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HALOPERIDOL is a brand name for Haloperidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In adults for: − Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate. − Acute treatment of delirium when non-pharmacological treatments have failed. − Treatment of mild to moderate chorea in Huntington’s…
Verbatim from this product's MHRA label. Tap a section to expand.
2). The dose recommendations for Haloperidol solution for injection are presented in Table 1.
Table 1:
Haloperidol dose recommendations for adults aged 18 years and above Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate - 5 mg intramuscularly.
- May be repeated hourly until sufficient symptom control is achieved. - In the majority of patients, doses of up to 15 mg/day are sufficient. The maximum dose is 20 mg/day. 4). 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 1:1 dose conversion rate followed by dose adjustment according to clinical response.
Acute treatment of delirium when non-pharmacological treatments have failed - 1 to 10 mg intramuscularly. - Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues, up to a maximum of 10 mg/day.
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 - 2 to 5 mg intramuscularly. - May be repeated hourly until sufficient symptom control is achieved or up to a maximum of 10 mg/day.
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 - 1 to 2 mg intramuscularly, at induction or 30 minutes before the end of anaesthesia.
Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated - 1 to 2 mg intramuscularly. 4). Special populations Elderly The recommended initial haloperidol dose in elderly patients is half the lowest adult dose.
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 maximum dose is 5 mg/day. Doses above 5 mg/day should only be considered in patients who have tolerated higher doses and after reassessment of the patient’s individual benefit-risk profile.
The safety of Haloperidol was evaluated in 284 haloperidol-treated subjects who participated in 3 placebo-controlled, and in 1295 haloperidol-treated subjects who participated in sixteen double-blind active comparator-controlled clinical studies.
Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (34%), insomnia (19%), agitation (15%), hyperkinesia (13%), headache (12%), psychotic disorder (9%), depression (8%), weight increased (8%), tremor (8%), hypertonia (7%), orthostatic hypotension (7%), dystonia (6%) and somnolence (5%).
In addition, the safety of Haloperidol decanoate was evaluated in 410 subjects who participated in 3 comparator studies (1 comparing haloperidol decanoate vs. fluphenazine and 2 comparing the decanoate formulation to the oral formulation), 9 open label studies and 1 dose response studies.
Table 2 lists adverse reactions as follows: − Reported in clinical studies with haloperidol. − Reported in clinical studies with haloperidol decanoate and relate to the active moiety. − From postmarketing experience with haloperidol and haloperidol decanoate.
Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol, and classified using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data).
The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category. 6) Reproductive System and Breast Disorders Erectile Dysfunction Amenorrhoea; Dysmenorrhoea; Galactorrhoea; Breast discomfort; Breast pain; Menorrhagia; Menstrual Disorder; Sexual Dysfunction Gynaecomastia, Priapism General Disorders and Administration Site Conditions Gait disturbance; Hyperthermia, Oedema Sudden death; Face oedema; Hypothermia Investigations Weight increased; Weight decreased Electrocardiogram QT prolonged Additional Information Electrocardogram QT-interval prolongation, torsade de pointes, ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia), and cardiac arrest have been reported with Haloperidol.
8). Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death. 7 times the risk of death in placebo-treated patients. 6% in the placebo group. , pneumonia) in nature. 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 is not indicated for the treatment of dementia-related behavioural disturbances. 8). 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. 4, Poor metabolisers of CYP2D6). 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 500 ms.
1. − Comatose state. − Central nervous system (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. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Renal impairment 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. 2). Hepatic impairment 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. 2). Paediatric population 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. 4). 6.
These effects may occur more frequently with high doses, and in predisposed patients. Class effects of antipsychotics Cardiac arrest has been reported with antipsychotics. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotics.
The frequency is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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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.
8). Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension. Cerebrovascular events 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. Neuroleptic malignant syndrome Haloperidol has been associated with neuroleptic malignant syndrome: a rare idiosyncratic response characterised by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness and increased serum creatine phosphokinase levels.
Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted. Tardive dyskinesia Tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation of the medicinal product.
The syndrome is mainly characterised 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 dosage 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. g. tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia). 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 […]