Risperidone, 2 mg, film-coated tablets, 20 pcs., Rapharma ZAO buy in Moscow at a low price

Risperidone is one of the popular and effective antipsychotic drugs (neuroleptics). The active substance itself is a benzisoxazole derivative. This medicine was first approved for use in 1993. Used in psychiatric and neurological practice. It is usually prescribed for all kinds of productive disorders, for example, hallucinations, delusions, etc. In addition, the drug reduces irritability and auto-aggression.

One of the advantages of Risperidone is that with its use the rate of elimination of mental and psychosomatic symptoms is twice as high as with the use of typical antipsychotics. In addition, this treatment appears to be safer.

Method of action

After oral administration, the drug is completely absorbed in the gastrointestinal tract and quickly distributed throughout the body. In this case, food does not affect the process in any way. Thanks to this, it is possible to achieve the optimal concentration of the substance in the plasma - it corresponds to the dose used.

A week after taking the drug, it is almost completely eliminated from the body - 70% is excreted in urine, 14% in feces. However, it is worth considering that in some situations slow elimination may occur. Most often this is due to poor functioning of the liver and kidneys (in old age, with renal failure, etc.).

Risperidone, 1 piece, 30 ml, 1 mg/ml, oral solution

Use in elderly patients with dementia

Increased mortality in older patients with dementia

Elderly patients with dementia treated with atypical antipsychotics experienced increased mortality compared with placebo in studies of atypical antipsychotics, including risperidone. When using risperidone in this population, the incidence of death was 4% for patients taking risperidone, compared with 3.1% for placebo. The mean age of patients who died was 86 years (range, 67–100 years). Data collected from two large observational studies show that older patients with dementia treated with typical antipsychotic medications also have a slightly increased risk of death compared with patients not treated. At present, insufficient data have been collected to accurately assess this risk. The reason for the increase in this risk is also unknown. Also unknown is the extent to which the increased mortality may be attributable to antipsychotic drugs rather than to the characteristics of this patient population.

Combined use with furosemide

For older patients with dementia taking oral risperidone, there was an increased mortality rate among patients taking furosemide and risperidone (7.3%; mean age 89 years, range 75-97 years) compared with those taking risperidone alone (3.1 %, mean age 84 years, range 70-96 years) and the furosemide-only group (4.1%, mean age 80 years, range 67-90 years). An increase in mortality in patients taking risperidone with furosemide was observed in 2 of 4 clinical studies. Concomitant use of risperidone with other diuretics (mainly low-dose thiazide diuretics) was not associated with an increase in mortality. No pathophysiological mechanisms have been established to explain this observation. However, special care should be taken when using the drug in such cases. Before prescribing, the risk/benefit ratio must be carefully assessed. There was no increase in mortality in patients taking other diuretics concomitantly with risperidone. Regardless of treatment, in older patients with dementia, dehydration is a common risk factor for mortality and should be carefully monitored. Regardless of treatment, dehydration is a common risk factor for mortality and should be carefully monitored in older patients with dementia.

An increase in cerebrovascular adverse events (acute and transient cerebrovascular events), including deaths, including deaths (mean age 85 years, range 73-97 years) was observed when risperidone was used compared with placebo in elderly patients with dementia. Therefore, risperidone should be used with caution in patients at risk of stroke.

Cardiovascular effects

In placebo-controlled clinical trials, an approximately 3-fold increased risk of cerebrovascular side effects was observed in patients with dementia taking certain atypical antipsychotic drugs.

Pooled data from 6 placebo-controlled studies involving primarily elderly patients with dementia (age >65 years) demonstrate that cerebrovascular adverse events (serious and non-serious) occurred in 3.3% (33/1009) of patients treated with risperidone. and in 1.2% (8/712) of patients receiving placebo. The risk ratio was 2.96 (1.34, 7.50) with a 95% confidence interval. The mechanism by which this risk increases is unknown. An increased risk cannot be excluded for other antipsychotic drugs, as well as for other patient populations.

Risperidone should be used with caution in patients with risk factors for stroke. The risk of cerebrovascular side effects is much higher in patients with mixed or vascular dementia compared to patients with Alzheimer's type dementia. Therefore, patients with any type of dementia other than Alzheimer's type dementia should not take risperidone. Clinicians should evaluate the risk/benefit ratio of risperidone in older patients with dementia, taking into account the predictors of stroke risk individually for each patient. Patients and caregivers should be cautioned to immediately report signs and symptoms of cardiovascular events, such as sudden weakness or stiffness/numbness in the face, legs, arms, as well as difficulty speaking and vision problems. All possible treatment options should be considered, including discontinuation of the drug. Risperidone should only be used for the short-term treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia, as an adjunct to non-pharmacological treatments when they are ineffective or limited in effectiveness, and when there is a risk of harm to the patient to himself or others . Patients' condition and the need for continued risperidone therapy should be continually assessed.

Switching from therapy with other antipsychotic drugs

When initiating treatment with risperidone for schizophrenia, if clinically warranted, it is recommended to gradually withdraw previous therapy. However, if patients are transferred from therapy with depot forms of antipsychotic drugs, it is recommended to start risperidone therapy instead of the next scheduled injection. The need for continued therapy should be assessed periodically.

Orthostatic hypotension.

Due to the α-adrenergic blocking effect of risperidone, orthostatic hypotension may occur, especially during the initial dose titration period. A clinically significant decrease in blood pressure in the post-marketing period is observed with simultaneous use of risperidone with antihypertensive drugs. If blood pressure decreases, consider reducing the dose of one or both drugs. In patients with known cardiovascular disease (heart failure, myocardial infarction, cardiac conduction disturbances, dehydration, hypovolemia or cerebrovascular disease), as well as dehydration, hypovolemia or cerebrovascular disease, the dose should be increased gradually as recommended.

Extrapyramidal symptoms and tardive dyskinesia.

Drugs with dopamine receptor antagonist properties can cause tardive dyskinesia, which is characterized by rhythmic involuntary movements, mainly of the tongue and/or facial muscles. The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If a patient experiences objective or subjective symptoms indicating tardive dyskinesia, the advisability of discontinuing all antipsychotic drugs, including Risperidone, should be considered.

Neuroleptic malignant syndrome.

In case of development of neuroleptic malignant syndrome, characterized by hyperthermia, muscle rigidity, instability of the function of the autonomic nervous system, disturbances of consciousness and increased activity of creatine phosphokinase in the blood serum (myoglobinuria (rhabdomyolysis) and acute renal failure may also be observed), it is necessary to discontinue all antipsychotic drugs, including risperidone .

Leukopenia, neutropenia and agranulocytosis.

Cases of leukopenia, neutropenia and agranulocytosis have been observed with the use of antipsychotics, including risperidone. Agranulocytosis was very rare (less than 1/10,000 patients) in post-marketing surveillance. Patients with a clinically significant decrease in the number of white blood cells or with drug-induced leukopenia/neutropenia should be observed during the first few months of treatment. At the first sign of a decrease in the number of blood leukocytes (in the absence of other reasons), discontinuation of risperidone should be considered. Patients with a clinically significant decrease in white blood cell count should be monitored for possible fever or other signs of infection. Patients with severe neutropenia (absolute neutrophil count less than 1*109) require discontinuation of risperidone and observation until neutrophil levels return to normal.

Parkinson's disease and dementia with Lewy bodies.

Antipsychotic medications, including risperidone, should be prescribed with caution to patients with Parkinson's disease or dementia with Lewy bodies. Both groups of patients have an increased risk of developing neuroleptic malignant syndrome and increased sensitivity to antipsychotic drugs (including dullness of pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms). Parkinson's disease may worsen when taking risperidone.

Intraoperative trembling iris syndrome.

This syndrome has been observed during cataract surgery in patients receiving drugs that are α1A-adrenergic receptor antagonists. Shaky iris syndrome may increase the risk of eye complications during and after eye surgery. The operating ophthalmologist should be informed that the patient is taking α1A-adrenergic receptor antagonists. The use of α1A-blockers before cataract surgery in patients receiving α1-adrenergic antagonists has not been studied.

Antiemetic effect.

An antiemetic effect was observed in preclinical studies of risperidone. This effect in humans may mask the signs and symptoms of overdose of certain drugs, as well as symptoms of such conditions as intestinal obstruction, hepatocerebral syndrome, or brain tumor.

Hyperglycemia, diabetes mellitus.

Hyperglycemia, diabetes mellitus, or exacerbation of existing diabetes mellitus have been observed during treatment with risperidone. It is likely that weight gain prior to treatment is also a predisposing factor. Very rarely, ketoacidosis and rarely, diabetic coma can occur. All patients should be clinically monitored for symptoms of hyperglycemia (polydipsia, polyuria, polyphagia and weakness) and diabetes mellitus. All patients with diabetes should be regularly monitored for worsening glucose control.

Increase in body weight.

Significant weight gain was observed with risperidone treatment. During risperidone therapy, it is necessary to monitor patients' body weight.

Hyperprolactinemia.

Based on the results of tissue culture studies, it has been suggested that the growth of breast tumor cells may be stimulated by prolactin. Although clinical and epidemiological studies have not shown a clear association between hyperprolactinemia and antipsychotic drug use, caution should be exercised when prescribing risperidone to patients with a history of this.

Caution is recommended when used in patients with hyperprolactinemia (including a history) or the risk of developing prolactin-dependent tumors, since risperidone may increase the concentration of prolactin in the blood.

Prolongation of the QT interval.

Prolongation of the QT interval has been very rarely observed in the post-marketing period. As with other antipsychotics, caution should be exercised when prescribing risperidone to patients with known cardiovascular disease, a family history of QT prolongation, bradycardia, or electrolyte imbalance (hypokalemia, hypomagnesemia) as this may increase the risk of arrhythmogenic effects; and when used simultaneously with drugs that increase the QT interval.

Cramps.

The ability of typical antipsychotics to lower the seizure threshold is known, so risperidone should be prescribed with caution to patients with epilepsy.

Priapism.

Due to the blockade of α-adrenergic receptors, risperidone can cause priapism.

Violation of thermoregulation.

Antipsychotic drugs may cause problems with body temperature regulation. Caution should be exercised when prescribing Risperidone to patients with conditions that may contribute to an increase in body temperature, such as intense physical activity, dehydration, exposure to high temperatures, or concomitantly using drugs with anticholinergic activity.

Venous thromboembolism.

Cases of venous thromboembolism have been reported with the use of antipsychotic drugs. Since patients taking antipsychotic drugs are often at risk of developing venous thromboembolism, all possible risk factors should be identified before and during treatment with risperidone, and preventive measures should be taken.

Children and teenagers.

Before prescribing Risperidone to children or adolescents with mental retardation, their condition should be carefully assessed for the presence of physical or social causes of aggressive behavior, such as pain or inadequate demands of the social environment. The sedative effect of risperidone should be carefully monitored in this population due to the possible effect on learning ability. Changing the timing of drug administration may improve control of the effects of sedation on attention in adolescents and children. Risperidone use was associated with mean increases in body weight and body mass index. Height changes in long-term studies were within expected age-specific norms. The effect of long-term use of risperidone on sexual development and growth has not been fully studied. Due to the possible impact of prolonged hyperprolactinemia on growth and sexual development in children and adolescents, regular clinical assessment of hormonal status should be carried out, including measurement of height, weight, monitoring of sexual development, menstrual cycle and other possible prolactin-dependent effects. During treatment with risperidone, regular assessment for the presence of extrapyramidal symptoms and other movement disorders should be carried out.

Indications for use

There are a number of ailments for which Risperidone tablets are particularly effective. The main ones include:

Schizophrenia (acute or chronic). The active substance makes it possible to carry out treatment at a symptomatic level.
Psychotic states. Helps eliminate emotional detachment, delusions, poor speech, etc.
Depression, if accompanied by anxiety.
Behavioral disorders, including outbursts of anger, severe agitation.
Dementia if aggressiveness is present.
Bipolar disorders. Treatment of mania.
Autism in children and adolescents. The tool allows you to fight auto-aggression.

The drug is also used in the treatment of relapses if a person is diagnosed with chronic schizophrenia and acute psychotic states periodically appear.

Risperidone, 20 pcs., 2 mg, film-coated tablets

If orthostatic hypotension occurs, especially in the initial period of dose selection, dose reduction should be considered.

Use in elderly patients with dementia

For older patients with dementia taking oral formulations of risperidone, increased mortality was observed in patients taking furosemide and risperidone (7.3%; mean age 80 years, range 67–90 years). No pathophysiological mechanisms have been established to explain this observation. Particular care should be taken when prescribing the drug in such cases. No increase in mortality was found in patients taking other diuretics concomitantly with risperidone. Regardless of treatment, dehydration is a common risk factor for mortality and should be carefully monitored in older patients with dementia.

Cerebrovascular disorders

In placebo-controlled randomized clinical trials, an approximately 3-fold increased risk of cerebrovascular adverse reactions was observed in patients with dementia taking certain atypical antipsychotic drugs. Pooled data from 6 placebo-controlled studies, including primarily elderly patients with dementia (age >65 years), demonstrate that cerebrovascular adverse events (serious and non-serious) occurred in 3.3% (33/1009) of patients treated with risperidone , and in 1.2% (8/712) of patients taking placebo. The risk ratio was 2.96 (1.34, 7.50) with a 95% confidence interval. The mechanism by which this risk increases is unknown. An increased risk cannot be excluded for other antipsychotic drugs, as well as for other patient populations. Risperidone should be used with caution in patients with risk factors for stroke.

The risk of cerebrovascular adverse reactions is much higher in patients with mixed or vascular dementia compared to patients with Alzheimer's dementia. Therefore, patients with any type of dementia other than Alzheimer's should not take Risperidone.

Clinicians should evaluate the risk/benefit ratio of using risperidone in elderly patients with dementia, taking into account the precursors of stroke risk individually for each patient. Patients and their caregivers should be cautioned to immediately report signs and symptoms of cerebrovascular events, such as sudden weakness or numbness in the face, legs, arms, or difficulty speaking or visual disturbances. All possible treatment options should be considered, including discontinuation of the drug. Risperidone should only be used for the short-term treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia, as an adjunct to nonpharmacologic treatments when they are ineffective or of limited effectiveness, and when there is a risk of harm to the patient himself or herself. to other persons.

Patients' condition and the need to continue risperidone therapy should be regularly assessed by a physician.

Orthostatic hypotension

Due to the α-blocking effect of risperidone, orthostatic hypotension may occur, especially during the initial dose titration period. A clinically significant decrease in blood pressure is observed when risperidone is coadministered with antihypertensive drugs. If blood pressure decreases, a dose reduction should be considered. In patients with diseases of the cardiovascular system, as well as in cases of dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually, as recommended (see section "Dosage and Administration").

Leukopenia, neutropenia, agranulocytosis

Leukopenia, neutropenia, and agranulocytosis were observed with the use of antipsychotic drugs, including the use of the drug Risperidone. Agranulocytosis has been observed very rarely during post-marketing surveillance. In patients with a history of clinically significant decreases in white blood cell counts or drug-related leukopenia/neutropenia, a complete blood count is recommended during the first months of therapy, and discontinuation of risperidone treatment should be considered at the first clinically significant decrease in white blood cell counts in the absence of other possible causes. Patients with clinically significant neutropenia are advised to be monitored for fever or symptoms of infection and to initiate treatment immediately if such symptoms occur. Patients with severe neutropenia (absolute neutrophil count less than 1 x 109/L) should discontinue risperidone until the white blood cell count normalizes.

Venous thromboembolism

Cases of venous thromboembolism have been reported with the use of antipsychotic drugs. Since patients taking antipsychotic drugs are often at risk of developing venous thromboembolism, all possible risk factors should be identified before and during treatment with Risperidone, and preventive measures should be taken.

Tardive dyskinesia and extrapyramidal disorders

Drugs with dopamine receptor antagonist properties can cause tardive dyskinesia, which is characterized by rhythmic involuntary movements, mainly of the tongue and/or facial muscles. There are reports that the occurrence of these symptoms is a risk factor for the development of tardive dyskinesia. Risperidone is less likely than classic antipsychotics to cause extrapyramidal symptoms. If signs and symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered.

Neuroleptic malignant syndrome

With the development of neuroleptic malignant syndrome, characterized by hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased activity of creatine phosphokinase (myoglobinuria - rhabdomyolysis - and acute renal failure can also be observed), it is necessary to discontinue all antipsychotic drugs, including Risperidone.

Parkinson's disease and dementia with Lewy bodies

Antipsychotic drugs, including risperidone, should be used with caution in patients with Parkinson's disease or dementia with Lewy bodies, as both groups of patients have an increased risk of developing neuroleptic malignant syndrome and increased sensitivity to antipsychotic drugs (including dullness of pain, confusion, postural instability with frequent falls and extrapyramidal symptoms).

Hyperglycemia and diabetes mellitus

Hyperglycemia, development of diabetes mellitus, and exacerbation of existing diabetes mellitus were observed during treatment with Risperidone. Establishing a relationship between the use of atypical antipsychotic drugs and impaired glucose metabolism is complicated by the increased risk of developing diabetes mellitus in patients with schizophrenia and the prevalence of diabetes mellitus in the general population. Given these factors, the relationship between the use of atypical antipsychotic drugs and the development of adverse effects associated with hyperglycemia is not fully established. All patients should be clinically monitored for symptoms of hyperglycemia and diabetes mellitus (see section "Side Effects").

Hyperprolactinemia

Tissue culture studies have shown that cell growth in breast tumors can be stimulated by prolactin. Risperidone should be used with caution in patients with hyperprolactinemia and potentially prolactin-dependent tumors.

Weight gain

During treatment with Risperidone, a significant increase in body weight was observed. It is necessary to monitor the body weight of patients during drug therapy. Patients should be advised to refrain from overeating due to the possibility of weight gain.

Prolongation of
the QT interval
As with other antipsychotics, caution should be exercised when prescribing Risperidone to patients with a history of cardiac arrhythmias, patients with congenital prolongation of the QT interval, and when used concomitantly with drugs that prolong the QT interval.

Priapism

Drugs with alpha-blocking effects can cause priapism. In post-marketing studies of Risperidone, reports of priapism have been reported.

Body temperature regulation

An undesirable effect attributed to antipsychotic drugs is the disruption of the body's ability to regulate body temperature. Caution should be exercised when prescribing Risperidone to patients with conditions that may contribute to an increase in core body temperature, such as intense physical activity, dehydration, exposure to high external temperatures, or concomitant use of drugs with anticholinergic activity.

Antiemetic effect

Preclinical studies have demonstrated the antiemetic effect of risperidone. When observed in humans, this effect may mask objective and subjective symptoms of overdose of some drugs, as well as diseases such as intestinal obstruction, Reye's syndrome, and brain tumors.

Seizures/Seizure Threshold

The ability of atypical antipsychotics to lower the threshold of seizure activity is known. Risperidone should be used with caution in patients with a history of epilepsy or seizures or other medical conditions that may lower the seizure threshold.

Intraoperative floppy iris syndrome (ISID)

ISDR was observed during surgery for the presence of cataracts in patients receiving therapy with drugs that have α1-adrenergic receptor antagonist activity, including risperidone drugs. ISDR increases the risk of complications associated with the organ of vision during and after surgery. The doctor performing such an operation should be informed in advance that the patient has taken or is currently taking drugs that have α1-adrenergic receptor antagonist activity. The potential benefit of discontinuing α1-adrenergic antagonist therapy before surgery has not been established and should be weighed against the risks associated with discontinuing antipsychotic therapy.

Kidney and liver failure

Although Risperidone has not been studied in patients with renal or hepatic impairment, caution should be exercised when using the drug in such patient populations.

Withdrawal syndrome

When stopping treatment, a gradual dose reduction is recommended. Withdrawal symptoms: very rarely - nausea, vomiting, sweating and insomnia when abruptly stopping high doses of antipsychotic drugs.

Use in children and adolescents

Before prescribing Risperidone to children or adolescents with mental retardation, their condition should be carefully assessed for the presence of physical or social causes of aggressive behavior, such as pain or inadequate demands of the social environment. The sedative effect of risperidone should be carefully monitored in this population due to the possible effect on learning ability. Changing the timing of risperidone administration may improve control of the effects of sedation on attention in adolescents and children. Risperidone use was associated with mean increases in body weight and body mass index. Height changes in longitudinal studies were within expected age-related norms. The effects of long-term use of risperidone on sexual development and growth have not been fully studied. Due to the possible impact of prolonged hyperprolactinemia on growth and sexual development in children and adolescents, regular clinical assessment of hormonal status should be carried out, including measurement of height, weight, monitoring of sexual development, menstrual cycle and other possible prolactin-dependent effects. During treatment with Risperidone, regular monitoring for the presence of extrapyramidal symptoms and other movement disorders should be carried out.

Excipients

Risperidone, film-coated tablets, contains lactose. Patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not be prescribed Risperidone, film-coated tablets.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Contraindications and restrictions

The use of Risperidone is completely prohibited in the following cases:

if the patient has paroxysmal epilepsy;
with Parkinson's disease;
during breastfeeding;
in the presence of hypersensitivity to the drug itself.

As for pregnancy, the use of the medicine during this period is not recommended. However, if its use causes less harm to the fetus than refusing therapy with this substance, the attending physician has the right to prescribe such a drug. However, the treatment itself must be supervised by a specialist.

There are also a number of diseases, in the presence of which the pills should be taken carefully with strict control of the dose and the body’s reaction. Their list includes the following:

diseases of the cardiovascular system;
cerebrovascular accident;
dehydration.

In addition, such an active substance is not recommended to be combined with other drugs that affect the central nervous system. If such therapy turns out to be mandatory, it is necessary to correctly determine the dose of each of the drugs used.

Special instructions and precautions

Consult your doctor:

if you have heart problems. These include irregular heart rhythms, or a tendency to have low blood pressure or if you are using medications to lower your blood pressure. Risperidone may cause low blood pressure. Dose adjustment required
if you have risk factors that predispose you to stroke, such as high blood pressure, cardiovascular disorders, pathological changes in cerebral vessels,
if you have ever experienced involuntary movements of your tongue, mouth or face,
if you have ever had a condition where symptoms include high fever, muscle stiffness, sweating or impaired consciousness (also known as neuroleptic malignant syndrome),
if you have Parkinson's disease or dementia,
if you have had a low level of white blood cells in your blood in the past (due to drugs or other causes),
if you have diabetes,
if you have epilepsy,
if you are a man and you have ever had a prolonged or painful erection,
if you have problems controlling your body temperature or experience overheating,
if you have kidney problems,
if you have liver problems,
if you have an abnormally high level of the hormone prolactin in your blood or are suspected of having a prolactin-dependent tumor,
if you or another member of your family has a history of blood clots, as antipsychotics predispose to blood clots.

If you are in any doubt if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone.

Considering that very rare cases of severe leukocytopenia have been observed with the use of Risperidone, the attending physician should periodically monitor the level of leukocytes in the blood.

Risperidone may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should measure your body weight regularly.

Both the development of diabetes mellitus and exacerbation of pre-existing diabetes mellitus have been noted in patients with diabetes mellitus taking Risperidone; your healthcare provider should monitor you for symptoms of high blood sugar. In patients with diabetes, blood glucose levels should be regularly monitored.

During eye surgery, the lens of the lens (cataract) may become cloudy, and the pupil (the black circle in the center of your eye) may not grow in size when needed. Additionally, the iris (the colored part of the eye) may become too flexible during surgery, which can cause damage to the eye. If you are planning eye surgery, be sure to tell your doctor that you are taking Risperidone.

Older people with dementia

In older patients with dementia, there is an increased risk of stroke. You should not take Risperidone if you have dementia due to a stroke.

You should visit your doctor frequently during treatment with risperidone.

Treatment should be started immediately if you or your caregiver notice a sudden change in mental status or sudden weakness or numbness of the face, arms or legs, especially on one side, or slurred speech, even for a short period of time. They may be signs of a stroke.

Children and teenagers

Before treatment for conduct disorder begins, other causes of aggressive behavior must be excluded.

If fatigue occurs during treatment with risperidone, changes in dosing time may alleviate any difficulty concentrating.

Before starting treatment, you should measure your weight or your child's weight, which should be done regularly during treatment.

A small and incomplete study found that there was an increase in height in children taking risperidone, but whether this was due to the drug or due to some other reason is not known.

Other medicines and Risperidone

Tell your doctor or pharmacist if you are taking, have recently taken or should take any other medicines.

It is especially important to consult your doctor or pharmacist if you are taking:

medicines that affect your brain activity, such as sedatives (benzodiazepines) or some pain medicines (opiates), allergy medicines (antihistamines), as risperidone may increase their sedative effects,
drugs that can affect the electrical activity of your heart, such as anti-malaria drugs, anti-arrhythmic drugs, antihistamines, antidepressants or other drugs to treat mental disorders,
drugs that cause a slow heartbeat
drugs that cause a decrease in potassium levels in the blood (for example, some diuretics),
drugs to treat high blood pressure. Risperidone may lower blood pressure,
drugs to treat Parkinson's disease (for example, levodopa),
diuretics used to treat heart problems or swelling of parts of the body due to the accumulation of excess fluid (for example, furosemide or chlorothiazide). Risperidone alone or with furosemide may increase the risk of stroke or death in older people with dementia.

The following drugs may reduce the effect of risperidone

rifampicin (a medicine to treat certain infections),
carbamazepine, phenytoin (medicines used to treat epilepsy),
phenobarbital.

If you start or stop taking these drugs, your risperidone dose may need to be adjusted.

The following drugs may increase the effect of Risperidone:

quinidine (used to treat some types of heart disease),
antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants,
beta blockers (used to treat high blood pressure),
phenothiazines (for example, drugs used to treat psychosis or as sedatives),
cimetidine, ranitidine (gastric acid blockers),
itraconazole and ketoconazole (medicines to treat fungal infections),
some medicines used to treat HIV/AIDS, such as ritonavir,
verapamil, a medicine used to treat high blood pressure and/or heart rhythm problems
sertraline and fluvoxamine, drugs used to treat depression and other mental disorders.

If you start or stop taking these drugs, your risperidone dose may need to be adjusted.

If you have any doubts about taking the drug, you should consult your doctor or pharmacist before use.

Taking Risperidone with food, drinks and alcohol

Risperidone can be taken with or without food. You should avoid drinking alcohol while taking Risperidone.

Pregnancy and breastfeeding

If you are pregnant, or think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking Risperidone.
The following symptoms may be observed in newborns of mothers who used Risperidone in the last trimester (last three months of pregnancy): trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, difficulty feeding. If your child develops any of these symptoms, you should see a doctor.
Risperidone may increase levels of a hormone called prolactin, which may affect fertility (see side effects).

Impact on the ability to drive a car and use machinery

Dizziness, fatigue, and vision problems may occur during treatment with Risperidone. In this case, you should stop driving or operating any machinery and tell your doctor.

Important information about the ingredients in Risperidone

Risperidone film-coated tablets contain lactose.

If your doctor has told you that you have an intolerance to certain sugars, talk to your doctor before taking Risperidone.

How to take Risperidone

Risperidone should be taken exactly as prescribed by your doctor.

If you have any doubts about taking the drug, you should consult your doctor or pharmacist before using Risperidone.

Recommended Doses

Treatment of schizophrenia

Adults

The initial dose is usually 2 mg per day, on the second day the dose can be increased to 4 mg per day
The dosage can be individually adjusted by your doctor, depending on the observed effect.
For most patients, the optimal dose is 4-6 mg per day
The total daily dose may be divided into one or two doses per day. Your doctor can determine the dose that is best for you.

Elderly patients

The starting dose is usually 0.5 mg twice daily
The dosage can be gradually increased by the attending physician from 1 mg to 2 mg twice daily
Your doctor can determine the optimal dose for you.

For the treatment of mania

Adults

The starting dose is usually 2 mg once daily
The dosage can be gradually adjusted by your doctor, depending on the observed effect.
For most patients, the optimal dose is 1-6 mg per day

Elderly patients

Your starting dose is usually 0.5 mg twice daily
If necessary, the dose can be increased to 1-2 mg twice a day, depending on the observed effect

Treatment of attacks of aggression in patients with Alzheimer's disease

Adults (including the elderly)

The starting dose is usually 0.25 mg twice daily
The dosage may be gradually adjusted by the doctor, depending on the observed effect.
For most patients, the optimal dose is 0.5 mg twice daily. Some patients may require a dose of 1 mg twice daily
The duration of treatment in patients with Alzheimer's disease should be no more than 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age should not use Risperidone to treat schizophrenia and mania.

Treatment of conduct disorder

The dosage depends on your child's weight

For children weighing less than 50 kg:

the starting dose is usually 0.25 mg once daily
if necessary, the dose can be increased gradually every other day by 0.25 mg per day
the usual maintenance dose is 0.25 mg to 0.75 mg once daily

For children weighing 50 kg or more:

the initial dose is usually 0.5 mg once daily
if necessary, this dose can be increased by 0.5 mg per day, no more than every other day
The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with conduct disorder should be no more than 6 weeks.

Risperidone should not be used in children under 5 years of age to treat conduct disorder.

Patients with kidney and liver problems

Regardless of the disease being treated, all initial and subsequent doses of risperidone should be halved. Dose increases should be gradual in these patients. Risperidone should be used with caution in this group of patients.

Mode of application

For oral administration

You must swallow the tablet with water.

If you take more Risperidone than recommended

Tell your doctor immediately and be sure to take the package with you.
In case of overdose, you may feel drowsiness or fatigue, or abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, or abnormal heart rhythms, or seizures.

If you forget to take Risperidone

If you forget to take the next dose of the drug, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, tell your doctor.
Do not take a double dose to make up for a missed dose.

If you stop taking Risperidone

You should not stop taking Risperidone on your own; you should talk to your doctor before stopping use of this drug, as relapse is possible. If your doctor decides to stop taking the medicine, your dosage may need to be gradually reduced over several days.

If you have any additional questions about the use of the drug, please contact your doctor or pharmacist.

Side effects

Although the drug is considered safe, in some cases certain side effects may occur. These include:

Drowsiness, fatigue, decreased concentration, tremors or seizures.
Abdominal pain, nausea, vomiting, constipation, sudden changes in body weight - decrease or increase.
Pressure surges.
Decreased libido and sexual dysfunction.
Autoimmune disorders.
Skin rash, dry skin, itching.
Allergic rhinitis.
Deterioration of vision.

Most often, such symptoms are temporary and disappear after finishing the course of taking the pills. However, if any side effects are detected, you must inform your doctor about it.

Risperidone

Use in elderly patients with dementia

Increased mortality in older patients with dementia

Combined use with furosemide

Cardiovascular effects

In placebo-controlled clinical trials, an approximately 3-fold increased risk of cerebrovascular side effects was observed in patients with dementia taking certain atypical antipsychotic drugs.

Switching from therapy with other antipsychotic drugs

Orthostatic hypotension.

Extrapyramidal symptoms and tardive dyskinesia.

Neuroleptic malignant syndrome.

Leukopenia, neutropenia and agranulocytosis.

Parkinson's disease and dementia with Lewy bodies.

Intraoperative trembling iris syndrome.

Antiemetic effect.

Hyperglycemia, diabetes mellitus.

Increase in body weight.

Significant weight gain was observed with risperidone treatment. During risperidone therapy, it is necessary to monitor patients' body weight.

Hyperprolactinemia.

Prolongation of the
QT .
Prolongation of the QT interval has been very rarely observed in the post-marketing period. As with other antipsychotics, caution should be exercised when prescribing risperidone to patients with known cardiovascular disease, a family history of QT prolongation, bradycardia, or electrolyte imbalance (hypokalemia, hypomagnesemia) as this may increase the risk of arrhythmogenic effects; and when used simultaneously with drugs that increase the QT interval.

Cramps.

The ability of typical antipsychotics to lower the seizure threshold is known, so risperidone should be prescribed with caution to patients with epilepsy.

Priapism.

Due to the blockade of α-adrenergic receptors, risperidone can cause priapism.

Violation of thermoregulation.

Venous thromboembolism.

Children and teenagers.