Haloperidol oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Drugs List
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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