Instruction for use: Risperidone

Dosage form: tablets

Active substance: Risperidone*

ATX

N05AX08Risperidone

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F00 Dementia in Alzheimer's disease (G30 +): Alzheimer's dementia; Alzheimer's dementia; Dementia in Alzheimer's disease

F20 Schizophrenia: Schizophrenic Conditions; An 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 agitation

F31.1 Bipolar affective disorder, current episode of mania without psychotic symptoms: Mania in bipolar disorders

F31.2 Bipolar affective disorder, current episode of mania with psychotic symptoms: Manic episode of bipolar disorder; Mania in bipolar disorders

F79 Mental retardation, unspecified: Mental retardation; Infantilism mental; Violation of mental activity; Oligophrenia; Lag behind mental development; Slowed development of intellectual abilities in children and adolescents; Delayed mental development in children; Maloumia; Oligopsihia; Mental failure; Impaired mental function; Lag behind in mental development; Lack of intellectual development in children; Lack of mental development in children; Mental retardation; Lack of mental development in children; Mental retardation

F91 Behavioral disorders: Juvenile and other behavioral disorders; Destructive behavior; Violation of behavior; Behavior 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

R45.6 Physical aggressiveness: Aggressiveness; Aggressive states; Aggression; Aggressive behavior; Autoaggression

Composition

Tablets covered with a film membrane 1 tab.

active substance:

risperidone 2/4 mg

auxiliary substances: corn starch pregelatinized starch - 43.3 / 86.6 mg; silicon dioxide colloid (aerosil) - 0.5 / 1 mg; magnesium stearate - 0.3 / 0.6 mg; stearic acid 0.6 / 1.2 mg; MCC - 43.3 / 86.6 mg; Opadry II white (polyvinyl alcohol - 2/4 mg, talc - 0,74 / 1,48 mg, macrogol (polyethylene glycol) - 1,01 / 2,02 mg, titanium dioxide - 1,25 / 2,5 mg) - 5/10 mg

Pharmachologic effect

The pharmacological action is neuroleptic.

Dosing and Administration

Inside. Eating does not affect the absorption of the drug.

Patients who have a persistent drowsiness when taking Risperidone Organic are recommended to divide the daily dose into two doses.

The elimination of Risperidone Organic is recommended to be carried out gradually. Very rarely, after abrupt discontinuation of high doses of antipsychotics, withdrawal syndrome is observed, including nausea, vomiting, hyperhidrosis and insomnia.

Schizophrenia

Adults. Risperidone Organica may be prescribed 1 or 2 times a day. The initial dose is 2 mg / day. On the second day, the dose can be increased to 4 mg / day. From this moment, the dose can either be maintained at the same level, or individually adjusted (if necessary). Usually the optimal dose is 4-6 mg / day. In some cases, a slower dose increase and a lower initial and maintenance dose may be justified. Doses higher than 10 mg / day did not show higher efficacy compared with smaller doses and may cause extrapyramidal symptoms. Due to the fact that safety of doses above 16 mg / day has not been studied, doses above this level can not be used.

Elderly patients. When starting therapy is recommended the appointment of risperidone another dosage (0.5-1 mg). Dosage can individually be increased by 1 mg / day. Risperidone Organic Tablets 2 mg can be prescribed for elderly patients when the maximum recommended daily dose is reached as a result of titration - 4 mg in 2 divided doses.

Children from 13 years. When starting therapy is recommended the appointment of risperidone another dosage (0.5 mg). If necessary, the dose can be increased not earlier than in 24 hours by 0.5-1 mg / day. Tablets Risperidone Organica 2 mg can be administered when a titration of a daily dose of 2 mg is achieved with good tolerability. Despite the effectiveness shown in the treatment of schizophrenia in adolescents with risperidone doses of 1-6 mg / day, no increase in efficacy was observed when doses exceeding 3 mg / day were given, and side effects developed more often. The use of doses above 6 mg / day has not been studied.

Manic episodes associated with bipolar disorder

Adults. The recommended initial dose of the drug is 2 mg / day in 1 dose. If necessary, this dose can be increased not earlier than 24 hours per 1 mg per day. For most patients, the optimal dose is 1-6 mg / day. The use of doses above 6 mg / day in patients with manic episodes has not been studied.

As with any other symptomatic therapy, the rationale for continuing treatment with the Organic Risperidon should be regularly evaluated and confirmed.

Elderly patients. When starting therapy is recommended the appointment of risperidone another dosage (0.5-1 mg). Dosage can individually be increased by 1 mg / day. Tablets Risperidone Organica 2 mg can be given to elderly patients when the maximum recommended daily dose is reached as a result of titration - 4 mg in 2 divided doses. Care should be taken because of limited experience in elderly patients.

Children from 10 years. When starting therapy is recommended the appointment of risperidone another dosage (0.5 mg). If necessary, the dosage can be increased at least after 24 hours by 0.5-1 mg per day until a dose of 1-2.5 mg / day is achieved with good tolerability. Tablets Risperidone Organica 2 mg can be prescribed to children under 10 years of age when they achieve a titration of a daily dose of 2 mg. Despite the efficacy shown in the treatment of manic episodes associated with bipolar disorder in children with doses of 0.5-6 mg / day, no increase in efficacy was seen when doses exceeding 2.5 mg / day were given, and side effects developed more often. The use of doses above 6 mg / day has not been studied.

Continuous aggression in patients with Alzheimer's disease

It is recommended that another dosage of risperidone is administered (less than 2 mg). With continued aggression in patients with Alzheimer's disease, risperidone should not be used for more than 6 weeks. During treatment, the condition of patients and the need for continuation of therapy should be regularly evaluated.

Continuous aggression in the structure of conduct disorder

Children from 5 to 18 years. For patients with a body weight of 50 kg or more, the appointment of risperidone with a different dosage (less than 2 mg) is recommended.

For patients with a body weight of less than 50 kg, the administration of risperidone to another dosage (less than 1 mg) is recommended.

As for any other symptomatic therapy, the feasibility of continuing treatment with risperidone should be regularly evaluated and confirmed.

Use in children under 5 years is not recommended because of lack of data on efficacy and safety.

Diseases of the liver and kidneys. In patients with kidney disease, the ability to excrete the active antipsychotic fraction is reduced compared to other patients. In patients with liver disease, there is an increased concentration of free fraction of risperidone in the blood plasma. The initial and maintenance doses according to the indications should be reduced 2 times, increasing the dose in patients with liver and kidney diseases should be slower. Patients in this category of risperidone should be administered with caution.

Release form

Tablets, film-coated, 2 mg or 4 mg. For 10 tab. in a planar cell box made of PVC film and foil of aluminum printed lacquered. By 2, 3, 5 or 6 contour cells are placed in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions for Risperidone

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life of Risperidone

3 years.

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