Haloperidol-Ratiopharm drops for oral administration 2 mg / ml 30 ml (Haloperidol)

Release form

Drops for oral administration.

Packing

Bottle 30 ml.

Pharmacological action

Antipsychotic drug (antipsychotic), a derivative of butyrophenone. It has a pronounced antipsychotic effect, blocks postsynaptic dopamine receptors in the mesolimbic and mesocortical structures of the brain. It inhibits the release of mediators, reducing the permeability of presynaptic membranes. High antipsychotic activity is combined with a moderate sedative effect (in small doses it has an activating effect) and a pronounced antiemetic effect. It causes extrapyramidal disorders, practically has no anticholinergic effect.

Sedative effect is due to blockade of the -adrenoreceptors of the reticular formation of the brain stem antiemetic effect - blockade of the dopamine D2 receptors of the trigger zone of the vomiting center hypothermic action and galactorrhea - blockade of the hypothalamic dopamine receptors. Long-term use is accompanied by a change in endocrine status, in the anterior pituitary gland, prolactin production increases and gonadotropic hormones decrease.

Eliminates persistent personality changes, nonsense, hallucinations, mania, increases interest in the environment.

Indications

Acute psychotic syndromes, accompanied by delusions, hallucinations, disorders of thinking and consciousness, catatonic syndromes, delirious and other exogenous psychotic syndromes.

Chronic endogenous and exogenous psychoses (suppression of symptoms and prevention of relapse).

Psychomotor agitation.

Vomiting, stuttering, when it is impossible to conduct other therapy or resistance to treatment.

Contraindications

Coma of various origins.

Children under 3 years.

Pregnancy.

Lactation.

Severe inhibition of central nervous system function with xenobiotics intoxication.

CNS diseases accompanied by pyramidal or extrapyramidal symptoms (including Parkinson's disease).

Hypersensitivity to haloperidol and / or other derivatives of butyrophenone or other excipients of the drug.

Caution: acute intoxication with alcohol, opioid analgesics, hypnotics, or psychotropic drugs that depress the central nervous system hepatic and renal failure hypokalemia bradycardia prolongation of the QT interval (including congenital prolongation of the QT interval syndrome) or the predisposition to this can be taken simultaneously. contribute to the development of hypokalemia, other clinically significant disorders of the heart (in particular, cardiac conduction disturbances, arrhythmias) prolactin-dependent tumors (for example, breast tumors) severe arterial hypotension or orthostatic dysregulation endogenous depression diseases of the hematopoietic system malignant neuroleptic syndrome in the history of organic brain diseases and epilepsy hyperthyroidism.

Special caution: is required in patients with neurological symptoms of damage to the subcortical structures of the brain and a low threshold for convulsive readiness (history or against the background of stopping alcohol intake), because haloperidol lowers the threshold for seizure activity, so grandmal-type seizures may occur. Patients with epilepsy should be treated with haloperidol only if anticonvulsant therapy is continued.

Haloperidol should not be used in severe depressive conditions. With concomitant depression and psychosis, haloperidol should be combined with antidepressants.

thyroxine may increase the frequency of undesirable effects associated with the use of haloperidol, patients with hyperthyroidism should not receive treatment with haloperidol, except when they are simultaneously receiving adequate antithyroid therapy.

Use during pregnancy and lactation

The use of the drug Haloperidol-ratiopharm during pregnancy is contraindicated. Before starting treatment, a pregnancy test should be performed. During treatment with the drug, it is necessary to use effective methods of contraception. Haloperidol is excreted in breast milk. The use of the drug Haloperidol-ratiopharm during breastfeeding is contraindicated.

Special instructions

If you experience, especially in the first three months of treatment, fever, gingivitis and stomatitis, pharyngitis, purulent sore throat and flu-like symptoms, you should immediately consult your doctor.

Avoid self-medication with analgesics.

Before starting treatment with haloperidol, patients need to conduct a general blood test (including differentiated counting of blood cells and platelet counts), ECG and electroencephalograms. If abnormalities are detected, haloperidol can only be used according to absolute indications and subject to mandatory control studies of general blood counts. Prior to treatment, correction of hypokalemia is necessary.

Special care is required in patients with organic brain damage, arteriosclerotic cerebrovascular disease, and endogenous depression during haloperidol therapy.

Due to the fact that elderly patients and patients with concomitant diseases of the cardiovascular system may experience cardiac conduction disturbances, regular monitoring of cardiac activity is recommended during therapy. In patients with pheochromocytoma, renal failure, heart failure, or cerebral insufficiency, hypotensive reactions may develop during treatment with haloperidol, so such patients need careful monitoring.

Although the prevalence of tardive dyskinesias is not well understood, elderly patients (especially elderly women) are prone to the development of this condition. The risk of developing late dyskinesias, especially the irreversible type, increases with increasing duration of treatment and with the use of antipsychotic doses. Tardive dyskinesias can also develop after short-term treatment in low doses. Antipsychotic treatment at the beginning can mask the symptoms of primary tardive dyskinesia. Symptoms may occur after discontinuation of the drug. Caution must be exercised when performing heavy physical work, taking a hot bath (heat stroke may develop due to suppression of central and peripheral thermoregulation in the hypothalamus).

No over-the-counter over-the-counter medicines should be taken during treatment (increased m-anticholinergic effects and the risk of heat stroke are possible).

Protect exposed skin from excessive sunlight due to the increased risk of photosensitivity reactions.

Treatment is discontinued gradually in order to avoid the "withdrawal" syndrome.

An antiemetic effect may mask signs of drug toxicity and make it difficult to diagnose these conditions, the first symptom of which is nausea.

Influence on the ability to drive vehicles and control mechanisms

During treatment, it is necessary to avoid (especially in the first stages of treatment) or to exercise caution when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Composition

1 ml drops contains:

Active ingredient: haloperidol 2 mg.

Excipients: methyl parahydroxybenzoate - 90 mg, propyl parahydroxybenzoate - 10 mg, lactic acid - 170 mg, purified water - 99.7 g.

Dosage and administration

1 ml of solution (20 drops) contains 2 mg of haloperidol 10 drops contain 1 mg of haloperidol.

The individual dose is determined by the attending physician and depends on the clinical picture, characteristics of the course of the disease, age and tolerability of the drug. The daily dose should be divided into 1-3 doses, at high doses a more frequent intake of individual doses is possible. If the doctor has not determined an individual dose for the patient, then the following treatment regimens are usually used.

Drops for oral administration are taken with food, dosed with a teaspoon, added to drinks or food, or on a piece of sugar (except for patients with diabetes mellitus).

Adults: the initial dose is 0.5-1.5 mg 2-3 times / day. Then the dose is gradually increased by 0.5-2 mg / day (in resistant cases, 2-4 mg / day) until the desired therapeutic effect is achieved. When relief of acute symptoms in stationary conditions, the initial daily dose may increase to 15 mg / day, in therapeutically resistant cases - higher. The maximum daily dose should not exceed 100 mg / day. The average therapeutic dose of 10-15 mg / day, in chronic forms of schizophrenia - 20-40 mg / day, in resistant cases - up to 50-60 mg / day. Supporting doses (without exacerbation) on an outpatient basis can fluctuate - 0.5-5 mg / day.

Children older than 3 years: treatment begins with a dose of 0.025-0.05 mg / kg body weight, divided into 2-3 doses. An increase in dose is possible up to 0.2 mg / kg body weight.

Elderly and physically debilitated patients: treatment begins with single doses not exceeding 0.5-1.5 mg. The daily dose is not recommended to increase more than 5 mg / day.

For children, elderly patients and debilitated patients: doses are increased no more than 1 time in 3-5 days.

Side effects

When applying a dose of 1-2 mg / day, undesirable effects are not pronounced and are transient in nature. When using higher doses, the incidence of adverse reactions increases.

From the nervous system: headache, dizziness, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fear, akathisia, euphoria, depression, lethargy, epilepsy attacks, the development of a paradoxical reaction - exacerbation of psychosis and hallucinations with long-term treatment - extrapyramidal disorders, including tardive dyskinesia (smacking and puckering of lips, pouting of cheeks, fast and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), late dystonia (rapid blinking or cramping of the eyelids, unusual facial expression, unusual body position, uncontrolled bending movements of the neck, trunk, arms and legs), malignant antipsychotic syndrome (shortness of breath or rapid breathing, tachycardia, arrhythmia, hyperthermia , increase or decrease in blood pressure, increased sweating, urinary incontinence, muscle stiffness, epileptic seizures, loss of consciousness).

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

From the respiratory system: respiratory rhythm disturbance, shortness of breath, pneumonia (bronchopneumonia).

From the digestive system: when used in high doses - loss of appetite, dry oral mucosa, hyposalivation, nausea, vomiting, diarrhea, constipation, impaired liver function, jaundice.

From the hemopoietic organs: transient leukopenia or leukocytosis, agranulocytosis, erythropenia, monocytosis.

From the genitourinary system: urinary retention (with prostatic hyperplasia), peripheral edema, chest pain, gynecomastia, hyperprolactinemia, menstrual irregularities, decreased potency, increased libido, priapism.

From the sensory organs: cataract, retinopathy, blurred vision.

Allergic reactions: maculopapular changes in the skin, acne, photosensitivity reactions, bronchospasm, laryngospasm, hyperpyrexia.

Laboratory indicators: hyponatremia, hyperglycemia, hypoglycemia.

Other: alopecia, heat stroke, weight gain.

Drug Interactions

Concomitant use of eianol and haloperidol can enhance the effects of alcohol and lead to arterial hypotension.

Increases the severity of the inhibitory effect on the central nervous system of ethanol, tricyclic antidepressants, opioid analgesics, barbiturates and other sleeping pills, drugs for general anesthesia.

Enhances the action of peripheral m-anticholinergics and most antihypertensive drugs (reduces the effect of guanethidine due to its displacement from alpha-adrenergic neurons and suppression of its capture by these neurons).

Inhibits the metabolism of tricyclic antidepressants and MAO inhibitors, while increasing (mutually) their sedation and toxicity.

When used concurrently with bupropion, it lowers the epileptic threshold and increases the risk of large epileptic seizures.

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

Reduces the vasoconstrictor effect of dopamine, phenylephrine, norepinephrine, ephedrine and epinephrine (blockade of -adrenoreceptors by haloperidol, can lead to a perversion of the effects of epinephrine and to 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 effects of bromocriptine (dose adjustment may be required).

When used with methyldopa, it increases the risk of developing mental disorders (including disorientation in space, slowdowns and difficulties in thinking processes).

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

M-anticholinergic drugs, 1st generation histamine H1 receptor blockers and antidiscinetic 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 microsomal oxidation inducers reduces the concentration of haloperidol in plasma.

With simultaneous use with lithium preparations (especially in high doses), encephalopathy may develop (may cause irreversible neurointoxication) and increased extrapyramidal symptoms.

With concomitant use with fluoxetine, the risk of developing side effects from the central nervous system, especially extrapyramidal reactions, increases.

When used concomitantly 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 effects of haloperidol.

Overdose

Due to the wide therapeutic index, intoxication usually develops only in cases of overdose.

Overdose symptoms: - severe extrapyramidal disorders: acute dyskinetic or dystonic symptoms, glossopharyngeal syndrome, spasm of the eye, laryngeal spasms, pharynx - drowsiness, sometimes coma, agitation and confusion system: decrease or increase in blood pressure, tachycardia or bradycardia, ECG changes such as lengthening of PQ and QT intervals, fluttering and ventricular fibrillation, cardiovascular failure - rarely - m-holinoblokiruyuschie effects: blurred vision, bouts of increased intracranial pressure, urine - rarely - respiratory complications: cyanosis, respiratory depression, respiratory failure, aspiration, pneumonia.

Treatment: symptomatic and supportive, following the general principles of overdose treatment, the following circumstances should be considered.

Attempts to induce vomiting may be hampered by the antiemetic effect of antipsychotic drugs. Due to the rapid absorption of gastric lavage is recommended only in cases of early diagnosis of overdose. Forced diuresis and dialysis are not effective.

Analeptics are contraindicated because Against the background of the use of haloperidol, due to a decrease in seizure threshold, there is a tendency to develop epileptic seizures. If severe extrapyramidal symptoms develop, antiparkinsonian drugs should be used, for example, biperiden / may require the use of antiparkinsonian agents for several weeks. Patients in coma undergo intubation. Pharyngeal muscle spasm can make intubation difficult, in which case short-acting muscle relaxants may be used.

In patients with symptoms of intoxication, ECG and basic functional indicators of the body should be constantly monitored until they are normalized. For arterial hypotension, due to the increase in paradoxical effects, drugs of the adrenaline series (epinephrine (epinephrine)), which affect the blood circulation, should be used instead of drugs such as norepinephrine (for example, continuous drip infusions of norepinephrine (norepinephrine)) or angina. Beta-adrenomimetics should be avoided because they cause increased vasodilation.

Hypothermia is treated by slow warming. Infusion solutions for use in patients with hypothermia should be heated.

If severe fever, antipyretic agents should be used, if necessary, ice baths.

M-cholin-blocking symptoms can be stopped with the use of physostigmine (1-2 mg I / O) (repeated if necessary) is not recommended in standard daily practice due to the severe undesirable effects of this drug.

Anticonvulsants are used to treat recurrent epileptiform convulsions, provided that artificial lung ventilation is possible because there is a risk of respiratory depression.

Storage conditions

Do not store above 25 ° C.

Keep out of the reach and sight of children.

active substance

Haloperidol

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