Haloperidol decanoate parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Depot injections of haloperidol decanoate.
Maintenance treatment of schizophrenia
Treatment of schizoaffective disorder with psychotic or manic symptoms
Maintenance treatment of schizophrenia or shizoaffective disorder in patients stabilised on oral haloperidol.
Initial dose requirements should be guided by the patient's previous dose of oral haloperidol and severity of symptoms.
Due to the long acting nature of haloperidol decanoate injections, supplementation with oral haloperidol may be required during the initial treatment period. Dosing of oral supplementation should be regularly reviewed and adjusted according to symptoms and tolerability. The combined daily dose of oral and depot haloperidol must not exceed the corresponding maximum oral haloperidol dose.
10 to 15 times the current daily dose of oral haloperidol. This usually equates to around 25mg to 150mg.
Titration and maintenance
Increase in steps of up to 50mg every 4 weeks according to individual patient response and tolerability.
A maintenance dose of between 50mg and 200mg every 4 weeks is expected to be effective.
Only use doses above 200mg every 4 weeks following an assessment of benefits and risks.
Maximum dose 300mg every 4 weeks.
Additional supplementation with oral haloperidol
If during initial treatment supplementation with oral haloperidol is required, the combined maximum daily dose of oral and depot haloperidol must not exceed the equivalent of 20mg oral haloperidol. A range of equivalent doses are reported in the literature but 2mg per day of oral haloperidol is considered approximately equivalent to 15mg per week of haloperidol decanoate injection.
A lower initial dose of 12.5mg to 25mg is recommended.
Titration and maintenance
Further dose increases should only be made if the initial dose is not sufficient to manage symptoms.
A maintenance dose of between 25mg and 75mg every 4 weeks is expected to be effective.
Only use doses above 75mg every 4 weeks in patients who have previously tolerated higher antipsychotic doses and following an assessment of benefits and risks.
Additional supplementation with oral haloperidol
If during initial treatment supplementation with oral haloperidol is required, the combined maximum daily dose of oral and depot haloperidol must not exceed the equivalent of 5mg oral haloperidol. This dose may only be exceeded in patients who previously received more than 5mg per day of oral haloperidol or in patients who have received long term treatment with oral haloperidol. A range of equivalent doses are reported in the literature but 2mg per day of oral haloperidol is considered approximately equivalent to 15mg per week of haloperidol decanoate injection.
Patients with Renal Impairment
Severe renal impairment
Reduce the initial dose. Undertake any dose increases in smaller increments and at longer intervals.
Patients with Hepatic Impairment
Hepatic impairment (all stages)
Halve the initial dose. Undertake any dose increases in smaller increments and at longer intervals.
Additional Dosage Information
Dose modifications due to QT prolongation
QTc prolonged but less than 500ms:Reduce the dose and monitor QTc closely.
QTc exceeds 500ms: Discontinue treatment.
Abrupt withdrawal is not recommended due to a higher risk of relapse. Treatment should be gradually withdrawn with regular review of symptoms. This includes transfer to other antipsychotic medication.
Due to the long acting nature of haloperidol decanoate, concomitant medication used to manage side effects (e.g. extrapyramidal symptoms) may need to be continued as effects can persist beyond discontinuation of the injection. These concomitant medicines should be regularly reviewed however and reduced/stopped when able.
For deep intramuscular injection in the gluteal region only.
Rotate administration between the two gluteal muscles.
If doses above 300mg are used (unlicensed), administration must be split into two separate injections as administration of volumes above 3ml may cause discomfort.
Children under 18 years
Hypersensitivity to benzyl alcohol
Basal ganglion lesion
Central nervous system depression
Decompensated cardiac failure
Dementia with Lewy bodies
History of torsade de pointes
History of ventricular arrhythmias
Long QT syndrome
Progressive supranuclear palsy
Recent myocardial infarction
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
History of high alcohol intake
Predisposition to narrow angle glaucoma
Predisposition to seizures
Risk of cerebrovascular accident
Alcohol withdrawal syndrome
Benign prostatic hyperplasia
CYP2D6 poor metaboliser genotype
History of jaundice
Severe renal impairment
Severe respiratory disease
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 suitable as sole treatment of depression or anxiety with depression
Some presentations may contain benzyl alcohol
Some products contain sesame oil
Use correct injection technique e.g. z-track technique
Vary injection site during prolonged therapy
Monitor serum electrolytes before and during treatment
Perform ECG before and during treatment
Monitor patients at risk for signs & symptoms of thromboembolism
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
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Review treatment if dystonia occurs following initiation or dose increases
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
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
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, however haloperidol decanoate must not be used to treat dementia-related behavioural disturbances.
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.
Haloperidol may lead to increases in prolactin. Studies have suggested prolactin may stimulate cell growth in human breast tumours. No clear association with the use of antipsychotics has been demonstrated but caution should be exercised in patients with prolactin-dependent tumours and patients with pre-existing hyperprolactinaemia. Raised prolactin may also suppress hypothalamic GnRH which may inhibit reproductive function in both female and male patients. Whist not stated in the manufacturer's information, other sources advise regular monitoring of prolactin levels during treatment.
Patients requiring antipsychotic treatment are thought to present with acquired risk factors for venous thromboembolism (VTE). As such, all risk factors for VTE should be identified and (where possible) managed prior to and during treatment.
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
Use haloperidol decanoate with caution in pregnancy.
An increased risk of spontaneous abortion, congenital anomaly and low birth weight has been reported with antipsychotics. No malformative or foetal toxicities have been shown following exposure to haloperidol, however published data is limited and animal studies have shown reproductive toxicity. Birth defects have been reported in isolated cases but these have followed use of haloperidol in combination with other medication. Tardive dyskinesia in the neonate may occur, particularly following use in the later stages of pregnancy. Newborn infants exposed during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal symptoms and/or withdrawal symptoms and data has indicated an increased risk of preterm delivery. As such, all newborn infants should be closely monitored. Long term effects on neurodevelopment are currently unknown. The manufacturer advises that haloperidol decanoate is avoided during pregnancy.
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. Due to the long acting nature of haloperidol decanoate, use of depots during pregnancy is only recommended where there is a risk of non-compliance to oral medication. Transfer to oral haloperidol may be considered but this process will carry potential for relapse and/or emergence of side effects and will be difficult to achieve rapidly in patients well established on the depot injection. 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 ).
Use haloperidol decanoate with caution in breastfeeding.
Haloperidol is excreted in human milk in small quantities. Whilst available data is limited, no adverse effects have been noted in exposed infants and long term follow up data has not indicated any adverse developmental effects when haloperidol is used alone. Because of the long acting nature of haloperidol decanoate, treatment cannot be rapidly withdrawn should adverse effects to the infant occur. Due to the lack of available information, the manufacturer advises either discontinuing breastfeeding or discontinuing treatment.
Schaefer (2015) advises that weaning of medication or limitations on breastfeeding are not required in patients well established on haloperidol decanoate. 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. Changes to medication will carry potential for relapse and/or emergence of side effects and will be difficult to achieve rapidly in patients well established on the depot injection. Initiation of haloperidol decanoate during breastfeeding is not recommended and where possible, an oral antipsychotic is preferred. 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
Altered liver function tests
Blood pressure changes
Glaucoma (closed angle)
Hypersensitivity reactions including anaphylaxis
Inappropriate secretion of antidiuretic hormone
Involuntary muscle contractions
Local reaction at injection site
Loss of libido
Neuroleptic malignant syndrome
Prolongation of QT interval
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Sudden death reported
Torsades de pointes
Toxic epidermal necrolysis
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 ).
Last Full Review Date: March 2018
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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 decanoate. Jansen-Cilag Ltd. Revised June 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 March 2018
UK teratology information service (UKTIS).
Available at: https://www.medicinesinpregnancy.org/bumps/monographs/USE-OF-HALOPERIDOL-IN-PREGNANCY/
Version 2 Last revised August 2014
Last accessed: 09 March 2018
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: 07 December 2016
Last accessed: 08 March 2018
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