Description
Latin name
Torendo
release form Tablett: //a.in-farm.ru/descriptions section = edit_piluli & id = 392345 & type_id = 1 tags, film-coated
Packaging
20 pcs.
Indications
– Acute and chronic schizophrenia and other psychotic conditions with productive and / or negative symptoms.
– Affective disorders in various mental illnesses.
– Behavioral disorders in patients with dementia with symptoms of aggressiveness (outbursts of anger, physical abuse), with mental disorders (agitation, delirium) or psychotic symptoms.
– As an adjunct therapy in the treatment of mania in bipolar disorders.
– As an adjunct therapy for behavioral disorders in adolescents from 15 years of age and adult patients with reduced intellectual level or mental retardation, in cases where destructive behavior (aggressiveness, impulsivity, autoaggression) is the leading one in the clinical picture of the disease.
Contraindications
– Lactation.
– Children and adolescents under 15 years of age (efficacy and safety not established).
– Hypersensitivity to the drug.
With caution, the drug should be used for diseases of the cardiovascular system (chronic heart failure, myocardial infarction, impaired conduction of the heart muscle), dehydration and hypovolemia, impaired cerebral circulation, Parkinson’s disease, seizures (including a history), severe renal or hepatic insufficiency, drug abuse or drug dependence, conditions predisposing to the development of pirouette type tachycardia (bradycardia, electrolyte imbalance, concomitant use of drugs that extend the QT interval), brain tumors, intestinal obstruction, in case of acute drug overdose, Reye’s syndrome (the antiemetic effect of risperidone can mask the symptoms of these conditions).
Pregnancy and lactation
The safety of risperidone during pregnancy has not been studied. The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Since risperidone and 9-hydroxy-risperidone are excreted in breast milk, if you need to use the drug during lactation, you should decide whether to stop breastfeeding.
Composition
1 film-coated tablet contains:
active substance: risperidone 4 mg.
excipients: cellulose *, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate.
shell: Opadry OZN28785 white **, quinoline yellow dye E 104, indigo carmine E 132. * Cellactose is a spray-dried compound consisting of 75% alpha-lactose monohydrate and 25% cellulose powder, dry matter ** Opadray OZN28785 is ready-made mixture of hypromellose, titanium dioxide, talc, propylene glycol
Dosage and administration of
Schizophrenia.
Adults and children over 15 years of age. Risperidone can be prescribed once or twice a day. The initial dose is 2 mg per day. On the second day, the dose should be increased to 4 mg per day. From this moment, the dose can either be maintained at the same level, or individually adjusted if necessary. Usually the optimal dose is 4-6 mg per day. In some cases, a slower dose increase and lower initial and maintenance doses may be warranted.
Doses above 10 mg per day have not shown higher efficacy compared to 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 cannot be used.
Information on the use of the drug for the treatment of schizophrenia in children under 15 years of age is not available.
Elderly patients. An initial dose of 0.5 mg twice daily is recommended. The dosage can be individually increased by 0.5 mg twice a day to 1-2 mg twice a day.
Diseases of the liver and kidneys. An initial dose of 0.5 mg per dose is recommended 2 times a day. This dose can gradually be increased to 1-2 mg per dose twice a day.
Drug abuse or drug dependence – the recommended daily dose of the drug is 2-4 mg.
Behavioral disorders in patients with dementia.
An initial dose of 0.25 mg per day is recommended twice daily (adequate dosage form should be used). If necessary, the dosage can be individually increased by 0.25 mg 2 times a day, not more often than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, some patients are shown taking 1 mg 2 times a day.
Once an optimal dose is reached, a once-daily dose may be recommended.
Mania for bipolar disorder
The recommended starting dose of Torendo is 2 mg per day at a time. If necessary, this dose can be increased by 2 mg per day, not more often than every other day. For most patients, the optimal dose is 2-6 mg per day. Behavioral disorders in patients with mental retardation
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, not more often 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 in dose to 1.5 mg per day.
Patients weighing less than 50 kg – The recommended starting dose of Torendo is 0.25 mg once daily. If necessary, this dose can be increased by 0.25 mg per day, not more often than every other day. For most patients, the optimal dose is a dose of 0.5 mg per day. However, for some patients, 0.25 mg per day is preferable, while others require a dose increase to 0.75 mg per day.
Long-term use of risperidone in adolescents should be carried out under the constant supervision of a physician.
Use in children under 15 years of age is not recommended.
Side effects of the
From the nervous system: insomnia, agitation, anxiety, headache, sometimes drowsiness, increased fatigue, dizziness, impaired attention, blurred vision, rarely extrapyramidal symptoms (tremor, stiffness, hypersalivation, bradykinesia, acute dystonia), mania or hypomania, stroke (in elderly patients with predisposing factors), as well as hypervolemia (either due to polydipsia or due to the syndrome of inadequate secretion of antidiuretic hormone), late discs nezia (involuntary rhythmic movements of mainly the tongue and / or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomous functions, impaired consciousness and an increase in the level of creatine phosphokinase), violation of thermoregulation and epileptic seizures.
From the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of hepatic transaminases, dry mouth, hypo-or hypersalivation, anorexia and / or increased appetite, increased or decreased body weight.
From the cardiovascular system: sometimes orthostatic hypotension, reflex tachycardia, or increased blood pressure.
From the hemopoietic organs: neutropenia, thrombocytopenia.
From the endocrine system: galactorrhea, gynecomastia, menstrual irregularities, amenorrhea, weight gain, hyperglycemia and exacerbation of preexisting diabetes mellitus.
From the genitourinary system: priapism, impaired erection, impaired ejaculation, anorgasmia, urinary incontinence.
Allergic reactions: rhinitis, rash, angioedema, photosensitivity.
From the skin: dry skin, hyperpigmentation, itching, seborrhea.
Other: arthralgia.
Overdose
Symptoms: drowsiness, sedation, conscious depression, tachycardia, arterial hypotension, extrapyramidal disorders, in rare cases QT prolongation.
Treatment: It is necessary to ensure the free passage of the respiratory tract to ensure adequate oxygenation and ventilation, gastric lavage (after intubation if the patient is unconscious) and the appointment of activated charcoal in combination with laxatives. Symptomatic therapy aimed at maintaining vital functions of the body. To timely diagnose possible heart rhythm disorders, ECG monitoring should be started as soon as possible. Careful medical monitoring and ECG monitoring are carried out until the symptoms of intoxication disappear. There is no specific antidote.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Expiration
2 years.
Deystvuyuschee substances
Risperidone
Terms of Pharmacy Leave
Prescription
dosage form
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
