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Quetiapine oral modified release

Updated 2 Feb 2023 | Antipsychotics

Presentation

Modified release formulations of quetiapine.

Drugs List

  • ATROLAK XL 150mg prolonged release tablet
  • ATROLAK XL 200mg prolonged release tablet
  • ATROLAK XL 300mg prolonged release tablet
  • ATROLAK XL 400mg prolonged release tablet
  • ATROLAK XL 50mg prolonged release tablet
  • BIQUELLE XL 150mg modified release tablet
  • BIQUELLE XL 200mg modified release tablet
  • BIQUELLE XL 300mg modified release tablet
  • BIQUELLE XL 400mg modified release tablet
  • BIQUELLE XL 50mg modified release tablet
  • BIQUELLE XL 600mg modified release tablet
  • BRANCICO XL 150mg prolonged release tablet
  • BRANCICO XL 200mg prolonged release tablet
  • BRANCICO XL 300mg prolonged release tablet
  • BRANCICO XL 400mg prolonged release tablet
  • BRANCICO XL 50mg prolonged release tablet
  • MINTRELEQ XL 150mg modified release tablet
  • MINTRELEQ XL 200mg modified release tablet
  • MINTRELEQ XL 300mg modified release tablet
  • MINTRELEQ XL 400mg modified release tablet
  • MINTRELEQ XL 50mg modified release tablet
  • quetiapine 150mg modified release tablet
  • quetiapine 200mg modified release tablet
  • quetiapine 300mg modified release tablet
  • quetiapine 400mg modified release tablet
  • quetiapine 50mg modified release tablet
  • quetiapine 600mg modified release tablet
  • SEROQUEL XL 150mg modified release tablet
  • SEROQUEL XL 200mg modified release tablet
  • SEROQUEL XL 300mg modified release tablet
  • SEROQUEL XL 400mg modified release tablet
  • SEROQUEL XL 50mg modified release tablet
  • SONDATE XL 150mg modified release tablet
  • SONDATE XL 200mg modified release tablet
  • SONDATE XL 300mg modified release tablet
  • SONDATE XL 400mg modified release tablet
  • SONDATE XL 50mg modified release tablet
  • ZALURON XL 150mg modified release tablet
  • ZALURON XL 200mg modified release tablet
  • ZALURON XL 300mg modified release tablet
  • ZALURON XL 400mg modified release tablet
  • ZALURON XL 50mg modified release tablet
  • Therapeutic Indications

    Uses

    Bipolar disorder: prevention of recurrence
    Major depressive episodes in patients with MDD: adjunctive treatment
    Treatment of depressive episodes associated with bipolar disorder
    Treatment of manic episodes associated with bipolar disorder
    Treatment of schizophrenia

    Dosage

    Adults

    Treatment of schizophrenia and manic episodes associated with bipolar disorder
    Administered at least one hour before a meal.
    Initial doses: 300mg on day one, and 600mg on day two.
    Maintenance dose: 600mg daily. The dose may be adjusted within the range 400mg to 800mg per day, depending on clinical response and patient tolerability.
    No dose adjustment is necessary for maintenance therapy in schizophrenia.

    Treatment of depressive episodes associated with bipolar disorder
    Administer once daily at bedtime.
    Initial doses: 50mg on day one, 100mg on day two, 200mg on day three and 300mg on day four.
    Maintenance dose: 300mg daily. The dose may be adjusted within the range 200mg to 600mg per day, depending on clinical response and patient tolerability.
    Doses greater than 300mg should be initiated by physicians experienced in treating bipolar disorder.

    For preventing recurrence of manic, depressive and mixed episodes in bipolar disorder
    Patients who have responded to quetiapine modified release for acute treatment of bipolar disorder should continue therapy at the same dose administered at bedtime. The dose may then be adjusted depending on clinical response and tolerability of the individual patient, within the range of 300mg to 800mg daily. The lowest effective dose should be used for maintenance therapy.

    Adjunctive treatment of major depressive episodes in major depressive disorder
    Administer once daily at bedtime.
    Initial doses: 50mg on days one and two, and 150mg on days three and four.
    Maintenance dose: The need to increase the dose from 150mg to 300mg daily should be based on individual patient evaluation.
    The risk of adverse effects increased with higher doses, therefore the lowest effective dose should be used.

    Elderly

    Initial dose: 50mg daily. Increase daily in increments of 50mg per day to an effective dose, depending on the clinical response and tolerability of the individual patient.

    In elderly patients with MDD
    Initial doses: 50mg daily on days one to three, increasing to 100mg daily on day four and 150mg daily on day 8. If dose increase to 300mg daily is required based on individual patient evaluation, this should not occur prior to day 22 of treatment.

    Safety and efficacy have not been evaluated in patients over 65 years with depressive episodes in bipolar disorder.

    Children

    Schizophrenia (unlicensed)
    Children aged 12 to 18 years
    Initial dose: 50mg once daily, under specialist supervision. Adjust in steps of 50mg daily according to response.
    Maintenance dose: 400mg to 800mg once daily.
    Maximum dose: 800mg once daily.

    Patients with Hepatic Impairment

    Initial dose: 50mg daily. Increase daily in increments of 50mg per day to an effective dose, depending on the clinical response and tolerability of the individual patient.

    Additional Dosage Information

    Switching from immediate release quetiapine
    Patients currently being treated with divided doses of immediate release quetiapine may be switched to modified release quetiapine at the equivalent total daily dose, taken once daily.

    Contraindications

    Children under 12 years
    Neutrophil count below 1.0 x 10 to the power of 9 / L
    Galactosaemia
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Children aged 12 to 18 years
    Constipation
    Elderly
    Family history of long QT syndrome
    Obesity
    Patients under 25 years
    Predisposition to aspiration or regurgitation
    Predisposition to hypotension
    Predisposition to venous thromboembolism
    Risk of cerebrovascular accident
    Suicidal ideation
    Breastfeeding
    Cardiovascular disorder
    Cerebrovascular disorder
    Dementia
    Diabetes mellitus
    Electrolyte imbalance
    Epileptic disorder
    Gastrointestinal obstruction
    Gastrointestinal stenosis
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of alcohol abuse
    History of drug misuse
    History of gastrointestinal obstruction
    History of raised intra-ocular pressure
    History of seizures
    History of torsade de pointes
    History of urinary retention
    Lactose intolerance
    Narrow angle glaucoma
    Parkinson's disease
    Pregnancy
    Prostate disorder
    Raised intra-ocular pressure
    Sleep apnoea
    Urinary retention

    Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
    Correct electrolyte disorders before treatment
    Patients at risk of suicide should be closely supervised
    Reduce dose in patients with hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Contains lactose
    Monitor blood glucose before and during treatment
    Monitor blood lipids before and during treatment
    Monitor patient weight before and during treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor closely patients experiencing severe lethargy or somnolence
    Monitor for constipation; give laxatives as required
    Monitor for mental changes, suicidal depression and antisocial behaviour
    Monitor patient initially- response may take 2 or more weeks
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Monitor patients with existing or tendency towards diabetes mellitus
    Monitor patients with intestinal obstruction
    Monitor periodically for signs or symptoms of hyperglycaemia
    Monitor serum electrolytes
    Potential for drug abuse
    Reassess treatment if suspected cardiomyopathy or myocarditis
    Symptoms of tardive dyskinesia can worsen or arise after discontinuation
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Children may experience increased frequency of certain side effects
    Consider discontinuation if signs of tardive dyskinesia occur
    Do not increase dosage in patients who develop akathisia
    Dysphagia & aspiration:caution in patients at risk for aspiration pneumonia
    May cause or exacerbate extrapyramidal symptoms
    May cause postural hypotension especially in elderly
    May cause weight gain
    Potential for withdrawal symptoms
    Risk of pancreatitis
    May affect results of some laboratory tests
    Avoid abrupt withdrawal
    Monitor for signs of relapse when withdrawing treatment
    Discontinue if neutrophil count below 1 x 10 to the power of 9/L
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if patient develops severe lethargy or somnolence
    Reduce dose in elderly
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Advise patient grapefruit products may increase plasma level
    Advise patient of increased risk of falls
    Advise patient/carers to report signs of suicide ideation or behaviour
    Advise patients on the risk of neutropenia and the significance of fever

    Depression (including depression in bipolar disorder) is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery.

    Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

    Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

    Quetiapine is not approved for the treatment of patients with dementia-related psychosis. Use of antipsychotics in elderly patients, particularly those with dementia, has been associated with an increased risk of co-morbidities (including stroke) and death. A higher mortality rate has also been associated with elderly patients with parkinsons disease.

    Metabolic parameters including weight, blood glucose and serum lipids should be monitored at baseline and periodically during treatment in line with antipsychotic guidelines. Any changes to these parameters should be managed as clinically appropriate.

    Certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin, vomiting, rhinitis and syncope), or may have different implications for children and adolescents (extrapyramidal symptoms and irritability) and one was identified that has not been previously seen in adult studies (increases in blood pressure). Changes in thyroid function tests have also been observed in children and adolescents. The long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks. Long term implications for cognitive and behavioural development are not known.

    Sleep apnoea syndrome has been reported in patients using quetiapine. Use caution in patients using concomitant central nervous syndrome depressants and who have a history of or at risk for sleep apnoea (e.g overweight, obese, male).

    Pregnancy and Lactation

    Pregnancy

    Use quetiapine with caution during pregnancy.

    The manufacturer recommends quetiapine is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Limited available data suggests risks are minimal however the risks are unknown. Animal studies have shown reproductive toxicity.

    Neonates exposed to quetiapine during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorders. Exposed newborns should therefore be monitored carefully.

    Lactation

    Use quetiapine with caution during breastfeeding.

    The manufacturer recommends making a decision of whether to discontinue breastfeeding or quetiapine treatment taking into account the benefit of both the mother and child.

    There is limited data available on the excretion of quetiapine into breast milk. LactMed (2020) indicates that low levels of quetiapine can be found in milk. Although limited, long term follow ups show exposed infants generally develop normally. Systematic reviews of second-generation anti psychotics concluded that quetiapine is a first or second line choice during breastfeeding. Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.

    Side Effects

    Agranulocytosis
    Allergic skin reactions
    Anaemia
    Anaphylactic reaction
    Angioedema
    Asthenia
    Blood lipid changes
    Blurred vision
    Bradycardia
    Breast swelling
    Cardiac arrest
    Constipation
    Creatine phosphokinase increased
    Diabetes mellitus
    Dizziness
    Dose-related decrease in thyroid hormone levels
    Dream abnormalities
    Drowsiness
    Dry mouth
    Dysarthria
    Dyspepsia
    Dysphagia
    Dyspnoea
    Elevated triglyceride levels
    Eosinophilia
    Erythema multiforme
    Exacerbation of diabetes
    Extrapyramidal effects
    Falls
    Fever
    Galactorrhoea
    Gamma glutamyl transferase (GGT) increased
    Haemoglobin decrease
    Headache
    Hepatitis
    Hyperglycaemia
    Hyperprolactinaemia
    Hypersensitivity reactions
    Hyponatraemia
    Hypothermia
    Hypothyroidism
    Ileus
    Inappropriate secretion of antidiuretic hormone
    Increase in serum ALT/AST
    Increase in total cholesterol
    Increased appetite
    Increased blood pressure
    Intestinal obstruction
    Irritability
    Jaundice
    Lens changes
    Leucopenia
    Menstrual disturbances
    Metabolic disorders
    Neuroleptic malignant syndrome
    Neutropenia
    Nightmares
    Orthostatic hypotension
    Palpitations
    Pancreatitis
    Peripheral oedema
    Priapism
    Prolongation of QT interval
    Pyrexia
    Reduced neutrophil count
    Reduced platelet count
    Restless legs
    Rhabdomyolysis
    Rhinitis
    Seizures
    Sexual dysfunction
    Sleep walking
    Somnolence
    Stevens-Johnson syndrome
    Stroke
    Suicidal tendencies
    Syncope
    Tachycardia
    Tardive dyskinesia
    Thrombocytopenia
    Torsades de pointes
    Toxic epidermal necrolysis
    Urinary retention
    Venous thrombosis
    Ventricular arrhythmias
    Vomiting
    Weight gain
    Withdrawal symptoms

    Effects on Laboratory Tests

    There have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine. Confirmation of questionable immunoassay screening results by an appropriate chromatographic technique is recommended.

    Withdrawal Symptoms and Signs

    Withdrawal symptoms have been reported after abrupt withdrawal, including insomnia, nausea, headache, diarrhoea, vomiting, dizziness and irritability. Withdrawal over one to two weeks is recommended.

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: March 2018

    Reference Sources

    Summary of Product Characteristics: Atrolak 50mg, 150mg, 200mg, 300mg, 400mg, prolonged-release tablets. Accord Healthcare Ltd. Revised October 2019.

    Summary of Product Characteristics: Biquelle XL 50mg, 150mg, 200mg, 300mg, 400mg, 600mg prolonged-release tablets. Aspire pharma Ltd. Revised November 2020.

    Summary of Product Characteristics: Brancico XL 50mg prolonged-release tablets. Zentiva. Revised February 2020.
    Summary of Product Characteristics: Brancico XL 150mg prolonged-release tablets. Zentiva. Revised February 2020.
    Summary of Product Characteristics: Brancico XL 200mg prolonged-release tablets. Zentiva. Revised February 2020.
    Summary of Product Characteristics: Brancico XL 300mg prolonged-release tablets. Zentiva. Revised February 2020.
    Summary of Product Characteristics: Brancico XL 400mg prolonged-release tablets. Zentiva. Revised February 2020.

    Summary of Product Characteristics: Mintreleq XL 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets. CEB PHARMA Limited. Revised February 2015

    Summary of Product Characteristics: Seroquel XL 50mg, 150mg, 200mg, 300mg, 400mg prolonged-release tablets. AstraZeneca UK Ltd. Revised July 2016.

    Summary of Product Characteristics: Sondate XL 50mg, 150mg, 200mg, 300mg, 400mg prolonged-release tablets. Teva UK Ltd. Revised August 2018.

    Summary of Product Characteristics: Zaluron XL 50mg, 150mg, 200mg, 300mg, 400mg prolonged-release tablets. Fontus Health Ltd. Revised September 2016.

    Clinical Knowledge Summaries - Pre-conception advice and management
    Schizophrenia
    Available at: https://cks.nice.org.uk/pre-conception-advice-and-management#!scenariorecommendation:14
    Last accessed: 19 March 2018

    Clinical Knowledge Summaries - Pre-conception advice and management
    Bipolar Disorder
    Available at: https://cks.nice.org.uk/pre-conception-advice-and-management#!scenariorecommendation:13
    Last accessed: 19 March 2018

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 February 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 233 - Quetiapine
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/?term=lactmed
    Last revised: 21 September 2020
    Last accessed: 18 February 2021

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