Haloperidol decanoate - instructions, use, indications, contraindications, action. Medicinal reference book geotar Haloperidol depot instructions for use

Composition of the medicinal product Haloperidol Decanoate

Haloperidol 50 mg

Other ingredients: ethyl alcohol, sesame oil.

1 ml of oil solution contains 70.52 mg of haloperidol decanoate, which corresponds to 50 mg of haloperidol.

Dosage form

Pharmacological properties

Due to the pronounced antidopamine effect associated with the influence on the chemoreceptors of the trigger zone and adenohypophysis, the drug has a pronounced antiemetic effect.

After intramuscular administration, the maximum concentration of active haloperidol in the blood serum is reached by days 3–9, after which it decreases. The half-life of Haloperidol Decanoate is 3 weeks. With monthly administration, a stable concentration of the drug in the blood plasma is established after 2–4 months. The pharmacokinetics of Haloperidol Decanoate after intramuscular administration is dose-dependent. A linear relationship was identified between the administration of the drug at a dose below 450 mg and the resulting concentration of haloperidol in the blood plasma. The empirically established concentration in the blood required for the manifestation of a therapeutic effect ranges from 4 to 20–25 μg/l. Haloperidol penetrates the BBB. The drug is 92% bound to blood plasma proteins, excreted from the body in the form of metabolites, 60% in feces, 40% in urine

Haloperidol Decanoate - indications for use

Contraindications

Cautions for use

If the use of Haloperidol Decanoate is necessary, oral haloperidol should first be administered to determine possible hypersensitivity.

Due to the fact that haloperidol is metabolized in the liver, caution is required when using the drug in severe hepatic pathology. With long-term use, periodic monitoring of blood counts and liver function is necessary.

Isolated cases of the development of convulsive syndrome during the use of haloperidol have been described. Therefore, in patients with epilepsy, as well as in patients with increased convulsive readiness (chronic intoxication of alcohol or other origins, a history of traumatic brain injury, etc.), Haloperidol Decanoate should be prescribed with caution.

For patients whose psychopathological disorders include symptoms of depressive syndrome, haloperidol should be prescribed in combination with antidepressants.

During the initial period of treatment with the drug, you should not drive a car or work in conditions with an increased risk of injury. Subsequently, the degree of restrictions is determined on an individual basis.

Treatment with the drug is not compatible with drinking alcohol.

It has been experimentally established that haloperidol does not significantly increase the number of congenital pathologies. In some cases, congenital developmental anomalies have been described during the use of haloperidol during pregnancy (usually when using the drug in combination with other drugs). Thus, haloperidol can be prescribed during pregnancy only if the expected benefits of treatment clearly exceed the possible teratogenic effect.

Haloperidol passes into breast milk. In some cases, extrapyramidal disorders have been observed in newborns whose mothers took haloperidol. Therefore, when prescribing haloperidol, it is recommended to stop breastfeeding.

When stored at low temperatures, a fraction of the active component may be released from the solution. This phenomenon can be eliminated by warming the ampoules in your hands or keeping them at room temperature for a certain time.

For administration, only homogeneous solution can be used!

Interactions with drugs

If there is a need for simultaneous antiparkinsonian therapy for the patient, a break should be taken after the last dose of Haloperidol Decanoate, given its prolonged effect.

The drug is able to enhance the effect of central nervous system depressants - alcohol, sedatives and hypnotics, as well as narcotic analgesics. Concomitant use of haloperidol with these drugs may cause respiratory depression. Enhances the effect of methyldopa on the central nervous system. Reduces the antiparkinsonian effect of levodopa.

Haloperidol Decanoate inhibits the metabolism of tricyclic antidepressants, so their levels in the blood plasma may increase with increased anticholinergic effects, as well as toxicity, including in relation to the cardiovascular system.

Pharmacokinetic studies revealed a moderate or moderate increase in the concentration of haloperidol in the blood serum when used simultaneously with quinidine, buspirone, and fluoxetine. If their combined use is necessary, a reduction in the dose of haloperidol may be necessary.

With long-term use of drugs that have the properties of liver enzyme inducers (carbamazepine, rifampicin, phenobarbital, etc.), the concentration of haloperidol in the blood decreases. Therefore, if their combined use is necessary, an increase in the dose of haloperidol may be required. In case of subsequent discontinuation of therapy with these drugs, the advisability of reducing the dose of Haloperidol Decanoate should be kept in mind.

Rarely, with the combined use of Haloperidol Decanoate and lithium salts, encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, brain stem symptoms, and coma were noted. In most cases, such disorders are reversible. The reason for their manifestation in this situation is not clear. If these disorders occur, you should immediately stop using Haloperidol Decanoate.

Haloperidol may reduce the effectiveness of oral anticoagulant therapy.

Haloperidol inhibits the action of epinephrine and other sympathomimetics, and also reduces the effectiveness of antihypertensive adrenergic blocking agents.

Haloperidol Decanoate - method of administration and dosage

It is recommended to administer a single monthly dose of the drug deep into the gluteal muscle. Switching to the use of a long-acting drug is advisable in cases where the patient is constantly taking an oral antipsychotic drug (usually haloperidol). The dose of the long-acting drug is calculated based on the dose of haloperidol or other antipsychotic used orally.

Initially, Haloperidol Decanoate should be administered every 4 weeks at a dose equivalent to 10 to 15 times the single oral dose, which for adults is usually 25 to 75 mg (0.5 to 1.5 mL) of Haloperidol Decanoate. The initial dose of Haloperidol Decanoate should not exceed 100 mg.

In the future, depending on the therapeutic response, the dose of the drug can be increased gradually by 50 mg until the optimal effect is achieved.

The usual maintenance dose, administered every 4 weeks, corresponds to 20 times the single daily dose of oral haloperidol.

Depending on the therapeutic effectiveness of Haloperidol Decanoate, if the symptoms of the disease re-intensify, additional oral use of haloperidol is possible.

The dosage regimen is established individually, taking into account the patient’s condition. It may be necessary to temporarily interrupt the course of treatment or use the drug more frequently than once every 4 weeks. It is undesirable to administer more than 3 ml of the drug in one injection due to the risk of discomfort in the patient.

In elderly and debilitated patients, the drug should be used in lower initial doses - 12.5–25 mg once every 4 weeks. In the future, depending on the patient’s condition, the dose of the drug can be increased

Side effects

Extrapyramidal symptoms

With long-term use, tremor, muscle rigidity, bradykinesia, akathisia, acute muscle dystonia, oculogyric crisis, and laryngeal dystonia are possible.

To eliminate them, antiparkinsonian drugs with anticholinergic effects should be prescribed, however, it must be taken into account that their constant use reduces the effectiveness of haloperidol.

Tardive dyskinesia

As with the use of other antipsychotics, it may occur with long-term use or withdrawal of the drug. It manifests itself as rhythmic movements of the muscles of the face, lips, tongue or lower jaw that are not subject to volitional control. Discontinue when taking haloperidol again, increasing the dose, or switching to another antipsychotic. If signs of tardive dyskinesia appear, it is advisable to continue treatment with another drug.

Neuroleptic malignant syndrome

A rare reaction that occurs as an idiosyncrasy is characterized by hyperthermia, generalized muscle rigidity, autonomic lability and impaired consciousness. An early sign of neuroleptic malignant syndrome is often hyperthermia. If characteristic symptoms appear, it is necessary to interrupt treatment with the antipsychotic and, under conditions of careful observation, begin maintenance and detoxification therapy.

Other CNS side effects

In some cases, depression, lethargy (up to a state similar to lethargy) or agitation, various dyssomnic phenomena, headache, transient mnestic-intellectual disturbances, dizziness, motor restlessness, feelings of anxiety, fear or euphoria, epileptic seizures of the “grand mal” type were noted. and resumption of psychotic symptoms.

Digestive tract

In rare cases - nausea, vomiting, loss of appetite and dyspepsia. Both an increase and a decrease in body weight are possible.

Endocrine system

Due to the antidopamine effect, hyperprolactinemia, galactorrhea, gynecomastia, oligo- and amenorrhea may occur. In extremely rare cases, hypoglycemia and decreased secretion of antidiuretic hormone were noted.

The cardiovascular system

In some cases, tachycardia and arterial hypotension may occur. Extremely rare - prolongation of the QT interval on the ECG and/or the appearance of ventricular arrhythmias. These disorders were observed in patients receiving the drug in high doses, or with a predisposition to disorders of the cardiovascular system.

Other side effects

Rarely, a slight decrease in the number of blood cells was detected, very rarely - agranulocytosis and thrombocytopenia (usually when combining haloperidol with other drugs), extremely rarely - changes in liver function, hepatitis (most often cholestatic).

In exceptional cases, hypersensitivity reactions (urticaria, photosensitivity, anaphylaxis) were observed.

Cases of constipation, blurred vision, dry mouth, urinary retention, priapism, erectile dysfunction, peripheral edema, increased sweating, salivation, heartburn, changes in body temperature (both increased and decreased) have been reported. Elderly patients may experience attacks of angle-closure glaucoma. Reactions at the injection site are also possible

Overdose

The main signs of overdose: severe extrapyramidal disorders (muscle rigidity, possible muscle hypertonicity, generalized or local tremor), arterial hypo- or hypertension, severe lethargy. In extreme cases, coma with respiratory depression may develop against the background of severe arterial hypotension. Ventricular arrhythmias may occur with prolongation of the QT interval.

There is no specific antidote. Symptomatic therapy is carried out: the stomach is washed, activated charcoal is administered. In a comatose state, the function of the respiratory system is supported, if necessary, with the use of a ventilator. Monitoring of ECG and critical hemodynamic parameters is necessary. To treat patients with severe arterial hypotension or circulatory failure, it is necessary to administer a sufficient volume of fluid, blood plasma or concentrated albumin intravenously, as well as the administration of vasopressive agents (norepinephrine or dopamine). Epinephrine should not be used because in combination with haloperidol it can cause paradoxical hypotension. For severe extrapyramidal disorders, antiparkinsonian drugs are prescribed parenterally

Antipsychotic drug (neuroleptic)

Active substance

Haloperidol

Release form, composition and packaging

Solution for intramuscular administration (oil) transparent, yellow or greenish-yellow.

Excipients: benzyl alcohol, sesame oil.

1 ml - dark glass ampoules (5) - plastic trays (1) - cardboard packs.

pharmachologic effect

Haloperidol decanoate is an ester of haloperidol and decanoic acid. When administered intramuscularly, slow hydrolysis releases haloperidol, which then enters the systemic circulation. Haloperidol decanoate is a butyrophenone-derived antipsychotic. Haloperidol is a strong antagonist of central dopamine receptors and is a strong antipsychotic.

Haloperidol is highly effective in the treatment of hallucinations and delusions, due to the direct blockade of central dopamine receptors (probably acts on mesocortical and limbic structures), and affects the basal ganglia (nigrostria). It has a pronounced calming effect during psychomotor agitation, and is effective against mania and other agitations.

The limbic activity of the drug manifests itself in a sedative effect; effective as an additional remedy for chronic pain.

Impact on the basal ganglia causes extrapyramidal reactions (dystonia, akathisia, parkinsonism).

In socially withdrawn patients, social behavior is normalized.

Severe peripheral antidopamine activity is accompanied by the development of nausea and vomiting (irritation of chemoreceptors), relaxation of the gastroduodenal sphincter and increased release of prolactin (blocks the prolactin-inhibiting factor in the adenohypophysis).

Pharmacokinetics

Suction and distribution

The Cmax of haloperidol released from the haloperidol depot after intramuscular injection is reached after 3-9 days. With regular monthly administration, the saturation stage is reached after 2-4 months. Pharmacokinetics with intramuscular administration is dose-dependent. At doses below 450 mg, there is a direct relationship between the dose and plasma concentration of haloperidol. To achieve a therapeutic effect, a plasma concentration of haloperidol of 20-25 mcg/l is required.

Haloperidol easily penetrates the BBB. Plasma protein binding - 92%.

Removal

T 1/2 about 3 weeks. Excreted through the intestines (60%) and kidneys (40%, including 1% unchanged).

Indications

• chronic schizophrenia and other psychoses, especially when treatment with rapid-acting haloperidol was effective and an effective, moderately sedative antipsychotic is needed;
• other disorders of mental activity and behavior that occur with psychomotor agitation and require long-term treatment.

Contraindications

• coma;
• CNS depression caused by drugs or alcohol;
• Parkinson's disease;
• damage to the basal ganglia;
• childhood;
• hypersensitivity to the components of the drug.

Carefully: decompensated diseases of the cardiovascular system (including angina pectoris, intracardiac conduction disorders, prolongation of the QT interval or a predisposition to this - hypokalemia, simultaneous use of other drugs that can cause prolongation of the QT interval), epilepsy, angle-closure glaucoma, hepatic and/or or renal failure, hyperthyroidism (with symptoms of thyrotoxicosis), pulmonary-cardiac and respiratory failure (including in COPD and acute infectious diseases), prostatic hyperplasia with urinary retention, alcoholism.

Dosage

The drug is intended exclusively for adults, only for intramuscular administration. Do not administer the drug intravenously.

Patients on long-term treatment with oral antipsychotics (mainly haloperidol) may be advised to switch to depot injections. The dose should be adjusted individually due to significant differences in response to treatment between patients. Dose selection should be carried out under strict medical supervision of the patient. The choice of the initial dose is carried out taking into account the symptoms of the disease, its severity, the dose of haloperidol or other antipsychotics prescribed during previous treatment.

At the beginning of treatment, every 4 weeks it is recommended to prescribe doses 10-15 times higher than the oral dose of haloperidol, which usually corresponds to 25-75 mg of Haloperidol Decanoate (0.5-1.5 ml). The maximum initial dose should not exceed 100 mg.

Depending on the effect, the dose can be increased stepwise, by 50 mg, until the optimal effect is obtained. Typically, the maintenance dose corresponds to 20 times the daily oral dose of haloperidol. If the symptoms of the underlying disease return during the dose selection period, treatment with Haloperidol Decanoate can be supplemented with haloperidol for oral administration.

Injections are usually given every 4 weeks, but due to large individual differences in effectiveness, more frequent use may be required.

Elderly patients and patients with oligophrenia A lower initial dose is recommended, for example, 12.5-25 mg every 4 weeks. In the future, depending on the effect, the dose may be increased.

Side effects

Side effects that develop during treatment with Haloperidol Decanoate are due to the action of haloperidol.

It is possible to develop local reactions associated with intramuscular administration of the drug.

From the nervous system: headache, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epileptic attacks, development of a paradoxical reaction - exacerbation of psychosis and hallucinations; with long-term treatment - extrapyramidal disorders, incl. tardive dyskinesia (smacking and wrinkling of the lips, puffing out of the cheeks, rapid and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), tardive dystonia (frequent blinking or spasms of the eyelids, unusual facial expression or body position, uncontrolled bending movements of the neck, torso , arms and legs) and neuroleptic malignant syndrome (difficulty or rapid breathing, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased sweating, urinary incontinence, muscle rigidity, epileptic seizures, loss of consciousness).

From the cardiovascular system: when used in high doses - decreased blood pressure, orthostatic hypotension, arrhythmias, tachycardia, ECG changes (prolongation of the QT interval, signs of flutter and ventricular fibrillation).

From the digestive system: when used in high doses - loss of appetite, dry mouth, hyposalivation, nausea, vomiting, diarrhea or constipation, impaired liver function, up to the development of jaundice.

From the hematopoietic system: rarely - transient leukopenia or leukocytosis, agranulocytosis, erythropenia and a tendency to monocytosis.

From the urinary system: urinary retention (with prostatic hyperplasia), peripheral edema.

From the reproductive system and mammary gland: pain in the mammary glands, gynecomastia, hyperprolactinemia, menstrual irregularities, decreased potency, increased libido, priapism.

From the side of the organ of vision: cataracts, retinopathy, blurred vision.

From the side of metabolism: hyperglycemia, hypoglycemia, hyponatremia.

For the skin and subcutaneous tissues: maculopapular and acne-like skin changes, photosensitivity.

Allergic reactions: rarely - bronchospasm, laryngospasm.

Others: alopecia, weight gain.

Overdose

The use of depot injections of the drug Haloperidol Decanoate is associated with a lower risk of overdose than oral administration of haloperidol. Symptoms of an overdose of Haloperidol Decanoate and haloperidol are the same. If an overdose is suspected, the longer action of the former should be taken into account.

Symptoms: development of known pharmacological effects and side effects in a more pronounced form. The most dangerous symptoms are extrapyramidal reactions, decreased blood pressure, and sedation. Extrapyramidal reactions manifest themselves in the form of muscle rigidity and general or localized tremor. More often it is possible to increase blood pressure rather than decrease it. In exceptional cases, the development of a coma with respiratory depression and arterial hypotension, turning into a shock-like state. Possible prolongation of the QT interval with the development of ventricular arrhythmias.

Treatment: there is no specific antidote. Airway patency during the development of a coma is ensured using an oropharyngeal or endotracheal tube; in case of respiratory depression, mechanical ventilation may be required. Monitor vital functions and ECG (until it is completely normalized), treat severe arrhythmias with appropriate antiarrhythmic drugs; with reduced blood pressure and circulatory arrest - intravenous administration of liquid, plasma or concentrated dopamine or norepinephrine as a vasopressor. The administration of epinephrine is unacceptable, because as a result of interaction with the drug Haloperidol Decanoate, blood pressure may increase significantly, which will require immediate correction. For severe extrapyramidal symptoms, administration of antiparkinsonian drugs with anticholinergic action for several weeks (symptoms may return after discontinuation of these drugs).

Drug interactions

Increases the severity of the depressant effect on the central nervous system of ethanol, tricyclic antidepressants, opioids, barbiturates and hypnotics, and agents for general anesthesia.

Enhances the effect of peripheral m-anticholinergic drugs and most antihypertensive drugs (reduces the effect of guanethidine due to its displacement from α-adrenergic neurons and suppression of its uptake by these neurons).

It inhibits the metabolism of tricyclic antidepressants and MAO inhibitors, thereby increasing (mutually) their sedative effect and toxicity.

When used simultaneously with bupropion, it reduces the epileptic threshold and increases the risk of grand mal seizures.

Reduces the effect of anticonvulsants (lowering the seizure threshold with haloperidol).

Weakens the vasoconstrictor effect of phenylephrine, norepinephrine, ephedrine and epinephrine (blockade of α-adrenergic receptors by haloperidol, which can lead to a distortion of the action of epinephrine and a paradoxical decrease in blood pressure).

Reduces the effect of antiparkinsonian drugs (antagonistic effect on dopaminergic structures of the central nervous system).

Changes (can increase or decrease) the effect.

Reduces the effect of bromocriptine (dose adjustment may be required).

When used with methyldopa, it increases the risk of developing mental disorders (including disorientation in space, slowing down and difficulty thinking).

Amphetamines reduce the antipsychotic effect of haloperidol, which in turn reduces their psychostimulant effect (blockade of α-adrenergic receptors by haloperidol).

Anticholinergic, antihistamine (1st generation) and antiparkinsonian drugs can enhance the m-anticholinergic effect of haloperidol and reduce its antipsychotic effect (dose adjustment may be required).

Long-term use of barbiturates and other inducers of microsomal oxidation reduces the concentration of haloperidol in plasma.

In combination with lithium preparations (especially in high doses), the development of encephalopathy (can cause irreversible neurointoxication) and increased extrapyramidal symptoms is possible.

When taken simultaneously with fluoxetine, the risk of developing side effects from the central nervous system, especially extrapyramidal reactions, increases.

When used simultaneously with drugs that cause extrapyramidal reactions, it increases the frequency and severity of extrapyramidal disorders.

Drinking strong tea or coffee (especially in large quantities) reduces the effect of haloperidol.

special instructions

In several cases, sudden death occurred in psychiatric patients receiving antipsychotic drugs.

If you are predisposed to prolongation of the QT interval (long QT syndrome, hypokalemia, use of drugs that prolong the QT interval), caution should be exercised during treatment due to the risk of prolongation of the QT interval.

Treatment should begin with oral haloperidol and only then proceed to injections of the drug Haloperidol Decanoate to identify unexpected adverse reactions.

If liver function is impaired, caution must be exercised, because the drug is metabolized in the liver.

With long-term treatment, regular monitoring of liver function and blood counts is necessary.

In isolated cases, Haloperidol Decanoate has caused convulsions. Treatment of patients with epilepsy and conditions predisposing to seizures (eg, head trauma, alcohol withdrawal) requires caution.

Thyroxine increases the toxicity of the drug. Treatment with Haloperidol Decanoate in patients suffering from hyperthyroidism is permissible only with appropriate thyreostatic treatment.

In case of simultaneous presence of depression and psychosis or in case of dominance of depression, Haloperidol Decanoate is prescribed together with antidepressants.

When antiparkinsonian therapy is carried out simultaneously after the end of treatment with Haloperidol Decanoate, it should be continued for several more weeks due to the faster elimination of antiparkinsonian drugs.

The drug Haloperidol Decanoate is an oil solution for intramuscular administration, therefore it is prohibited to administer it intravenously.

During treatment with the drug, it is prohibited to drink alcohol. In the future, the degree of prohibition is determined based on the individual reaction of the patient.

At the beginning of treatment with the drug and especially when used in high doses, a sedative effect of varying severity may occur with a decrease in attention, which can be aggravated by alcohol intake.

Caution must be exercised when performing heavy physical work or taking a hot bath (heat stroke may develop due to suppression of central and peripheral thermoregulation in the hypothalamus).

During treatment, you should not take “anti-cold” over-the-counter medications (anticholinergic effects and the risk of heat stroke may increase).

Exposed skin should be protected from excess solar radiation due to the increased risk of photosensitivity.

Treatment is stopped gradually to avoid withdrawal syndrome.

Impact on the ability to drive vehicles and operate machinery

At the beginning of treatment with Haloperidol Decanoate, it is prohibited to drive a car or perform work associated with an increased risk of injury and/or requiring increased concentration.

Pregnancy and lactation

Studies involving a large number of patients indicate that Haloperidol Decanoate does not cause a significant increase in the incidence of malformations. In a few isolated cases, congenital malformations have been observed when Haloperidol Decanoate was used concomitantly with other drugs during fetal development. Prescribing the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Haloperidol Decanoate is excreted in breast milk. Prescribing the drug during breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the baby. In some cases, the development of extrapyramidal symptoms in infants was observed when the drug was taken by a nursing mother.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored in its original packaging to protect from light, out of the reach of children at a temperature not exceeding 25°C. Shelf life - 5 years. Do not use after the expiration date stated on the package.

Country of origin

Product group

Antipsychotic drug (neuroleptic)

Release forms

• 1 ml - dark glass ampoules (5) - contour plastic packaging (1) - cardboard packs. 1 ml - dark glass ampoules (5) - contour plastic packaging (1) - cardboard packs.

Description of the dosage form

• The solution for intramuscular administration is oily, transparent, yellow or greenish-yellow.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• haloperidol decanoate 70.52 mg, which corresponds to the content of haloperidol 50 mg. Excipients: benzyl alcohol, sesame oil.

Haloperidol decanoate indications for use

• - chronic schizophrenia and other psychoses, especially when treatment with rapid-acting haloperidol was effective and an effective, moderately sedative antipsychotic is needed; - other disorders of mental activity and behavior that occur with psychomotor agitation and require long-term treatment.

Haloperidol decanoate contraindications

• - comatose state; - CNS depression caused by drugs or alcohol; - Parkinson's disease; - damage to the basal ganglia; - childhood; - hypersensitivity to the components of the drug. With caution: decompensated diseases of the cardiovascular system (including angina pectoris, intracardiac conduction disorders, prolongation of the QT interval or a predisposition to this - hypokalemia, simultaneous use of other drugs that can cause prolongation of the QT interval), epilepsy, angle-closure glaucoma, liver and/or renal failure, hyperthyroidism (with symptoms of thyrotoxicosis), pulmonary-cardiac and respiratory failure (including with COPD and acute infectious diseases), prostatic hyperplasia with urinary retention, alcoholism.

Haloperidol decanoate dosage

• 50 mg 50 mg/ml

Haloperidol decanoate side effects

• Side effects that develop during treatment are due to the action of haloperidol. From the nervous system: headache, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epileptic attacks, development of a paradoxical reaction - exacerbation of psychosis and hallucinations; with long-term treatment - extrapyramidal disorders, incl. tardive dyskinesia (smacking and wrinkling of the lips, puffing out of the cheeks, rapid and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), tardive dystonia (frequent blinking or spasms of the eyelids, unusual facial expression or body position, uncontrolled bending movements of the neck, torso , arms and legs) and neuroleptic malignant syndrome (difficulty or rapid breathing, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased sweating, urinary incontinence, muscle rigidity, epileptic seizures, loss of consciousness). From the cardiovascular system: when used in high doses - decreased blood pressure, orthostatic hypotension, arrhythmias, tachycardia, ECG changes (prolongation of the QT interval, signs of flutter and ventricular fibrillation). From the digestive system: when used in high doses - loss of appetite, dry mouth, hyposalivation, nausea, vomiting, diarrhea or constipation, impaired liver function, up to the development of jaundice.

Drug interactions

Storage conditions

• keep away from children
• store in a place protected from light

Haloperidol decanoate is a long-acting antipsychotic drug. After intramuscular administration, the active substance, the antipsychotic haloperidol, which in its chemical structure is a butyrophenone derivative, is gradually released from the haloperidol decanoate ester by hydrolysis. It has a central antidopaminergic effect. By blocking dopaminergic receptors in the mesocortical and limbic systems, haloperidol is effective in the treatment of hallucinations and delusions. The drug has a pronounced calming effect during psychomotor agitation.
Due to the pronounced antidopamine effect associated with the influence on the chemoreceptors of the trigger zone and adenohypophysis, the drug has a pronounced antiemetic effect.
After intramuscular administration, the maximum concentration of active haloperidol in the blood serum is reached on days 3-9, after which it decreases. The half-life of Haloperidol decanoate is 3 weeks. With monthly administration, a stable concentration of the drug in the blood plasma is established after 2-4 months. The pharmacokinetics of Haloperidol decanoate after intramuscular administration is dose-dependent. A linear relationship was identified between the administration of the drug at a dose below 450 mg and the resulting concentration of haloperidol in the blood plasma. The empirically established concentration in the blood required for the manifestation of a therapeutic effect ranges from 4 to 20-25 mcg/l. Haloperidol penetrates the BBB. The drug is 92% bound to blood plasma proteins, excreted from the body in the form of metabolites, 60% in feces, 40% in urine.

Indications for use of the drug Haloperidol decanoate

Maintenance therapy for chronic forms of schizophrenia in cases where previously used haloperidol had a good therapeutic effect, especially when there is a need to use a potent antipsychotic with a mild sedative effect; anti-relapse treatment for acute psychotic conditions.

Use of the drug Haloperidol decanoate

Enter only intramuscularly. IV administration is prohibited!
It is recommended to administer a single monthly dose of the drug deep into the gluteal muscle. Switching to the use of a long-acting drug is advisable in cases where the patient is constantly taking an oral antipsychotic drug (usually haloperidol). The dose of the long-acting drug is calculated based on the dose of haloperidol or other antipsychotic used orally.
Initially, Haloperidol decanoate should be administered every 4 weeks at a dose equivalent to 10 to 15 times the single oral dose, which for adults is usually 25 to 75 mg (0.5 to 1.5 mL) of Haloperidol decanoate. The initial dose of the drug should not exceed 100 mg.
In the future, depending on the therapeutic response, the dose of Haloperidol decanoate can be increased gradually by 50 mg until the optimal effect is achieved.
The usual maintenance dose, administered every 4 weeks, corresponds to 20 times the single daily dose of oral haloperidol.
Depending on the therapeutic effectiveness of Haloperidol decanoate, if the severity of symptoms of the disease increases again, additional oral use of haloperidol is possible.
The dosage regimen is established individually, taking into account the patient’s condition. It may be necessary to temporarily interrupt the course of treatment or use the drug more frequently than once every 4 weeks. It is undesirable to administer more than 3 ml of the drug in one injection due to the risk of discomfort in the patient.
In elderly and debilitated patients, the drug should be used in lower initial doses - 12.5-25 mg once every 4 weeks. In the future, depending on the patient’s condition, the dose of the drug can be increased.

Contraindications to the use of the drug Haloperidol decanoate

Hypersensitivity to the components of the drug, coma, severe depression of the central nervous system of toxic (alcohol or drug) origin, Parkinson's syndrome, pathological process localized in the basal ganglia region. Not for use in children. Relative contraindications include pregnancy and breastfeeding.

Side effects of the drug Haloperidol decanoate

CNS
Extrapyramidal symptoms
With long-term use, tremor, muscle rigidity, bradykinesia, akathisia, acute muscle dystonia, oculogyric crisis, and laryngeal dystonia are possible.
To eliminate them, antiparkinsonian drugs with anticholinergic effects should be prescribed, however, it must be taken into account that their constant use reduces the effectiveness of haloperidol.
Tardive dyskinesia
As with the use of other antipsychotics, it may occur with long-term use or withdrawal of the drug. It manifests itself as rhythmic movements of the muscles of the face, lips, tongue or lower jaw that are not subject to volitional control. Discontinue when taking haloperidol again, increasing the dose, or switching to another antipsychotic. If signs of tardive dyskinesia appear, it is advisable to continue treatment with another drug.
Neuroleptic malignant syndrome
A rare reaction that occurs as an idiosyncrasy is characterized by hyperthermia, generalized muscle rigidity, autonomic lability and impaired consciousness. An early sign of neuroleptic malignant syndrome is often hyperthermia. If characteristic symptoms appear, it is necessary to interrupt treatment with the antipsychotic and, under conditions of careful observation, begin maintenance and detoxification therapy.
Other CNS side effects
In some cases, depression, lethargy (up to a state similar to lethargy) or agitation, various dyssomnic phenomena, headache, transient mnestic-intellectual disturbances, dizziness, motor restlessness, feelings of anxiety, fear or euphoria, epileptic seizures of the grand mal type and resumption of psychotic symptoms.
Digestive tract
In rare cases - nausea, vomiting, loss of appetite and dyspeptic symptoms. Both an increase and a decrease in body weight are possible.
Endocrine system
Due to the antidopamine effect, hyperprolactinemia, galactorrhea, gynecomastia, oligo- and amenorrhea may occur. Hypoglycemia and decreased secretion of antidiuretic hormone were observed extremely rarely.
The cardiovascular system
In some cases, tachycardia and arterial hypotension may occur. Extremely rare - prolongation of the interval Q—T on the ECG and/or the appearance of ventricular arrhythmias. These disorders were noted in patients receiving the drug in high doses, or with a predisposition to disorders of the cardiovascular system.
Other side effects
Rarely, a slight decrease in the number of blood cells was detected, very rarely - agranulocytosis and thrombocytopenia (usually when combining haloperidol with other drugs), extremely rarely - changes in liver function, hepatitis (most often cholestatic).
In exceptional cases, hypersensitivity reactions (urticaria, photosensitivity, anaphylaxis) were detected.
Cases of constipation, blurred vision, dry mouth, urinary retention, priapism, erectile dysfunction, peripheral edema, increased sweating, salivation, heartburn, changes in body temperature (both increased and decreased) have been reported. In elderly patients, attacks of angle-closure glaucoma may be detected. Reactions at the injection site are also possible.

Special instructions for the use of the drug Haloperidol decanoate

Isolated cases of sudden death of psychiatric patients taking antipsychotic drugs, in particular haloperidol, have been described. Since during treatment with haloperidol, a number of patients noted an increase in the interval Q—T on the ECG, the drug should be used with caution in patients at risk of prolongation of the interval Q—T(extended Q—T, hypokalemia, simultaneous use of other drugs that can cause prolongation of the interval Q—T).
If the use of Haloperidol decanoate is necessary, oral haloperidol should be administered first to determine possible hypersensitivity.
Due to the fact that haloperidol is metabolized in the liver, caution is required when using the drug in severe hepatic pathology. With long-term use, periodic monitoring of blood counts and liver function is necessary.
Isolated cases of the development of convulsive syndrome during the use of haloperidol have been described. Therefore, patients with epilepsy, as well as patients with increased convulsive readiness (chronic intoxication of alcohol or other origins, a history of traumatic brain injury, etc.), should be prescribed haloperidol decanoate with caution.
For patients whose psychopathological disorders include symptoms of depressive syndrome, haloperidol should be prescribed in combination with antidepressants.
During the initial period of treatment with the drug, you should not drive vehicles or work in conditions with an increased risk of injury. Subsequently, the degree of restrictions is determined individually.
Treatment with the drug is incompatible with drinking alcohol.
It has been experimentally established that haloperidol does not significantly increase the number of congenital pathologies. In some cases, congenital developmental anomalies have been described during the use of haloperidol during pregnancy (usually when the drug is used in combination with other drugs). Thus, haloperidol can be prescribed during pregnancy only if the expected benefits of treatment clearly exceed the possible teratogenic effect.
Haloperidol passes into breast milk. In some cases, extrapyramidal disorders have been observed in newborns whose mothers took haloperidol. Therefore, when prescribing haloperidol, it is recommended to stop breastfeeding.
When stored at low temperatures, a fraction of the active component may be released from the solution. This phenomenon can be eliminated by warming the ampoules in your hands or keeping them at room temperature for a certain time.
For administration, only homogeneous solution can be used!

Drug interactions Haloperidol decanoate

Thyroxine increases the toxicity of haloperidol, therefore, in patients with hyperthyroidism, haloperidol can only be used under the guise of adequate thyreostatic therapy.
If there is a need for simultaneous antiparkinsonian therapy for the patient, a break should be taken after the last dose of Haloperidol decanoate, given its prolonged effect.
The drug can enhance the effect of central nervous system depressants - alcohol, sedatives and hypnotics, as well as narcotic analgesics. Concomitant use of haloperidol with these drugs may cause respiratory depression. Enhances the effect of methyldopa on the central nervous system. Reduces the antiparkinsonian effect of levodopa.
Haloperidol decanoate inhibits the metabolism of tricyclic antidepressants, so their levels in the blood plasma may increase with increased anticholinergic effects, as well as toxicity, including in relation to the cardiovascular system.
Pharmacokinetic studies revealed a moderate or moderate increase in the concentration of haloperidol in the blood serum when used simultaneously with quinidine, buspirone, and fluoxetine. If their combined use is necessary, a reduction in the dose of haloperidol may be necessary.
With long-term use of drugs that have the properties of liver enzyme inducers (carbamazepine, rifampicin, phenobarbital, etc.), the concentration of haloperidol in the blood decreases. Therefore, if their combined use is necessary, an increase in the dose of haloperidol may be required. In case of subsequent discontinuation of therapy with these drugs, the advisability of reducing the dose of Haloperidol decanoate should be kept in mind.
Rarely, with the combined use of Haloperidol decanoate and lithium salts, encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, brain stem symptoms, and coma were noted. In most cases, such disorders are reversible. The reason for their manifestation in this situation is not clear. If these disorders occur, you should immediately stop using Haloperidol decanoate.
Haloperidol may reduce the effectiveness of oral anticoagulant therapy.
Haloperidol inhibits the action of epinephrine and other sympathomimetics, and also reduces the effectiveness of antihypertensive adrenergic blocking agents.

Overdose of the drug Haloperidol decanoate, symptoms and treatment

With parenteral use of the long-acting drug (Haloperidol decanoate), the likelihood of overdose is lower than with oral use of haloperidol. If an overdose of Haloperidol decanoate is suspected, the prolonged nature of the drug's action should be taken into account.
The main signs of overdose: severe extrapyramidal disorders (muscle rigidity, possible muscle hypertonicity, generalized or local tremor), arterial hypotension or hypertension (arterial hypertension), severe lethargy. In some cases, coma with respiratory depression may develop against the background of severe arterial hypotension. Ventricular arrhythmias may occur with prolongation of the interval Q—T.
There is no specific antidote. Symptomatic therapy is carried out: the stomach is washed, activated charcoal is used. In a comatose state, the function of the respiratory system is supported, if necessary, with the use of a ventilator. Monitoring of ECG and critical hemodynamic parameters is necessary. To treat patients with severe arterial hypotension or circulatory failure, it is necessary to administer a sufficient volume of fluid, blood plasma or concentrated albumin intravenously, as well as the administration of vasopressive agents (norepinephrine or dopamine). Epinephrine should not be used because in combination with haloperidol it can cause paradoxical hypotension. For severe extrapyramidal disorders, antiparkinsonian drugs are prescribed parenterally.

Storage conditions for the drug Haloperidol decanoate

In a place protected from light at a temperature of 15-30 °C.

List of pharmacies where you can buy Haloperidol decanoate:

• Saint Petersburg

solution for intramuscular injection (oil) 50 mg/1 ml: amp. 5 pieces. Reg. No.: P N015065/01

Clinical and pharmacological group:

Antipsychotic drug (neuroleptic)

Release form, composition and packaging

Solution for intramuscular administration (oil) transparent, yellow or greenish-yellow.

Excipients: benzyl alcohol, sesame oil.

1 ml - dark glass ampoules (5) - contour plastic packaging (1) - cardboard packs.

Description of the active components of the drug " Haloperidol decanoate»

pharmachologic effect

Haloperidol decanoate is an ester of haloperidol and decanoic acid. When administered intramuscularly, slow hydrolysis releases haloperidol, which then enters the systemic circulation. Haloperidol decanoate is a butyrophenone-derived antipsychotic. Haloperidol is a strong antagonist of central dopamine receptors and is a strong antipsychotic.

Haloperidol is highly effective in the treatment of hallucinations and delusions, due to the direct blockade of central dopamine receptors (probably acts on mesocortical and limbic structures), and affects the basal ganglia (nigrostria). It has a pronounced calming effect during psychomotor agitation, and is effective against mania and other agitations.

The limbic activity of the drug manifests itself in a sedative effect and is effective as an additional remedy for chronic pain.

Impact on the basal ganglions causes extrapyramidal reactions (dystonia, akathisia, parkinsonism).

In socially withdrawn patients, social behavior is normalized.

Severe peripheral antidopamine activity is accompanied by the development of nausea and vomiting (irritation of chemoreceptors), relaxation of the gastroduodenal sphincter and increased release of prolactin (blocks the prolactin-inhibiting factor in the adenohypophysis).

Indications

- chronic schizophrenia and other psychoses, especially when treatment with rapid-acting haloperidol was effective and an effective neuroleptic with moderate sedative action is needed;

- other disorders of mental activity and behavior that occur with psychomotor agitation and require long-term treatment.

Dosage regimen

The drug is intended exclusively for adults, exclusively for intramuscular administration!

Do not administer IV!

For adults: Patients on long-term treatment with oral antipsychotics (mainly haloperidol) may be advised to switch to depot injections.

The dose should be adjusted on an individual basis due to significant individual differences in response to treatment. Dose selection should be carried out under strict medical supervision of the patient. The choice of the initial dose is carried out taking into account the symptoms of the disease, its severity, the dose of haloperidol or other antipsychotics prescribed during previous treatment.

At the beginning of treatment, every 4 weeks it is recommended to prescribe doses 10-15 times higher than the dose of oral haloperidol, which usually corresponds to 25-75 mg of Haloperidol Decanoate (0.5-1.5 ml). The maximum initial dose should not exceed 100 mg.

Depending on the effect, the dose can be increased stepwise, by 50 mg, until the optimal effect is obtained. Typically the maintenance dose corresponds to 20 times the daily dose of oral haloperidol. If symptoms of the underlying disease return during the dose adjustment period, treatment with Haloperidol Decanoate can be supplemented with oral haloperidol.

Injections are usually given every 4 weeks, but due to large individual differences in effectiveness, more frequent use may be required.

Elderly patients and patients with oligophrenia: A lower initial dose is recommended, for example 12.5-25 mg every 4 weeks. In the future, depending on the effect, the dose may be increased.

Side effect

Side effects that develop during treatment are due to the action of haloperidol.

From the nervous system: headache, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epileptic attacks, development of a paradoxical reaction - exacerbation of psychosis and hallucinations; with long-term treatment - extrapyramidal disorders, incl. tardive dyskinesia (smacking and wrinkling of the lips, puffing out of the cheeks, rapid and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), tardive dystonia (frequent blinking or spasms of the eyelids, unusual facial expression or body position, uncontrolled bending movements of the neck, torso , arms and legs) and neuroleptic malignant syndrome (difficulty or rapid breathing, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased sweating, urinary incontinence, muscle rigidity, epileptic seizures, loss of consciousness).

From the cardiovascular system: when used in high doses - decreased blood pressure, orthostatic hypotension, arrhythmias, tachycardia, ECG changes (prolongation of the QT interval, signs of flutter and ventricular fibrillation).

From the digestive system: when used in high doses - loss of appetite, dry mouth, hyposalivation, nausea, vomiting, diarrhea or constipation, impaired liver function, up to the development of jaundice.

From the hematopoietic system: rarely - transient leukopenia or leukocytosis, agranulocytosis, erythropenia and a tendency to monocytosis.

From the urinary system: urinary retention (with prostatic hyperplasia), peripheral edema.

From the reproductive system: pain in the mammary glands, gynecomastia, hyperprolactinemia, menstrual irregularities, decreased potency, increased libido, priapism.

From the side of the organ of vision: cataracts, retinopathy, blurred vision.

From the side of water-electrolyte balance: hyponatremia.

Metabolism: hyper- and hypoglycemia.

Allergic reactions: maculopapular and acne-like skin changes, photosensitivity, rarely - bronchospasm, laryngospasm.

Possible development local reactions associated with the injection.

Others: alopecia, weight gain.

Contraindications

- comatose state;

- CNS depression caused by drugs or alcohol;

- Parkinson's disease;

- damage to the basal ganglia;

- childhood;

- hypersensitivity to the components of the drug.

With caution: decompensated diseases of the cardiovascular system (including angina pectoris, intracardiac conduction disorders, prolongation of the QT interval or a predisposition to this - hypokalemia, simultaneous use of other drugs that can cause prolongation of the QT interval), epilepsy, angle-closure glaucoma, liver and/or renal failure, hyperthyroidism (with symptoms of thyrotoxicosis), pulmonary-cardiac and respiratory failure (including in COPD and acute infectious diseases), prostatic hyperplasia with urinary retention, alcoholism.

Pregnancy and lactation

Studies involving a large number of patients indicate that Haloperidol Decanoate does not cause a significant increase in the incidence of malformations. In a few isolated cases, congenital malformations have been observed when Haloperidol Decanoate was used concomitantly with other drugs during fetal development. Prescribing the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Haloperidol Decanoate passes into breast milk. Prescribing the drug during breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the baby. In some cases, the development of extrapyramidal symptoms in infants was observed when the drug was taken by a nursing mother.

Use for liver dysfunction

The drug is prescribed with caution to patients with liver failure.

Use for renal impairment

The drug is prescribed with caution to patients with renal failure.

Use in old age

Application for children

The drug is contraindicated in children.

special instructions

In several cases, sudden death occurred in psychiatric patients receiving antipsychotic drugs. If you are predisposed to prolongation of the QT interval (long QT syndrome, hypokalemia, taking drugs that prolong the QT interval), caution should be exercised during treatment due to the risk of prolongation of the QT interval.

Treatment should begin with oral haloperidol and only then proceed to injections of the drug Haloperidol Decanoate to identify unexpected adverse reactions.

If liver function is impaired, caution must be exercised, because the drug is metabolized in the liver.

With long-term treatment, regular monitoring of liver function and blood counts is necessary.

In isolated cases, Haloperidol Decanoate has caused convulsions. Treatment of patients with epilepsy and conditions predisposing to seizures (eg, head trauma, alcohol withdrawal) requires caution.

Thyroxine increases the toxicity of the drug. Treatment of patients suffering from hyperthyroidism is permissible only with appropriate thyreostatic treatment.

In case of simultaneous presence of depression and psychosis or in case of dominance of depression, Haloperidol Decanoate is prescribed together with antidepressants.

When antiparkinsonian therapy is carried out simultaneously after the end of treatment with Haloperidol Decanoate, it should be continued for several more weeks due to the faster elimination of antiparkinsonian drugs.

The drug Haloperidol Decanoate is an oil solution for intramuscular administration, therefore it is prohibited to administer it intravenously!

In the future, the degree of prohibition is determined based on the individual reaction of the patient. During treatment with the drug, it is prohibited to drink alcohol.

At the beginning of treatment with the drug and especially during the use of high doses, a sedative effect of varying severity may occur with a decrease in attention, which can be aggravated by alcohol intake.

Caution must be exercised when performing heavy physical work or taking a hot bath (heat stroke may develop due to suppression of central and peripheral thermoregulation in the hypothalamus).

During treatment, you should not take “anti-cold” over-the-counter medications (anticholinergic effects and the risk of heat stroke may increase).

Exposed skin should be protected from excess solar radiation due to the increased risk of photosensitivity.

Treatment is stopped gradually to avoid withdrawal syndrome.

Overdose

The use of depot injections of the drug Haloperidol Decanoate is associated with a lower risk of overdose than oral administration of haloperidol. Symptoms of an overdose of Haloperidol Decanoate and haloperidol are the same. If an overdose is suspected, the longer action of the former should be taken into account.

Symptoms: development of known pharmacological effects and side effects in a more pronounced form. Symptoms that pose the greatest danger: extrapyramidal reactions, decreased blood pressure, sedation. Extrapyramidal reactions manifest themselves in the form of muscle rigidity and general or localized tremor. More often it is possible to increase blood pressure rather than decrease it. In exceptional cases, the development of a coma with respiratory depression and arterial hypotension, turning into a shock-like state. Possible prolongation of the QT interval with the development of ventricular arrhythmias.

Treatment: there is no specific antidote. The airway of a comatose patient is ensured using an oropharyngeal or endotracheal tube; if respiratory depression occurs, artificial ventilation may be required. Vital functions and ECG are monitored until it is completely normalized, severe arrhythmias are treated with appropriate antiarrhythmic drugs, with reduced blood pressure and circulatory arrest - intravenous administration of fluid, plasma or concentrated albumin and dopamine, or norepinephrine as a vasopressor. The administration of epinephrine is unacceptable, because as a result of interaction with the drug Haloperidol Decanoate, blood pressure may increase significantly, which requires immediate correction. For severe extrapyramidal symptoms, administer antiparkinsonian drugs with anticholinergic action for several weeks (symptoms may return after discontinuation of these drugs!).

Drug interactions

Storage conditions and periods

Storage conditions:

store at a temperature of 15-30°C, protected from light and out of reach of children.

Best before date:

5 years. Use within the expiration date indicated on the package.

Drug interactions

Increases the severity of the depressant effect on the central nervous system of ethanol, tricyclic antidepressants, opioid analgesics, barbiturates and hypnotics, and general anesthesia.

Enhances the effect of peripheral M-anticholinergic drugs and most antihypertensive drugs (reduces the effect of guanethidine due to its displacement from α-adrenergic neurons and suppression of its uptake by these neurons).

It inhibits the metabolism of tricyclic antidepressants and MAO inhibitors, thereby increasing (mutually) their sedative effect and toxicity.

When used simultaneously with bupropion, it reduces the epileptic threshold and increases the risk of grand mal seizures.

Reduces the effect of anticonvulsants (lowering the seizure threshold with haloperidol).

Weakens the vasoconstrictor effect of dopamine, phenylephrine, norepinephrine, ephedrine and epinephrine (blockade of α-adrenergic receptors by haloperidol, which can lead to a distortion of the action of epinephrine and a paradoxical decrease in blood pressure).

Reduces the effect of antiparkinsonian drugs (antagonistic effect on dopaminergic structures of the central nervous system).

Changes (may increase or decrease) the effect of anticoagulants.

Reduces the effect of bromocriptine (dose adjustment may be required).

When used with methyldopa, it increases the risk of developing mental disorders (including disorientation in space, slowing down and difficulty thinking).

Amphetamines reduce the antipsychotic effect of haloperidol, which in turn reduces their psychostimulant effect (blockade of α-adrenergic receptors by haloperidol).

Anticholinergic, antihistamine (1st generation) and antiparkinsonian drugs can enhance the M-anticholinergic effect of haloperidol and reduce its antipsychotic effect (dose adjustment may be required).

Long-term use of carbamazepine, barbiturates and other inducers of microsomal oxidation reduces the concentration of haloperidol in plasma.

In combination with lithium preparations (especially in high doses), the development of encephalopathy (can cause irreversible neurointoxication) and increased extrapyramidal symptoms is possible.

When taken simultaneously with fluoxetine, the risk of developing side effects from the central nervous system, especially extrapyramidal reactions, increases.

When used simultaneously with drugs that cause extrapyramidal reactions, it increases the frequency and severity of extrapyramidal disorders.

Drinking strong tea or coffee (especially in large quantities) reduces the effect of haloperidol.