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Instructions

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Instruction for use: Haloperidol-Akri

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Dosage form: tablets

Active substance: Haloperidol*

ATX

N05AD01 Haloperidol

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F20 Schizophrenia: Schizophrenic conditions; Exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with excitation

F23 Acute and transient psychotic disorders: Psychogenic psychosis; Psychosis acute; Short-term psychotic disorder

F29 Inorganic psychosis, unspecified: Childhood psychoses; Psychomotor agitation in psychoses; Hallucinatory-delusional disorders; Hallucinatory-delusional syndrome; Intoxication psychosis; Manic-delusional disorders; Manic chronic psychosis; Manic psychosis; Acute psychosis; paranoid psychosis; Paranoid psychosis; Subacute psychosis; Presenile psychosis; Psychosis; Intoxicating psychosis; Psychosis is paranoid; Psychosis in children; Reactive psychosis; Chronic psychosis; Chronic hallucinatory psychosis; Chronic psychosis; Chronic psychotic disorder; Schizophrenic psychosis

F84.0 Childhood Autism: Autism; Autism children; Autism early childhood; Kanner's syndrome; Early Childhood Autism

F95.2 Combining vocalisms and multiple motor tics [de la Tourette's syndrome]: Gilles de la Tourette's disease or syndrome; Gilles de la Tourette's Syndrome; Tourette's disease; Gilles de la Tourette's Syndrome; Gilles de la Tourette syndrome; The syndrome of Gilles de la Tourette; Gilles de la Tourett Syndrome; Tourette's Syndrome

G10 Huntington's disease: Huntington's disease (chorea); Houteon Huntington; Goettington's Horea; Chorea degenerative; Chorea hereditary; Chorea progressive chronic

R11 Nausea and vomiting: Postoperative vomiting; Nausea; Vomiting; Vomiting in the postoperative period; Vomiting medication; Vomiting in the background of radiation therapy; Vomiting uncontrollable; Vomiting in radiation therapy; Persistent vomiting; Indomitable vomiting; Postoperative nausea; Vomiting with chemotherapy; Vomiting of the central genesis; Vomiting with cytotoxic chemotherapy; Persistent hiccups; Repeated vomiting

Composition and release form

Tablets 1 table.

haloperidol 1.5 or 5 mg

in a planar cell pack of 10; in a pack of cardboard 5 or 10 (5 mg) packages.

Pharmachologic effect

Pharmacological action - antipyretic, analgesic, antipsychotic, anticonvulsant, antihistamine, neuroleptic, antiemetic, sedative.

It blocks postsynaptic D2-receptors, reduces the excitability of dopamine neurons, regulates psychomotor and neurovegetative disorders.

Pharmacodynamics

Stimulates the metabolism of the brain, has a tranquilizing and pronounced antiemetic effect; causes extrapyramidal motor reactions; reduces the release of growth hormone and increases - prolactin. Changes the concentration of dopamine.

Pharmacokinetics

When ingested absorbed by 60%, Cmax is achieved after 3-6 hours. The volume of distribution is 18 l / kg. In blood, 92% binds to proteins. Undergoes biotransformation in the liver. T1 / 2 - 24 hours (12-37 hours). 40% of a single dose is excreted in the urine for 5 days (1% - unchanged) and 15% - with feces. Cl - 12 ml / kg / min.

Indications for Haloperidol-Akri

Acute and chronic psychotic disorders (schizophrenia, psychosis), Gilles de la Tourette's syndrome, children's autism, Huntington's chorea, indomitable vomiting, prevention and treatment of nausea and vomiting in chemotherapy.

Contraindications

Hypersensitivity, CNS diseases with pyramidal and extrapyramidal symptoms, severe toxic CNS depression caused by medications, depression, hysteria, pregnancy, breast-feeding, children's age (up to 3 years).

Application in pregnancy and lactation

Contraindicated. For the duration of treatment, breastfeeding should be discontinued.

Side effects

Akathisia, extrapyramidal disorders, persistent late dyskinesia, late dystonia, anticholinergic effects, reduced fluid intake, fatigue or weakness, orthostatic hypotension, agranulocytosis, obstructive jaundice, neuroleptic malignant syndrome, symptoms of diabetes insipidus, glaucoma exacerbation, tendency to monocytosis, allergic reactions.

Interaction

Strengthens the effect of antihypertensive drugs, opioid analgesics, barbiturates, ethanol and ethanol-containing drugs. With a joint admission with epinephrine, hypotension and tachycardia are possible.

Dosing and Administration

Inside. Adults and adolescents with an initial dose of 0.0005 g 2-3 times a day. The maximum dose for adults is 0.1 g / day. Children 3-5 years: 1/4 dose, 6-15 years - 1/2 dose for adults.

Psychotic disorders, behavioral disorders, Gilles de la Tourette's syndrome: children aged 3-12 years or with a body weight of 15-40 kg - the initial dose is 0.00005 g / kg / day in 2-3 doses. If necessary, the daily dose is increased by 0.0005 g once every 5-7 days until a dose of 75 μg / kg / day is reached.

Children's autism: the initial dose is 0.000025 g / kg / day (up to 0.00005 g / kg / day).

Older patients: 0.0005-0.002 g 2-3 times a day (a gradual increase in doses is possible).

Precautionary measures

Precautions are prescribed for cardiovascular diseases with the phenomena of decompensation, violations of the conductivity of the myocardium, severe kidney diseases. In the case of the development of tardive dyskinesia, it is necessary to gradually reduce the dose and use another drug. Do not use during work drivers of vehicles and people whose profession is associated with increased concentration of attention. During the period of application it is prohibited to drink alcoholic beverages.

Storage conditions for haloperidol-Akri

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Haloperidol-Akri

3 years.

Do not use after the expiry date printed on the package.

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