PMS-HaloperidolExcipient information presented when available limited, particularly for generics ; consult specific product labeling. Haloperidol is a butyrophenone antipsychotic that nonselectively blocks postsynaptic dopaminergic Effects of anadrol 2 receptors in the brain Haldol 2 mg injection ; Risch Behavioral disorders tablet, concentrate: Treatment of severe behavioral problems in children with haldol 2 mg injection, explosive hyperexcitability that cannot be accounted for by immediate provocation. Reserve for use haldol 2 mg injection these children only after failure to respond to psychotherapy or medications other than antipsychotics. Short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms:
Haloperidol Injection BP 5mg/ml - Summary of Product Characteristics (SmPC) - (eMC)
A low initial dose is recommended and this must be adjusted according to the patient's response in order to determine the minimal effective dose see section 5. 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 with haloperidol solution for injection must be discontinued as soon as clinically indicated and, if further treatment is needed, oral haloperidol should be initiated at a 1: Acute treatment of delirium when non-pharmacological treatments have failed. Treatment of mild to moderate chorea in Huntington's 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. Further doses may be administered and adjusted according to the patient's response. Careful and gradual dose up-titration in elderly patients is recommended. The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with renal impairment.
However, patients with severe renal impairment may require a lower initial dose, with further doses administered and adjusted according to the patient's response see section 5. The influence of hepatic impairment on the pharmacokinetics of haloperidol has not been evaluated. Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose. Further doses may be administered and adjusted according to the patient's response see sections 4. The safety and efficacy of haloperidol solution for injection in children and adolescents below 18 years of age have not been established.
No data are available. Haloperidol solution for injection is recommended for intramuscular administration only see section 4.
For instructions on handling haloperidol solution for injection, see section 6. Rare cases of sudden death have been reported in psychiatric patients receiving antipsychotics, including haloperidol see section 4. Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death.
Analyses of seventeen placebo-controlled studies modal duration of 10 weeks , largely in patients taking atypical antipsychotics, revealed a risk of death in treated patients of between 1. Over the course of a typical 10 week controlled study, the rate of death in patients treated with antipsychotics was about 4. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular e. Observational studies suggest that treatment of elderly patients with haloperidol is also associated with increased mortality.
This association may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months. The extent to which this association is attributable to the medicinal product, as opposed to being confounded by patient characteristics, has not yet been elucidated.
Haloperidol solution for injection is not indicated for the treatment of dementia-related behavioural disturbances. The risk of these events appears to increase with high doses, high plasma concentrations, in predisposed patients or with parenteral use, particularly intravenous administration.
Haloperidol solution for injection is recommended for intramuscular administration only. However, if administered intravenously, continuous ECG monitoring must be performed for QTc interval prolongation and for ventricular arrhythmias. Caution is advised in patients with bradycardia, cardiac disease, family history of QTc prolongation or history of heavy alcohol exposure.
Caution is also required in patients with potentially high plasma concentrations see section 4. A baseline ECG is recommended before intramuscular dosing. During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed in all patients, but continuous ECG monitoring is recommended for repeated intramuscular doses.
ECG monitoring is recommended up to 6 hours after administration of Haloperidol solution for injection to patients for prophylaxis or treatment of postoperative nausea and vomiting. Whilst on therapy, it is recommended to reduce the dose if QTc is prolonged, but haloperidol must be discontinued if the QTc exceeds ms. Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started.
Therefore, baseline and periodic electrolyte monitoring is recommended. Tachycardia and hypotension including orthostatic hypotension have also been reported see section 4. Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension. In randomised, placebo-controlled clinical studies in the dementia population, there was an approximately 3-fold increased risk of cerebrovascular adverse events with some atypical antipsychotics.
Observational studies comparing the stroke rate in elderly patients exposed to any antipsychotic to the stroke rate in those not exposed to such medicinal products found an increased stroke rate among exposed patients. This increase may be higher with all butyrophenones, including haloperidol. The mechanism for this increased risk is not known.
An increased risk cannot be excluded for other patient populations. Haloperidol must be used with caution in patients with risk factors for stroke. Haloperidol has been associated with neuroleptic malignant syndrome: Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment must be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.
Tardive dyskinesia may appear in some patients on long-term therapy or after discontinuation of the medicinal product.
The syndrome is mainly characterized by rhythmic involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients. The syndrome may be masked when treatment is reinstituted, when the dose is increased or when a switch is made to a different antipsychotic. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including haloperidol, must be considered.
Extrapyramidal symptoms may occur e. The use of haloperidol has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Acute dystonia may occur during the first few days of treatment with haloperidol, but later onset as well as onset after dose increases has been reported. Dystonic symptoms can include, but are not limited to, torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements, including oculogyric crisis.
Males and younger age groups are at higher risk of experiencing such reactions. Acute dystonia may necessitate stopping the medicinal product. Antiparkinson medicinal products of the anticholinergic type may be prescribed as required to manage extrapyramidal symptoms, but it is recommended that they are not prescribed routinely as a preventive measure.
If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping haloperidol if its excretion is faster than that of haloperidol in order to avoid the development or aggravation of extrapyramidal symptoms. The possible increase in intraocular pressure must be considered when anticholinergic medicinal products, including antiparkinson medicinal products, are administered concomitantly with haloperidol.
It has been reported that seizures can be triggered by Haloperidol. Caution is advised in patients suffering from epilepsy and in conditions predisposing to seizures e. As haloperidol is metabolised by the liver, half the initial dose and caution is advised in patients with hepatic impairment see sections 4.
Isolated cases of liver function abnormalities or hepatitis, most often cholestatic, have been reported see section 4. Thyroxin may facilitate Haloperidol toxicity. Antipsychotic therapy in patients with hyperthyroidism must be used only with caution and must always be accompanied by therapy to achieve a euthyroid state.
Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia and oligo or amenorrhoea see section 4.
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin. Although no clear association with the administration of antipsychotics and human breast tumours has been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Haloperidol must be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours see section 5.
Hypoglycaemia and syndrome of inappropriate antidiuretic hormone secretion have been reported with haloperidol see section 4. Cases of venous thromboembolism VTE have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Haloperidol and preventive measures undertaken.
If antipsychotics are withdrawn, recurrence of symptoms related to the underlying condition may not become apparent for several weeks or months. There have been very rare reports of acute withdrawal symptoms including nausea, vomiting and insomnia after abrupt withdrawal of high doses of antipsychotics.
Gradual withdrawal is advisable as a precautionary measure. It is recommended that haloperidol is not used alone in patients in whom depression is predominant.
It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist see section 4. There is a risk in the treatment of manic episodes of bipolar disorder for patients to switch from mania to depression.
Monitoring of patients for the switch to a depressive episode with the accompanying risks such as suicidal behaviour is important in order to intervene when such switches occur. Haloperidol is contraindicated in combination with medicinal products known to prolong the QTc interval see section 4. Caution is advised when haloperidol is used in combination with medicinal products known to cause electrolyte imbalance see section 4. Haloperidol is metabolised by several routes see section 5. The major pathways are glucuronidation and ketone reduction.
Inhibition of these routes of metabolism by another medicinal product or a decrease in CYP2D6 enzyme activity may result in increased haloperidol concentrations. Examples of medicinal products that may increase haloperidol plasma concentrations based on clinical experience or drug interaction mechanism include:. Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc-prolongation see section 4.
It is recommended that patients who take haloperidol concomitantly with such medicinal products be monitored for signs or symptoms of increased or prolonged pharmacologic effects of haloperidol, and the haloperidol dose be decreased as deemed necessary.
Coadministration of haloperidol with potent enzyme inducers of CYP3A4 may gradually decrease the plasma concentrations of haloperidol to such an extent that efficacy may be reduced. Enzyme induction may be observed after a few days of treatment. Maximal enzyme induction is generally seen in about 2 weeks and may then be sustained for the same period of time after the cessation of therapy with the medicinal product.
During combination treatment with inducers of CYP3A4, it is recommended that patients be monitored and the haloperidol dose increased as deemed necessary. After withdrawal of the CYP3A4 inducer, the concentration of haloperidol may gradually increase and therefore it may be necessary to reduce the haloperidol dose.