Quetiapine ER

Class
Antipsychotics
Subclass
Atypical antipsychotics
Substance name
QUEtiapine fumarate ER
Brand names
Seroquel XR®
Common formulations
Tablet
See also
Quetiapine (Seroquel®)
Dosage and administration
Adults patients
Treatment
Bipolar disorder • Manic or mixed episodes
•
Start at: 300 mg PO daily on day 1, followed by 600 mg PO daily on day 2 and 400-800 mg PO daily on day 3
•
Maintenance: 400-800 mg PO daily
•
Maximum: 800 mg per day
Dosage for monotherapy or as adjunct to lithium or divalproex.
Bipolar disorder • Depressive episodes
•
Start at: 50 mg PO daily on day 1, followed by 100 mg PO daily on day 2, 200 mg PO daily on day 3, and 300 mg PO daily on day 4
•
Maintenance: 300 mg PO daily
•
Maximum: 300 mg per day
Bipolar disorder • Maintenance therapy
•
Start at: 50 mg PO daily
•
Maintenance: 400-800 mg PO daily
•
Maximum: 800 mg per day
Administered in combination with lithium or divalproex.
Adjunctive treatment
Adjunctive treatment for major depressive disorder
•
Start at: 50 mg PO daily on days 1 and 2, followed by 150 mg PO daily on day 3
•
Maintenance: 150-300 mg PO daily
•
Maximum: 300 mg per day
Other off-label uses
•
Treatment of generalized anxiety disorder
Indications for use
Labeled indications
Adults
•
Treatment of bipolar disorder (depressive episodes)
•
Treatment of bipolar disorder (maintenance therapy)
•
Treatment of bipolar disorder (manic or mixed episodes)
•
Treatment of schizophrenia
•
Adjunctive treatment for major depressive disorder
Off-label indications
Adults
•
Treatment of generalized anxiety disorder
Safety risks
Boxed warnings
Increased risk of mortality
•
Do not use quetiapine for the management of dementia-related psychosis in elderly patients because of the increased risk of fatal cerebrovascular accidents.
Suicidal ideation
•
Use extreme caution in patients with major depressive disorder or other psychiatric disorders, particularly in young adults. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to quetiapine or its components
Warnings and precautions
Anticholinergic syndrome
•
Use caution in patients with urinary retention, prostatic hypertrophy, constipation, or taking anticholinergic medications.
Antipsychotic withdrawal
•
Do not discontinue abruptly in any patient.
Aspiration pneumonia
•
Use caution in elderly patients, particularly with advanced Alzheimer's disease.
Cataract
•
Maintain a high level of suspicion, as long-term use of quetiapine has been associated with an increased risk of cataracts.
Falls
•
Maintain a high level of suspicion, as quetiapine may cause somnolence, orthostatic hypotension, motor and sensory instability, leading to falls and injuries.
Hematologic disorders
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of leukopenia, neutropenia, and agranulocytosis.
Hyperprolactinemia
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of hyperprolactinemia.
Hypotension
•
Use caution in patients with known CVD (history of myocardial infarction or ischemic heart disease, HF, or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).
Hypothyroidism
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of hypothyroidism. Monitor TSH and fT4 levels.
Mania
•
Use caution in patients with bipolar disorder. Screen patients for any personal or family history of bipolar disorder before initiating quetiapine.
Metabolic changes
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.
Neuroleptic malignant syndrome
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of neuroleptic malignant syndrome.
Orthostatic hypotension
•
Use caution in patients with cardiovascular or cerebrovascular disease, dehydration/hypovolemia, or taking antihypertensive agents.
Prolonged QT interval
•
Use extreme caution Concomitant use of other QT-prolonging agents. Avoid using quetiapine with other QT-prolonging agents, including class IA or III antiarrhythmics, antipsychotics (such as ziprasidone, chlorpromazine, thioridazine), antibiotics (such as gatifloxacin, moxifloxacin), or other medications known to prolong the QT interval (such as pentamidine, levomethadyl acetate, methadone).
•
Use caution in patients at increased risk of QT prolongation, such as the elderly, patients with CVD, family history of QT prolongation, congestive HF, or cardiac hypertrophy.
Seizure
•
Use caution with seizure disorder or low seizure threshold.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Tardive dyskinesia
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of tardive dyskinesia.
Torsades de pointes, SCD
•
Use caution High risk for torsade de pointes and/or SCD. Avoid using quetiapine in patients with a history of cardiac arrhythmias, such as bradycardia, hypokalemia, hypomagnesemia, or congenital QT prolongation.
Specific populations
Renal impairment
CrCl ≥ 10 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 10 mL/min
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
Start at dose of 50 mg/day and titrate in increments of 50 mg/day.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in humans. Enroll patients in a dedicated pregnancy outcome monitoring registry. Monitor neonates for extrapyramidal and/or withdrawal symptoms.
Breastfeeding
Use only if benefits outweigh potential risks.
Very low levels in breastfed infants (< 5%).
Unlikely to cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Dizziness, dry mouth, fatigue, ↑ appetite, somnolence
Common 1-10%
•
Disorientation, dysarthria, extrapyramidal signs, gastroenteritis, hyperhidrosis, hypersomnia, hypotension, lethargy, migraine, restless legs syndrome, orthostatic hypotension, parkinsonism, akathisia, anxiety, arthralgia, back pain, blurred vision, confusion, constipation, ↓ libido, dental pain, depression, dyspepsia, ear pain, falls, inattention, irritability, loss of appetite, muscle spasms, myalgia, nasal congestion, nausea, neck pain, nightmares, paresthesia, polyuria, restlessness, sluggishness, vertigo, vomiting, weight gain, sinusitis, tachycardia, tremor, urinary tract infections, upper respiratory tract infections
Uncommon < 1%
•
Dystonia
Unknown frequency
•
↓ WBC count, ↓ serum sodium, ↓ blood neutrophil count, ↑ serum CK, galactorrhea, priapism, bradycardia, ↑ serum gamma-glutamyltransferase, dyspnea, cognitive impairment, motor impairment, ↑ blood eosinophil count, urinary retention, agranulocytosis, ileus, sleep apnea, nocturia, ↓ platelet count, seizure, ↑QT interval, amnesia, confusion, suicidal ideation, tardive dyskinesia, hepatitis, somnambulism, rhabdomyolysis, neuroleptic malignant syndrome, syndrome of inappropriate antidiuretic hormone secretion, anaphylaxis, cardiomyopathy, myocarditis, hepatic necrosis, bowel obstruction, acute liver failure, cutaneous vasculitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS syndrome, acute generalized exanthematous pustulosis, acute pancreatitis, acute ischemic stroke, colonic ischemia
Interactions
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