Torendo Ku-tab, 30 pcs., 1 mg, lozenges
Classification of the incidence of side effects (WHO): very often >1/10 (more than 10%); often >1/100 to <1/10 (more than 1% but less than 10%); infrequently from >1/1000 to <1/100 (more than 0.1%, but less than 1%); rarely from > 1/10000 to <1/1000 (more than 0.01%, but less than 0.1%); very rare from <1/10000, including isolated reports (less than 0.01%).
From the hematopoietic system:
uncommon - neutropenia, thrombocytopenia; very rarely - anemia, eosinophilia, agranulocytosis.
From the endocrine system:
very rarely - weight gain, hyperglycemia and exacerbation of pre-existing diabetes mellitus, water intoxication due to polydipsia or syndrome of inappropriate secretion of antidiuretic hormone (SIADH); often - excitement, anxiety, insomnia, headache, agitation; infrequently - drowsiness, dizziness, increased fatigue, difficulty concentrating; rarely - extrapyramidal symptoms*, mania or hypomania, hypervolemia (due to either polydipsia or SIADH); very rarely - tardive dyskinesia (involuntary rhythmic movements, mainly of the tongue and/or face), neuroleptic malignant syndrome**, convulsions, epileptic seizures, thermoregulation disorders.
From the senses:
uncommon - blurred vision, conjunctivitis, blepharitis, dry cornea, lacrimation, eye pain, ear pain, tinnitus; rarely - glaucoma, blurred vision.
From the SSS side:
often - tachycardia (including reflex tachycardia); uncommon - decreased blood pressure (including orthostatic hypotension), increased blood pressure, stroke (in elderly patients with predisposing factors), AV block, sinus bradycardia, thrombosis.
From the respiratory system:
often - rhinitis, cough; uncommon - nasal congestion, sore throat, aspiration pneumonia; rarely - sleep apnea, pneumonia, influenza, sinusitis, otitis media, tonsillitis.
From the digestive system:
uncommon - dryness of the oral mucosa, hyper- or hyposalivation, constipation, dyspepsia, nausea, vomiting, abdominal pain, anorexia; rarely - intestinal obstruction.
From the skin:
rarely - dry skin, hyperpigmentation, rash, itching, seborrhea, angioedema, photosensitivity.
From the urinary system:
often - urinary incontinence; infrequently - cystitis.
From the reproductive system:
uncommon - galactorrhea, amenorrhea, menstrual irregularities; rarely - gynecomastia, priapism, erectile dysfunction, ejaculation disorders, anorgasmia.
From the musculoskeletal system:
often - back pain, pain in the limbs; uncommon - muscle weakness, myalgia, arthralgia; rarely - rhabdomyolysis.
Laboratory indicators:
uncommon - hyperprolactinemia***; very rarely - hyperglycemia; increased activity of liver transaminases.
Other:
rarely - peripheral edema.
*Extrapyramidal symptoms: Risperidone has less potential to cause extrapyramidal disorders compared to classical antipsychotics. However, in some cases, the following extrapyramidal symptoms may develop: tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia. These symptoms are usually mild and reversible after dose reduction and/or administration of antiparkinsonian drugs (if necessary).
**Neuroleptic malignant syndrome (NMS): a rare, potentially dangerous condition associated with the use of antidepressants, incl. risperidone. Symptoms of NMS: increased body temperature (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, blood pressure fluctuations, tachycardia, profuse sweating, cardiac arrhythmia, increased CPK activity).
Some cerebrovascular symptoms have been reported during use of risperidone; they developed predominantly among elderly patients with existing risk factors.
***Hyperprolactinemia: Risperidone, depending on the dose, can cause an increase in prolactin levels in the blood with the following possible manifestations: galactorrhea, gynecomastia, menstrual irregularities and amenorrhea.
Torendo Ku-tab, 0.5 mg, lozenges, 30 pcs.
Classification of the incidence of side effects (WHO): very often >1/10 (more than 10%); often >1/100 to <1/10 (more than 1% but less than 10%); infrequently from >1/1000 to <1/100 (more than 0.1%, but less than 1%); rarely from > 1/10000 to <1/1000 (more than 0.01%, but less than 0.1%); very rare from <1/10000, including isolated reports (less than 0.01%).
From the hematopoietic system:
uncommon - neutropenia, thrombocytopenia; very rarely - anemia, eosinophilia, agranulocytosis.
From the endocrine system:
very rarely - weight gain, hyperglycemia and exacerbation of pre-existing diabetes mellitus, water intoxication due to polydipsia or syndrome of inappropriate secretion of antidiuretic hormone (SIADH); often - excitement, anxiety, insomnia, headache, agitation; infrequently - drowsiness, dizziness, increased fatigue, difficulty concentrating; rarely - extrapyramidal symptoms*, mania or hypomania, hypervolemia (due to either polydipsia or SIADH); very rarely - tardive dyskinesia (involuntary rhythmic movements, mainly of the tongue and/or face), neuroleptic malignant syndrome**, convulsions, epileptic seizures, thermoregulation disorders.
From the senses:
uncommon - blurred vision, conjunctivitis, blepharitis, dry cornea, lacrimation, eye pain, ear pain, tinnitus; rarely - glaucoma, blurred vision.
From the SSS side:
often - tachycardia (including reflex tachycardia); uncommon - decreased blood pressure (including orthostatic hypotension), increased blood pressure, stroke (in elderly patients with predisposing factors), AV block, sinus bradycardia, thrombosis.
From the respiratory system:
often - rhinitis, cough; uncommon - nasal congestion, sore throat, aspiration pneumonia; rarely - sleep apnea, pneumonia, influenza, sinusitis, otitis media, tonsillitis.
From the digestive system:
uncommon - dryness of the oral mucosa, hyper- or hyposalivation, constipation, dyspepsia, nausea, vomiting, abdominal pain, anorexia; rarely - intestinal obstruction.
From the skin:
rarely - dry skin, hyperpigmentation, rash, itching, seborrhea, angioedema, photosensitivity.
From the urinary system:
often - urinary incontinence; infrequently - cystitis.
From the reproductive system:
uncommon - galactorrhea, amenorrhea, menstrual irregularities; rarely - gynecomastia, priapism, erectile dysfunction, ejaculation disorders, anorgasmia.
From the musculoskeletal system:
often - back pain, pain in the limbs; uncommon - muscle weakness, myalgia, arthralgia; rarely - rhabdomyolysis.
Laboratory indicators:
uncommon - hyperprolactinemia***; very rarely - hyperglycemia; increased activity of liver transaminases.
Other:
rarely - peripheral edema.
*Extrapyramidal symptoms: Risperidone has less potential to cause extrapyramidal disorders compared to classical antipsychotics. However, in some cases, the following extrapyramidal symptoms may develop: tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia. These symptoms are usually mild and reversible after dose reduction and/or administration of antiparkinsonian drugs (if necessary).
**Neuroleptic malignant syndrome (NMS): a rare, potentially dangerous condition associated with the use of antidepressants, incl. risperidone. Symptoms of NMS: increased body temperature (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, blood pressure fluctuations, tachycardia, profuse sweating, cardiac arrhythmia, increased CPK activity).
Some cerebrovascular symptoms have been reported during use of risperidone; they developed predominantly among elderly patients with existing risk factors.
***Hyperprolactinemia: Risperidone, depending on the dose, can cause an increase in prolactin levels in the blood with the following possible manifestations: galactorrhea, gynecomastia, menstrual irregularities and amenorrhea.
Torendo ku-tab
Torendo® Ku-tab lozenges are fragile and should not be squeezed through the foil packaging as they may break. The package is opened by carefully pulling the edge of the blister foil, marked with a dot, and the tablet is removed, then it should be immediately placed on the tongue. The tablet begins to dissolve in the mouth within a few seconds and can be swallowed without water; do not mix the drug in the mouth with food, bite or chew.
For schizophrenia
For adults and children over the age of 15 years, risperidone can be prescribed 1-2 times a day.
The initial dose 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. Usually 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 >10 mg/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 the drug in doses >16 mg/day has not been studied, doses above this level should not be used.
There is no information on the use of the drug for the treatment of schizophrenia in children under 15 years of age.
For elderly patients, it is recommended to use the drug at an initial dose of 0.5 mg 2 times a day. The dose can be individually increased by 0.5 mg 2 times / day to 1-2 mg 2 times / day.
For patients with liver and kidney diseases, it is recommended to use the drug at an initial dose of 0.5 mg 2 times a day. This dose can be gradually increased to 1-2 mg 2 times / day.
For drug abuse or drug dependence
The recommended daily dose of the drug is 2-4 mg.
For behavioral disorders in patients with dementia
The recommended initial dose of the drug is 0.25 mg 2 times a day (in an adequate dosage form). 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 / day. Some patients are advised to use the drug 1 mg 2 times a day.
Once the optimal dose is reached, it may be recommended to use the drug once a day.
Mania in bipolar disorder
The recommended initial dose of the drug is 2 mg/day at a time. If necessary, this dose can be increased by 2 mg/day, no more than every other day. For most patients, the optimal dose is 2-6 mg/day.
For behavioral disorders in patients with mental retardation
For patients weighing ≥50 kg, it is recommended to use the drug at an initial dose of 0.5 mg 1 time / 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 it is preferable to use 0.5 mg/day, or increase the dose to 1.5 mg/day.
For patients weighing ≤50 kg, it is recommended to use the drug at an initial dose of 0.25 mg 1 time / 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 it is preferable to use 0.25 mg/day, or increase the dose to 0.75 mg/day.
Long-term use of the drug Torendo® Qu-tab in adolescents should be carried out under the constant supervision of a physician.
The use of the drug in children under 15 years of age is not recommended.
Overdose
Symptoms: drowsiness, sedation, depression of consciousness, tachycardia, arterial hypotension, extrapyramidal disorders, in rare cases, prolongation of the QT interval.
Treatment: it is necessary to ensure an open airway to ensure adequate oxygenation and ventilation, gastric lavage (after intubation, if the patient is unconscious) and the administration of activated charcoal in combination with laxatives. Symptomatic therapy aimed at maintaining vital body functions.
For timely diagnosis of possible heart rhythm disturbances, it is necessary to begin ECG monitoring as soon as possible. Careful medical observation and ECG monitoring are carried out until the symptoms of intoxication completely disappear. There is no specific antidote.
