Instruction for use: Haloperidol decanoate

Dosage form: solution for intramuscular administration (oily)

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

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

F91 Behavioral disorders: Juvenile and other behavioral disorders; Destructive behavior; Violation of behavior; Behavioral disorders; Mixed behavioral disorders; Behavioral Disorder; Behavioral disorder in adolescents with 15 years of age and adults; Violations in behavior; Behavioral disorders in childhood; Behavioral disorders in old age; Behavioral disorders in children; Behavior Disorder; Behavioral disorders in children

R41.8.0 * Intellectual-mnestic disorders: Secondary impairments of mnestic functions; Difficulty concentrating; Difficulty of mental activity; Intellectual insufficiency; Intellectual-mnestic violation; Intellectual-mnestic disorder; Infantilism mental; Cognitive impairment; Intellectual disability; Breach of mnestic functions; Violation of mental activity; Thinking disorder; Impairment of mental performance; Dysfunction of mental function; Thinking disorders; The weakening of intellectual productivity; Lag behind mental development; Primary disorders of mnestic functions; Decrease in intellectual productivity; Decrease of intellectual-mnestic functions; Scattering; Mental Disorders; Disorder of thinking; Decreased intellectual productivity; Reduction of intellectual-mnestic functions; Decreased intellectual capacity; Decreased intellectual ability; Decreased intellectual abilities in elderly patients; Decreased mental function; Decreased mental function; Decreased memory in old age; Decreased mental activity; Decreased intellectual level; The deterioration of intellectual-mnestic functions; Chronic mental performance disorders

R45.1 Anxiety and agitation: Agitation; Anxiety; Explosive excitability; Internal stimulation; Excitability; Excitation; Excitation acute; Psychomotor agitation; Hyperexcitability; Motor excitement; Cessation of psychomotor agitation; Nervous excitement; Restlessness; Night trouble; Acute stage of schizophrenia with excitation; Acute mental agitation; Paroxysm of excitation; Overexcitation; Increased excitability; Increased nervous excitability; Increased emotional and cardiac excitability; Increased agitation; Mental arousal; Psychomotor agitation; Psychomotor agitation in psychoses; Psychomotor agitation of an epileptic nature; Psychomotor paroxysm; Psychomotor fit; Symptoms of Excitation; Symptoms of psychomotor agitation; The state of agitation; A state of anxiety; Excitation status; A state of heightened concern; The state of psychomotor agitation; Conditions of anxiety; Excitation conditions; The state of excitement in somatic diseases; Excitation level; Feelings of anxiety; Emotional arousal

Composition

Solution for intramuscular administration oily 1 ml

active substance:

haloperidol decanoate 70.52 mg

(corresponding to 50 mg of haloperidol)

auxiliary substances: benzyl alcohol - 15 mg; sesame oil - up to 1 ml

Pharmachologic effect

Pharmacological action - antipsychotic, neuroleptic, antiemetic.

Dosing and Administration

IM, in the gluteal region.

It is intended exclusively for adults, exclusively for intramuscular injection. It is forbidden to enter IV.

Doses exceeding 3 ml should be avoided, in order to avoid an unpleasant feeling of bursting at the injection site.

Adults: patients who are on long-term treatment with oral antipsychotics (mainly haloperidol), we can recommend switching to depot injections. The dose should be selected on an individual basis due to significant individual differences in the response. Selection of the dose should be carried out with strict medical supervision of the patient. The choice of the initial dose is made taking into account the symptoms of the disease, its severity, the dose of haloperidol or other antipsychotics prescribed during the previous treatment.

At the beginning of treatment every 4 weeks, it is recommended to prescribe doses 10-15 times higher than oral haloperidol, which usually corresponds to 25-75 mg of haloperidol decanoate (0.5-1.5 ml). The maximum initial dose should not exceed 100 mg.

Depending on the effect, the dose can be stepped up to 50 mg, until the optimal effect is obtained. Usually, the maintenance dose corresponds to a 20-fold daily dose of oral haloperidol. When the symptoms of the underlying disease recur in the period of dose selection, treatment of haloperidol with decanoate can be supplemented with oral haloperidol. Usually, injections are administered every 4 weeks, but in view of the large individual differences in efficacy, a more frequent use of the drug may be required.

Elderly patients and patients with oligophrenia: a smaller initial dose is recommended, for example - 12.5-25 mg every 4 weeks. In the future, depending on the effect, the dose can be increased.

Release form

Solution for intramuscular administration oily, 50 mg / ml. In an ampoule of dark glass I hydrolytic class with a point for a break of 1 ml. In a plastic pallet of 5 pcs. 1 plastic pallet in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Haloperidol decanoate

In 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 decanoate

5 years.

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