Haloperidol-ratopharm (Haloperidol-ratiopharm)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHaloperidolHaloperidol
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    • Dosage form: & nbspdrops for oral administration
    Composition:100 ml of the preparation contain:
    active substance: haloperidol 0.20 g; Excipients: methyl parahydroxybenzoate 0.09 g, propyl parahydroxybenzoate 0.01 g, lactic acid 0.17 g, purified water 99.70 g.
    Description:A clear, colorless solution.
    Pharmacotherapeutic group:Antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.D.01   Haloperidol

    Pharmacodynamics:Antipsychotic agent (neuroleptic), a derivative of butyrophenone. 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, violates the reverse neuronal capture and deposition. High antipsychotic activity is combined with a moderate sedative effect (in small doses has an activating effect) and pronounced antiemetic effect. Causes extrapyramidal disorders, virtually no cholinoblocking effect.
    Sedative action is due to blockade of alpha-adrenergic receptors of the reticular formation of the brain stem; antiemeticaction - blockade of dopamine D2 receptors in the trigger zone of the vomiting center; hypothermic action and galactorrhea - blockade of dopamine receptors of the hypothalamus. Prolonged reception is accompanied by a change in the endocrine status, in the anterior pituitary gland prolactin production increases and decreases - gonadotropic hormones.
    Eliminates persistent personality changes, delusions, hallucinations, mania, increases interest in the environment. Effective in patients resistant to other neuroleptic drugs. Has some activating effect. In hyperactive children, eliminates excessive motor activity, behavioral disorders (impulsivity, difficulty concentrating, aggressiveness).
    Antipsychotic effect reaches its maximum only after 1-3 weeks of continuous treatment, sedation evident almost immediately.
    Pharmacokinetics:Absorption if taken orally - 60%. Connection with blood plasma proteins - 92%. The maximum concentration in the plasma is achieved by oral intake after 3 hours, after intramuscular injection - 10-20 minutes. The volume of distribution is -18 l / kg, the connection with plasma proteins is 92%.Easily passes through gistogematicalkie barriers, including the blood-encephalic barrier.
    Metabolized in the liver, has the effect of "first pass" through the liver. There are no active metabolites. The half-life at oral intake is 24 hours (12-37 hours), intramuscular injection - 21 hours (17-25 hours), with intravenous administration - 14 hours (10-19 hours).
    It is excreted with bile and urine: after ingestion with bile 15% are excreted, with urine - 40% (including 1% - unchanged). Penetrates into breast milk.
    The concentration in the plasma increases gradually, reaching a maximum 3-9 days after the injection (in the elderly, 1 day), and then decreases with a half-period of 3 weeks. Equilibrium plasma concentration is achieved after 3-4 injections (monthly administration) and is 4-20 mg / ml (10.6-53.2 μmol / L).
    Indications:Basic therapy of psychotic disorders in acute and subacute psychoses; basic and supporting therapy of chronic delusional and hallucinatory psychoses; disorders of behavior in the elderly and childhood, psychosomatic disorders.
    Contraindications:- hypersensitivity to haloperidol and / or other derivatives of the bootosterophenone or other substances of the finished dosage form;
    - Acute intoxication with alcohol, opiates, hypnotics or psychotropic drugs that depress the central nervous system;
    - diseases of the central nervous system, accompanied by pyramidal or extrapyramidal symptoms (including Parkinson's disease);
    - hysteria;
    - endogenous depression;
    - coma;
    - pregnancy and the period of breastfeeding;
    - children under the age of 3 years.
    Drops for oral administration are additionally contraindicated in patients with intolerance to alkyl-4-hydroxybenzoate.
    Carefully:- Insufficiency of liver and / or kidney function;
    - previous heart disease;
    Decompensated diseases of the cardiovascular system (including angina pectoris, intracardiac conduction disturbances, prolongation of the QT interval or predisposition to it - hypokalemia, simultaneous use of other drugs that can cause prolongation of the QT interval);
    - an angle-closure glaucoma;
    - pulmonary-cardiac and respiratory failure (including chronic obstructive pulmonary diseases and acute infectious diseases);
    - prostatic hyperlasia with a delay of urine;
    - Prolactin-dependent tumors, incl. mammary cancer;
    - severe hypotension or orthostatic dysregulation;
    - diseases of the hematopoietic system; - a malignant neuroleptic syndrome in the anamnesis;
    - epilepsy and organic diseases of the brain;
    - hyperthyroidism;
    - Alcoholism;
    - children and adolescents, old age.
    Pregnancy and lactation:The use of the drug during pregnancy and during breastfeeding is contraindicated. Therefore, before the start of treatment should be carried out a pregnancy test, and during treatment, whenever possible, pregnancy should be avoided.
    Dosing and Administration:
    Inside.
    Individual dosage is prescribed by the attending physician and depends on the clinical picture, the features of the course of the disease, the age and tolerability of the drug. The daily dose is divided into 1-3 doses; at higher doses, more frequent intake of individual doses is possible. If the doctor has not prescribed a different dosage, the following treatment regimens are usually used.
    Drops for ingestion are taken during meals, dosed with a teaspoon, adding to drinks or food, or a piece of sugar (except for patients suffering from diabetes mellitus).
    Adults and adolescents usually take 0.5-1.5 mg haloperidol at the beginning of treatment 2-3 times a day. Then the dose is gradually increased by 0.5-2 mg per day (in resistant cases, 2-4 mg per day) until the required therapeutic effect is achieved.
    When acute acute symptoms are relieved under steady-state conditions, initial daily doses may be increased to 15 mg haloperidol, in therapeutically-resistant cases and above. The maximum daily dose should not exceed 100 mg of haloperidol.
    On average, the therapeutic dose is usually 10-15 mg per day, with chronic forms of schizophrenia - 20-40 mg per day, in resistant cases - up to 50-60 mg per day. Supporting doses (outside the exacerbation) in outpatient settings can range from 0.5 mg to 5 mg per day.
    Children over 3 years: treatment is started with a dose of 0.025-0.05 mg / kg body weight divided into 2-3 doses. Increase in dosage is possible up to 0.2 mg / kg of body weight.
    Patients of advanced age and physically weakened patients: treatment is started with single doses not exceeding 0.5-1.5 mg. The daily dose is not desirable to increase above 5 mg.
    Children, elderly patients and the weakened patients are increased very slowly, not more than once every 3-5 days.
    10 drops contain 1 mg of haloperidol.
    Side effects:From the nervous system: headaches, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epileptic seizures, development of paradoxical reaction - exacerbation of psychosis and hallucinations; with prolonged treatment - extrapyramidal disorders, incl. tardive dyskinesia (smacking and puckering lips, bombast, fast and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of arms and legs), tardive dystonia (rapid blinking or spasms of the eyelids, unusual facial expression or posture, uncontrolled curving movement of the neck, trunk, , hands and feet), and neuroleptic malignant syndrome (difficulty or tachypnea, tachycardia, arrhythmia, pyrexia, increase or decrease in blood pressure, sweating, Neder urine, muscle stiffness, epileptic admission, loss of consciousness).
    From the cardiovascular system: when used in high doses - blood pressure, orthostatic hypotension, arrhythmia, tachycardia, changes in the electrocardiogram (QT interval elongation, features flutter and ventricular fibrillation).
    From the digestive system: when used in high doses-decreased appetite, dry mouth, hypo-salivation, nausea, vomiting, diarrhea or constipation, impaired liver function, until the development of jaundice.
    From the hematopoiesis: rarely - temporary leukopenia or leucocytosis, agranulocytosis, erythropenia and a tendency to monocytosis.
    From the genitourinary system: retention of urine (with hyperplasia of the prostate gland), peripheral edema, pain in the mammary glands, gynecomastia, hyperprolactinaemia, violation of the menstrual cycle, decreased potency, increased libido, priapism.
    From the sense organs: cataract, retinopathy, blurred vision. Allergic reactions: maculopapular changes in skin and acne, photosensitivity, rarely - bronchospasm, laryngospasm, hyperpyrexia. Laboratory indicators: hyponatremia, hyper- or hypoglycemia.
    Other: alopecia, heat stroke, weight gain.
    Overdose:Symptoms: rigidity of muscles, tremor, drowsiness, lowering blood pressure, sometimes - increasing blood pressure. In severe cases - coma, respiratory depression, shock.
    Treatment: ingestion - gastric lavage, reception of activated charcoal. With respiratory depression - artificial ventilation. To improve blood circulation, intravenously injected with plasma or albumin solution, norepinephrine. Epinephrine in these cases, use is strictly prohibited! Reduction of extrapyramidal symptoms - central holinoblokatory and antiparkinsonian means. Dialysis is ineffective.
    Interaction:Increases the severity of the inhibitory effect on the central nervous system of ethanol, tricyclic antidepressants, opioid analgesics, barbiturates and other hypnotics, funds for general anesthesia. Strengthens the action of peripheral M-holinoblokatorov and most antihypertensive drugs (reduces the effect of guanetidine due to its displacement from alpha-adrenergic neurons and suppression of its capture by these neurons).
    It inhibits the metabolism of tricyclic antidepressants and MAO inhibitors, while their (mutually) sedative effect and toxicity increase. Prevents the suppression of diazoxide release of insulin.
    With simultaneous use with bupropion reduces the epileptic threshold and increases the risk of major epileptic seizures. Reduces the effect of anticonvulsants (reducing the convulsive threshold with haloperidol).
    Weaken the vasoconstrictive effect of dopamine, phenylephrine, norepinephrine, ephedrine and epinephrine (blockade of alpha-adrenergic receptors by haloperidol may lead to a distortion of the action of epinephrine and a paradoxical decrease in blood pressure).
    Reduces the effect of antiparkinsonian agents (antagonistic effect on the 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 increases the risk of developing mental disorders (including disorientation in space, slowing down and complicating the processes of thinking).
    Amphetamines reduce antipsychotic effect of haloperidol, which, in turn, reduces their inducing effect (haloperidol blockade of alpha-adrenoceptors).
    Anticholinergic, antihistamine (1st generation) and antidiskinetic agents can enhance the M-holinolitic effect of haloperidol and reduce its antipsychotic effect (dose adjustment may be required).
    Long-term administration 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 an increase in extrapyramidal symptoms.
    With simultaneous administration with fluoxetine, the risk of side effects from the central nervous system increases, especially extrapyramidal reactions. With simultaneous use with drugs that cause extrapyramidal reactions, increases the frequency and severity of estropyramide disorders.
    The use of strong tea or coffee (especially in large quantities) reduces the effect of haloperidol.
    Special instructions:Before the start of treatment with the drug, it is necessary to conduct blood tests with the establishment of a differentiated picture of blood cells with a mandatory count of the number of platelets.When the pathology is detected, the drug can be used only in case of urgent necessity and with obligatory repeated examinations of the blood picture.
    During therapy, patients should regularly monitor the electrocardiogram, blood formula, liver samples.
    With the development of tardive dyskinesia, it is recommended that the dose be gradually reduced (until the drug is completely discontinued).
    Care must be taken when performing heavy physical work, taking a hot bath (it is possible to develop a heat stroke due to the suppression of central and peripheral thermoregulation in the hypothalamus).
    During treatment, do not take "cold" non-prescription drugs (possibly increasing the anticholinergic effects and the risk of heat stroke).
    Protect open areas of the skin from excessive sunlight due to the increased risk of photosensitivity.
    Treatment is stopped gradually to avoid the occurrence of the "withdrawal" syndrome.
    An antiemetic effect can mask the signs of drug toxicity and make it difficult to diagnose conditions, the first symptom of which is nausea.
    When mixing drops for ingestion with coffee and black tea, poorly soluble complexes, which impedes resorption. With simultaneous administration of lithium, the doses of both drugs should be as low as possible. It was noted that doses for children of 6 mg per day cause additional improvement in behavioral disorders and tics.
    In outpatient settings, a method of continuously increasing single and daily dosages is preferred. Under steady-state conditions, treatment can begin immediately with the administration of high doses, which allows you to quickly achieve the desired therapeutic effect.
    A sudden change in dose increases the risk of side effects.
    With prolonged use of haloperidol, the dose reduction should be step-like and very slow (another reduction in doses should be carried out at sufficiently long intervals).
    Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Drops for oral administration.
    Packaging:For 30 ml of the preparation in a bottle of brown glass with a stopper-dosing device and a lid; 1 bottle with instructions for use in a cardboard box.
    For 100 ml of the preparation in a bottle of brown glass with a pipette; 1 bottle with instructions for use in a cardboard box.
    Storage conditions:List B. Under normal conditions in a place inaccessible to children.
    Shelf life:
    5 years.
    Do not use after the expiration date!
    Terms of leave from pharmacies:On prescription
    Registration number:П N015719 / 02
    Date of registration:30.06.2009 / 20.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:ratiofarm GmbHratiofarm GmbH Germany
    Manufacturer: & nbsp
    Information update date: & nbsp20.03.2012
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