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HALDOL TM is a brand name for Haloperidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adult patients aged 18 years and above • Treatment of schizophrenia and schizoaffective disorder. • Acute treatment of delirium when non-pharmacological treatments have failed. • Treatment of moderate to severe manic episodes associated with bipolar I disorder. • Treatment of acute psychomotor agitation associated…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults A low initial dose is recommended, which subsequently may be adjusted according to the patient’s response. 2).
Oral solution:
The dose recommendations for HALDOL oral solution are presented in Table 1.
Table 1:
Haloperidol dose recommendations for adults aged 18 years and above Treatment of schizophrenia and schizoaffective disorder • 2 to 10 mg/day orally, as a single dose or in 2 divided doses. Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg/day.
• Adjustments to the dose may be made every 1 to 7 days. • Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit-risk should be assessed when considering doses above 10 mg/day.
• The maximum dose is 20 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses. Acute treatment of delirium when non-pharmacological treatments have failed • 1 to 10 mg/day orally, as a single dose or in 2 to 3 divided doses.
• 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 moderate to severe manic episodes associated with bipolar I disorder • 2 to 10 mg/day orally, as a single dose or in 2 divided doses.
• Adjustments to the dose may be made every 1 to 3 days. • Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit-risk should be assessed when considering doses above 10 mg/day.
• The maximum dose is 15 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses. 4). Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder • 5 to 10 mg orally, repeated after 12 hours if necessary to a maximum of 20 mg/day.
4). • When switching from haloperidol intramuscular injection, HALDOL orally should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response. 5 to 5 mg/day orally, as a single dose or in 2 divided doses.
The safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 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 patients who participated in 3 comparator studies (1 comparing haloperidol decanoate versus fluphenazine and 2 comparing the decanoate formulation to oral haloperidol), 9 open label studies and 1 dose response study.
Table 4 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 from the available data.
The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category. 6) Reproductiv e system and breast disorders Erectile dysfunction Amenorrhoea Galactorrhoea Dysmenorrho ea Breast pain Breast discomfort Menorrhagia Menstrual disorder Sexual dysfunction Priapism Gynaecomastia General disorders and administrati on site conditions Hyperthermia Oedema Gait disturbance Sudden death Face oedema Hypothermia Investigatio ns Weight increased Weight decreased Electrocardiogra m QT prolonged Electrocardiogram QT prolonged, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), torsade de pointes and sudden death 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.
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. 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 treatment. During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed in all patients. 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.
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.
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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• Adjustments to the dose may be made every 1 to 3 days. • The need for continued treatment must be reassessed after no more than 6 weeks. 5 to 5 mg/day orally, as a single dose or in 2 divided doses. • Adjustments to the dose may be made every 1 to 7 days.
• The need for continued treatment must be reassessed every 6 to 12 months. Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated • 2 to 10 mg/day orally, as a single dose or in 2 divided doses.
• Adjustments to the dose may be made every 1 to 3 days. 25 ml and above). The quantity (ml) required to achieve a given single dose using HALDOL oral solution is presented in Table 2. 4). Missed dose If patients miss a dose, it is recommended that they take the next dose as usual, and do not take a double dose.
Special populations Elderly Clinical studies with oral haloperidol in the treatment of tic disorders, including Tourette’s syndrome, did not include patients aged 65 years and above. 5 mg/day. • All other indications – half the lowest adult dose.
The haloperidol dose may be adjusted according to the patient’s response. Careful and gradual dose up-titration in elderly patients is recommended. The maximum dose in elderly patients 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.
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, and adjust the dose with smaller increments and at […]
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. HALDOL 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 characterized 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 must 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 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 HALDOL, 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 HALDOL, 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 HALDOL if its excretion is faster than that of haloperidol in order to avoid the development or aggravation […]