However, hepatic impairment may have significant effects on the pharmacokinetics of haloperidol because it is extensively metabolised in the liver. Name of the medicinal product 2. Drug withdrawal syndrome neonatal see section 4. Dose adjustment is recommended in elderly patients see section 4. Plasma concentrations measured at various time points and after various durations of treatment, were either undetectable or ranged up to a maximum of

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Caution is advised in patients suffering from epilepsy and in conditions predisposing to seizures e. Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation see section 4.

Gradual withdrawal is advisable as a precautionary measure. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotics. Cases of venous thromboembolism VTE have been reported with antipsychotics.

Haloperidol crosses the haliperidol barrier easily. Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.

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Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder. Back to top Janssen-Cilag Ltd contact details. Plasma concentrations measured at various time points and after various durations of treatment, were either undetectable or ranged up to a maximum of Blood and lymphatic system disorders.

Haldol 2mg/ml oral solution

Posology Adults A low initial dose is recommended, which subsequently may be adjusted according to the patient’s response. Show table of contents Hide table of contents 1. 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.

Caution is also required in patients with potentially high plasma concentrations see section 4. The results are within the observed variability in haloperidol pharmacokinetics.

Qualitative and quantitative composition 3. Sudden death Face oedema Hypothermia. Respiratory, thoracic and mediastinal disorders. A high inter-subject variability in plasma concentrations was observed.

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 of extrapyramidal symptoms. Extrapyramidal disorder Hyperkinesia Headache.

Haldol 2mg/ml oral solution – Summary of Product Characteristics (SmPC) – (eMC)

Name of the medicinal product 2. To view the changes to a medicine you must sign up and log in.


These studies included mainly children and adolescents aged between 2 and 17 years. The risk of ventricular arrhythmias, possibly associated with QTc prolongation, must be considered. The activity on the basal ganglia probably underlies the undesirable extrapyramidal motor effects dystonia, akathisia and parkinsonism.

Examples of medicinal products that syringr increase haloperidol plasma concentrations based on clinical experience or drug interaction mechanism include: There was a trend toward shorter half-lives in children compared to adults. In patients who develop these symptoms, increasing the dose may be detrimental.

Reproductive system and breast disorders. Interaction studies have only been performed in adults. Metabolic and nutritional disorders. Treatment of tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.

Steady state is reached within 1 week of treatment initiation.