Quetiapine

Class
Antipsychotics
Subclass
Atypical antipsychotics
Substance name
QUEtiapine fumarate
Brand names
Seroquel®
Common formulations
Film-coated tablet
See also
Quetiapine ER (Seroquel XR®)
Dosage and administration
Adults patients
Treatment
Bipolar disorder • Maintenance therapy
•
Maintenance: 200-400 mg PO BID
•
Maximum: 800 mg per day
Administered in combination with lithium or divalproex.
Bipolar disorder • Depressive episodes
•
Start at: 50 mg PO qHS on day 1, followed by 100 mg PO qHS on day 2, 200 mg PO qHS on day 3, and 300 mg PO qHS on day 4
•
Maintenance: 300 mg PO qHS
•
Maximum: 300 mg per day
Bipolar disorder • Manic or mixed episodes
•
Start at: 50 mg PO BID on day 1, followed by 100 mg PO BID on day 2, 150 mg PO BID on day 3, and 200 mg PO BID on day 4
•
Maintenance: 200-400 mg PO BID
•
Maximum: 800 mg per day
Further dosage adjustments up to 800 mg/day by day 6 should be in increments of no greater than 200 mg/day.
Schizophrenia • Acute treatment
•
Start at: 25 mg PO BID on day 1
•
Maintenance: 150-750 mg PO daily, in 2-3 divided doses
•
Maximum: 750 mg per day
Titrate in 25-50 mg BID-TID increments on days 2 and 3 to a range of 300-400 mg by day 4. Consider titrating further in 25-50 mg twice daily increments at intervals of at least 2 days.
Schizophrenia • Maintenance therapy
•
Maintenance: 400-800 mg PO daily, in 2-3 divided doses
•
Maximum: 800 mg per day
Delirium • Off-label
•
25-200 mg PO daily
Alternative
•
25 - 100 mg PO qHS
Generalized anxiety disorder • Off-label
•
Start at: 25 - 50 mg PO daily
•
Maintenance: 50-200 mg PO daily, in 1-3 divided doses
•
Maximum: 300 mg per day
May gradually increase dose based on response and tolerability every ≥ 7 days.
Insomnia • Off-label
•
Start at: 12.5 mg PO daily
•
Maintenance: 25-50 mg PO daily
•
Maximum: 50 mg per day
Psychosis in patients with Parkinson's disease • Off-label
•
Start at: 12.5 - 25 mg PO qHS
•
Maintenance: 40 - 185 mg PO daily, in 1-3 divided doses
Increase dose gradually based on response and tolerability in increments of 12.5 to 25 mg every 1 to 2 weeks.
Adjunctive treatment
OCD • Refractory • Off-label
•
Start at: 25 - 50 mg PO daily
•
Maintenance: 25 - 400 mg PO daily, in 1-3 divided doses
Increase dose gradually based on response and tolerability in increments of 25 to 100 mg every 2 to 3 weeks.
Alternative
•
300 mg PO daily
PTSD • Off-label
•
Start at: 25 mg PO qHS
•
Maintenance: 25 - 800 mg PO daily, in 1-3 divided doses
Increase dose in 25 mg increments every 1 to 2 days up to 100 mg at bedtime by the end of week 1; may further adjust daily dose based on response and tolerability in increments of 25 mg/day.
Other off-label uses
•
Treatment of delusional parasitosis
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 (acute treatment)
•
Treatment of schizophrenia (maintenance therapy)
Off-label indications
Adults
•
Treatment of delirium
•
Treatment of delusional parasitosis
•
Treatment of generalized anxiety disorder
•
Treatment of insomnia
•
Treatment of psychosis in patients with Parkinson's disease
•
Adjunctive treatment for OCD (refractory)
•
Adjunctive treatment for PTSD
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 children, adolescents, and 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
•
Use caution in patients with leukopenia/neutropenia include pre-existing low white cell count (WBC) and history of drug induced leukopenia/neutropenia.
Hyperprolactinemia
•
Maintain a high level of suspicion, as quetiapine has been associated with an increased risk of hyperprolactinemia.
Hypotension
•
Use caution in patients with cardiovascular or cerebrovascular disease, dehydration/hypovolemia, or taking antihypertensive agents.
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.
Prolonged QT interval
•
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. 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).
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.
Stroke
•
Use caution in elderly subjects with dementia.
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 as quetiapine is associated with an increased risk of these adverse events. 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 25 mg/day and titrate in increments of 25-50 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%
•
Agitation, ↑ serum cholesterol, ↑ serum triglycerides, constipation, dizziness, dry mouth, headache, somnolence, weight gain
Common 1-10%
•
Amblyopia, ataxia, incoordination, loss of balance, dysphagia, hypothyroidism, dysarthria, hypersomnia, dyskinesia, dystonia, gastroesophageal reflux disease, gastroenteritis, urinary tract infections, restless legs syndrome, hypertension, hypotension, ↑ blood glucose, ↑ liver enzymes, ↑ serum ALT, ↑ serum AST, ↑ serum prolactin, infection, lethargy, orthostatic hypotension, parkinsonism, pharyngitis, abdominal pain, anxiety, asthenia, back pain, dental pain, depression, speech disturbance, dyspepsia, fatigue, ↑ appetite, irritability, nasal congestion, nausea, nightmares, pain, palpitations, hypertonia, blurred vision, peripheral edema, muscle twitching, akathisia, paresthesia, extrapyramidal signs, cough, arthralgia, skin rash, syncope, pain in extremity, sweating, fever, hypoesthesia, vomiting, rhinitis, sinusitis, tachycardia, tremor
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, falls, 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
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