Haloperidol (Haloperidol)

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: & nbsppills
    Composition:
    For one tablet:
    active substance: haloperidol 1.5 mg or 5 mg.
    Excipients: potato starch 51 mg or 126 mg, lactose monohydrate 63 mg or 158 mg, gelatin 1.3 mg or 3 mg, talc 2 mg or 5 mg, magnesium stearate 1.2 mg and 3 mg.
    Description:Tablets white or white with a slightly yellowish hue, flat, cylindrical, with a bevel (for tablets with a dosage of 1.5 mg), with a risk and a facet (for tablets with a dosage of 5 mg).
    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. 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;antiemetic effect - 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.
    Haloperidol decanoate in comparison with haloperidol has a longer action. 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). The theraic effect of the prolonged form can last up to 6 weeks.
    Pharmacokinetics:Absorption if taken orally - 60%. TCmax with oral intake - 3 hours. The volume of distribution - 18 l / kg, the connection with plasma proteins - 92%. Easily passes through the histohematological barriers, including the BBB. Metabolized in the liver, has the effect of "first pass" through the liver. In the metabolism of the drug, the isoenzymes CYP2D6, CYRZAZ, CYPZA5, CYPZA7 are involved.It is an inhibitor of CYP2D6. There are no active metabolites. T1 / 2 for oral administration - 24 h.
    It is excreted with bile and urine: after ingestion with bile 15% are excreted, with urine - 40% (including 1% - unchanged). Penetrates into breast milk.
    Indications:Psychoses (manic-depressive, epileptic, against a background of schizophrenia, alcoholic, medicinal, including "steroid"), psychomotor excitation of various genesis, delirium and hallucinations (paranoid states, acute psychosis), Tourette's disease, oligophrenia, agitated depression, Huntington's chorea, long persistent and resistant to therapy, hiccups, nausea and vomiting in chemotherapy, stammering, impaired behavior in the elderly and childhood (including hyperactivity in children, children's autism), psychosomatic disorders.
    Contraindications:Hypersensitivity, severe inhibition of central nervous system function against xenobiotic intoxication, coma of various genesis, central nervous system diseases, accompanied by pyramidal or extrapyramidal symptoms (including Parkinson's disease), depression, hysteria, pregnancy, lactation period, children's age (up to 3 years).
    Carefully:Decompensated diseases of the cardiovascular system (including angina pectoris, intracardiac conduction disturbances, prolongation of Q-T interval or predisposition to it - hypokalemia, simultaneous use of other drugs that can cause lengthening of the Q-T interval, epilepsy, closed-and-taut glaucoma, hepatic and / or renal insufficiency, thyrotoxicosis (with thyrotoxicosis), pulmonary-cardiac and respiratory failure (including acute infectious diseases), hyperplasia th gland with a delay of urine, alcoholism.
    Pregnancy and lactation:The use of the drug is contraindicated.
    Dosing and Administration:Inside, during or after a meal, with a full (240 ml) glass of water or milk, the initial dose for adults is 1.5-5 mg 2-3 times a day. If necessary, the dose is gradually increased to achieve the desired therapeutic effect (on average - up to 10-15 mg, with chronic forms of schizophrenia - up to 20-60 mg). The maximum dose is 100 mg / day. Duration of treatment 2-3 months. Reduce the dose slowly, maintenance doses - 5-10 mg / day.
    Elderly or weakened patients at the beginning of treatment appoint inward at 1,5-2,5 mg 2-3 times a day (depending on the patient's condition).
    Children from 3 to 12 years: 25-75 mkg / kg per day in 2-3 sessions.
    If there is no effect within 1 month, treatment should not be continued.
    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; long-term treatment - extrapyramidal disorders, including late dyskinesia (smacking lips and lips, inflating cheeks, fast and wormlike movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the hands and feet), late dystonia (rapid blinking or spasms of the eyelids, unusual facial expression or body position, uncontrolled curving movements of the neck, trunk, arms and legs) and malignant neuroleptic syndrome (shortness or rapid breathing, tachycardia, arrhythmia, hyperthermia, increase or decrease blood pressure, increased sweating, urinary incontinence, muscle rigidity, epileptic seizures, sweating of consciousness).
    From the CAS side: when used in high doses - lowering blood pressure, orthostatic hypotension, arrhythmias, tachycardia, changes in the ECG (prolongation of the Q-T interval, signs of flutter and fibrillation of the ventricles).
    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 leukocytosis, 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 and acneiform skin changes photosensitization, rarely - bronchospasm, laryngospasm.
    Laboratory indicators: hyponatremia, hyper- or hypoglycemia.
    Other: alopecia, weight gain.
    Overdose:Symptoms: muscle stiffness, tremor, drowsiness, decreased, and sometimes increased blood pressure. In severe cases - a coma; respiratory depression, shock.
    Treatment: when ingested - gastric lavage, Activated carbon. With respiratory depression - IVL. To improve blood circulation in / in, inject plasma or albumin solution, norepinephrine. Epinephrine in these cases, use is strictly prohibited! Reduction of extrapyramidal symptoms - central holinoblokatory and antiparkinsonian drugs. Dialysis is ineffective.
    Interaction:Increases the severity of the inhibitory effect on the central nervous system of ethanol, tricyclic antidepressants, opioid analgesics, barbiturates and hypnotics, means for general anesthesia.
    Strengthens the action of peripheral m-holinoblokatorov and most antihypertensives (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 monoamine oxidase inhibitors, while their (sedative) effect and toxicity increase.
    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).
    , Decreases the vasoconstrictor action of dopamine, phenylephrine, norepinephrine, epinephrine and ephedrine (alpha adrenoceptor blockade haloperidol, which can lead to 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).
    In the application with methyldopa increases the risk of developing mental disorders (in Vol. H. Disorientation in space, slowing and difficulty thinking processes).
    Amphetamines reduce antipsychotic effect of haloperidol, which, in turn, reduces their inducing effect (haloperidol blockade of alpha-adrenoceptors).
    Anticholinergic,antihistamine (1 generation) and anti-Parkinsonian drugs can enhance the m-cholinoblock 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 Li + preparations (especially in high doses), the development of encephalopathy (may 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 incidence and severity of extrapyramidal disorders.
    Use - strong tea or coffee (especially in large quantities) reduces the effect of haloperidol.
    Special instructions:During therapy, patients should regularly monitor the electrocardiogram, the blood formula, and "liver" tests.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.
    Before the appointment of the prolonged form, the patient should first be transferred from any other antipsychotic to haloperidol (prevention of unexpected hypersensitivity to haloperidol).
    It was noted that doses for children 6 mg / day cause additional improvement in behavioral disorders and tics.
    Effect on the ability to drive transp. cf. and fur:During the reception of haloperidol it is prohibited to drive vehicles, service mechanisms and other types of work requiring increased concentration of attention.
    Form release / dosage:Tablets of 1.5 mg and 5 mg.
    Packaging:
    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    50 tablets per can of polymeric materials.
    5 contour squares or 1 jar along with instructions for use are placed in a pack of cardboard.
    Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:2 years. After the expiration of the drug does not apply.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004343/09
    Date of registration:01.06.2009 / 12.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.03.2017
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