Haloperidol injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing haloperidol
Drugs List
Therapeutic Indications
Uses
Acute delirium
Chorea
Post operative nausea and vomiting
Post-operative nausea and vomiting: prevention
Severe acute psychomotor agitation
Acute treatment of delirium when non-pharmacological treatments have failed.
Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Treatment of mild to moderate chorea in Huntingtons disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated.
Unlicensed Uses
Nausea,vomiting in terminal care when other drugs ineffective/unavailable
Restlessness and confusion in palliative care
Nausea and vomiting in palliative care.
Restlessness and confusion in palliative care.
Dosage
Adults
Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Initial dose: 5mg by intramuscular injection.
The dose maybe repeated hourly until sufficient symptoms control is achieved. Doses of up to 15mg per day are sufficient. Maximum dose is 20mg per day.
Evaluate continued use early in treatment. If further treatment is required, treatment should be converted to oral haloperidol at a 1:1 conversion rate.
Acute treatment of delirium when non-pharmacological treatments have failed.
Initial dose: 1mg to 10mg by intramuscular injection.
Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2 to 4 hour intervals if agitation continues, up to a maximum of 10mg per day.
Treatment of mild to moderate chorea in Huntingtons disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Initial dose: 2 to 5mg by intramuscular injection.
The dose may be repeated hourly until sufficient symptom control is achieved or up to a maximum of 10mg per day.
Post operative nausea and vomiting.
1mg to 2mg by intramuscular injection. For prevention, the dose should be administered at induction or 30 minutes before the end of anaesthesia.
Nausea and vomiting in palliative care (unlicensed)
2.5mg to 10mg over 24 hours by subcutaneous infusion.
Restlessness and confusion in palliative care (unlicensed)
Continuous use: 5mg to 15mg per 24 hours as a continuous subcutaneous infusion.
As required use: 2.5mg by subcutaneous injection repeated every 2 hours if required.
Elderly
The recommended initial haloperidol dose in elderly patients is half the lowest adult dose.
Further doses may be administered and adjusted according to the patients response. Careful and gradual dose up titration in elderly patients is recommended.
The maximum dose is 5mg per day.
Doses above 5mg per day should only be considered in patients who have tolerated higher doses and after reassessment of the patients individual benefit-risk profile.
Alternative dose for nausea and vomiting
500micrograms by intramuscular injection. For prevention, the dose should be administered at induction or 30 minutes before the end of anaesthesia.
Children
Nausea and vomiting in palliative care (unlicensed)
Children aged 12 to 18 years
1.5mg to 5mg over 24 hours by continuous intravenous or subcutaneous infusion.
Children aged 1 month to 12 years
25micrograms/kg to 85micrograms/kg over 24 hours by continuous intravenous or subcutaneous infusion.
Patients with Renal Impairment
Start with small doses in severe impairment due to the risk of increased cerebral sensitivity.
Patients with Hepatic Impairment
Reduce the initial dose by 50% and administer subsequent doses according to response.
Administration
Licensed for intramuscular injection only.
May be administered unlicensed for some indications as a subcutaneous injection, continuous subcutaneous infusion or a continuous intravenous infusion.
Contraindications
Neonates under 1 month
Basal ganglion lesion
Bradycardia
Central nervous system depression
Coma
History of ventricular arrhythmias
Hypokalaemia
Long QT syndrome
Parkinson's disease
Phaeochromocytoma
Second degree atrioventricular block
Severe cardiac disorder
Third degree atrioventricular block
Torsade de pointes
Precautions and Warnings
Children 1 month to 18 years
Debilitation
Elderly
Family history of long QT syndrome
Family history of sudden death
Predisposition to epileptic disorder
Predisposition to narrow angle glaucoma
Prolonged starvation
Risk of cerebrovascular accident
Alcohol withdrawal syndrome
Alcoholism
Benign prostatic hyperplasia
Brain damage
Breastfeeding
Cardiovascular disorder
Dementia
Depression
Electrolyte imbalance
Epileptic disorder
Haematological disorder
Hepatic disorder
Hepatic impairment
History of jaundice
History of neuroleptic malignant syndrome
History of torsade de pointes
Myasthenia gravis
Pregnancy
Prolactin-dependent neoplasm
Severe renal impairment
Severe respiratory disease
Subarachnoid haemorrhage
Thyroid dysfunction
Ventricular arrhythmias
Correct electrolyte disorders before treatment
Advise impaired alertness may affect ability to drive or operate machinery
May reduce seizure threshold
Not suitable as sole treatment of depression or anxiety with depression
Perform ECG before and during treatment
Monitor ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor serum electrolytes
Fine vermicular movements of the tongue may be sign of tardive dyskinesia
If hypotension requiring a vasopressor occurs adrenaline should not be used
Increased risk for venous thromboembolism - take preventive measures
May cause or exacerbate extrapyramidal symptoms
Potential for withdrawal symptoms
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
Not licensed for all indications in all age groups
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient to avoid exposure to direct sunlight
In schizophrenia, response to haloperidol may be delayed. If treatment is withdrawn the reoccurrence of symptoms may not become apparent for some time.
Dementia patients treated with antipsychotics have been found to be at a greater risk of death. haloperidol is not licensed for the treatment of dementia related behavioural disturbances.
Gradual withdrawal is recommended as relapse and acute withdrawal symptoms may occur after abrupt cessation of high doses of antipsychotic drugs.
Pregnancy and Lactation
Pregnancy
Use haloperidol with caution in pregnancy.
The anticipated benefit of the use of haloperidol during human pregnancy should be weighed against the potential hazards to the mother and foetus. The safety of haloperidol in pregnancy has not been confirmed. Animal studies suggest moderate risk and there have been some reports of limb defects in 1st trimester use, however a causative link has not been established. The dose and duration of treatment should be as low and short as possible and avoiding the first trimester if possible.
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.
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. There have been cases of drowsiness and extrapyramidal symptoms in breast-fed children including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding problems. If the use of haloperidol is essential, the benefits of breast feeding should be balanced against the potential risks.
Note that haloperidol has the potential to cause hyperprolactinaemia which in turn can cause galactorrhoea.
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
Counselling
Haloperidol may impair alertness, this may affect the patient's ability to drive and operate machinery, and so patients should be advised not to until their individual susceptibility is known.
Advise patients to avoid direct sunlight as photosensitisation may occur with higher doses.
Potentiates the effect of alcohol. Advise patients to avoid alcohol while on haloperidol therapy.
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
Constipation
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
Local reaction at injection site
Loss of libido
Menorrhagia
Menstrual disturbances
Micturition disorders
Muscle rigidity
Muscle spasm
Musculoskeletal disturbances
Neuroleptic malignant syndrome
Neutropenia
Nystagmus
Oculogyric crisis
Oedema
Orthostatic hypotension
Pancytopenia
Parkinsonism
Photosensitivity
Priapism
Prolongation of QT interval
Pruritus
Psychotic disorder
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
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: May 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Haldol Injection. Janssen-Cilag Ltd. Revised November 2011
Summary of Product Characteristics: Haloperidol 5mg/ml injection. Concordia International - formerly AMCo. Revised September 2017.
Summary of Product Characteristics: Haloperidol injection BP 5mg/ml. Mercury Pharma International Ltd. Revised January 2014.
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: 10 December 2015
Last accessed: 09 May 2106
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 September 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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