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Drugs List

  • HALDOL 2mg/ml oral liquid sugar-free
  • HALKID 200microgram/ml oral solution
  • haloperidol 1.5mg tablets
  • haloperidol 10mg tablets
  • haloperidol 10mg/5ml oral solution sugar-free
  • haloperidol 200microgram/ml oral solution sugar-free
  • haloperidol 500microgram tablets
  • haloperidol 5mg tablets
  • haloperidol 5mg/5ml oral solution sugar-free
  • Therapeutic Indications

    Uses

    Acute delirium
    Chorea
    Gilles de la Tourette syndrome
    Motor tic
    Schizophrenia and other psychoses
    Severe acute psychomotor agitation
    Severe aggression in childhood autism (short term treatment)
    Short term treatment of aggression in mod to severe Alzheimer's dementia
    Treatment of moderate to severe manic episodes

    Treatment of schizophrenia and schizoaffective disorder in adults and children aged 13 to 18 years.

    Acute treatment of delirium when non pharmacological treatments have failed.

    Treatment of moderate to severe manic episodes associated with bipolar I disorder.

    Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.

    Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimers dementia and vascular dementia when non pharmacological treatments have failed and when there is a risk of harm to self or others.

    Treatment of tic disorders, including Tourettes syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.

    Treatment of mild to moderate chorea in Huntingtons disease, when other medicinal products are ineffective or not tolerated.

    Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.

    Unlicensed Uses

    Nausea,vomiting in terminal care when other drugs ineffective/unavailable
    Restlessness and confusion in palliative care

    Restlessness and confusion in palliative care.

    Nausea and vomiting in palliative care.

    Dosage

    Adults

    Treatment of schizophrenia and schizoaffective disorder
    2mg to 10mg per day as a single dose or in divided doses.
    Dose adjustments may be made every 1 to 7 days. Doses of up to 10mg per day are sufficient. Maximum dose is 20mg per day.

    Acute treatment of delirium
    1mg to 10mg per day. As a single dose or in 2 to 3 divided doses.
    Starting at the lowest dose and adjusted in increments at 2 to 4 hour intervals if agitation continues. Maximum dose 10mg per day.

    Treatment of moderate to severe manic episodes associated with bipolar I disorder.
    2mg to 10mg daily. As a single dose or in divided doses.
    Dose adjustments may be made every 1 to 3 days. Doses of up to 10mg per day are sufficient. Maximum dose is 15mg daily.
    Evaluate continued use early in treatment.

    Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
    5mg to 10mg, repeated after 12 hours if necessary.
    Maximum dose 20mg daily. Evaluate continued use early in treatment. When switching from haloperidol intramuscular injection, a 1:1 conversion rate should be used.

    Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimers dementia and vascular dementia when non pharmacological treatments have failed and when there is a risk of harm to self or others.
    0.5mg to 5mg per day. As a single dose or in divided doses.
    Dose adjustments may be made every 1 to 3 days. Evaluate continued use after no more than 6 weeks.

    Treatment of tic disorders, including Tourettes syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
    0.5mg to 5mg per day. As a single dose or in divided doses.
    Dose adjustments may be made every 1 to 7 days. Evaluate continued use every 6 to 12 months.

    Treatment of mild to moderate chorea in Huntingtons disease, when other medicinal products are ineffective or not tolerated.
    2mg to 10mg per day. As a single dose or in divided doses.
    Dose adjustments may be made every 1 to 3 days.

    Nausea and vomiting in palliative care (unlicensed)
    Initial dose: 1.5mg once or twice a day. Dose may be increased to 5mg to 10mg a day, given in divided doses, if considered necessary.

    Restlessness and confusion in palliative care (unlicensed)
    2mg as a single dose. Dose may be repeated every 2 hours if necessary.

    Elderly

    Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimers dementia and vascular dementia when non pharmacological treatments have failed and when there is a risk of harm to self or others.
    0.5mg per day.

    For all other indications: use 50% of the lowest adult dose.

    Maximum dose is 5mg per day.

    Doses above 5mg per day may be considered in patients who have tolerated higher doses and after reassessment of the patients benefit risk profile.

    Children

    Treatment of schizophrenia and schizoaffective disorder in adults and children aged 13 to 18 years.
    0.5mg to 3mg per day. In 2 to 3 divided doses.
    Assess the individuals benefit risk ratio when considering doses above 3mg per day.
    Maximum dose is 5mg per day. Evaluate duration individually.

    Alternative dose:
    0.25mg to 1.5mg twice a day. Alternatively 0.16mg to 1mg three times a day.
    Evaluate individual risk benefit should be assessed when considering doses above 3mg daily.
    Maximum dose 5mg per day.

    Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
    Children aged 12 to 18 years: 0.5mg to 5mg per day. In 2 to 3 divided doses.
    Children aged 6 to 12 years: 0.5mg to 3mg per day. In 2 to 3 divided doses.

    Evaluate continued use after 6 weeks.

    Alternative dose:
    Children aged 12 to 18 years: 0.25mg to 2.5mg twice daily. Alternatively 0.16mg to 1.6mg 3 times a day. Evaluate continued use after 6 weeks and regularly thereafter.
    Children aged 6 to 12 years: 0.25mg to 1.5mg twice a day. Alternatively 0.16mg to 1mg 3 times a day. Evaluate continued use after 6 weeks and regularly thereafter.

    Treatment of tic disorders, including Tourettes syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
    Children aged 10 to 18 years: 0.5mg to 3mg per day. In 2 to 3 divided doses.

    Evaluate continued use every 6 to 12 weeks.

    Alternative dose:
    Children aged 10 to 18 years: 0.25mg to 1.5mg twice daily. Alternatively 0.16mg to 1mg 3 times a day. Evaluate continued use after 6 to 12 months.

    Nausea and vomiting in palliative care (unlicensed)
    Children aged 12 to 18 years: 1.5mg once a day taken at night. Increased if necessary to 1.5mg twice a day.
    Maximum dose is 5mg twice daily.

    Restlessness and confusion in palliative care (unlicensed)
    Children aged 1 to 18 years: 10 micrograms per kg to 20 micrograms per kg every 8 to 12 hours.

    Patients with Renal Impairment

    Patients with severe renal impairment may require a lower initial dose, with subsequent adjustments at smaller increments and at longer intervals than in patients without renal impairment.

    Patients with Hepatic Impairment

    Halve the initial dose, and adjust the dose with smaller increments and at longer intervals than in patients without hepatic impairment.

    Contraindications

    Children under 1 year
    Basal ganglion lesion
    Central nervous system depression
    Coma
    Decompensated cardiac failure
    Dementia with Lewy bodies
    History of torsade de pointes
    History of ventricular arrhythmias
    Hypokalaemia
    Long QT syndrome
    Parkinson's disease
    Progressive supranuclear palsy
    Recent myocardial infarction
    Second degree atrioventricular block
    Third degree atrioventricular block
    Torsade de pointes

    Precautions and Warnings

    Children aged 1 to 6 years
    Elderly
    Family history of long QT syndrome
    Predisposition to narrow angle glaucoma
    Predisposition to seizures
    Predisposition to venous thromboembolism
    Risk of cerebrovascular accident
    Alcohol withdrawal syndrome
    Alcoholism
    Arteriosclerosis
    Benign prostatic hyperplasia
    Bradycardia
    Brain damage
    Breastfeeding
    Cardiovascular disorder
    CYP2D6 poor metaboliser genotype
    Depression
    Electrolyte imbalance
    Epileptic disorder
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    History of jaundice
    Hyperprolactinaemia
    Hypotension
    Lactose intolerance
    Myasthenia gravis
    Postural hypotension
    Pregnancy
    Prolactin-dependent neoplasm
    Renal impairment
    Severe respiratory disease
    Subarachnoid haemorrhage
    Thyroid dysfunction

    Consider preventative measures in patients at risk of thromboembolism
    Correct electrolyte disorders before treatment
    Reduce dose and/or alter dose interval in patients with hepatic impairment
    Reduce dose in patients with severe renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Not all available brands are licensed for all indications
    Not suitable as sole treatment of depression or anxiety with depression
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Perform ECG before and during treatment
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Monitor serum electrolytes
    Monitor serum prolactin during long-term use
    Do not increase dosage in patients who develop akathisia
    If hypotension requiring a vasopressor occurs adrenaline should not be used
    May cause or exacerbate extrapyramidal symptoms
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Review treatment if dystonia occurs following initiation or dose increases
    Avoid abrupt withdrawal
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if tardive dyskinesia occurs
    Discontinue treatment if QTc exceeds 500msec
    Dose adjustment required if patient starts/stops smoking during therapy
    Maintain treatment at the lowest effective dose
    Not licensed for all indications in all age groups
    Reduce dose in elderly
    Advise patient not to take St John's wort concurrently
    Advise that effects are potentiated by CNS depressants (including alcohol)
    May cause impaired fertility
    Advise patient to avoid exposure to direct sunlight

    Evaluate the risk-benefit of treatment in patients with risk factors for ventricular arrhythmias such as a personal or family history of QT prolongation, cardiac disease, subarachnoid haemorrhage, uncorrected electrolyte disturbances (e.g. hypokalaemia, hypocalcaemia, hypomagnesaemia), starvation, alcohol abuse or a family history of sudden death.

    Reduce dose if QT interval is prolonged and discontinue if time exceeds 500 milliseconds.

    Discontinue treatment immediately if neuroleptic malignant syndrome occurs. Signs of autonomic dysfunction such as tachycardia, labile arterial pressure and sweating may precede onset of hyperthermia acting as early warning signs.

    In schizophrenia, response to haloperidol may be delayed. If treatment is withdrawn the reoccurrence of symptoms may not become apparent for some time.

    Increased mortality has been reported following use of haloperidol in elderly patients with dementia. The extent to which this association is attributable to haloperidol itself as opposed to the patient characteristics is unclear.

    Use in elderly patients is associated with an increased risk of stroke. The mechanism for this increased risk is unclear but caution should be exercised in patients with risk factors for stroke.

    Tardive dyskinesia may occur during long term treatment or following discontinuation. Symptoms typically include rhythmic voluntary movements of the tongue, face, mouth or jaw and can be permanent. Consider discontinuing all antipsychotics at the first appearance of signs or symptoms. It should be noted, the syndrome can be masked when treatment is reinstated, doses are increased or treatment is switched to another antipsychotic.

    Haloperidol is associated with the development of akathisia, usually during the first few weeks of treatment. Dose increases should be avoided in patients experiencing akathisia.

    Acute dystonias have been reported during the first few days of treatment but can also occur during later treatment, particularly following dose increases. Male patients and young adults are at a higher risk of experiencing reactions. Acute dystonia may require treatment discontinuation.

    Extrapyramidal symptoms are often managed with antiparkinson medicines. Whilst they can be effective in managing the side effects, concomitant use with haloperidol can have further negative side effects, particularly medicines with anticholinergic properties. As such they should only be used to treat extrapyramidal side effects rather than for prevention and use should be restricted where possible.

    Caution is advised in patients with thyroid disorders as thyroxine may facilitate haloperidol toxicity. Patients with hyperthyroidism must be managed with appropriate treatment to maintain a euthyroid state.

    Raised prolactin may suppress hypothalamic GnRH which may inhibit reproductive function in both female and male patients.

    Use with caution in patients who are poor metabolisers of CYP2D6 as they may be more susceptible to interactions with other medicines.

    Pregnancy and Lactation

    Pregnancy

    Use haloperidol with caution in pregnancy.

    The data available regarding haloperidol use in pregnancy suggests there is no malformative or foetal neonatal toxicity. However there have been isolated case reports of birth defects following foetal exposure to haloperidol. Animal studies have shown reproductive toxicity.

    Manufacturers recommend avoiding the use of haloperidol in pregnancy, particularly in the first trimester.

    Neonates exposed to antipsychotic drugs during the third trimester are at risk of adverse effects including extrapyramidal and withdrawal symptoms such as agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding problems. Dose reduction or interruption may be considered in the days preceding delivery. When used up to delivery it is advised that the neonate be monitored for at least 2 days for adaptation problems.

    Where patients are already stable on an antipsychotic and are likely to relapse without medication, continuation of treatment with close monitoring is advised. The potential for relapse should treatment change or stop should always be considered as an untreated severe psychiatric illness can have a significant impact on maternal and foetal health. Where patients wish to discontinue antipsychotic therapy during pregnancy, the potential risk of relapse should be discussed and where possible, appropriate psychological interventions offered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use haloperidol with caution in breastfeeding.

    Haloperidol is excreted in breast milk. However, there is insufficient information on the effects of haloperidol in breastfed infants. Manufacturers advise a decision should be made whether to discontinue breastfeeding or to discontinue haloperidol therapy, taking into account the benefit of the child and therapy for the woman.

    Schaefer (2015) advises that weaning of medication or limitations on breastfeeding are not required in patients well established on haloperidol. The potential for relapse should treatment change or stop should be considered as an untreated severe psychiatric illness can lead to disruption of the early mother-baby relationship. Where patients wish to discontinue antipsychotic therapy during breastfeeding, the potential risk of relapse should be discussed and where possible, appropriate psychological interventions offered.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Agitation
    Agranulocytosis
    Akathisia
    Akinesia
    Altered liver function tests
    Amenorrhoea
    Antimuscarinic effects
    Arrhythmias
    Blood pressure changes
    Blurred vision
    Bradykinesia
    Breast pain
    Bronchospasm
    Cardiac arrest
    Cholestasis
    Confusion
    Convulsions
    Depression
    Dizziness
    Dry mouth
    Dyskinesia
    Dysmenorrhoea
    Dyspnoea
    Dystonia
    ECG changes
    Exfoliative dermatitis
    Extrapyramidal effects
    Extrasystoles
    Facial oedema
    Gait abnormality
    Galactorrhoea
    Gastrointestinal disorder
    Glaucoma (closed angle)
    Gynaecomastia
    Headache
    Hepatic failure
    Hepatitis
    Hyperhidrosis
    Hyperkinesia
    Hyperprolactinaemia
    Hypersalivation
    Hypersensitivity reactions including anaphylaxis
    Hyperthermia
    Hypertonia
    Hypoglycaemia
    Hypokinesia
    Hypothermia
    Inappropriate secretion of antidiuretic hormone
    Insomnia
    Involuntary muscle contractions
    Jaundice
    Laryngeal oedema
    Laryngospasm
    Lens opacities
    Leucopenia
    Leukocytoclastic vasculitis
    Loss of libido
    Menorrhagia
    Menstrual disturbances
    Micturition disorders
    Muscle rigidity
    Muscle spasm
    Musculoskeletal disturbances
    Neuroleptic malignant syndrome
    Neutropenia
    Nystagmus
    Oculogyric crisis
    Oedema
    Pancytopenia
    Parkinsonism
    Photosensitivity
    Priapism
    Prolongation of QT interval
    Pruritus
    Psychotic disorder
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Rash
    Restlessness
    Rigidity
    Sedation
    Sexual dysfunction
    Somnolence
    Stevens-Johnson syndrome
    Sudden death reported
    Tachycardia
    Tardive dyskinesia
    Thrombocytopenia
    Thromboembolism
    Torsades de pointes
    Torticollis
    Toxic epidermal necrolysis
    Tremor
    Trismus
    Urticaria
    Ventricular fibrillation
    Ventricular tachycardia
    Visual disturbances
    Weight changes

    Withdrawal Symptoms and Signs

    Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been reported after abrupt discontinuation of high doses of antipsychotic drugs. Relapse may also occur and gradual withdrawal is advisable.

    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: October 2018

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Haldol tablets and oral solution. Janssen-Cilag Ltd. Revised June 2017.
    Summary of Product Characteristics: Halkid 200 micrograms/ml oral solution. Thame laboratories Ltd. Revised January 2018.
    Summary of Product Characteristics: Haloperidol 1.5mg, 5mg, 10mg, & 20mg tablets. Teva. Revised June 2017.
    Summary of Product Characteristics: Haloperidol 500mcg capsules. Teva. Revised January 2012.
    Summary of Product Characteristics: Haloperidol oral solution 5mg/5ml and 10mg/5ml. Pinewood Pharmaceuticals. Revised October 2017.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Haloperidol Last revised: 01 October 2018
    Last accessed: 18 October 2018

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 October 2018

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