage adjustment may be necessary.1
Renal Impairment
Clearance may be decreased in severe renal impairment, but dosage adjustment not necessary.1
Common Adverse Effects
Somnolence, dizziness, dry mouth, constipation, increased ALT, weight gain, dyspepsia.a
Interactions for Quetiapine Fumarate
Metabolized principally by CYP3A4.1 b Does not appear to inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro; pharmacokinetic interaction with substrates of these isoenzymes unlikely.1 b
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors or inducers of CYP3A4; potential pharmacokinetic interaction (altered quetiapine metabolism).1 b
Specific Drugs
|
Drug |
Interaction |
Comments |
|---|---|---|
|
Alcohol |
Potentiation of cognitive and motor effects of alcohol1 |
Avoid alcohol during therapy with quetiapine1 |
|
Antifungals, azole (e.g., fluconazole, itraconazole, ketoconazole) |
Substantial decrease in quetiapine clearance with concomitant use of ketoconazole, resulting in increased peak plasma quetiapine concentrations1 |
Use concomitantly with caution; dosage adjustment of quetiapine may be necessary1 |
|
Barbiturates |
Possible increased quetiapine clearance1 |
Increased quetiapine dosage may be required1 |
|
Carbamazepine |
Possible increased quetiapine clearance1 |
Increased quetiapine dosage may be required1 |
|
Cimetidine |
Decreased quetiapine mean clearance1 |
No dosage adjustment of quetiapine required1 |
|
CNS agents |
Possible additive CNS effects1 |
Use with caution1 |
|
Divalproex sodium |
Increased peak plasma quetiapine concentrations, with no effect on extent of absorption or mean quetiapine clearance; decreased peak plasma valproic acid concentrations and extent of absorption, but not significant1 |
|
|
Dopamine agonists |
Antagonistic effects1 |
|
|
Erythromycin |
Decreased quetiapine clearance1 |
Use concomitantly with caution1 |
|
Fluoxetine |
No effect on quetiapine pharmacokinetics1 |
|
|
Glucocorticoids |
Possible increased quetiapine clearance1 |
Increased quetiapine dosage may be required1 |
|
Haloperidol |
No effect on quetiapine pharmacokinetics1 |
|
|
Hypotensive agents |
Additive hypotensive effects1 |
|
|
Imipramine |
No effect on quetiapine pharmacokinetics1 |
|
|
Levodopa |
Antagonistic effects1 |
|
|
Lithium |
No effect on lithium pharmacokinetics1 |
|
|
Lorazepam |
Decreased lorazepam clearance1 |
|
|
Phenytoin |
Substantially increased quetiapine clearance1 |
Increased quetiapine dosage may be required;1 23 caution advised if phenytoin is withdrawn and replaced with a non-inducer (e.g., valproate)1 |
|
Rifampin |
Possible increased quetiapine clearance1 |
Increased quetiapine dosage may be required1 |
|
Risperidone |
No effect on quetiapine pharmacokinetics1 |
|
|
Thioridazine |
Substantially increased quetiapine clearance1 |
Quetiapine Fumarate Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed after oral administration, with peak plasma concentrations attained within 1.5 hours.1 b Bioavailability of tablet formulation is 100% relative to an oral solution (not commercially available in US).1 b
Food
Bioavailability is marginally affected by food.1 b
Distribution
Extent
Widely distributed throughout the body.1
Distributed into milk in animals; not known whether distributed into human milk.1
Plasma Protein Binding
Elimination
Metabolism
Extensively metabolized to inactive metabolites, principally via CYP3A4.1 b
Elimination Route
Excreted in urine (73%) and feces (20%), with <1% of the drug excreted unchanged.1 b
Half-life
Special Populations
In patients with hepatic impairment, clearance is 30% lower and AUC and peak plasma concentrations are 3 times higher than those of healthy individuals.1
In patients with severe renal impairment (Clcr 10–30 mL/minute), clearance may be reduced by 25% compared with healthy individuals; however, plasma concentrations in patients with renal impairment were within the range of those seen in healthy patients.1
In geriatric patients, clearance is decreased by about 40% compared with younger patients.1
Stability
Storage
Oral
Tablets
25°C (may be exposed to 15–30°C).1
Actions
-
Exact mechanism of antipsychotic action is not known; may involve antagonism at serotonin type 1 (5-hydroxytryptamine [5-HT1A]),1 6 7 15 17 type 2 (5-HT2A, 5-HT2C),1 2 3 4 5 6 7 8 9 10 11 12 14 15 16 17 23 and type 6 (5-HT6) receptors,17 and at dopamine receptors.1 2 3 4 5 6 7 8 9 10 11 12 14 15 16 17 26 28
-
Antagonism at other receptors (e.g., α1-adrenergic receptors, histamine H1 receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).1
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
-
Risk of orthostatic hypotension, especially during initial dosage titration and at times of re-initiation of therapy or increases in dosage.1
-
Risk of somnolence and impairment of judgment, thinking, or motor skills; avoid driving, operating machinery, or performing hazardous tasks until effects on the individual are known.1
-
Importance of avoiding alcohol during quetiapine therapy.1
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
-
Importance of avoiding overheating or dehydration.1
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).1
-
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
|
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
|---|---|---|---|---|
|
Oral |
Tablets, film-coated |
25 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
|
50 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
||
|
100 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
||
|
200 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
||
|
300 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
||
|
400 mg (of quetiapine) |
Seroquel (with povidone) |
AstraZeneca |
AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.
References
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80. Reviewers’ comments (personal observations).
81. Bristol-Myers Squibb, Princeton, NJ: Personal communication.
82. AstraZeneca, Wayne, PA: Personal communication.
83. Eli Lilly and Company, Indianapolis, IN: Personal communication.
84. Novartis Pharmaceuticals Corporation, East Hanover, NJ: Personal communication.
85. Janssen Pharmaceuticals, Titusville, NJ: Personal communication.
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98. Dear healthcare professional letter regarding adding important safety information regarding the use of atypical antipsychotics in elderly patients with dementia-related psychosis to the prescribing information for Seroquel (quetiapine fumarate). Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2005 Jul.
a. AstraZeneca Pharmaceuticals. Seroquel (quetiapine fumarate) tablets prescribing information. Wilmington, DE; 2005 Dec.
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