Index of drugs

Long-term supportive therapy for schizophrenia and other psychoses (especially paranoid), other behavioral disorders or mental disorders in which the use of a neuroleptic drug is indicated.

1 ampoule (1 ml) contains 50 mg of Haloperidol as a decanoate. The solution contains 15 mg of benzyl alcohol in 1 ml.

Antipsychotic drugs from the group of butyrophenone derivatives. It blocks dopaminergic receptors, shows antagonism towards noradrenaline and is less pronounced against serotonin. It has a minimal antihistamine effect and is a cholinergic receptor antagonist. It is slowly absorbed from the site of administration and penetrates into the systemic circulation. After the second dose, the drug concentration reaches steady state. The dose used during the month is clinically equivalent to a 20-fold oral maintenance dose.

Hypersensitivity to haloperidol or any of the excipients (the product contains peanut oil). Comatose states. Inhibition of o.u.n. Parkinson's disease. Damage to the basal ganglia. The use of haloperidol is contraindicated in patients with a clinical heart disorder, e.g. a recent acute myocardial infarction, decompensated heart failure, arrhythmias treated with class IA and III antiarrhythmics, QTc prolongation, ventricular arrhythmia ortorsade de pointes in an interview, bradycardia, heart block IIst. and III. and decompensated hypokalemia. Haloperidol should not be used concomitantly with QT prolonging medications.

There have been sudden deaths of patients with mental disorders who have used antipsychotics, including haloperidol. In elderly patients with dementia who have been treated with antipsychotics, there is a slightly increased risk of death compared to those who were not treated. The preparation is not approved for the treatment of dementia related to behavioral disorders. Very rarely have QT prolongation and / or ventricular arrhythmias associated with rare cases of sudden death from haloperidol reported. They may occur more frequently after high doses and in predisposed patients. Before initiating haloperidol in patients at risk for ventricular arrhythmia, a risk / benefit ratio should be considered, especially in patients with cardiac disease, sudden family deaths and / or prolongation of the QT interval, uncompensated electrolyte disturbances such as hypokalaemia or hypocalcemia, after subarachnoid haemorrhage, with alcohol addiction, malnourished, especially at the beginning of treatment until the plasma concentration of haloperidol is achieved. The risk of QT interval prolongation and / or ventricular arrhythmias may be increased after high doses or after parenteral administration of Haloperidol, particularly intravenously. Caution should be used in patients whose metabolism involving CYP 2D6 is slower and when using cytochrome P450 inhibitors. The concomitant use of other antipsychotics should be avoided. Before starting treatment, ECG is recommended for all patients, especially in elderly patients with a history of cardiac dysfunction or a family history of such changes. During treatment, individual ECG need to be considered for each patient (eg when increasing the dose). If the QT interval is prolonged, the dose should be reduced if the QT interval exceeds 500 ms. Haloperidol should be discontinued. Periodic monitoring of electrolyte concentrations is recommended, especially in patients who are taking diuretics or with underlying medical conditions. There was an approximate 3-fold increase in the risk of cerebrovascular adverse events in patients with dementia treated with atypical antipsychotics. Haloperidol should be used with caution in patients at risk of stroke. In the case of a neuroleptic malignant syndrome, the drug should be discontinued, symptomatic treatment should be carried out and the patient carefully observed.Tardive dyskinesia may occur after prolonged treatment or after discontinuation of the drug. Some patients may still be present. These symptoms may not show up when increasing the dose or switching to another antipsychotic medicine. If tardive dyskinesia occurs, treatment should be discontinued immediately. As with other neuroleptics, symptoms of extrapyramidal syndrome may occur. Drugs used in Parkinsonism with a cholinolytic effect can be used, but routine prescription is not recommended. If there is a need for simultaneous administration of drugs used in Parkinson's disease (to avoid the onset or exacerbation of extrapyramidal syndrome), taking them can be continued after stopping haloperidol if their excretion proceeds faster than haloperidol. It should be remembered that the intraocular pressure may be increased when haloperidol is co-administered with anticholinergics, including those used in parkinsonism. Caution should be exercised in patients with epilepsy or predisposed to convulsions (eg patients with alcohol withdrawal and brain damage) and in patients with liver disease (risk of liver dysfunction or hepatitis, most commonly with cholestasis). Thyroxine may increase the toxicity of haloperidol decanoate. In people with hyperthyroidism, antipsychotic treatment can only be performed with extreme caution and always maintaining normal thyroid function. Before and during treatment with the preparation, all possible risk factors for venous thromboembolism should be identified and appropriate preventive measures should be taken. It is recommended that the patient is considered to be taking the solution of haloperidol as a solution. to the shock, initially received haloperidol orally to exclude the possibility of unexpected hypersensitivity reactions. In cases where depression is the dominant symptom, haloperidol should not be used alone. The preparation can be used with antidepressants in conditions when depression and psychosis coexist. In schizophrenia, the response to antipsychotics may be delayed. Also in the case of discontinuation of medications, the recurrence of symptoms may be visible after a few weeks or months. Caution is advised in patients with renal insufficiency and phaeochromocytoma. Due to the peanut oil content, the preparation is contraindicated in patients who are allergic to peanut or soya. The preparation must not be administered intravenously.

It can only be used during pregnancy if the benefit to the mother outweighs the potential risk to the fetus. The dose should be as small as possible and the treatment time as short as possible. Newborns exposed to antipsychotics in the third trimester of pregnancy are at risk of adverse reactions, including transient extrapyramidal symptoms and / or withdrawal symptoms. There are reports of stimulation, increased or decreased muscle tone, tremors, drowsiness, respiratory failure and feeding disorders - newborns should be carefully monitored. Haloperidol is excreted in breast milk. Isolated cases of extrapyramidal symptoms have been reported in breastfed babies. The use of the drug in a breastfeeding woman should be considered taking into account the risk of side effects in the child.

Very common: agitation, insomnia, extrapyramidal disorder, hyperkinesia, headache. Common: depression, psychiatric disorders, tardive dyskinesia, dystonia, dyskinesia, akathisia, slowness, hypokinesis, hypertension, drowsiness, facial masking, tremor, dizziness, blurred vision, involuntary eye strain, orthostatic hypotension, hypotension, constipation , dry mouth, excessive salivation, nausea, vomiting, abnormal liver function tests, rash, urinary retention, erectile dysfunction, injection site reactions, weight gain or loss. Uncommon: leukopenia, hypersensitivity, confusion, decreased or loss of libido, anxiety, convulsions, parkinsonism, akinesia, symptom of the toothed wheel, sedation, involuntary muscle contractions, blurred vision, tachycardia, apnea, hepatitis, jaundice, hypersensitivity reactions to light, urticaria, pruritus, hyperhidrosis, torticollis, muscular tremors, muscle cramps, musculoskeletal stiffness, amenorrhea, dysmenorrhea, galactorrhea, chest discomfort, breast pain, gait disturbances, hyperthermia, edema. Rare: hyperprolactinemia, movement disorders, neuroleptic malignant syndrome, nystagmus, bronchospasm, trismus, fasciculations, menorrhagia, menstrual disorders, sexual dysfunction, QT interval prolongation.Not known: agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, anaphylactic reactions, syndrome of abnormal secretion of antidiuretic hormone, hypoglycaemia, ventricular fibrillation,torsade de pointes, ventricular tachycardia, additional spasms, laryngeal edema, laryngeal spasm, severe hepatic failure, cholestasis, leukocytoclastic vasculitis, exfoliative dermatitis, discontinuation syndrome in the newborn, gynecomastia, priapism, sudden death, facial edema, hypothermia. In addition, there was observed: prolongation of the QT interval,torsade de pointesventricular dysfunction, including ventricular fibrillation and ventricular tachycardia, cardiac arrest (these effects may occur more frequently after high doses and in predisposed patients), toxic epidermal necrolysis, Stevens-Johnson syndrome, cases of venous thromboembolism, including cases of congestion pulmonary artery and deep vein thrombosis.

Intramuscularly. Adults. The dose should be adjusted individually, the initial dose depends on the severity of symptoms and the dose of the previously used oral form. The recommended starting dose is 50 mg haloperidol every 4 weeks. In more severe cases, the dose may be increased by 50 mg every 4 weeks up to a maximum of 300 mg. Half-dose may be given every 2 weeks. High-dose haloperidol may be necessary in patients with severe symptoms or in patients treated with high oral maintenance doses, however clinical experience with doses> 300 mg per month is limited. When replacing oral neuroleptics with haloperidol, 500 mg chlorpromazine per day or 25 mg fluphenazine decanoate every 2 weeks or 40 mg flupentixol decanoate every 2 weeks is equivalent to 100 mg haloperidol once a month.
In elderly patients, treatment should be started with a low initial dose of 12.5-25 mg haloperidol every 4 weeks, if necessary, the dose can be increased.