Risperidone - Instructions For Use, Reviews, Price, Analogs, Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Risperidone

Risperidone: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Risperidone

ATX code: N05AX08

Active ingredient: Risperidone (Risperidone)

Producer: Ozone LLC (Russia), Atoll LLC (Russia), Aurobindo Pharma, Ltd. (India), Kanonpharma production CJSC (Russia), North Star (Russia), Berezovsky pharmaceutical plant (Russia)

Description and photo update: 2018-22-10

Prices in pharmacies: from 99 rubles.

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Risperidone is an antipsychotic drug.

Release form and composition

Risperidone dosage forms:

• film-coated tablets: capsule-shaped, biconvex, engraving "A" on one side, risk and engraving on the other (depending on the dose); 0.5 mg - green, engraved on the second side "50"; 1 mg - white, engraved on the second side "51"; 2 mg - light orange, engraved on the second side "52"; 3 mg - yellow, engraved on the second side "53"; 4 mg - green, engraved on the second side "54"; 6 mg - white, engraved on the second side "55"; the shape of tablets and the composition of auxiliary components from different manufacturers can vary (5, 10, 15, 20 or 30 pcs. in blisters, in a cardboard box 1-6, 10 packs; in polymer cans of 10, 20, 30, 40, 50, 60, 90 or 100 pcs., In a cardboard box 1 can);
• oral solution: colorless, transparent, has a slight characteristic odor (in vials of 30 or 100 ml, in a cardboard box 1 bottle complete with a dosing syringe).

The composition of the core of 1 tablet:

• active ingredient: risperidone - 0.5, 1, 2, 3, 4, 6 mg;
• additional components (0.5 / 1/2/3/4/6 mg): lactose monohydrate - 59.5 / 59/118/177/236/234 mg; microcrystalline cellulose - 38.75 / 38.75 / 77.5 / 116.25 / 155/155 mg; colloidal silicon dioxide - 0.5 / 0.5 / 1 / 1.5 / 2/2 mg; magnesium stearate - 0.75 / 0.75 / 1.5 / 2.25 / 3/3 mg.

Composition of the shell of 1 tablet:

• 0.5 / 4 mg: Opadry green 03B51373 (hypromellose-6cP - 62.5%; titanium dioxide - 26.4%; macrogol - 6.25%; quinoline yellow dye - 4%; indigo carmine - 0.85%) - 3.58 / 14.29 mg;
• 1/6 mg: Opadry white Y-1-7000 (hypromellose-5cP - 62.5%; titanium dioxide - 31.25%; macrogol - 6.25%) - 3.57 / 14.29 mg;
• 2 mg: Opadry orange 03B53576 (hypromellose-6cP - 62.5%; titanium dioxide - 29.704%; macrogol - 6.25%; dye iron oxide red - 0.35%; dye iron oxide yellow - 1.154%; dye iron oxide black - 0.042%) - 7.14 mg;
• 3 mg: Opadry yellow 03B52852 (hypromellose-6cP - 62.5%; titanium dioxide - 28.75%; macrogol - 6.25%; quinoline yellow dye - 2.5%) - 10.71 mg.

Composition of 1 ml solution:

• active ingredient: risperidone - 1 mg;
• additional components: sodium benzoate - 2.36 mg; tartaric acid - 7.5 mg; sodium hydroxide - up to pH 3 + 0.2; water - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Risperidone is one of the selective monoaminergic antagonists with high affinity for serotonergic 5-HT ₂ and dopaminergic D ₂ receptors. Also, the substance binds to α ₁ -adrenergic receptors and slightly weaker - to α ₂ -adrenergic and H ₁ -histaminergic receptors. Does not possess tropicity to cholinergic receptors.

The main effects of the drug:

• antipsychotic: due to blockade of D ₂ -dopaminergic receptors of the mesocortical / mesolimbic system;
• hypothermic: due to blockade of dopamine receptors in the hypothalamus;
• antiemetic: due to the blockade of dopamine D ₂ -receptors of the trigger zone of the vomiting center;
• sedative: due to blockade of adrenergic receptors of the reticular formation of the brain stem.

Risperidone helps to reduce the productive symptoms of schizophrenia (manifested in the form of delirium, hallucinations), automatism, aggressiveness. During therapy, less suppression of motor activity is observed and catalepsy is induced to a lesser extent than with classical antipsychotic therapy.

Balanced central antagonism to dopamine and serotonin leads to a decrease in the propensity for extrapyramidal adverse reactions and an expansion of the therapeutic effect of the drug to cover the affective / negative symptoms of schizophrenia.

Pharmacokinetics

After oral administration, complete absorption occurs, the maximum concentration in the blood plasma is reached after 1-2 hours. Food intake does not affect the absorption of the drug. The absolute bioavailability of risperidone is 70%.

The substance is rapidly distributed in the body. The volume of distribution is from 1 to 2 l / kg. In plasma, it binds to albumin and alpha ₁ -glycoprotein. Risperidone is 90% bound to plasma proteins, 9-hydroxyrisperidone (the main active metabolite of risperidone) - by 77%.

In most patients, the equilibrium concentration of risperidone in the body is reached within 24 hours, 9-hydroxyrisperidone - after 4-5 days. The plasma concentration of Risperidone in the blood is proportional to the dose received (within the therapeutic dose).

It is metabolized by the cytochrome P ₄₅₀ CYP2D6 isoenzyme to 9-hydroxyrisperidone (has a pharmacological effect similar to risperidone). Risperidone and 9-hydroxyrisperidone are the active antipsychotic fraction. The isoenzyme CYP2D6 undergoes genetic polymorphism. With intensive metabolism by the isoenzyme CYP2D6, risperidone is rapidly converted to 9-hydroxyrisperidone, while with a weak metabolism, this transformation occurs much more slowly. In patients with intensive metabolism, a lower concentration of the substance and a higher concentration of the main metabolite are noted than in patients with a weak metabolism, while after taking one / several doses, the total pharmacokinetics of the active antipsychotic fraction in patients with a weak and intensive metabolism of CYP2D6 is similar.

Another metabolic pathway for risperidone is N-dealkylation. In general, the substance at clinically significant concentrations does not inhibit the metabolism of drugs undergoing biotransformation by isoenzymes of the cytochrome P _{450 system}, including CYP 2E1, CYP 2c8 / 9/10, CYP 2D6, CYP 1A2, CYP 2A6, CYP ZA5 and CYP 3A4.

In patients with psychosis after oral administration, the half-life (T _1/2) of risperidone is approximately 3 hours, the main metabolite and active antipsychotic fraction is 24 hours.

70% of the dose after a week of admission is excreted in the urine, 14% in the feces. In urine, risperidone and its main metabolite make up 35–45% of the dose. The rest is inactive metabolites.

The plasma concentration of risperidone is directly proportional to the dose received over the therapeutic dose range.

The plasma concentration of the active antipsychotic fraction in elderly patients after a single dose is on average 43% higher, T _1/2 lasts 38% longer, and clearance decreases by 30%. With impaired renal function of moderate / severe degree, there is an increase in plasma concentration and a decrease in the clearance of the active antipsychotic fraction by an average of 60%.

In hepatic insufficiency, the plasma concentrations of risperidone do not change, but there is an increase in the average concentration of its free fraction in blood plasma by 35%.

Indications for use

• schizophrenia;
• manic episodes associated with severe / moderate bipolar disorder;
• persistent aggression in patients with dementia, which is caused by moderate / severe Alzheimer's disease, not amenable to non-pharmacological methods of correction in cases where there is a likelihood of harm by the patient to himself / others (short therapy up to 6 weeks);
• incessant aggression in the structure of behavioral disorders in children over 5 years of age with mental retardation, which is diagnosed in accordance with DSM-IV, in which drug therapy is indicated due to the severity of aggression / other destructive behavior; pharmacological treatment should be part of a broader program that includes educational and psychosocial activities; Risperidone may be prescribed by a specialist in pediatric neurology, child and adolescent psychiatry, or by a physician familiar with the treatment of behavioral disorders in children and adolescents (brief symptomatic therapy up to 6 weeks);
• dementia (behavioral disorder therapy) (solution).

Contraindications

Absolute:

• syndrome of glucose-galactose malabsorption, lactase deficiency, galactosemia (tablets);
• age up to 5 years (therapy of incessant aggression in behavioral disorders in children with mental retardation);
• age up to 10 years (therapy of manic episodes in the structure of bipolar disorder) (solution);
• age up to 13 years (schizophrenia therapy) (solution);
• age up to 18 years (therapy of schizophrenia and manic episodes in the structure of bipolar disorder) (tablets);
• lactation period;
• individual intolerance to the components of the drug.

Relative (Risperidone is prescribed with caution and under medical supervision):

• chronic heart failure, myocardial infarction, cardiac muscle conduction disorders and other diseases of the cardiovascular system;
• hypovolemia and dehydration;
• Parkinson's disease;
• disorders of cerebral circulation;
• convulsions and epilepsy, including a burdened history;
• severe hepatic / renal impairment;
• overuse of drugs / drug dependence;
• cases of acute drug overdose;
• Reye's syndrome;
• conditions that predispose to the appearance of tachycardia such as pirouette (electrolyte imbalance, bradycardia, combination therapy with drugs that prolong the QT interval);
• combination therapy with furosemide;
• thrombophlebitis (tablets);
• the presence of risk factors for the development of thromboembolism of the venous vessels (solution);
• hyperglycemia;
• intestinal obstruction;
• brain tumor;
• diffuse Lewy body disease (solution);
• combination with other drugs of central action (solution);
• pregnancy;
• old age (in the treatment of manic episodes in the structure of bipolar disorder) (pills);
• old age with dementia.

Instructions for the use of Risperidone: method and dosage

Risperidone is taken orally. Food intake has no effect on its effectiveness.

Schizophrenia

For adults, the drug can be administered 1 or 2 times a day.

The initial daily dose is 2 mg. On the second day, the dose is doubled. In the future, Risperidone is used in this dose or the regimen is individually adjusted.

In most cases, 4-6 mg per day is considered optimal. In some cases, slower dose increases and lower starting and maintenance doses may be justified.

Taking more than 10 mg of Risperidone per day does not increase the effectiveness, while the risk of extrapyramidal symptoms increases. The maximum allowable daily dose is 16 mg.

For elderly patients, Risperidone is prescribed 0.5 mg 2 times a day. If necessary, a phased increase (by 0.5 mg) is possible until a daily dose of 2–4 mg is reached.

For adolescents from 13 years of age, the drug in the form of a solution can be prescribed 0.5 mg once a day (in the morning or evening). With good tolerance (not earlier than after 24 hours), the dose can be increased by 0.5–1 mg per day to the recommended dose (3 mg per day). The maximum permissible daily dose for this group of patients is 6 mg.

In case of persistent drowsiness, it is recommended to use a reduced dose of Risperidone (1/2 daily dose in 2 divided doses).

Manic episodes in the structure of bipolar disorder

The recommended starting dose for adults is 2 mg once a day. If necessary, after 24 hours, the dose may be increased by 1 mg. The optimal range for most patients is 1 to 6 mg per day. The feasibility of continuing treatment should be assessed periodically.

The initial dose for elderly patients is 0.5 mg 2 times a day. If necessary, it is possible to increase a single dose by 0.5 mg until the optimal dose is reached (as a rule, 2 times a day, 1-2 mg). The experience of using Risperidone in this group of patients is limited, therefore, therapy requires caution.

For children from 10 years of age, the drug in the form of a solution is prescribed 0.5 mg 1 time per day (in the morning or evening). Not earlier than 24 hours later, the dose may be increased by 0.5–1 mg per day. With good tolerance, the drug is used at 1–2.5 mg per day. The optimal range for most patients is 0.5 to 6 mg (maximum) per day.

In case of persistent drowsiness, it is recommended to use a reduced dose of Risperidone (1/2 daily dose in 2 divided doses).

Persistent aggression in people with dementia associated with Alzheimer's

The recommended initial dose is 2 times a day (in the morning and evening), 0.25 mg. No more than 1 time per day, a single dose may be increased by 0.25 mg.

In most cases, a single dose of 0.5 mg is optimal, but sometimes an increase to 1 mg is required.

Risperidone should not be given for more than 6 weeks. During the period of its use, it is necessary to assess the feasibility of therapy.

Persistent aggression in the structure of conduct disorder in children with mental retardation over 5 years old

Recommended dosage regimen:

• weight from 50 kg: initial dose - 0.5 mg once a day. The dose may be increased by 0.5 mg no more than once a day. The permissible dose range is 0.5–1.5 mg;
• weight up to 50 kg: initial dose - 0.25 mg once a day. No more than 1 time per day, the dose may be increased by 0.25 mg. The permissible dose range is 0.25–0.75 mg.

Risperidone is usually prescribed in a course of up to 6 weeks. During a long course, constant medical supervision is required. During the period of taking the drug, it is necessary to assess the appropriateness of therapy.

Dementia (Behavioral Disorder Therapy)

The recommended starting dose of oral solution is 0.25 mg 2 times a day. Not more often than every other day, a single dose can be increased by 0.25 mg. In most cases, this dose is optimal, but sometimes Risperidone is prescribed 1 mg 2 times a day.

After improving the patient's condition, they can be transferred to the drug intake once a day.

Features of the drug use

In the presence of kidney / liver disease, Risperidone is prescribed with caution in a 2-fold dose reduced. Its increase should be carried out more slowly.

The drug should be withdrawn gradually. Acute withdrawal symptoms include vomiting, nausea, insomnia, and increased sweating. As a rule, they appear in very rare cases. It is also possible to develop relapses of psychotic symptoms and involuntary movements.

When switching from therapy with other antipsychotic drugs, their cancellation should be carried out gradually. When transferring from depot forms of antipsychotic drugs, it is recommended to start therapy with Risperidone instead of the next scheduled injection. Periodically, it is necessary to assess the appropriateness of continuing the current therapy with antiparkinsonian drugs.

Side effects

Most often (> 5%) while taking Risperidone, the following adverse reactions develop: upper respiratory tract infections, parkinsonism, anxiety, insomnia, headache. Dose-dependent disorders include akathisia and parkinsonism.

Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an uncertain frequency - if it is impossible to assess frequency of occurrence of violation):

• lymphatic system / hematological disorders: infrequently - anemia, neutropenia, a decrease in the number of leukocytes, thrombocytopenia, a decrease in hemoglobin levels, a decrease in the number of eosinophils and hematocrit; rarely - agranulocytosis, granulocytopenia;
• cardiovascular system: often - arterial hypertension, tachycardia; infrequently - lengthening of the QT interval on the ECG, atrioventricular block, palpitations, left / right bundle branch block, atrial fibrillation, cardiac conduction disturbances, ECG abnormalities, hypotension, bradycardia, hot flashes, orthostatic hypotension; rarely - sinus bradycardia / arrhythmia, pulmonary embolism, deep vein thrombosis;
• organ of vision: often - blurred vision, conjunctivitis; infrequently - blurred vision, increased lacrimation, conjunctival hyperemia, periorbital edema, eye discharge, dry eyes, photophobia; rarely - involuntary rotation of the eyeballs, decreased visual acuity, impaired eye movement, intraoperative sagging iris syndrome, crusting at the edge of the eyelid, occlusion of the retinal artery, glaucoma;
• nervous system: very often - parkinsonism, drowsiness, headache, sedation; often - dyskinesia, dystonia, akathisia, tremor, dizziness, lethargy; infrequently - imbalance, loss of consciousness, lack of response to stimuli, fainting, decreased level of consciousness, impaired consciousness, hypersomnia, transient ischemic attack, dysarthria, stroke, impaired attention, postural dizziness, tardive dyskinesia, taste disorder, psychomotor agitation, taste perversion, cerebral ischemia, convulsions, hypesthesia, paresthesia, impaired movement, coordination and speech; rarely - diabetic coma, cerebrovascular disorders, head tremor, neuroleptic malignant syndrome;
• kidney / urinary tract: often - urinary incontinence, enuresis; infrequently - dysuria, urinary retention, pollakiuria;
• organ of hearing: infrequently - tinnitus, ear pain, vertigo;
• digestive system: often - dry mouth, vomiting, diarrhea, dyspepsia, abdominal discomfort, constipation, nausea, abdominal pain, toothache, hypersalivation; infrequently - gastroenteritis, fecaloma, dysphagia, gastritis, flatulence, fecal incontinence; rarely - lip edema, pancreatitis, tongue edema, intestinal obstruction, cheilitis; very rarely - ileus;
• respiratory system: often - cough, nasal congestion, pain in the pharynx / larynx, shortness of breath, nosebleeds; infrequently - aspiration pneumonia, wheezing, wet wheezing, pulmonary congestion, impaired breathing and airway patency, dysphonia; rarely - sleep apnea syndrome, hyperventilation;
• skin: often - erythema, skin rash; infrequently - discoloration, dryness and skin lesions, urticaria, violation of the integrity of the skin, acne, itching, acne, hyperkeratosis, seborrheic dermatitis, alopecia; rarely - dandruff, drug rash; very rarely - Quincke's edema;
• endocrine system: often - an increase in the level of prolactin; rarely - glucosuria, impaired production of antidiuretic hormone;
• musculoskeletal system: often - pain in the limbs, back and buttocks, muscle spasms, musculoskeletal pain, arthralgia; infrequently - muscle pain in the chest, an increase in the level of creatine phosphokinase, neck pain, joint stiffness, muscle weakness, swelling of the joints, poor posture, myalgia; rarely - rhabdomyolysis;
• infections: often - ear infections, pneumonia, bronchitis, influenza, upper respiratory and urinary tract infections, sinusitis; infrequently - otitis media, tonsillitis, viral infections, inflammation of the subcutaneous fat, eye infections, localized infections, respiratory tract infections, acarodermatitis, cystitis, onychomycosis; rarely - chronic otitis media, lower respiratory tract infections, subcutaneous abscess;
• metabolism and nutrition: often - increased / decreased appetite, weight gain; infrequently - weight loss, anorexia, polydipsia, diabetes mellitus, increased cholesterol concentration, hyperglycemia; rarely - hypoglycemia, water intoxication, increased concentration of triglycerides and insulin; very rarely, diabetic ketoacidosis;
• liver / biliary tract: infrequently - an increase in liver enzymes, an increase in the level of gamma-glutamyltransferase and transaminases; rarely, jaundice;
• psyche: very often - insomnia; often - sleep disturbances, anxiety, depression, agitation, anxiety; infrequently - lethargy, nightmares, mania, confusion, nervousness, decreased libido; rarely - flattening of affect, anorgasmia;
• immune system: infrequently - hypersensitivity reactions; rarely - anaphylactic reaction, drug hypersensitivity;
• reproductive system / mammary glands: infrequently - amenorrhea, gynecomastia, galactorrhea, sexual / erectile dysfunction, ejaculatory disorders, menstrual disorders, breast discomfort, pain in the breast, vaginal discharge; rarely - discharge from the mammary glands, delayed menstruation, priapism, engorgement / enlargement of the mammary glands;
• general disorders: often - asthenia, edema, fatigue, pyrexia, chest pain, generalized / peripheral edema, pain; infrequently - feeling unwell, facial swelling, chest discomfort, gait disturbance, slowness, discomfort, malaise, chills, flu-like condition, fever, thirst; rarely - induration, cold extremities, withdrawal syndrome, decrease in body temperature, hypothermia;
• others: often - falling; rarely - withdrawal syndrome in newborns (if a woman took the drug during pregnancy).

Side effects, which in clinical studies in pediatric patients were observed with a greater frequency than in other groups of patients: cough, abdominal pain, drowsiness / sedation, vomiting, fatigue, increased appetite, headache, fever, diarrhea, tremors, enuresis, upper respiratory tract infections, nasal congestion, dizziness.

Overdose

The main symptoms are: decreased blood pressure, drowsiness, depression of consciousness, tachycardia, sedation, extrapyramidal symptoms, rarely - convulsions and lengthening of the QT interval. With the simultaneous use of increased doses of Risperidone and paroxetine, the development of bidirectional ventricular tachycardia (pirouette type) was noted.

In cases of overdose, consideration should be given to the possibility of overdose from taking multiple drugs.

To ensure adequate oxygen supply and ventilation, a clear airway must be achieved and maintained. Also shown is gastric lavage and activated charcoal along with a laxative for an hour after an overdose. To detect possible arrhythmias, ECG monitoring should be started immediately. It should be carried out until the symptoms of intoxication completely disappear.

There is no specific antidote for risperidone. In case of an overdose, appropriate symptomatic therapy should be carried out, the action of which is aimed at maintaining the vital functions of the body. Collapse and decrease in blood pressure are eliminated by adrenergic agonists and / or intravenous fluid infusions. In cases of acute extrapyramidal symptoms, m-anticholinergics (in particular, trihexyphenidil) are administered. Constant medical supervision is carried out until the symptoms of overdose disappear.

special instructions

In elderly patients with dementia treated with Risperidone, there is an increased mortality compared with placebo (there is insufficient data to accurately assess this risk). Also, an increased risk was noted in this group of patients when combined with furosemide. The pathophysiological mechanisms explaining this observation have not been established, but this combination requires caution. Before prescribing such a combination, it is necessary to balance the benefits with the risks. Regardless of treatment, dehydration is a common risk factor for mortality and should be closely monitored.

In elderly patients with dementia who are at risk of developing a stroke, there is an increased likelihood of developing disorders of the cerebrovascular system (the appointment of Risperidone requires caution).

During therapy, especially during the initial dose selection, orthostatic hypotension may develop. A decrease in blood pressure, which has clinical significance, can be observed when combined with antihypertensive drugs. When blood pressure is lowered, consideration should be given to reducing the dose of one / both drugs.

When objective / subjective symptoms appear that indicate tardive dyskinesia, it is necessary to consider the feasibility of discontinuing Risperidone.

In cases of the development of neuroleptic malignant syndrome, therapy is canceled. The main symptoms include: hyperthermia, impaired consciousness, muscle stiffness, instability of the autonomic nervous system function, increased serum creatine phosphokinase activity.

When the first signs of a decrease in the number of blood leukocytes appear (in the absence of other reasons), the question of discontinuing therapy should be considered. The condition of patients with a clinically significant decrease in the number of blood leukocytes should be monitored for possible fever or other signs of infection. In severe neutropenia, after discontinuation of Risperidone, monitoring is required until normal neutrophil levels are restored.

Due to the increased risk of developing neuroleptic malignant syndrome and the presence of hypersensitivity to antipsychotic drugs (including dulling of pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms), Risperidone is prescribed with caution in patients with Parkinson's disease or dementia with Lewy bodies. … It is also necessary to take into account the likelihood of worsening the course of Parkinson's disease.

Due to its antiemetic effect, Risperidone can mask signs of overdose of certain drugs, as well as symptoms of conditions such as hepatocerebral syndrome, brain tumor, or intestinal obstruction.

According to the instructions, Risperidone, due to the blockade of α-adrenergic receptors, can lead to the development of priapism.

In all patients, clinical monitoring of the presence of symptoms of hyperglycemia (polyuria, polydipsia, weakness and polyphagia) and diabetes mellitus should be carried out.

During therapy, it is necessary to control the body weight of patients.

The drug can lead to dysregulation of body temperature.

Before prescribing Risperidone, children or adolescents with mental retardation require a thorough assessment of their condition for the presence of social / physical causes of aggressive behavior. Because of the possible effect on learning ability, sedation should be closely monitored in this patient population. Improvement can be achieved by changing the time of its reception.

Influence on the ability to drive vehicles and complex mechanisms

Driving while using Risperidone should be abandoned.

Application during pregnancy and lactation

• pregnancy: therapy requires caution, since special studies have not been conducted; before prescribing the drug, it is necessary to assess the ratio of benefit to risk; with the use of Risperidone in the third trimester of pregnancy, there is a possibility of extrapyramidal disorders / withdrawal syndrome in newborns [possible symptoms include tremor, agitation, respiratory distress syndrome, muscle tone / nutrition disorders (are reversible, but require prolonged therapy)];
• lactation period: the drug is not prescribed.

Pediatric use

• under 5 years of age: therapy of persistent aggression in conduct disorder in children with mental retardation;
• age up to 10 years: therapy of manic episodes in the structure of bipolar disorder (solution);
• age up to 13 years: schizophrenia therapy (solution);
• age up to 18 years: therapy of schizophrenia and manic episodes in the structure of bipolar disorder (pills).

With impaired renal function

The appointment of risperidone in severe renal failure requires caution.

For violations of liver function

Prescribing risperidone for severe hepatic impairment requires caution.

Use in the elderly

Caution required:

• old age in the treatment of manic episodes in the structure of bipolar disorder (pills);
• old age with dementia.

Drug interactions

Possible interactions:

• drugs that increase the QT interval, including tricyclic and tetracyclic antidepressants (amitriptyline, maprotiline), antiarrhythmics (amiodarone, quinidine, procainamide, disopyramide, propafenone, sotalol), some antihistamines, other antipsychotics, some anti-malarial drugs drugs that can cause electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia, drugs that inhibit hepatic metabolism of risperidone: the combination requires caution;
• centrally acting substances / drugs, especially alcohol, opiates, antihistamines, benzodiazepines: increasing the likelihood of sedation; the combination requires caution;
• levodopa and dopamine receptor agonists: decrease in their effectiveness; if their combined use is necessary, especially at the terminal stage of Parkinson's disease, the appointment of the minimum effective doses of each of the drugs is indicated;
• drugs with antihypertensive action: the development of clinically significant hypotension;
• paliperidone: an increase in the concentration of the active antipsychotic fraction; the combination is not recommended;
• potent inhibitors of the isoenzyme CYP2D6, including paroxetine, quinidine: an increase in the plasma concentration of risperidone; a dose adjustment may be required, especially at the beginning / when such a combination is canceled;
• inhibitors of the isoenzyme CYP3A4 and / or P-gp, including itraconazole, ketoconazole: a significant increase in the plasma concentration of the active antipsychotic fraction of risperidone; a dose adjustment may be required, especially at the beginning / when such a combination is canceled;
• inducers of the isoenzyme CYP3A4 and / or P-gp, including rifampicin, carbamazepine, phenytoin, phenobarbital: a decrease in the plasma concentration of the active antipsychotic fraction of risperidone; its dose may need to be adjusted, especially at the beginning / when such a combination is canceled; it is necessary to take into account that the action of inducers of the CYP3A4 isoenzyme manifests itself gradually, and therefore it may take up to 14 days before reaching the maximum effect after the start of administration, respectively, the same period may be required when the inducer of the CYP3A4 isoenzyme is canceled until the effect disappears;
• phenothiazines, some beta-blockers: an increase in the plasma concentration of risperidone, but not the active antipsychotic fraction;
• protease inhibitors and ritonavir: increasing the concentration of the active antipsychotic fraction of risperidone;
• verapamil: increased plasma concentrations of risperidone and active antipsychotic fraction;
• antagonists of H ₂ -receptors, including ranitidine, cimetidine: increased bioavailability of risperidone, the effect on the concentration of the active antipsychotic fraction is insignificant;
• fluoxetine, paroxetine: an increase in the concentration of risperidone in plasma, the effect on the concentration of the active antipsychotic fraction is insignificant;
• tricyclic antidepressants: an increase in the plasma concentration of risperidone;
• sertraline, fluvoxamine (in a daily dose of more than 100 mg): an increase in the plasma concentration of the active antipsychotic fraction of risperidone;
• furosemide: combination in elderly patients with dementia requires caution.

Analogs

Analogs of Risperidone are: Speridan, Risset, Torendo, Rispolept, Rispaxol, Rileptid, Risdonal, Leptinorm, Rilept, Sizodon-San, Rezalen, Ridonex.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life:

• tablets - 2 years;
• solution - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Risperidone

According to reviews, Risperidone is an effective drug that can be used for a long time in chronic mental illness.

Of the shortcomings, they most often indicate the development of adverse reactions, including increased appetite, fatigue, drowsiness, restlessness, frequent urge to urinate, water retention in the body, headaches, internal agitation, blurred vision, and decreased blood pressure. The manifestation of parkinsonism during therapy is not expressed or completely absent.

Price for Risperidone in pharmacies

The approximate price for Risperidone is:

• 2 mg tablets (20 pcs. in a package): 125-190 rubles;
• 4 mg tablets (20 pcs. in a package): 140-180 rubles.

Risperidone: prices in online pharmacies

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!