Haloperidol WZF – indications, action, dosage, side effects

Proven content

Haloperidol is a neuroleptic or antipsychotic drug that belongs to the butyrophenone group. This preparation is designed to reduce anxiety, psychomotor agitation and psychomotor drive. Haloperidol is a drug intended for adults. Check what you should know before taking the drug.

Haloperidol – action

Haloperidol is an antipsychotic drug belonging to the group of butyrophenone derivatives. The active substance of Haloperidol is the substance of the same name, i.e. haloperidol. Thanks to it, the drug has a strong antipsychotic and sedative effect. Haloperidol acts on the central nervous system by blocking dopamine receptors (mainly of the D2 type).

This drug is effective in relieving the productive symptoms of schizophrenia such as hallucinations and delusions. It is helpful in alleviating mania or various syndromes in which agitation occurs.

Haloperidol helps in states of anxiety, agitation and psychomotor drive. The drug increases the concentration of prolactin secreted in the body, and also reduces vomiting, nausea and hiccups. However, it should be remembered that it can lead to clear extrapyramidal disorders and depression.

Haloperidol obtains its highest concentration after oral administration within 2-6 hours. The concentration of the drug in the blood is normalized after about 2 weeks after taking the first tablet. Haloperidol easily crosses the placenta, into breast milk and the blood-brain barrier. It is metabolized in the liver and excreted in faeces and urine.

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Haloperidol – indications

The indications for the use of Haloperidol vary depending on the age of the patient. In adults aged 18 years or over, the drug is given when:

1. schizophrenia and schizoaffective disorder;
2. delirium as an emergency treatment when other non-pharmacological treatments have not worked;
3. moderate to severe manic episodes that occur in people with bipolar disorder;
4. strong psychomotor agitation in the course of psychotic disorders and manic episodes during bipolar disorder;
5. aggression and psychotic symptoms in patients with moderate or severe dementia in the course of Alzheimer’s disease, or with vascular origin in the case of ineffectiveness of non-pharmacological treatment, when the patient poses a threat to himself and other people;
6. tics, such as in people with Tourette’s syndrome;
7. mild to moderate cases of Huntington’s disease, when other treatments have not worked or have side effects.

In children and adolescents, Haloperidol is used when:

1. diagnose schizophrenia in adolescents aged 13-17 years in a situation where other drugs are ineffective or not tolerated;
2. severe attacks of aggression in children and adolescents aged 6-17 years with autism or various developmental disorders, when other drugs are not effective or are not tolerated;
3. tics, such as in Tourette’s syndrome in children and adolescents 10-17 years of age who have functional disorders when educational therapy, psychotherapy or other pharmacological treatments fail.

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Haloperidol – contraindications

It turns out that even if there are indications for the use of Haloperidol, it cannot be taken in every situation. The main contraindication to the use of Haloperidol is hypersensitivity, i.e. allergy to any component of the drug. The other contraindications are:

1. coma;
2. lack of central nervous system function;
3. Parkinson’s disease;
4. dementia with Lewy bodies;
5. supranuclear palsy;
6. prolonged QTc interval on the ECG (also congenital long QT syndrome);
7. previous acute myocardial infarction;
8. heart failure;
9. history of ventricular arrhythmias or torsade de pointer disorders;
10. hypokalemia;
11. concomitant use of drugs that prolong the QT interval on the ECG.

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Haloperidol – precautions

It should be remembered that some diseases and other health-related conditions may be a contraindication to the use of Haloperidol or an indication to change the dosage regimen. It may turn out that the patient’s condition may be an indication for regular check-ups.

Among people using, among others Haloperidol with mental disorders, sudden deaths have been reported. The risk of dying from the drug is higher in older adults with dementia-related psychosis due to cardiovascular problems or infections. The risk of death with Haloperidol is much higher than with other antipsychotics.

Some deaths were associated with prolongation of the QTc interval and / or ventricular dysfunction. The risk of death is higher in the case of high doses, people at risk or those who receive the drug parenterally, such as in the form of injections.

The risk of ventricular heart failure is higher in people:

1. with bradycardia;
2. with family history of QTc prolongation;
3. with heart disease;
4. slowly metabolizing with the participation of the 2D6 isoenzyme cytochrome P450;
5. having a problem with alcohol;
6. electrolyte disturbances which are not corrected, such as hypokalaemia and hypomagnesaemia;
7. with low pressure.

Each time before starting the use of Haloperidol, the doctor will refer the patient to an ECG and electrolyte levels. In addition, both tests should be regularly monitored, especially among people taking diuretics or suffering from other diseases at the same time.

In the event of a prolongation of the QT interval, the doctor decides to interrupt the treatment or adjust the dose.

Life-threatening neuroleptic malignant syndrome may also appear during the use of Haloperidol, the first symptom of which is high fever. In addition, there may be muscle tension, muscle stiffness, disturbed consciousness, impulse or heart rhythm disturbances, and increased levels of creatine phosphokinase.

When the patient notices the above symptoms, he should stop using the preparation as soon as possible and seek medical help to implement appropriate treatment.

Caution should also be exercised in the case of long-term use of the preparation or in the event of a sudden discontinuation of its use, as this may lead to involuntary movements including, for example, involuntary movements of the tongue, mouth, face or jaw. If you notice such symptoms, please consult your doctor.

In addition, during the use of Haloperidol, an extrapyramidal syndrome may appear, manifested, among others, by tremors and severe muscle tension, akathisia, acute dystonia, excessive salivation. Consult your doctor about these symptoms, who may advise you to stop taking the medicine. Also, anticholinergic drugs that are used to treat Parkinson’s should not be used concomitantly, as this combination may lead to an increase in intraocular pressure.

Caution when using Haloperidol people with epilepsy and those who may develop seizures, such as those with brain damage, should also be careful. The drug may cause seizures.

In addition, remember that the drug is metabolized in the liver, so people with liver disorders should be especially careful. Caution should also be exercised by people with hyperthyroidism due to thyroxine, which may increase the toxic effects of haloperidol.

Haloperidol can also stimulate the secretion of prolactin, which can lead to galactorrhea, gynecomastia, or menstrual disorders. Therefore, caution should be exercised in people who have an increased secretion of prolactin. Additionally, Haloperidol may lead to the development of hypoglycaemia and the syndrome of inappropriate antidiuretic hormone secretion.

Haloperidol as well as other antipsychotics can lead to thromboembolism. Therefore, before prescribing the drug, the doctor conducts a careful interview with the patient in order to know all the risk factors associated with thrombotic disease.

Haloperidol should be discontinued gradually to avoid withdrawal symptoms such as nausea, vomiting or insomnia. The drug should be discontinued gradually under medical supervision.

People with schizophrenia may notice the therapeutic effect of Haloperidol more slowly, and after its discontinuation, it may be visible for up to several months.

The use of Haloperidol as a monotherapy in the treatment of depression is not recommended, while antidepressants and Haloperidol may be used simultaneously. The drug may also shift the manic phase to the depression phase in patients with bipolar disorder. This phase can be associated with the onset of suicidal thoughts, so be vigilant.

The preparation contains lactose, therefore people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should exercise caution when using the drug. Some components of the drug can cause an allergic reaction.

It should also be remembered that Haloperidol may affect the ability to drive and use machines. The drug may reduce the patient’s psychomotor skills. It causes drowsiness and disrupts the ability to focus.

The risk is much higher when you first start taking high doses, and also when you consume alcohol at the same time. It is not recommended to drive or operate machinery until the patient’s response to the drug has been checked.

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Haloperidol – dosage

Haloperidol is a drug in the form of droplets that are administered orally, as well as tablets or an injectable solution. Be careful not to exceed the recommended doses of the drug, as it will not increase the effectiveness of the preparation and may harm the health and life of the patient.

Any doubts related to the use of Haloperidol should be clarified with the attending physician. In addition, the lowest effective dose should be used during treatment. The dosage of Haloperidol for adults is as follows:

1. schizophrenia and schizoaffective disorders – use 2 to 10 mg in one daily dose or divided into two doses. In the case of people with the first stage of schizophrenia, it often turns out that the effects are visible after administering 2-4 mg of haloperidol daily. However, in subsequent cases, the doctor decides to increase the amount to 10 mg, but the dose is adjusted at intervals of 1-7 days. The highest possible daily dose is 20 mg, however high doses of Haloperidol increase the risk of extrapyramidal symptoms. The final dose is adjusted individually to the patient;
2. delirium – Haloperidol can be used for the acute treatment of delirium when other drug treatments have failed. In this case, from 1 to 10 mg of haloperidol in 1, 2 or 3 divided doses is used. Treatment always starts with the lowest possible dose. If the excitation persists, the dose may be adjusted at intervals of 2-4 hours. However, the maximum dose of 10 mg per day should not be exceeded;
3. moderate to severe manic episodes in bipolar disorder – 2 to 10 mg are used in one or two divided doses. The dose is adjusted every 1-3 days. The maximum daily dose is 15 mg daily. In each case, it is the doctor who decides on the further use of the drug and individual adjustment of the dose;
4. periods of strong psychomotor agitation in psychotic disorders and episodes of mania in bipolar disorder – a dose of 5 to 10 mg is used, repeated if necessary after 12 hours. The daily dose is up to 20 mg, but the doctor decides whether to continue using Haloperidol;
5. aggression and psychotic symptoms in people with moderate to severe dementia in Alzheimer’s disease and dementia of vascular origin, in the event of failure of the current non-pharmacological treatment, when such a person poses a threat to himself or others – 0,5 to 5 mg is used in one or two divided doses. This dose is adjusted by your doctor every 1-3 days. He assesses the justification for continuing the treatment after approx. 6 weeks of using Haloperidol;
6. tics, e.g. in Tourette’s syndrome in the case of ineffectiveness of educational treatment, psychotherapy or other pharmacological treatment – 0,5 to 5 mg is used in one or two divided doses. The dose is adjusted by the doctor every 1 to 7 days, and the need for further use of Haloperidol is assessed after 6-12 months;
7. mild to moderate chorea in Huntington’s disease in case of lack of efficacy or intolerance to other pharmacological treatment – 2 to 10 mg of haloperidol in one or two divided doses is used. The dose of the drug is adjusted every 1-3 days.

It is recommended to use doses less than 1 mg, therefore Haloperidol is administered in droplets, which allows the dose to be adjusted accordingly. No dosage adjustment is necessary in the event of renal dysfunction, however, caution should be exercised.

In cases of severe renal insufficiency, it may be necessary to use the lower one the initial dose of Haloperidol and longer intervals between successive doses.

Liver disorders require the initial dose to be reduced by half, while the amount of subsequent doses depends on the patient’s response to the drug.

For children and adolescents, the dosage of Haloperidol is as follows:

1. schizophrenia (adolescents aged 13-17) in case of ineffectiveness or intolerance to other methods of treatment – 0,5-3 mg a day is used in two or three divided doses. The maximum daily dose is 5 mg of haloperidol, but the administration of doses of 3 mg requires the physician to assess the benefits and risks associated with the use of the preparation. The doctor individually assesses the effectiveness of the treatment;
2. aggressive behavior in adolescents and children aged 6 to 17 years with autism or generalized development disorders in the absence of effectiveness or intolerance to other forms of treatment – in children from 6 to 11 years of age, doses of 0,5 to 3 mg per day are used in two or three divided doses , in adolescents from 12 to 17 years of age, a dose of 0,5 to 5 mg per day in 2 or 3 divided doses. The doctor assesses the need to continue treatment after approximately 6 weeks;
3. tics, e.g. in Tourette’s syndrome, in children and adolescents with significant functional disorders, when educational therapy, psychotherapy or other pharmacological treatment did not bring the expected results – 0,5 to 3 mg is used, divided into 2 or 3 doses. The doctor decides to continue the treatment after about 6-12 months.

Haloperidol – pregnancy and breastfeeding

During pregnancy, you should not use any medication without consulting your doctor. Before starting the use of any medicine, it is necessary to clarify with the doctor all doubts related to the risks and benefits of using a given preparation.

The preparation is not recommended during pregnancy and breastfeeding. In addition, Haloperidol can impair fertility in both women and men.

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Haloperidol – interactions with other drugs

Before starting to use Haloperidol, inform your doctor about all medications you are taking, including those without a prescription.

It should be remembered not to use drugs that prolong the QTc interval in the ECG record at the same time, because the drug increases the risk of prolongation of the QTc interval, and thus the risk of serious heart problems. These are the drugs:

1. class Ia and III antiarrhythmics such as, for example, quinidine, ibutilide, sotalol and the like;
2. antipsychotics e.g. sertindole; pimozide;
3. antidepressants, e.g. escitalopram;
4. antibacterials e.g. levofloxacin, erythomycin;
5. when given during malaria, e.g. halofantrine;
6. antifungal agents, e.g. pentamidine;
7. administered during stomach problems, e.g. dolasetron;
8. antihistamines – astemizole and mizolastine;
9. oncology, such as, for example, toremifene or vandetanib;
10. others, such as bepridil and methadone.

In addition, be careful when taking medications that affect the body’s electrolyte balance at the same time. These disorders may affect the way the heart works.

When taking Haloperidol, one should also be careful while taking drugs that inhibit the activity of the cytochrome P3 isoenzyme 4A2 or 6D450, because these drugs may increase concentration of haloperidol. Those are:

1. 3A4 – e.g. erythromycin, ketoconazole, alprazolam, verapamil etc .;
2. 2D6 – e.g. duloxetine, sertraline, vnelafaxine etc.
3. combination of 2D6 and 3A4 – e.g. ritonavir or fluoxetine.

Increased levels of haloperidol in the blood can lead to serious side effects. If the physician determines that the use of drugs belonging to the above groups is necessary, the patient should be cautious and monitored. Your doctor may lower your dose of Haloperidol if deemed necessary.

Caution should also be exercised when using drugs that increase the activity of the cytochrome P3 4A450 isoenzyme, such as phenytoin or St. John’s wort, which can also lead to decrease in haloperidol levels and thus the drug is less effective. You may need to modify your medication.

In addition, Haloperidol increases the effect of drugs that depress the central nervous system and alcohol, and increases the effect on the central nervous system in the case of simultaneous use of methyldopa. Haloperidol has the opposite effect of adrenaline and other sympathomimetic substances and may therefore reverse the effects of antihypertensive drugs.

The drug may also reduce the effectiveness of levodopa and other drugs that stimulate dopamine receptors. Haloperidol may also suppress the elimination of tricyclic antidepressants by increasing their plasma concentration and increasing the neuronal toxicity of lithium.

Caution is also advised when Haloperidol is used concomitantly with anticoagulants.

Haloperidol – side effects

Haloperidol, like any other drug, may cause side effects. However, it should be remembered that they will not appear in every patient, and also that they are expected the benefits of using Haloperidol usually outweigh the possible risks.

The most commonly reported side effects of Haloperidol are:

1. stimulation;
2. insomnia;
3. pyramidal disorders;
4. hyperkinesia;
5. headaches.

Common side effects of Haloperidol include:

1. depression;
2. psychotic disorders;
3. tardive dyskinesia;
4. bouts of compulsive looking with the rotation of the eyeballs;
5. dystonia;
6. dyskinesia;
7. he mentioned;
8. motor slowdown;
9. dystonia;
10. increased muscle tension;
11. somnolence;
12. muscle tremors;
13. dizziness;
14. blurred vision;
15. arterial hypotension;
16. orthostatic hypotension;
17. constipation;
18. dry mouth;
19. excessive salivation;
20. nausea;
21. vomiting;
22. abnormal liver function tests;
23. rash;
24. urine retention;
25. erectile dysfunction;
26. fluctuations in body weight.

The uncommon side effects of Haloperidol include:

1. hypersensitivity;
2. entanglement;
3. decreased or loss of libido;
4. seizures;
5. involuntary muscle contractions;
6. sedation;
7. apnea;
8. muscle cramps;
9. jaundice;
10. hives;
11. musculoskeletal stiffness;
12. amenorrhea;
13. pedestrians pains;
14. blurred vision;
15. Galactorrhea in the breasts.

Rarely reported side effects of Haloperidol include:

1. hyperprolactinemia;
2. neuroleptic malignant syndrome;
3. nystagmus;
4. bronchospasm;
5. trismus;
6. menstrual hemorrhage and menstrual disorders;
7. sexual dysfunction.

Moreover, with Haloperidol, patients also report other side effects, the frequency of which has not been established. It is i.a. haematological disorders, syndrome of inappropriate antidiuretic hormone secretion, immobility, masked face, ventricular fibrillation, sudden death, laryngeal edema or cramps, cholestasis, gynecomastia, Stevens-Johnson syndrome, etc.

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.