50 mg/ml and 100 mg/ml solution for injectionPRESCRIBING INFORMATION
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
The HALDOL® DECANOATE SmPCs are available at:
Please click the following product name to access the full SmPC
For maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol.
DOSAGE & ADMINISTRATION:
For use in adults (≥ 18 years) only. Treatment initiation/dose titration must be under close clinical supervision. Single deep intramuscular injection in the gluteal region; not for intravenous use. Determine dosage individually. When transitioning from oral haloperidol, 25 - 150 mg for most patients; continue increasing by 50 mg every 4 weeks to maximum 300 mg. Adjustment of dosing interval may be required. Assess benefit/risk when considering doses above 200 mg every 4 weeks. If supplementation with non-decanoate during transition/dose adjustment/episodes of exacerbation of psychotic symptoms, maximum combined total dose of haloperidol is 20 mg/day.
Elderly: Start with low dose of 12.5 mg - 25 mg. After four weeks, increase dose according to patient’s response. Most effective dose expected in range 25 - 75 mg every 4 weeks. Adjustment of dosing interval may be required. Assess benefit/risk when considering higher doses. If supplementation with non-decanoate during transition/dose adjustment/episodes of exacerbation of psychotic symptoms, maximum combined total dose of haloperidol is 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: No data available.
Comatose states; 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. Sudden death reported rarely. Haldol® decanoate not indicated for dementia-related behavioural disturbances. Cardiovascular effects: QTc prolongation and/or ventricular arrhythmias; risk increases with high doses/high plasma concentrations/in predisposed patients/with parenteral use (particularly intravenous). 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® decanoate if QTc > 500 ms. Baseline and periodic electrolyte monitoring recommended; if abnormal, correct before treatment with haloperidol 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® decanoate; 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 initiation: Patients considered for Haldol® decanoate should be initially put on oral haloperidol to reduce unexpected adverse sensitivity to haloperidol. Depression: Not to be used alone where depression is predominant. Poor metabolisers of CYP2D6: Caution in poor metabolisers of cytochrome P450 (CYP) 2D6 who are co-administered a CYP3A4 inhibitor.
Very common: Extrapyramidal disorder.
Common: Depression, insomnia, akathisia, Parkinsonism, masked facies, tremor, somnolence, sedation, constipation, dry mouth, salivary hypersecretion, muscle rigidity, sexual dysfunction, injection site reaction, weight increased.
Other side effects: Leukopenia, agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, neuroleptic malignant syndrome, tardive dyskinesia, convulsion, tachycardia, ventricular fibrillation, Torsade de pointes, extrasystoles, acute hepatic failure, cholestasis, hepatitis, jaundice, dermatitis exfoliative, leukocytoclastic vasculitis, rhabdomyolysis, trismus, urinary retention, 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.
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.
Excreted in breast milk; small amounts of haloperidol detected in plasma/urine of breast-fed infants; benefits should be balanced against risks.
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® decanoate 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
PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS
|PRESENTATIONS||PACK SIZES||MARKETING AUTHORISATION NUMBER(S)||BASIC NHS COSTS|
|50mg/ml ampoules||5 x 1ml||PL 00242/0094||£19.06|
|100mg/ml ampoules||5 x 1ml||PL 00242/0095||
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: September 2018