Instructions for use HALOPERIDOLUM

Release form and composition

The drug is available in the form of an oil solution for intramuscular (IM) administration: a transparent greenish-yellow or yellow liquid (1 ml in dark glass ampoules; 5 ampoules in plastic trays, 1 tray in a cardboard box and instructions for use Haloperidol decanoate).

1 ml of solution contains:

• active ingredient: haloperidol decanoate – 70.52 mg, which is equivalent to the content of 50 mg of haloperidol;
• auxiliary components: sesame oil, benzyl alcohol.

Haloperidol price, where to buy

The price of Haloperidol tablets 1.5 mg 50 pieces is 45-50 rubles.

10 ampoules of 5 mg/ml cost approximately 75 rubles.

• Online pharmacies in RussiaRussia

ZdravCity

• Haloperidol solution for intravenous and intramuscular injection.
  5mg/ml amp. 1ml No. 10Ozon LLC 96 rub. order
• Haloperidol Welfarm solution for intravenous and intramuscular injection. 5mg/ml amp. 1ml 10 pcs. Welfarm LLC

  RUB 199 order

  Read also:  Tsifran OD: indications, application features, analogues, side effects
• Haloperidol-Ratiopharm drops for internal use. approx. 2mg/ml 30mlTeva

  51 RUR order

• Haloperidol-Richter solution for intravenous and intramuscular injection. 5mg/ml 1ml 5 pcs. JSC Gedeon Richter

  126 rub. order

• Haloperidol tablets 1.5 mg 50 pcs. Ozon LLC

  47 RUR order

Pharmacological properties

Pharmacodynamics

Haloperidol decanoate is a strong neuroleptic, a butyrophenone derivative, a long-acting antipsychotic drug. Its active substance is an ester of decanoic acid and haloperidol, which is a pronounced antagonist of central dopamine receptors. After administration, haloperidol is released by slow hydrolysis and enters the systemic circulation.

Thanks to the direct blockade of central dopamine receptors in the treatment of hallucinations and delusions, haloperidol is highly effective. It is believed that this occurs as a result of its action on mesocortical and limbic structures. It has a pronounced calming effect during psychomotor agitation, mania and other agitations.

The activity of the drug in relation to the limbic system is manifested in a sedative effect. Haloperidol is indicated as an adjunctive treatment for patients with chronic pain.

The substance acts on the basal ganglia, causing extrapyramidal reactions in the form of dystonia, akathisia, and parkinsonism.

In disorders characterized by social withdrawal, after taking Haloperidol decanoate, patients experience normalization of social behavior.

Pronounced antidopamine activity has an irritating effect on chemoreceptors, causing the development of nausea and vomiting. In addition, it is accompanied by relaxation of the gastroduodenal sphincter and blocks the prolactin-inhibiting factor in the adenohypophysis, which leads to increased release of prolactin.

Pharmacokinetics

After intramuscular injection, the maximum concentration (Cmax) of haloperidol is achieved after 3–9 days. In plasma, the saturation stage occurs during monthly administration after 2–4 injections. Pharmacokinetics is dose-dependent; when doses below 450 mg are used, a direct relationship is observed between plasma concentration and dose. The therapeutic effect occurs after the plasma concentration of haloperidol reaches 20–25 mcg/l.

Plasma protein binding – 92%.

Haloperidol easily crosses the blood-brain barrier (BBB) ​​and is excreted in breast milk.

The half-life (T1/2) is approximately 21 days. Up to 60% of the administered substance is excreted through the intestines, 40% through the kidneys, of which about 1% is unchanged.

Pharmacodynamics and pharmacokinetics

The active component is a butyrophenone derivative. Blocks dopamine, postsynaptic receptors in the mesocortical, mesolimbic structures of the brain, has a pronounced antipsychotic effect. Despite its high antipsychotic activity , the drug combines moderate sedative and antiemetic effects. It does not have an anticholinergic effect, but causes extrapyramidal disorders. The sedative effect is due to the blockade of alpha-adrenergic receptors in the reticular pharmacy.

The antiemetic effect is achieved by blocking the vomiting center in the trigger zone. When dopamine receptors are blocked in the hypothalamus, galactorrhea and hypothermic effects appear. With long-term therapy, a change in endocrine status occurs, the production of gonadotropic hormones decreases and the synthesis of prolactin due to the effect on the anterior lobe. The drug eliminates persistent personality changes, mania, hallucinations, delusions, and increases the patient’s interest in the world around him.

Haloperidol is prescribed to patients who have developed resistance to other antipsychotic medications. The drug has an activating effect on patients.

In hyperactive children, Haloperidol can eliminate behavioral disorders and excessive motor activity.

Haloperidol decanoate has a longer duration of action compared to haloperidol.

The therapeutic effect of prolonged forms of the drug lasts up to 6 weeks.

The maximum concentration after using the solution is observed after 10-20 minutes, when using tablets - after 3-6 hours. The solution and tablets are excreted in urine and feces in a ratio of 2:3. Drops are excreted in bile (15%) and urine (40%).

Contraindications

Absolute:

• coma of various origins;
• depression of the central nervous system (CNS) resulting from taking medications or drinking alcohol;
• Parkinson's disease, other diseases of the central nervous system, which are accompanied by pyramidal or extrapyramidal symptoms;
• damage to the basal ganglia;
• depression, hysteria;
• pregnancy period;
• breast-feeding;
• childhood;
• hypersensitivity to the components of the drug.

Haloperidol decanoate should be prescribed with caution for epilepsy, decompensated diseases of the cardiovascular system (including angina pectoris, prolongation of the QT interval, intracardiac conduction disorders, hypokalemia or concomitant therapy with drugs that may prolong the QT interval), angle-closure glaucoma, liver failure, hyperthyroidism ( with symptoms of thyrotoxicosis), renal failure, prostatic hyperplasia with urinary retention, pulmonary-cardiac and respiratory failure (including chronic obstructive pulmonary disease, acute infectious diseases), alcoholism.

During pregnancy, Haloperidol decanoate is allowed to be prescribed only in cases where the expected therapeutic effect for the mother outweighs the potential threat to the fetus.

Indications for use of Haloperidol

Indications for use are as follows. The drug is prescribed for hallucinations , delusions, acute psychosis, paranoid states , psychomotor agitation, “steroid” psychosis, alcoholic and drug psychosis, agitated depression, mental retardation, Tourette’s disease , psychoses of various origins, Huntington’s chorea , psychosomatic disorders, stuttering, childhood autism , hyperactivity in children.

Haloperidol decanoate, instructions for use: method and dosage

Haloperidol decanoate is an oil solution, therefore its intravenous administration is strictly contraindicated.

The solution is intended for parenteral administration by deep intramuscular injection into the gluteal region.

It should be borne in mind that the administration of a solution in a dose exceeding 3 ml is accompanied by an unpleasant feeling of fullness at the injection site.

When prescribing the initial dose of Haloperidol decanoate, the symptoms of the disease, its severity, and the previous dose of haloperidol or other antipsychotics are taken into account.

The dose must be selected individually under strict medical supervision of the patient, due to significant differences in responses to treatment in different patients.

Recommended dosage: initial dose – 0.5–1.5 ml, which corresponds to 25–75 mg of haloperidol, 1 time in 28 days. The initial dose of haloperidol decanoate should be 10–15 times higher than the oral form of haloperidol, but should not exceed 100 mg. Taking into account the effect, the initial dose can be increased in increments of 50 mg until the desired optimal effect is obtained. A single maintenance dose is usually 20 daily doses of haloperidol taken orally. If during the dose selection period the symptoms of the underlying disease recur, treatment can be supplemented with oral forms.

If necessary, taking into account the individual characteristics of the effect of the drug, more frequent intramuscular administration of the solution is possible (once every 14 days).

For patients with oligophrenia and elderly patients, the initial dose should be from 12.5 to 25 mg of the drug once every 28 days. Depending on the individual response to therapy, the dose is increased.

Side effects

• from the nervous system: drowsiness or insomnia (especially at the beginning of therapy), fears, restlessness, agitation, anxiety, headache, akathisia, depression, euphoria, epileptic attacks, lethargy, paradoxical reactions - hallucinations and exacerbation of psychosis; during long-term treatment - extrapyramidal disorders, including tardive dyskinesia (wrinkling of the lips, smacking, puffing out of the cheeks, worm-like rapid movements of the tongue, uncontrolled chewing movements, movements of the arms and legs), tardive dystonia (spasms of the eyelids, rapid blinking, unusual facial expression or position body, bending uncontrolled movements of the neck, arms, torso and legs), neuroleptic malignant syndrome [rapid or difficult breathing, increased or decreased blood pressure (BP), hyperthermia, increased sweating, tachycardia, arrhythmia, muscle rigidity, urinary incontinence, loss of consciousness, epileptic seizures];
• from the cardiovascular system: against the background of high doses - decreased blood pressure, arrhythmias, tachycardia, orthostatic hypotension, signs of ventricular flutter and fibrillation, prolongation of the QT interval;
• from the digestive system: with the use of high doses - dry mouth, loss of appetite, nausea, vomiting, hyposalivation, diarrhea or constipation, functional disorders of the liver, including the development of jaundice;
• from the hematopoietic system: rarely - agranulocytosis, transient leukocytosis or leukopenia, tendency to monocytosis, erythropenia;
• from the urinary system: peripheral edema, with prostatic hyperplasia - urinary retention;
• from the reproductive system and mammary gland: menstrual irregularities, pain in the mammary glands, hyperprolactinemia, gynecomastia, increased libido, decreased potency, priapism;
• from the organ of vision: blurred vision, cataracts, retinopathy;
• from the metabolic side: hyponatremia, hyperglycemia, hypoglycemia;
• dermatological reactions: maculopapular rash, acne, photosensitivity;
• allergic reactions: rarely - laryngospasm, bronchospasm;
• local reactions: possible - development of adverse events associated with the administration of Haloperidol decanoate;
• other: weight gain, alopecia.

Instructions:

Clinical and pharmacological group

02.001 (Antipsychotic drug (neuroleptic))

Release form, composition and packaging

The solution for intravenous and intramuscular administration is colorless or slightly yellowish, transparent.

Excipients: lactic acid, water for injection.

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

Tablets are white or almost white, flat, round, bevelled, practically odorless, with “I|I” engraved on one side.

Excipients: potato starch, colloidal silicon dioxide, gelatin, magnesium stearate, talc, corn starch, lactose monohydrate.

25 pcs. - blisters (2) - cardboard packs.

Tablets are white or almost white, flat, disc-shaped, unmarked, practically odorless.

Excipients: potato starch, colloidal silicon dioxide, gelatin, magnesium stearate, talc, corn starch, lactose monohydrate.

25 pcs. - blisters (2) - cardboard packs.

pharmachologic effect

Haloperidol is an antipsychotic drug belonging to the butyrophenone derivatives. It has a pronounced antipsychotic and antiemetic effect. The action of haloperidol is associated with the blockade of central dopamine (D2) and α-adrenergic receptors in the mesocortical and limbic structures of the brain. Blockade of D2 receptors in the hypothalamus leads to a decrease in body temperature and galactorrhea (increased production of prolactin). Inhibition of dopamine receptors in the trigger zone of the vomiting center underlies the antiemetic effect. Interaction with dopaminergic structures of the extrapyramidal system can lead to extrapyramidal disorders. Pronounced antipsychotic activity is combined with a moderate sedative effect (in small doses it has an activating effect). Strengthens the effect of sleeping pills, narcotic analgesics, general anesthesia, analgesics and other drugs that depress the function of the central nervous system.

Pharmacokinetics

Absorbed by passive diffusion, in non-ionized form, mainly from the small intestine. Bioavailability - 60-70%. When administered orally, Cmax in the blood is reached after 2-6 hours, when administered intramuscularly - after 20 minutes. The therapeutic effect occurs at a plasma concentration of 20-25 mg/l. Vd large, 7.9±2.5 l/kg. Communication with blood proteins - 92%. Haloperidol is metabolized in the liver; the metabolite is pharmacologically inactive. Haloperidol also undergoes oxidative N-dealkylation and glucuronidation. T1/2 from plasma after oral administration - 24 hours (12-38 hours), after intramuscular administration - 21 hours (13-36 hours), after intravenous administration - 14 hours (10-19 hours). Excreted in the form of metabolites through the intestines - 60% (including with bile - 15%), by the kidneys - 40% (including 1% - unchanged). Easily penetrates histohematic barriers, incl. through the placental and hematoencephalic, penetrates into breast milk.

Dosage

The dosage depends on the clinical response of the patient. Most often, this means a gradual increase in the dose in the acute phase of the disease; in the case of maintenance doses, a gradual reduction in the dose to ensure the lowest effective dose. High doses are used only in cases of ineffectiveness of lower doses. Average doses are suggested below.

Solution for intravenous and intramuscular administration

To relieve psychomotor agitation in the first days, haloperidol is prescribed IM 2.5-5 mg 2-3 times a day, or IV in the same dosage (the ampoule should be diluted in 10-15 ml of water for injection), the maximum daily dose is 60 mg. Once a stable sedative effect is achieved, they switch to taking the drug orally.

For elderly patients: 0.5 - 1.5 mg (0.1-0.3 ml of solution), maximum daily dose - 5 mg (1 ml of solution).

For children over 3 years of age, the dose is 0.025-0.05 mg/day, divided into 2 injections. The maximum daily dose is 0.15 mg/kg.

Parenteral administration of haloperidol should be carried out under close medical supervision, especially in elderly patients and children. After achieving a therapeutic effect, you should switch to taking the drug orally.

Pills

Prescribed orally, 30 minutes before meals (can be taken with milk to reduce irritation to the gastric mucosa).

The initial daily dose is 1.5-5 mg, divided into 2-3 doses. Then the dose is gradually increased by 1.5-3 mg (in resistant cases up to 5 mg) until the required therapeutic effect is achieved. The maximum daily dose is 100 mg. On average, the therapeutic dose is 10-15 mg/day, for chronic forms of schizophrenia - 20-40 mg/day, if necessary, the dose can be increased to 50-60 mg/day. The average duration of treatment is 2-3 months. Maintenance doses (outside of exacerbation) - from 0.5-0.75 mg to 5 mg/day (the dose is reduced gradually).

Children aged 3-12 years (with body weight 15-40 kg): 0.025-0.05 mg/kg body weight/day 2-3 times/day, increasing the dose no more than once every 5-7 days, up to the daily dose 0.15 mg/kg.

For behavioral disorders, Tourette's syndrome: 0.05 mg/kg/day, divided into 2-3 doses and increasing the dose no more than once every 5-7 days to 3 mg/day. For autism - 0.025-0.05 mg/kg/day.

Elderly and debilitated patients are prescribed 1/3-1/2 the usual dose for adults, the dose is increased no more often than every 2-3 days.

As an antiemetic, 1.5-2.5 mg is prescribed orally.

Overdose

In case of an overdose of the drug, acute neuroleptic reactions may occur.

Symptoms: muscle rigidity, tremor, drowsiness, decreased, sometimes increased blood pressure, in severe cases - coma, respiratory depression, shock, prolongation of the QT interval with ventricular arrhythmia.

An increase in body temperature, which may be one of the symptoms of neuroleptic malignant syndrome, should be especially alarming. In severe cases of overdose, various forms of impaired consciousness may occur, including coma, and convulsive reactions.

Treatment: cessation of therapy with neuroleptics, if taken orally - against the background of maintenance therapy, gastric lavage, activated charcoal, if consciousness is not darkened and there is no coma, convulsions. If respiratory depression occurs, artificial ventilation may be required. For hypotension and collapse - intravenously, plasma or concentrated albumin, dopamine or norepinephrine are administered as a vysopressor to maintain blood circulation. Epinephrine is strictly prohibited in these cases, as it can provoke extreme hypotension! To relieve extrapyramidal symptoms, use central antiparkinsonian drugs with anticholinergic action (for example, 1-2 mg benztropine mesylate IV or IM). Their withdrawal should be done with caution. Diazepam, glucose solution, nootropics, vitamins B and C are administered intravenously. Dialysis is ineffective. There is no specific antidote.

Drug interactions

Haloperidol enhances the inhibitory effect of opioid analgesics, hypnotics, tricyclic antidepressants, general anesthesia, and alcohol on the central nervous system.

When used simultaneously with antiparkinsonian drugs (levodopa, etc.), the therapeutic effect of these drugs may be reduced due to the antagonistic effect on dopaminergic structures.

When used with methyldopa, disorientation, difficulty and slowdown in thinking processes may develop.

Haloperidol can weaken the effect of adrenaline (epinephrine) and other sympathomimetics, causing a “paradoxical” decrease in blood pressure and tachycardia when used together.

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).

When combined with anticonvulsants (including barbiturates and other inducers of microsomal oxidation), the doses of the latter should be increased, because haloperidol lowers the threshold for seizure activity; in addition, serum concentrations of haloperidol may also decrease. In particular, when drinking tea or coffee at the same time, the effect of haloperidol may be weakened.

Haloperidol may reduce the effectiveness of indirect anticoagulants, so when taken together, the dose of the latter should be adjusted.

Haloperidol slows down the metabolism of tricyclic antidepressants and MAO inhibitors, resulting in an increase in their plasma levels and increased toxicity.

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

When haloperidol is taken concomitantly with fluoxetine, the risk of side effects on the central nervous system, especially extrapyramidal reactions, increases.

When administered simultaneously with lithium, especially in high doses, it can cause irreversible neurointoxication and also increase extrapyramidal symptoms.

When taken simultaneously with amphetamines, the antipsychotic effect of haloperidol and the psychostimulating effect of amphetamines are reduced due to the blockade of α-adrenergic receptors by haloperidol.

Haloperidol may decrease the effect of bromocriptine.

Anticholinergic, antihistamine (1st generation), antiparkinsonian drugs may increase anticholinergic side effects and reduce the antipsychotic effect of haloperidol.

Thyroxine may increase the toxicity of haloperidol. In case of hyperthyroidism, haloperidol can be prescribed only with simultaneous administration of appropriate thyreostatic therapy.

When used simultaneously with anticholinergic drugs, intraocular pressure may increase.

Use during pregnancy and lactation

Haloperidol does not significantly increase the incidence of congenital malformations. There are isolated cases of birth defects when taking haloperidol concomitantly with other medications during pregnancy. Taking haloperidol during pregnancy is permissible only in cases where the expected benefit to the mother outweighs the risk to the fetus. Haloperidol is excreted in breast milk. In cases where the use of haloperidol is unavoidable, the benefits of breastfeeding relative to the potential dangers must be justified. In some cases, estrapyramidal symptoms have been observed in newborns whose mothers took haloperidol during lactation.

Side effects

At low daily doses (on average up to 3-5 mg), haloperidol is usually well tolerated, side effects are mild. At higher doses, side effects develop more often. The most common reactions are from the nervous system.

From the central nervous system: extrapyramidal disorders of varying severity. Most patients experience transient akinetic-rigid syndrome, oculogyric crises, akathisia, and dystonic phenomena.

The development of neuroleptic malignant syndrome (NMS) is possible, one of the first signs of which is an increase in body temperature.

A state of restlessness, anxiety, agitation, depression, epileptic attacks, the development of a paradoxical reaction - exacerbation of psychotic disorders.

With long-term use of haloperidol, tardive dyskinesia may develop, especially in elderly patients and patients with organic failure of the central nervous system, so the dose of the drug for this category of patients should be reduced.

At the beginning of therapy, lethargy, drowsiness or insomnia, and headache may be observed, which disappear after the prescription of correctors (anti-Parkinsonian drugs).

From the cardiovascular system: arrhythmias, tachycardia, when using high doses - decreased blood pressure; orthostatic hypotension, blood pressure lability; very rarely - ECG changes (prolongation of the QT interval, signs of flutter and ventricular fibrillation at high doses and in cases of predisposition).

From the hematopoietic organs: transient leukopenia or leukocytosis, erythropenia, lymphomonocytosis, rarely - agranulocytosis.

Dermatological reactions: allergic reactions, rash, toxicoderma, dry skin, photosensitivity, hyperfunction of the sebaceous glands.

From the digestive system: anorexia, dyspepsia, dry mouth, sometimes hypersalivation, nausea, vomiting, constipation, diarrhea, increased activity of liver transaminases, jaundice.

From the endocrine system: dysmenorrhea, frigidity, gynecomastia, pain in the mammary glands, galactorrhea, impotence, increased libido, priapism, weight gain.

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

Other: increased fatigue, decreased thirst, heat stroke, alopecia, hyponatremia, hyper- or hypoglycemia.

Storage conditions and periods

Haloperidol tablets 1.5 mg: store at a temperature of 15-30°C, out of the reach of children.

Haloperidol tablets 5 mg: store at a temperature of 15-30°C, out of the reach of children.

Haloperidol solution for intravenous and intramuscular administration: store at a temperature of 15-30°C, protected from light, out of the reach of children.

Best before date:

5 years.

Do not use the drug after the expiration date indicated on the package.

Indications

- acute and chronic psychoses, accompanied by agitation, hallucinatory and delusional disorders (schizophrenia, affective disorders, psychosomatic disorders);

- behavioral disorders, personality changes (paranoid, schizoid and others), incl. and in childhood, autism, Gilles de la Tourette syndrome;

- tics, Gettington's chorea;

- hiccups that persist for a long time and cannot be treated;

- vomiting that cannot be treated with classical antiemetics, including those associated with antitumor therapy;

- premedication before surgery.

Contraindications

- depression of the central nervous system, incl. and severe toxic depression of central nervous system function caused by xenobiotics, coma of various origins;

- diseases of the central nervous system accompanied by pyramidal and extrapyramidal disorders (Parkinson's disease);

- lesions of the basal ganglia;

- children under 3 years of age;

- depression;

- hypersensitivity to butyrophenone derivatives;

- hypersensitivity to the ingredients of the drug.

Caution should be exercised in case of decompensated cardiovascular diseases (including angina pectoris); in case of cardiac muscle conduction disturbance; for severe kidney and liver diseases; pulmonary heart failure (including bronchial asthma and acute infections); epilepsy; history of convulsive conditions; angle-closure glaucoma; hyperthyroidism (thyrotoxicosis); prostatic hyperplasia (urinary retention), active alcoholism.

special instructions

Parenteral administration should be carried out under the strict supervision of a physician, especially in the case of elderly patients and children. Once the therapeutic effect is achieved, you should switch to the oral form of treatment.

Because haloperidol may cause QT prolongation, caution should be exercised if there is a risk of QT prolongation (QT syndrome, hypokalemia, drugs known to prolong the QT interval), especially when administered parenterally. Due to the metabolism of haloperidol in the liver, it is important to exercise caution when prescribing it to patients with impaired hepatic function.

There are known cases of seizures caused by haloperidol. Patients with epilepsy and patients in conditions predisposing to the development of convulsive syndrome (alcoholism, brain injury) should use the drug with extreme caution.

If you are lactose intolerant, please note that a 1.5 mg tablet contains 157 mg of lactose, a 5 mg tablet contains 153.5 mg.

During heavy physical activity or taking a hot bath, caution is required due to the possible development of heat stroke as a result of ineffective central and peripheral thermoregulation of the hypothalamus due to taking the drug.

The patient should be warned about the need to avoid taking medications for colds purchased without a prescription, because it is possible to enhance the anticholinergic effects of haloperidol and develop heat stroke. During treatment, patients should regularly monitor ECG, blood counts, and liver tests.

To relieve extrapyramidal disorders, antiparkinsonian drugs (cyclodol), nootropics, and vitamins are prescribed; their use is continued after haloperidol is discontinued if they are eliminated from the body faster than haloperidol in order to avoid increased extrapyramidal symptoms.

The severity of extrapyramidal disorders is related to the dose; often, when the dose is reduced, they may decrease or disappear.

In some cases, signs of neurological disorders are observed when the drug is discontinued, after a long course of treatment, so haloperidol should be discontinued, gradually reducing the dose.

If tardive dyskinesia develops, the drug should not be abruptly discontinued; A gradual dose reduction is recommended.

Exposed skin should be protected from excess sunlight due to the increased risk of photosensitivity in such cases.

The antiemetic effect of haloperidol may mask signs of drug toxicity and make it difficult to diagnose conditions in which nausea is the first symptom.

Impact on the ability to drive vehicles and operate machinery

While taking haloperidol, driving vehicles, servicing machinery and performing other types of work that require increased concentration, as well as drinking alcohol, is prohibited.

Use for renal impairment

Caution should be exercised in severe kidney disease.

Use for liver dysfunction

Caution should be exercised in severe liver disease.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Overdose

An overdose of haloperidol is manifested by a significant severity of established side pharmacological effects with the development of undesirable reactions. The most dangerous symptoms include a decrease in blood pressure, extrapyramidal reactions in the form of general or localized tremor and muscle rigidity, sedation, and sometimes a coma with arterial hypotension and respiratory depression, turning into shock. There is a risk of prolongation of the QT interval, leading to the development of ventricular arrhythmias.

Treatment: there is no specific antidote. When treating a suspected overdose, it should be taken into account that Haloperidol decanoate has a long-lasting effect. To ensure airway patency, it is necessary to use an oropharyngeal or endotracheal tube; in case of severe respiratory depression, artificial ventilation is performed. It is necessary to ensure careful monitoring of the patient's condition, monitoring vital functions and electrocardiogram (ECG). Antiarrhythmic therapy is continued until the ECG is completely normalized. In case of low blood pressure and circulatory arrest, the use of concentrated albumin and norepinephrine or dopamine, intravenous fluid, and plasma are recommended as vasopressors. If severe extrapyramidal symptoms develop, regular administration of antiparkinsonian drugs with anticholinergic action is required for several weeks. It should be borne in mind that after discontinuation of these drugs, extrapyramidal symptoms may resume.

The use of epinephrine is contraindicated. Its interaction with haloperidol may cause a significant increase in blood pressure and require immediate dose adjustment.

special instructions

Haloperidol decanoate injections should be started after a positive response to pre-therapy with oral haloperidol, this will reduce the risk of unexpected adverse reactions.

During the use of antipsychotic drugs in psychiatric patients, episodes of sudden death have been observed in rare cases.

Long-term therapy must be accompanied by regular studies to monitor blood counts and liver function.

Due to the risk of seizures in patients with epilepsy, head injuries, alcohol withdrawal, or other conditions predisposing to seizures, special caution is required.

The use of Haloperidol decanoate in patients suffering from hyperthyroidism is allowed only against the background of simultaneous appropriate thyreostatic therapy.

A combination with antidepressants is indicated in the treatment of patients with depression and psychosis or when depression is dominant.

With concomitant antiparkinsonian therapy after discontinuation of the drug Haloperidol decanoate, it is recommended to continue it for several weeks due to the faster elimination of antiparkinsonian drugs. Haloperidol should be discontinued gradually to prevent withdrawal symptoms.

During initial therapy or the use of high doses of the drug, sedation with decreased attention may occur. The severity of the sedative effect of Haloperidol decanoate can aggravate alcohol consumption, therefore it is forbidden to drink alcohol during the treatment period.

During treatment, it is recommended to avoid heavy physical activity and not take hot baths, since heat stroke may occur due to inhibition of central and peripheral thermoregulation in the hypothalamus.

Due to the increased risk of photosensitivity, it is necessary to avoid exposure to direct sunlight with exposed skin.

Do not take cold medications without consulting a doctor because they may increase the anticholinergic effect, which increases the risk of heat stroke.

Impact on the ability to drive vehicles and complex mechanisms

At the beginning of the injection use of Haloperidol decanoate solution, patients are prohibited from driving vehicles and performing any activities that require increased concentration and/or involve a high risk of injury.

Use during pregnancy and lactation

It is contraindicated to administer Haloperidol decanoate during pregnancy and lactation.

During pregnancy, the drug may be prescribed only in cases where the expected therapeutic effect for the mother outweighs the potential threat to the fetus.

The use of Haloperidol decanoate during lactation causes the development of extrapyramidal symptoms in infants. If it is necessary to prescribe the drug to the mother, it is recommended to stop breastfeeding.

Drug interactions

• tricyclic antidepressants, ethanol, opioid analgesics, hypnotics, barbiturates, general anesthesia: the severity of their inhibitory effect on the central nervous system increases;
• peripheral m-anticholinergics, antihypertensive drugs: the effect of most antihypertensive drugs and peripheral m-anticholinergics is enhanced;
• tricyclic antidepressants, monoamine oxidase inhibitors: the metabolism of these drugs slows down, and there is a simultaneous increase in the sedative effect and toxicity of these drugs and haloperidol;
• bupropion: the risk of significant epileptic seizures increases due to a decrease in the epileptic threshold of bupropion;
• anticonvulsants: haloperidol causes a decrease in the seizure threshold, reducing their effectiveness;
• dopamine, ephedrine, epinephrine, phenylephrine, norepinephrine: the vasoconstrictor effect of these drugs is weakened; a paradoxical decrease in blood pressure is possible when haloperidol is combined with epinephrine;
• antiparkinsonian drugs: Haloperidol decanoate clinically significantly reduces their effectiveness;
• anticoagulants: their therapeutic effect may increase or decrease;
• bromocriptine: due to a decrease in the effect of bromocriptine, its dose may need to be adjusted;
• methyldopa: in patients taking methyldopa, the risk of spatial disorientation, slowing or difficulty in thinking processes, and the development of other mental disorders increases;
• amphetamines: the psychostimulating effect of amphetamines and the antipsychotic effect of haloperidol decrease;
• lithium preparations: possible increase in extrapyramidal symptoms, development of irreversible neurointoxication (encephalopathy), especially with high doses of lithium;
• anticholinergic, antiparkinsonian, antihistamine (first generation) drugs: interaction with these drugs can cause an increase in the m-anticholinergic effect of haloperidol, reducing its antipsychotic activity. In this case, the need to adjust the dose of Haloperidol decanoate should be considered;
• carbamazepine, barbiturates: against the background of long-term therapy with inducers of microsomal oxidation, the concentration of haloperidol in plasma decreases;
• fluoxetine: the likelihood of developing extrapyramidal reactions and other side effects from the central nervous system increases when haloperidol is combined with fluoxetine;
• drugs that cause extrapyramidal reactions: the frequency and severity of extrapyramidal disorders increases;
• tea, coffee: it should be borne in mind that the consumption of these drinks reduces the therapeutic effect of haloperidol.

Experts' opinion

Most doctors believe that the drug has shown good results over many years of use. It successfully relieves a person from the manifestations of the disease with major and borderline mental disorders. And all the side effects of the drug have been well studied and can be predicted.

To obtain a therapeutic effect and avoid complications, you should never take an antipsychotic without control. Only a specialist can fully calculate the harm and benefit that the drug brings and select the dosage. If you do not take into account contraindications and do not follow the instructions of the treating doctor, overestimating the recommended dose, you cannot exclude a high risk of complications. They will certainly manifest themselves with negative symptoms with multiple disorders of the mental state and functioning of internal organs.