Prescribing information For Healthcare Professionals Only

ACTIVE INGREDIENT(S):

Haloperidol

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S):

Adults (≥ 18 years): Schizophrenia and schizoaffective disorder; acute treatment of delirium when non-pharmacological treatments failed; moderate to severe manic episodes associated with bipolar I disorder; acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder; persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when non-pharmacological treatments failed and risk of harm to self/others; tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments failed; mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective/not tolerated.
Paediatric patients: Schizophrenia in 13 to 17 year olds when other pharmacological treatments failed/not tolerated; persistent, severe aggression in 6 to 17 year olds with autism or pervasive developmental disorders, when other treatments failed/not tolerated; tic disorders, including Tourette’s syndrome, in 10 to 17 year olds with severe impairment after educational, psychological and other pharmacological treatments failed.

DOSAGE & ADMINISTRATION:

Oral use.
Adults: 
Low initial dose recommended, adjusted according to patient's response. Schizophrenia/ schizoaffective disorder: 2 - 10 mg/day (single or 2 divided doses); adjust dose every 1-7 days. Maximum dose: 20 mg/day.
Delirium: 1 - 10 mg/day (single or 2-3 divided doses); adjust at 2- to 4-hour intervals if necessary. Maximum dose: 10 mg/day. Severe manic episodes with bipolar I disorder: 2 - 10 mg/day (single or 2 divided doses); adjust dose every 1-3 days. Maximum dose: 15 mg/day. Acute psychomotor agitation with psychotic disorder or manic episodes with bipolar I disorder: 5 - 10 mg, repeated after 12 hours if necessary. Maximum dose: 20 mg/day. Persistent aggression/psychotic symptoms in patients with moderate/severe Alzheimer’s dementia and vascular dementia: 0.5 - 5 mg/day (single or 2 divided doses); adjust dose every 1-3 days. Reassess need for continued treatment before 6 weeks. Tic disorders: 0.5 - 5 mg/day (single or 2 divided doses); adjust dose every 1-7 days. Reassess need for continued treatment every 6-12 months. Mild to moderate chorea in Huntington’s disease: 2 - 10 mg/day (single or 2 divided doses); adjust dose every 1-3 days.

Elderly: Persistent aggression/psychotic symptoms in patients with moderate/severe Alzheimer’s dementia and vascular dementia: 0.5 mg/day. All other indications: Half lowest adult dose. Maximum dose: 5 mg/day. 
Renal impairment: Not evaluated. Caution but no dose adjustment recommended. Hepatic impairment: Not evaluated. Halve initial dose and adjust with smaller increments at longer intervals.

Children:
Schizophrenia: 13 to 17 years: 0.5 - 3 mg/day, in divided doses (2-3 times a day). Maximum dose: 5 mg/day.
Persistent, severe aggression with autism/pervasive developmental disorders: 6 – 11 years: 0.5 - 3 mg/day. 12 to 17 years: 0.5 - 5 mg/day. In divided doses (2-3 times a day). Reassess need for treatment after 6 weeks. Tic disorders: 10 to 17 years: 0.5 - 3 mg/day in divided doses (2-3 times a day). Reassess need for treatment every 6-12 months. Safety/efficacy in children below ages stated have not been established. 

Gradual withdrawal required.

CONTRAINDICATIONS:

Comatose state; CNS depression; Parkinson’s disease; Dementia with Lewy bodies; Progressive supranuclear palsy; Known QTc interval prolongation or congenital long QT syndrome; Recent acute myocardial infarction; Uncompensated heart failure; History of ventricular arrhythmia or torsades de pointes; Uncorrected hypokalaemia; Concomitant treatment with medicinal products that prolong the QT interval; Hypersensitivity to any ingredient.

SPECIAL WARNINGS & PRECAUTIONS:

Increased mortality in elderly with dementia and dementia-related psychosis (but Haldol® not indicated). Sudden death reported rarely. Cardiovascular effects: QTc prolongation and/or ventricular arrhythmias; risk increases with high doses/high plasma concentrations/in predisposed patients/with parenteral use. Caution in patients with bradycardia, cardiac disease, family history of QTc prolongation, history of heavy alcohol exposure, poor CYP2D6 metabolisers. Baseline ECG recommended. Discontinue Haldol® if QTc > 500 ms. Baseline and periodic electrolyte monitoring recommended; if abnormal, correct before treatment with Haldol® starts. Caution in patients with hypotension or orthostatic hypotension. Cerebrovascular events: caution in patients with risk factors for stroke. Neuroleptic malignant syndrome: Withdraw treatment immediately if symptoms seen; give supportive therapy and monitor. Tardive dyskinesia: May appear after long-term therapy (or discontinuation); may be permanent/masked; consider discontinuing all antipsychotic treatment. Extrapyramidal symptoms (EPS): May occur, most likely in first weeks; increasing dose may be detrimental. Preventive anticholinergic antiparkinson drugs not to be prescribed routinely but may have to be continued after stopping Haldol®; possible increase in intraocular pressure with concomitant anticholinergic drugs. Seizures/Convulsions: Caution in epilepsy and conditions predisposing to seizures. Hepatobiliary: Metabolised by liver; isolated cases of liver function abnormalities/hepatitis (mostly cholestatic). Endocrine system: Caution in hyperthyroidism; add therapy to achieve euthyroid state. Hormonal effects of antipsychotics include hyperprolactinaemia; caution in patients with pre-existing hyperprolactinaemia and possible prolactin-dependent tumours. Hypoglycaemia and inappropriate antidiuretic hormone secretion reported. Venous thromboembolism (VTE): Cases reported with antipsychotic drugs;

identify all possible risk factors for VTE before/during treatment and take preventive measures. Treatment response/withdrawal: Possible delayed response to antipsychotics. Gradually withdraw drug; very rare reports of acute withdrawal symptoms after abrupt withdrawal. Recurrence of symptoms may not become apparent for several weeks/months Depression: Not to be used alone where depression is predominant. Switch from mania to depression: Risk in patients treated for manic episodes in bipolar disorder; monitor for signs including suicidal behaviour and intervene if seen. Haldol oral solution contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

SIDE EFFECTS:

Very common: Agitation, insomnia, extrapyramidal disorder, hyperkinesia, headache.
Common: Depression, psychotic disorder, tardive dyskinesia, akathisia, bradykinesia, dyskinesia, dystonia, hypokinesia, hypertonia, dizziness, somnolence, tremor, oculogyric crisis, visual disturbance, hypotension (including orthostatic), vomiting, nausea, constipation, dry mouth, salivary hypersecretion, liver function test abnormal, rash, urinary retention, erectile dysfunction, weight increased/decreased.
Other side effects: Leukopenia, agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, anaphylactic reaction, hyperprolactinaemia, inappropriate antidiuretic hormone secretion, convulsion, parkinsonism, neuroleptic malignant syndrome, tachycardia, ventricular fibrillation, Torsade de pointes, extrasystoles, acute hepatic failure, cholestasis, hepatitis, jaundice, leukocytoclastic vasculitis, dermatitis exfoliative, angioedema, trismus, rhabdomyolysis, drug withdrawal syndrome neonatal, priapism, sudden death, electrocardiogram QT prolonged. Class effects: cardiac arrest and venous thromboembolism (including cases of pulmonary embolism and deep vein thrombosis).

Refer to SmPC for other side effects.

PREGNANCY:

Preferable to avoid use in pregnancy; use only if benefit outweighs risk. Neonates exposed during third trimester are at risk of adverse effects including extrapyramidal and/or withdrawal symptoms; monitor carefully.

LACTATION:

Excreted in breast milk; small amounts of haloperidol detected in plasma/urine of breast-fed infants; benefits should be balanced against risks.

INTERACTIONS:

Contraindicated: drugs known to prolong QTc interval (e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide, dronedarone, ibutilide, citalopram, escitalopram, erythromycin, azithromycin, clarithromycin, levofloxacin, moxifloxacin, telithromycin, phenothiazine derivatives, pimozide, sertindole, ziprasidone, pentamidine, halofantrine, dolasetron, toremifene, vandetanib, bepridil, methadone); Caution: drugs causing electrolyte imbalance. Increase in haloperidol plasma concentrations: CYP3A4/CYP2D6 inhibitors (e.g. alprazolam, fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone, posaconazole, saquinavir, verapamil, voriconazole, bupropion, chlorpromazine, duloxetine, paroxetine, promethazine, sertraline, venlafaxine, fluoxetine, ritonavir), buspirone; monitor for signs/symptoms of increased or prolonged pharmacologic effects of haloperidol. Increase in QTc observed when haloperidol given with combination of ketoconazole (400 mg/day) and paroxetine (20 mg/day). Decrease in haloperidol plasma concentrations: potent CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's Wort); monitor patients and increase dose of Haldol® if necessary. Effect of haloperidol: Increased central nervous system (CNS) depression produced by other CNS-depressant drugs (e.g. alcohol, hypnotics, sedatives or strong analgesics). Enhanced CNS effect seen with methyldopa. May antagonise adrenaline/other sympathomimetic agents (e.g. stimulants like amphetamines) and reverse blood pressure-lowering effects of adrenergic-blocking agents (e.g. guanethidine). May antagonise effects of levodopa and other dopamine agonists. Inhibits metabolism of tricyclic antidepressants (e.g. imipramine, desipramine). Other: Rarely (and mostly reversible) encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, acute brain syndrome and coma with lithium; stop therapy immediately if symptoms occur. Antagonism of anticoagulant phenindione.

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM

FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG UK.

Prescribing information last revised: January 2019