Effect of risperidone
The mechanism of action is caused by the effect on dopamine, serotonin, adrenergic and histamine receptors of nerve cells. Due to the fact that in many endogenous, organic mental diseases the functions of these receptor systems are changed, risperidone has a fairly broad therapeutic effect:
- For productive symptoms of psychosis and schizophrenia (delusions and hallucinations), for negative ones - apathy, isolation, lack of emotions, autism.
- Reduces pathologically elevated mood (mania).
- Calming, anti-anxiety, hypnotic effect.
- Reduces (or removes) aggressiveness, self-aggression.
- Anti-suicidal action.
- Reducing the pathological craving for drugs and alcohol in case of addiction.
- Removes obsessive thoughts, actions and sensations.
Rispolept, 2 mg, film-coated tablets, 20 pcs.
Inside,
regardless of food intake.
Schizophrenia
Adults.
Rispolept® can be prescribed 1 or 2 times a day. The initial dose of Rispolept® is 2 mg/day. On the second day, the dose should be increased to 4 mg/day. From this point on, the dose can either be kept at the same level or individually adjusted if necessary. Typically the optimal dose is 4–6 mg/day. In some cases, a slower dose escalation and lower initial and maintenance doses may be justified.
Doses above 10 mg/day do not show greater efficacy than lower doses and may cause extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg/day has not been studied, doses above this level cannot be used.
Benzodiazepines can be added to Rispolept® therapy if additional sedation is required.
Elderly patients.
The recommended initial dose is 0.5 mg per dose 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1–2 mg 2 times a day. If it is necessary to use a dose of 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Teenagers over 13 years old.
The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dose can be increased after at least 24 hours by 0.5–1 mg per day to the recommended dose of 3 mg/day if well tolerated. The safety of doses above 6 mg/day has not been studied.
For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day.
If it is necessary to use a dose of 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
There is no information on the use of the drug for the treatment of schizophrenia in children under 13 years of age.
Behavioral disorders in patients with dementia
The recommended initial dose is 0.25 mg per dose 2 times a day. If necessary, the dose can be increased individually by 0.25 mg 2 times a day, no more than every other day. For most patients, the optimal dose is 0.5 mg 2 times a day. However, some patients are advised to take 1 mg 2 times a day.
Once the optimal dose is reached, it may be recommended to take the drug once a day.
If it is necessary to use doses of 0.25 or 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Bipolar disorders with mania
Adults.
The recommended initial dose of the drug is 2 or 3 mg/day at a time. If necessary, this dose can be increased at least after 24 hours by 1 mg/day. For most patients, the optimal dose is 1–6 mg/day.
Teenagers and children over 10 years old.
The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dose can be increased after at least 24 hours by 0.5–1 mg/day to the recommended dose of 2.5 mg/day if well tolerated. For most patients, the optimal dose is 0.5–6 mg/day.
If it is necessary to use a dose of 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
The safety of doses above 6 mg/day has not been studied.
For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day.
There is no information on the use of the drug for the treatment of bipolar disorders in children under 10 years of age.
Behavioral disorders
Patients weighing 50 kg or more.
The recommended initial dose of the drug is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg/day no more than every other day. For most patients, the optimal dose is 1 mg/day. However, for some patients, 0.5 mg/day is preferable, while some require an increase in dose to 1.5 mg/day. If it is necessary to use a dose of 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Patients weighing less than 50 kg.
The recommended initial dose of the drug is 0.25 mg once a day. If necessary, this dose can be increased by 0.25 mg/day no more than every other day. For most patients, the optimal dose is 0.5 mg/day. However, for some patients, 0.25 mg/day is preferable, while some require an increase in dose to 0.75 mg/day. If it is necessary to use doses of 0.25 or 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Long-term use of the drug Rispolept® in adolescents should be carried out under the constant supervision of a physician.
Use in children under 5 years of age has not been studied.
Autism in children and adolescents
The dose of Rispolept® should be selected individually. The recommended initial dose of the drug is 0.25 mg/day for patients weighing less than 20 kg and 0.5 mg/day for patients weighing 20 kg or more. On the 4th day of administration, the dose can be increased by 0.25 mg/day for patients weighing less than 20 kg and by 0.5 mg/day per day for patients weighing 20 kg or more.
This dose should be used until approximately the 14th day of treatment, when it is necessary to evaluate the effectiveness. Further increase in dose is carried out only in case of lack of effectiveness. The dose can be increased at intervals of 2 weeks or more by 0.25 mg/day for patients weighing less than 20 kg and by 0.5 mg/day for patients weighing 20 kg or more.
In clinical studies, the maximum daily dose did not exceed 1.5 mg/day for patients weighing less than 20 kg and 2.5 mg/day for patients weighing 20 kg or more, and 3.5 mg/day for patients with weight body more than 45 kg.
Table
Doses of the drug Rispolept® in the treatment of autism in children (per day)
| Body weight, kg | Days 1–3, mg | Days 4–14+, mg | Increase the dose (if necessary) | Recommended dose, mg |
| Less than 20 | 0,25 | 0,5 | +0.25 mg after 2 weeks or more | 0,5–1,5 |
| 20 or more | 0,5 | 1 | +0.5 mg after 2 weeks or more | 1–2,5* |
* For patients weighing more than 45 kg, higher doses may be required, the maximum dose studied is 3.5 mg/day.
If it is necessary to use doses of 0.25 or 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Rispolept® can be prescribed 1 or 2 times a day.
For patients who experience persistent drowsiness, it is recommended to take a daily dose 1 time before bedtime or 2 times a day.
If consistent efficacy is observed, the decision may be made to gradually reduce the dose to achieve an optimal balance of efficacy and safety.
Use in children under 5 years of age has not been studied.
Other patient groups
Patients with liver and kidney diseases.
Patients with kidney disease have a reduced ability to eliminate the active antipsychotic fraction compared to other patients. In patients with liver disease, there is an increased concentration of the free fraction of risperidone in the blood plasma.
The initial and maintenance dose, in accordance with the indications, should be reduced by 2 times; the dose increase in patients with liver and kidney diseases should be carried out more slowly.
If it is necessary to use doses of 0.25 or 0.5 mg, it is recommended to prescribe the drug Rispolept®, an oral solution.
Rispolept® should be prescribed with caution in this category of patients.
Release form
One of the advantages of this drug is the presence of all the dosage forms necessary for psychiatrists: tablets, drops, extended-release injections (depot).
Pills
2 or 4 milligrams per package of 10,20,30,50,60 or 100 pieces
Drops
. In bottles of 30 or 100 milliliters. A special graduated pipette is included, which is used to determine the amount of a single dose to take.
Depot
. In powder form for the preparation of a long-acting intramuscular suspension. Dosages: 25, 37.5 and 50 milligrams. It is used as an intramuscular injection, which will ensure slow release and entry of the drug into the blood over 2 - 3 weeks. Produced under the name RISPOLEPT CONST.
Rispolept solution for oral administration 1 mg/ml bottle 30 ml N1x1 Janssen Pharmaceuticals N.V.
Violations of laboratory and instrumental parameters: often - increased prolactin levels, increased body weight; uncommon – prolongation of the QT interval on the electrocardiogram, ECG abnormalities, increased transaminase levels, decreased number of leukocytes in the blood, increased body temperature, increased number of eosinophils in the blood, decreased hemoglobin level, increased level of creatine phosphokinase, increased cholesterol concentration; rarely - a decrease in body temperature, an increase in triglyceride concentrations. From the cardiovascular system: often – tachycardia, arterial hypertension; uncommon – atrioventricular block, His bundle block, atrial fibrillation, palpitations, cardiac conduction disturbances; rarely - sinus bradycardia, pulmonary embolism, deep vein thrombosis. Hematological disorders and disorders of the lymphatic system: infrequently - anemia, thrombocytopenia; rarely – granulocytopenia, agranulocytosis. From the nervous system: very often - parkinsonism, headache, drowsiness, sedation; often – akathisia, dizziness, tremor, dystonia, lethargy, dyskinesia; uncommon – lack of response to stimuli, loss of consciousness, fainting, impaired consciousness, stroke, transient ischemic attack, dysarthria, impaired attention, hypersomnia, postural dizziness, imbalance, tardive dyskinesia, speech impairment, impaired coordination, hypoesthesia, taste disorders, perversion taste, convulsions, cerebral ischemia, movement disorders; rarely - neuroleptic malignant syndrome, diabetic coma, cerebrovascular disorders, head tremor. Ophthalmological disorders: often – blurred vision, conjunctivitis; uncommon – redness of the eyes, blurred vision, discharge from the eyes, swelling of the area around the eyes, dry eyes, increased lacrimation, photophobia; rarely - decreased visual acuity, involuntary rotation of the eyeballs, glaucoma, intraoperative floppy iris syndrome. From the ear and labyrinth: uncommon – pain in the ear, tinnitus. Respiratory, thoracic and mediastinal disorders: often - shortness of breath, nosebleeds, cough, nasal congestion, pain in the larynx and pharynx; uncommon – wheezing, aspiration pneumonia, pulmonary congestion, respiratory distress, moist rales, airway obstruction, dysphonia; rarely – sleep apnea syndrome, hyperventilation. From the gastrointestinal tract: often - vomiting, diarrhea, constipation, nausea, abdominal pain, dyspepsia, dry mouth, stomach discomfort, hypersalivation; uncommon – dysphagia, gastritis, fecal incontinence, fecaloma, gastroenteritis, flatulence; rarely – intestinal obstruction, pancreatitis, swelling of the lips, cheilitis. From the kidneys and urinary tract: often – enuresis; uncommon – urinary retention, dysuria, urinary incontinence, pollakiuria. From the skin and subcutaneous tissues: often – rash, erythema; uncommon – skin lesions, skin disorders, itching, acne, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis; rarely – dandruff; very rarely - Quincke's edema. From the musculoskeletal system and connective tissue: often – arthralgia, back pain, pain in the extremities; uncommon – muscle weakness, myalgia, neck pain, swollen joints, poor posture, stiffness in the joints, muscle pain in the chest; rarely – rhabdomyolysis. From the endocrine system: rarely - impaired production of antidiuretic hormone. Metabolic and nutritional disorders: often – increased appetite, decreased appetite; uncommon – diabetes mellitus, anorexia, polydipsia, hyperglycemia; rarely – hypoglycemia, water intoxication; very rarely - diabetic ketoacidosis. Infections: often - pneumonia, flu, bronchitis, upper respiratory tract infections, urinary tract infections, sinusitis, ear infections; uncommon – viral infections, tonsillitis, inflammation of subcutaneous fat, otitis media, eye infections, localized infections, akarodermatitis, respiratory tract infections, cystitis, onychomycosis; rarely – chronic otitis media. Vascular disorders: uncommon – hypotension, orthostatic hypotension, hot flashes. General disorders and phenomena caused by administration of the drug: often - pyrexia, fatigue, peripheral edema, generalized edema, asthenia, chest pain; uncommon – facial swelling, gait disturbance, poor health, sluggishness, flu-like condition, thirst, chest discomfort, chills; rarely – hypothermia, withdrawal syndrome, cold extremities. From the immune system: infrequently – hypersensitivity; rarely – drug hypersensitivity, anaphylactic reaction. Hepatobiliary disorders: rarely – jaundice. From the reproductive system and mammary glands: infrequently - amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorders, galactorrhea, gynecomastia, menstrual disorder, vaginal discharge; rarely - priapism. Pregnancy, postpartum and neonatal periods: rarely - withdrawal syndrome in newborns. Mental disorders: very often – insomnia; often - restlessness, agitation, sleep disturbances, anxiety; infrequently - confusion, mania, decreased libido, lethargy, nervousness; rarely – anorgasmia, flattening of affect.
Indications
Risperidone was originally used to treat schizophrenia and psychosis. But as experience has accumulated about the action of this medicine, the indications for its use have expanded. Currently indicated for the following diseases and conditions:
- Schizophrenia
- Schizotypal disorder
- Organic mental disorders
- Schizoid personality disorder
- Manic and hypomanic states in bipolar affective disorder, schizoaffective disorder
- Psychoses
- Delusions: paranoia, paranoid, paraphrenia
- Depressive and anxiety states, neuroses and neurosis-like conditions
- Aggressiveness
- Autism
The drug is recommended for adults and children over 13 years of age. At a younger age, it is prescribed by the doctor’s decision in cases where the potential risk of side and negative effects of the drug is less than the risk of worsening the condition as the disease progresses.
Instructions for use RISPOLEPT®
The drug should be used with caution in patients with diseases of the cardiovascular system (including chronic heart failure, previous myocardial infarction, conduction disorders), dehydration, hypovolemia, cerebrovascular accident, Parkinson's disease, convulsions (including history), severe renal or hepatic failure, drug abuse or drug dependence, conditions predisposing to the development of torsade de pointes (bradycardia, electrolyte imbalance, concomitant use of drugs that prolong the QT interval), brain tumors , intestinal obstruction, in cases of acute drug overdose, in Reye's syndrome (since the antiemetic effect of risperidone can mask the symptoms of these conditions), during pregnancy, in patients under the age of 15 years (since the safety and effectiveness of the drug have not been established) .
In case of schizophrenia, at the beginning of treatment with Rispolept, it is recommended to gradually discontinue previous therapy if clinically justified. At the same time, if patients are transferred from depot therapy with antipsychotic drugs, it is recommended to start Rispolept therapy instead of the next scheduled injection. The need to continue current antiparkinsonian drug therapy should be periodically assessed.
Due to the alpha-adrenergic blocking effect of Rispolept, orthostatic hypotension may occur, especially during the initial dose selection period. If arterial hypotension occurs, 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.
There are reports that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Rispolept is less likely to cause extrapyramidal symptoms than classic antipsychotics. If signs and symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered.
In case of development of NMS, characterized by hyperthermia, muscle rigidity, instability of autonomic functions, disturbances of consciousness and increased CPK levels, it is necessary to discontinue all antipsychotic drugs, including Rispolept.
When carbamazepine and other liver enzyme inducers are discontinued, the dose of Rispolept should be reduced.
During treatment with Rispolept, patients should be advised to refrain from overeating due to the possibility of weight gain.
Use in pediatrics
Data on the safety and effectiveness of Rispolept in children under 15 years of age
are absent, so prescribing the drug to this category of patients is not recommended. Long-term use of Rispolept in adolescents should be carried out under the constant supervision of a physician.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, until individual sensitivity to the drug is determined, patients should avoid driving vehicles and other activities that require high concentration and speed of psychomotor reactions.
Use during pregnancy and breastfeeding
There are no absolute contraindications to taking risperidone during pregnancy and lactation. However, due to the lack of special research in this direction, use during pregnancy is allowed only in cases described by the following formulation: when the benefits of taking it for the pregnant woman outweigh the potential risks to the fetus.
Due to the fact that risperidone passes into breast milk, it is recommended to transfer the child to artificial nutrition for the period of treatment of a breastfeeding mother.
Rispolept oral solution 1 mg/ml 30 ml bottle in Moscow
Inside,
regardless of food intake.
Schizophrenia
Adults.
Rispolept® can be prescribed 1 or 2 times a day. The initial dose of Rispolept® is 2 mg/day. On the second day, the dose should be increased to 4 mg/day. From this point on, the dose can either be kept at the same level or individually adjusted if necessary. Typically the optimal dose is 4–6 mg/day. In some cases, a slower dose escalation and lower initial and maintenance doses may be justified.
Doses above 10 mg/day do not show greater efficacy than lower doses and may cause extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg/day has not been studied, doses above this level cannot be used.
Benzodiazepines can be added to Rispolept® therapy if additional sedation is required.
Elderly patients.
The recommended initial dose is 0.5 mg per dose 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1–2 mg 2 times a day.
Teenagers over 13 years old.
The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dose can be increased after at least 24 hours by 0.5–1 mg per day to the recommended dose of 3 mg/day if well tolerated. The safety of doses above 6 mg/day has not been studied.
For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day.
There is no information on the use of the drug for the treatment of schizophrenia in children under 13 years of age.
Behavioral disorders in patients with dementia
The recommended initial dose is 0.25 mg per dose 2 times a day. If necessary, the dose can be increased individually by 0.25 mg 2 times a day, no more than every other day. For most patients, the optimal dose is 0.5 mg 2 times a day. However, some patients are advised to take 1 mg 2 times a day.
Once the optimal dose is reached, it may be recommended to take the drug once a day.
Bipolar disorders with mania
Adults.
The recommended initial dose of the drug is 2 or 3 mg/day at a time. If necessary, this dose can be increased at least after 24 hours by 1 mg/day. For most patients, the optimal dose is 1–6 mg/day.
Teenagers and children over 10 years old.
The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dose can be increased after at least 24 hours by 0.5–1 mg/day to the recommended dose of 2.5 mg/day if well tolerated. For most patients, the optimal dose is 0.5–6 mg/day.
The safety of doses above 6 mg/day has not been studied.
For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day.
There is no information on the use of the drug for the treatment of bipolar disorders in children under 10 years of age.
Behavioral disorders
Patients weighing 50 kg or more.
The recommended initial dose of the drug is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg/day no more than every other day. For most patients, the optimal dose is 1 mg/day. However, for some patients, 0.5 mg/day is preferable, while some require an increase in dose to 1.5 mg/day.
Patients weighing less than 50 kg.
The recommended initial dose of the drug is 0.25 mg once a day. If necessary, this dose can be increased by 0.25 mg/day no more than every other day. For most patients, the optimal dose is 0.5 mg/day. However, for some patients, 0.25 mg/day is preferable, while some require an increase in dose to 0.75 mg/day.
Long-term use of the drug Rispolept® in adolescents should be carried out under the constant supervision of a physician.
Use in children under 5 years of age has not been studied.
Autism in children and adolescents
The dose of Rispolept® should be selected individually. The recommended initial dose of the drug is 0.25 mg/day for patients weighing less than 20 kg and 0.5 mg/day for patients weighing 20 kg or more. On the 4th day of administration, the dose can be increased by 0.25 mg/day for patients weighing less than 20 kg and by 0.5 mg/day per day for patients weighing 20 kg or more.
This dose should be used until approximately the 14th day of treatment, when it is necessary to evaluate the effectiveness. Further increase in dose is carried out only in case of lack of effectiveness. The dose can be increased at intervals of 2 weeks or more by 0.25 mg/day for patients weighing less than 20 kg and by 0.5 mg/day for patients weighing 20 kg or more.
In clinical studies, the maximum daily dose did not exceed 1.5 mg/day for patients weighing less than 20 kg and 2.5 mg/day for patients weighing 20 kg or more, and 3.5 mg/day for patients with weight body more than 45 kg.
Table
Doses of the drug Rispolept® in the treatment of autism in children (per day)
| Body weight, kg | Days 1–3, mg | Days 4–14+, mg | Increase the dose (if necessary) | Recommended dose, mg |
| Less than 20 | 0,25 | 0,5 | +0.25 mg after 2 weeks or more | 0,5–1,5 |
| 20 or more | 0,5 | 1 | +0.5 mg after 2 weeks or more | 1–2,5* |
* For patients weighing more than 45 kg, higher doses may be required, the maximum dose studied is 3.5 mg/day.
Rispolept® can be prescribed 1 or 2 times a day.
For patients who experience persistent drowsiness, it is recommended to take a daily dose 1 time before bedtime or 2 times a day.
If consistent efficacy is observed, the decision may be made to gradually reduce the dose to achieve an optimal balance of efficacy and safety.
Use in children under 5 years of age has not been studied.
Other patient groups
Patients with liver and kidney diseases.
Patients with kidney disease have a reduced ability to eliminate the active antipsychotic fraction compared to other patients. In patients with liver disease, there is an increased concentration of the free fraction of risperidone in the blood plasma.
The initial and maintenance dose, in accordance with the indications, should be reduced by 2 times; the dose increase in patients with liver and kidney diseases should be carried out more slowly.
Rispolept® should be prescribed with caution in this category of patients.
Side effects
The drug is usually well tolerated. According to clinic doctors, it is one of the well-tolerated antipsychotics. In approximately 10% of cases, the following side effects are possible.
- Increased muscle tone, restlessness, trembling, feeling of stiffness, “extrapyramidal syndrome,” parkinsonism. To prevent these phenomena, correctors may be additionally prescribed: trihexyphenidyl (Cyclodol), biperiden (Akineton, Mendylex, Bezac), amantadine (PK-Merz), etc.
- Headache.
- Insomnia.
Rare but unpleasant side effects include metabolic (metabolic) disorders: weight gain and the development of diabetes. As a rule, such effects develop in persons predisposed to this.
Therefore, to avoid them, it is recommended to conduct an examination with blood tests before starting therapy to exclude an increase in glucose and prolactin in the blood.
Rispolept®
Side effects of the drug Rispolept® in therapeutic doses are given with a distribution by frequency and system-organ classes. Determination of the frequency of side effects: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10,000 and <1 /1000), very rare (< 1/10,000).
Infections:
very often - in elderly patients with dementia - urinary tract infections; often - nasopharyngitis, upper respiratory tract infections, sinusitis, urinary tract infections, in elderly patients with dementia - pneumonia, phlegmon, in children - rhinitis, influenza-like diseases; uncommon - ear infections, viral infections, pharyngitis, tonsillitis, bronchitis, eye infections, localized infections, cystitis, onychomycosis, acrodermatitis, bronchopneumonia, respiratory tract infections, tracheobronchitis.
Mental disorders:
very often - insomnia; often - anxiety, nervousness, in elderly patients with dementia - confusion, in children - lethargy; infrequently - agitation, flattening of affect, sleep disturbances, weakened libido, anorgasmia; very rarely - mania.
From the nervous system:
very often - parkinsonism (including extrapyramidal disorders, cogwheel syndrome, akinesia, bradykinesia, hypokinesia, muscle rigidity), in children - drowsiness, headaches, sedation; often - akathisia (including restlessness), drowsiness, dizziness, sedation, tremor, dystonia (including muscle spasms, involuntary muscle contractions, muscle contracture, involuntary eye movements, tongue paralysis), lethargy, postural dizziness, dyskinesia (including muscle twitching, chorea and choreoathetosis), fainting, in elderly patients with dementia - a depressed state, in children - dysarthria, impaired attention, gait disturbance; uncommon - lack of response to stimuli, loss of coordination, loss of consciousness, speech impairment, hypoesthesia, movement disorder, tardive dyskinesia, cerebral ischemia, cerebrovascular disorders, NMS.
From the senses:
often - impaired visual acuity, ear pain, in elderly patients with dementia - conjunctivitis; uncommon - tinnitus, conjunctival hyperemia, blurred vision, involuntary rotation of the eyeballs, swelling of the eyelids, periorbital edema, crust formation on the edges of the eyelids, dry eyes, increased lacrimation, photophobia, increased intraocular pressure.
From the cardiovascular system:
often - tachycardia, orthostatic hypotension, decreased blood pressure, in elderly patients with dementia - transient ischemic attack, myocardial infarction, stroke, in children - palpitations; uncommon - sinus bradycardia, sinus tachycardia, palpitations, AV block, right and left bundle branch block, flushing; very rarely - atrial fibrillation.
From the respiratory system:
often - nasal congestion, shortness of breath, nosebleeds, sinus congestion, in elderly patients with dementia - cough, rhinorrhea, in children - cough, rhinorrhea, pain in the larynx and pharynx, pulmonary congestion; uncommon - wheezing, aspiration pneumonia, dysphonia, productive cough, airway obstruction, moist rales, respiratory distress, nasal swelling, hyperventilation; very rarely - sleep apnea syndrome.
From the digestive system:
often - nausea, constipation, dyspepsia, vomiting, diarrhea, salivation, dry mouth, stomach discomfort, abdominal pain; in elderly patients with dementia - dysphagia, fecaloma; infrequently - encopresis, gastritis, swelling of the lips, cheilitis, aptialism; very rarely - intestinal obstruction, pancreatitis, jaundice.
From the hematopoietic system:
often - anemia; uncommon - granulocytopenia; very rarely - thrombocytopenia, agranulocytosis.
Allergic reactions:
uncommon - hypersensitivity; very rarely - Quincke's edema, anaphylactic shock.
From the endocrine system:
uncommon - hyperprolactinemia, diabetic coma; very rarely - impaired ADH secretion.
From the side of metabolism:
often in elderly patients with dementia there is a decrease in appetite, in children there is an increase in appetite; infrequently - polydipsia, anorexia; rarely - diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication.
Dermatological reactions:
often - rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, in elderly patients with dementia - erythema, in children - itching, acne; uncommon - skin pigmentation disorders, erythematous rashes, papular rashes, generalized rash, maculopapular rash; very rarely - alopecia.
From the musculoskeletal system:
often - back pain, arthralgia, pain in the limbs, in elderly patients with dementia - gait disturbances, swelling of the joints, in children - myalgia, neck pain; Uncommon: muscle pain in the chest, joint stiffness, muscle weakness, rhabdomyolysis.
From the urinary system:
often - urinary incontinence, in children - enuresis, pollakiuria; uncommon - pain when urinating; very rarely - urinary retention.
From the reproductive system:
often - lack of ejaculation, in children - galactorrhea; uncommon - menstrual irregularities, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, breast enlargement, sexual dysfunction, retrograde ejaculation; very rarely - priapism.
From the side of metabolism:
often - fatigue, asthenia, fever, pain in the chest; in elderly patients with dementia - peripheral edema, gait disturbance; in children - slowness, discomfort in the chest; infrequently - thirst, flu-like condition, edema, poor health, facial swelling, general edema, chills, cold extremities, withdrawal syndrome; very rarely - hypothermia.
From the laboratory parameters:
often - increased CK activity, increased heart rate, in elderly patients with dementia - increased body temperature, in children - increased body weight, increased prolactin concentration; uncommon - increased ALT activity, ECG disturbance, increased number of eosinophils in the blood, increased AST activity, increased number of leukocytes in the blood, increased blood glucose levels, decreased hemoglobin concentration, decreased hematocrit, decreased body temperature, decreased blood pressure; very rarely - prolongation of the QT interval on the ECG.
Below are additionally listed the adverse reactions that are observed when using risperidone intramuscularly (the drug Rispolept Konsta).
Infections:
lower respiratory tract infections, gastroenteritis, subcutaneous abscess.
From the blood and lymphatic system:
neutropenia.
From the side of metabolism:
hyperglycemia, weight loss.
From the mental side:
depression, sleep disorders.
From the nervous system:
paresthesia, convulsions.
From the senses:
blepharospasm, vertigo.
From the cardiovascular system:
bradycardia, increased blood pressure.
From the digestive system:
toothache, tongue spasm, increased GGT activity.
Dermatological reactions:
eczema.
From the musculoskeletal system:
pain in the buttocks.
From the reproductive system:
delayed menstruation, delayed ejaculation, oligomenorrhea, discomfort in the mammary glands.
Other:
pain, gait disturbances, detection of glucose in the urine, increased activity of microsomal liver enzymes.
Risperpet
From the nervous system: insomnia, agitation, anxiety, headache, sometimes - drowsiness, fatigue, dizziness, decreased ability to concentrate, blurred vision, rarely - extrapyramidal symptoms (tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia) , mania or hypomania, stroke (in elderly patients with predisposing factors).
In patients with schizophrenia - hypervolemia (either due to polydipsia or due to the syndrome of inappropriate ADH secretion), tardive dyskinesia (involuntary rhythmic movements, mainly of the tongue and / or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased levels of CPK), thermoregulation disorders, epileptic seizures.
From the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of liver transaminases, dry mouth, hypo- or hypersalivation, anorexia, increased or decreased body weight.
From the cardiovascular system: sometimes - orthostatic hypotension, reflex tachycardia or increased blood pressure.
From the hematopoietic organs: neutropenia, thrombocytopenia.
From the endocrine system: galactorrhea, gynecomastia, menstrual irregularities, amenorrhea, weight gain, hyperglycemia.
From the genitourinary system: priapism, erectile dysfunction, ejaculation disorders, orgasm disorders, urinary incontinence.
Allergic reactions: rhinitis, rash, angioedema, photosensitivity.
From the skin: dry skin, hyperpigmentation, itching, seborrhea.
Other: arthralgia.
Overdose. Symptoms: drowsiness, sedation, tachycardia, decreased blood pressure, extrapyramidal disorders, rarely - prolongation of the QT interval.
Treatment: ensure an open airway to ensure adequate oxygen supply and ventilation, gastric lavage (after intubation, if the patient is unconscious) and the administration of activated charcoal along with a laxative. Immediately begin ECG monitoring to identify possible arrhythmias. There is no specific antidote. It is necessary to carry out symptomatic therapy aimed at maintaining the vital functions of the body. With a decrease in blood pressure and vascular collapse, administer intravenous infusion solutions and/or adrenergic stimulants. In case of development of acute extrapyramidal symptoms - anticholinergic drugs. Constant medical observation and monitoring should be continued until symptoms of intoxication disappear.
Rispolept tablets po 2mg bl N10x2 Janssen Pharmaceuticals N.V.
Schizophrenia. Adults. Rispolept can be prescribed once or twice a day. The initial dose of Rispolept is 2 mg per day. On the second day, the dose can be increased to 4 mg per day. From this point on, the dose can either be kept at the same level or individually adjusted if necessary. Usually the optimal dose is 4-6 mg per day. In some cases, a slower dose escalation and lower initial and maintenance doses may be justified. Doses higher than 10 mg per day have not been shown to be more effective than lower doses and may cause extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg per day has not been studied, doses above this level are not recommended. Elderly patients. An initial dose of 0.5 mg twice daily is recommended. The dosage can be individually increased by 0.5 mg twice daily to 1-2 mg twice daily. Children from 13 years old. The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dosage can be increased after at least 24 hours by 0.5 - 1 mg per day to the recommended dose of 3 mg per day if well tolerated. Despite the effectiveness demonstrated in the treatment of schizophrenia in adolescents with doses of 1-6 mg per day, no additional effectiveness was observed at doses above 3 mg per day, and higher doses caused more side effects. Doses higher than 6 mg per day have not been studied. For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day. Manic episodes associated with bipolar disorder. Adults. The recommended initial dose of the drug is 2 mg per day at a time. If necessary, this dose can be increased after at least 24 hours by 1 mg per day. For most patients, the optimal dose is 1-6 mg per day. Doses higher than 6 mg per day have not been studied in patients with manic episodes. As with any other symptomatic therapy, the advisability of continuing treatment with Rispolept should be regularly assessed and confirmed. Elderly patients. An initial dose of 0.5 mg twice daily is recommended. The dosage can be individually increased by 0.5 mg twice daily to 1-2 mg twice daily. Caution must be exercised due to limited experience with the drug in elderly patients. Children from 10 years old. The recommended initial dose is 0.5 mg once daily in the morning or evening. If necessary, the dosage can be increased after at least 24 hours by 0.5 - 1 mg per day to the recommended dose of 1-2.5 mg per day if well tolerated. Despite the effectiveness demonstrated in the treatment of manic episodes associated with bipolar disorder in children with doses of 0.5-6 mg per day, no additional effectiveness was observed at doses above 2.5 mg per day, and higher doses caused more side effects. Doses higher than 6 mg per day have not been studied. For patients who experience persistent drowsiness, it is recommended to take half the daily dose 2 times a day. Persistent aggression in patients with dementia due to Alzheimer's disease. A starting dose of 0.25 mg twice daily is recommended. If necessary, the dosage can be increased individually by 0.25 mg 2 times a day, no more than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, some patients are advised to take 1 mg 2 times a day. Rispolept should not be used for more than 6 weeks in patients with persistent aggression in patients with dementia due to Alzheimer's disease. During treatment, patients' condition should be assessed on a regular basis, as well as the need for continued therapy. Persistent aggression in the structure of conduct disorder. Children from 5 to 18 years old. Patients weighing 50 kg or more - the recommended initial dose of the drug is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg per day, no more than every other day. For most patients, the optimal dose is 1 mg per day. However, for some patients, 0.5 mg per day is preferable, while some require an increase to 1.5 mg per day. Patients weighing less than 50 kg - the recommended initial dose of the drug is 0.25 mg once a day. If necessary, this dose can be increased by 0.25 mg per day, no more than every other day. For most patients, the optimal dose is 0.5 mg per day. However, for some patients, 0.25 mg per day is preferable, while some require an increase in dose to 0.75 mg per day. As with any symptomatic therapy, the appropriateness of continued treatment with Rispolep should be regularly assessed and confirmed. Use in children under 5 years of age is not recommended due to lack of data. Liver and kidney diseases. Patients with kidney disease have a reduced ability to eliminate the active antipsychotic fraction compared to other patients. In patients with liver disease, there is an increased concentration of the free fraction of risperidone in the blood plasma. The initial and maintenance dose, in accordance with the indications, should be reduced by 2 times; the dose increase in patients with liver and kidney diseases should be carried out more slowly. Rispolept should be prescribed with caution in this category of patients. Mode of application. Inside. Eating does not affect the absorption of the drug. If it is necessary to use doses less than 1.0 mg, it is recommended to use the drug Rispolept, an oral solution. It is recommended to discontinue taking the drug gradually. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia, have been observed very rarely after abrupt cessation of high-dose antipsychotic medications. Transition from therapy with other antipsychotic drugs. When starting treatment with Rispolept, it is recommended to gradually discontinue previous therapy if clinically justified. Moreover, if patients are transferred from therapy with depot forms of antipsychotic drugs, then it is recommended to start therapy with Rispolept instead of the next scheduled injection. The need to continue current antiparkinsonian drug therapy should be periodically assessed.
