Formulary
Haloperidol decanoate: Indications, Dosing, Side Effects and Interactions
Haloperidol decanoate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Haloperidol decanoate: Indications, Dosing, Side Effects and Interactions
Haloperidol decanoate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Maintenance in schizophrenia and schizoaffective disorder [in patients currently stabilised on oral haloperidol]**
- **Adult** (By Deep Intramuscular Injection): Initially 25-150 mg every 4 weeks, initial dose should be based on previous daily dose of oral haloperidol (10-15 times the daily dose of oral haloperidol is recommended), adjusted in steps of up to 50 mg every 4 weeks if required, adjustment of the dosing interval may be required, depending on individual patient response; usual maintenance 50-200 mg every 4 weeks (max. per dose 300 mg every 4 weeks), dose to be administered into gluteal muscle, the individual benefit-risk should be assessed when considering doses above 200 mg every 4 weeks, if supplementation with oral haloperidol is required, the combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 20 mg per day.
- **Elderly** (By Deep Intramuscular Injection): Initially 12.5-25 mg every 4 weeks, increased if necessary to 25-75 mg every 4 weeks, adjustment of the dosing interval may be required, depending on individual patient response, dose to be administered into gluteal muscle, doses above 75 mg every 4 weeks should only be considered in patients who have tolerated higher doses and after reassessment of the individual benefit-risk, if supplementation with oral haloperidol is required, the combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 5 mg per day, or the previously administered oral haloperidol dose in patients who have received long-term treatment with oral haloperidol.
Cautions
For all antipsychotic drugs Blood dyscrasias; cardiovascular disease; conditions predisposing to seizures; depression; diabetes (may raise blood glucose); epilepsy; history of jaundice; myasthenia gravis; Parkinson's disease (may be exacerbated); photosensitisation (may occur with higher dosages); prostatic hypertrophy; severe respiratory disease; susceptibility to angle-closure glaucoma Cautions, further information Cardiovascular disease An ECG may be required, particularly if physical examination identifies cardiovascular risk factors, personal history of cardiovascular disease, or if the patient is being admitted as an inpatient. Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: for all antipsychotics (other than quetiapine and clozapine) in patients with parkinsonism or Lewy Body Disease (risk of severe extrapyramidal symptoms) in behavioural and psychological symptoms of dementia (BPSD), unless symptoms are severe and other non-pharmacological treatments have failed (increased risk of stroke) for use as a hypnotic, unless sleep disorder is due to psychosis or dementia (risk of confusion, hypotension, extrapyramidal side-effects, and falls) in patients prone to falls (may cause gait dyspraxia, parkinsonism) if prescribed a phenothiazine (other than prochlorperazine for nausea, vomiting, or vertigo; chlorpromazine for relief of persistent hiccups; levomepromazine as an antiemetic in palliative care) as first-line treatment (sedative, significant antimuscarinic (anticholinergic) toxicity in older people, and safer and more efficacious alternatives exist) if prescribed an antipsychotic drug with moderate or marked antimuscarinic effects (e.g. chlorpromazine, clozapine, flupenthixol, fluphenazine, pipothiazine, promazine, and zuclopenthixol) in patients with a history of prostatism or urinary retention (high risk of urinary retention) Cautions For haloperidol decanoate Bradycardia; electrolyte disturbances (correct before treatment initiation); family history of QTc-interval prolongation; history of heavy alcohol exposure; hyperthyroidism; hypotension (including orthostatic hypotension); prolactin-dependent tumours; prolactinaemia; risk factors for stroke; when transferring from oral to depot therapy, the dose by mouth should be reduced gradually
Contraindications
CNS depression; comatose states; congenital long QT syndrome; dementia with Lewy bodies; history of torsade de pointes; history of ventricular arrhythmia; Parkinson's disease; progressive supranuclear palsy; QT-interval prolongation; recent acute myocardial infarction; uncompensated heart failure; uncorrected hypokalaemia
Side effects
For all antipsychotic drugs Common or very common Agitation; amenorrhoea; arrhythmias; constipation; dizziness; drowsiness; dry mouth; erectile dysfunction; fatigue; galactorrhoea; gynaecomastia; hyperglycaemia; hyperprolactinaemia; hypersalivation; hypotension (dose-related); insomnia; leucopenia; movement disorders; muscle rigidity; neutropenia; parkinsonism; postural hypotension (dose-related); QT interval prolongation; rash; seizure; tremor; urinary retention; vomiting; weight increased Uncommon Agranulocytosis; confusion; neuroleptic malignant syndrome (discontinue-potentially fatal) Rare or very rare Sudden death; withdrawal syndrome neonatal Side-effects, further information For depot antipsychotics-side-effects may persist until the drug has been cleared from its depot site. Overdose Phenothiazines cause less depression of consciousness and respiration than other sedatives. Hypotension, hypothermia, sinus tachycardia, and arrhythmias may complicate poisoning. For details on the management of poisoning see Antipsychotics under Emergency treatment of poisoning . Side-effects For haloperidol decanoate Common or very common Depression; sexual dysfunction Uncommon Eye disorders; headache; neuromuscular dysfunction; vision disorders Frequency not known Angioedema; breast abnormalities; cardiac arrest; dyspnoea; gait abnormal; hepatic disorders; hyperhidrosis; hypersensitivity vasculitis; hypoglycaemia; menstrual cycle irregularities; muscle complaints; musculoskeletal stiffness; nausea; oedema; pancytopenia; photosensitivity reaction; psychotic disorder; respiratory disorders; restlessness; rhabdomyolysis; SIADH; skin reactions; temperature regulation disorders; thrombocytopenia; trismus; weight decreased Side-effects, further information Haloperidol is a less sedating antipsychotic.
Interactions
**Other interactions (21):**
- Examples include: Class IA antiarrhythmics (e.g.
- Medicinal products that may increase haloperidol plasma concentrations Haloperidol is metabolised by several routes (see section 5.2).
- Inhibition of these routes of metabolism by another medicinal product or a decrease in CYP2D6 enzyme activity may result in increased haloperidol concentrations.
- Based on limited and sometimes conflicting information, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to...
- Examples of medicinal products that may increase haloperidol plasma concentrations (based on clinical experience or drug interaction mechanism) include: CYP3A4 inhibitors - alprazolam,...
- Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc-prolongation (see section 4.4).
Pregnancy
For all antipsychotic drugs Extrapyramidal effects and withdrawal syndrome have been reported occasionally in the neonate when antipsychotic drugs are taken during the third trimester of pregnancy. Following maternal use of antipsychotic drugs in the third trimester, neonates should be monitored for symptoms including agitation, hypertonia, hypotonia, tremor, drowsiness, feeding problems, and respiratory distress. Pregnancy For haloperidol decanoate Manufacturer advises it is preferable to avoid-moderate amount of data indicate no malformative or fetal/neonatal toxicity, however there are isolated case reports of birth defects following fetal exposure, mostly in combination with other drugs; reproductive toxicity shown in animal studies.
Breast feeding
For all antipsychotic drugs There is limited information available on the short- and long-term effects of antipsychotic drugs on the breast-fed infant. Animal studies indicate possible adverse effects of antipsychotic medicines on the developing nervous system. Chronic treatment with antipsychotic drugs whilst breast-feeding should be avoided unless absolutely necessary. Phenothiazine derivatives are sometimes used in breast-feeding women for short-term treatment of nausea and vomiting.
Hepatic impairment
Manufacturer advises caution. Dose adjustments Manufacturer advises halve initial dose and then adjust if necessary with smaller increments and at longer intervals.
Renal impairment
Manufacturer advises use with caution. Dose adjustments Manufacturer advises consider lower initial dose in severe impairment and then adjust if necessary with smaller increments and at longer intervals.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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