TORENDO Q-TAB PILL D/RUSS. 1MG

Active ingredient

I pill contains:
active ingredient: Risperidone - 0.5 mg, 1 mg or 2 mg.

Therapeutic indications

• schizophrenia (acute and chronic) and other psychotic states with productive and / or negative symptoms;
• affective disorders in various mental illnesses;
• behavioral disorders in patients with dementia with symptoms of aggressiveness (outbreak of anger, physical abuse), with mental disorders (agitation, delusions) or psychotic symptoms;
• as an adjuvant therapy in the treatment of mania in bipolar disorders;
• as an adjuvant therapy of behavioral disorders in adolescents from 15 years and adult patients with reduced intellectual level or mental retardation, in cases where destructive behavior (aggressiveness, impulsivity, auto-aggression) is leading in the clinical picture of the disease.

Dosage and administration

Torendo® Ku-Tab for sucking fragile, they should not be squeezed through the packaging foil, because they may break. The package is opened by gently pulling the edge of the blister foil, marked with a dot, and the pill is removed, then it should be put on the tongue immediately.The pill begins to dissolve in the mouth within seconds and can be swallowed without water. The pill should not be cracked or chewed.

Schizophrenia.
Adults and children over 15 years. Risperidone may be administered 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 point on, 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 justified.
Doses above 10 mg per day did not show higher efficacy compared with smaller doses and may cause the appearance of 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 younger than 15 years old is not available.
Elderly patients. An initial dose of 0.5 mg per dose is recommended twice a day. The dosage can be individually increased to 0.5 mg twice a day to 1-2 mg twice a day.
Diseases of the liver and kidneys. The recommended initial dose of 0.5 mg per reception, 2 times a day. This dose can be gradually increased to 1-2 mg per dose twice a day.
Abuse of drugs or drug dependence - the recommended daily dose of the drug - 2-4 mg.
Behavioral disorders in patients with dementia.
An initial dose of 0.25 mg per dose twice a day is recommended (an 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 a day. However, some patients are shown taking 1 mg 2 times a day.
Upon reaching the optimal dose, it may be recommended to take the drug once a day.

Manias for Bipolar Disorders
The recommended initial dose of the drug - 2 mg per day at a time. If necessary, this dose can be increased by 2 mg per day, no more than a 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 - 0.5 mg per 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 it is preferable to take 0.5 mg per day, while some require an increase in the dose to 1.5 mg per day.
Patients weighing less than 50 kg - The recommended initial dose of the drug - 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 it is preferable to take 0.25 mg per day, while others need to increase the dose to 0.75 mg per day.
Long-term use of Torendo® Q-Tab in adolescents should be under the constant supervision of a physician.
Use in children under 15 is not recommended.
Hypersensitivity to the drug; lactation period, children under 15 years of age (efficacy and safety have not been established).

Contraindications:

Hypersensitivity to the drug; breastfeeding period, mania for bipolar affective disorders in children under 18 years of age (efficacy and safety have not been established), schizophrenia (acute and chronic), and other psychotic states with productive and / or negative symptoms in children under 15 years of age; affective disorders in various mental illnesses in children under the age of 15 years.

Special instructions and precautionary measures

With caution:

• Pregnancy
• Cardiovascular diseases (chronic heart failure, previous myocardial infarction, cardiac muscle conduction disturbances)
• dehydration and hypovolemia
• disorders of cerebral circulation
• Parkinson's disease
• convulsions (including history)
• severe renal or hepatic impairment
• drug abuse or drug dependence
• conditions predisposing to the development of pirouette-type tachycardia (bradycardia, electrolyte imbalance, concomitant medication, prolonging the QT interval)
• brain tumor, intestinal obstruction, cases of acute drug overdose, Reye's syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions)
• Advanced age with dementia
• Use in combination with Furosemide
• Thrombophlebitis
• Hyperglycemia

Interaction with other drugs

Given that risperidone has an effect primarily on the central nervous system, it should be used with caution in combination with other drugs of central action and with alcohol.
Risperidone reduces the effectiveness of levodopa and other dopamine agonists. Clozapine reduces the clearance of risperidone.
When Carbamazepine was used, a decrease in plasma active antipsychotic fraction of risperidone was observed. Similar effects can be observed when using other hepatic enzyme inducers. Phenothiazines, tricyclic antidepressants, and some β-blockers may increase plasma concentrations of risperidone, but this does not affect the concentration of the active antipsychotic fraction.
Fluoxetine can increase the concentration of risperidone in plasma, but to a lesser extent, the concentration of the active antipsychotic fraction, so the dose of risperidone should be adjusted.
When using risperidone together with other drugs that are highly bound to plasma proteins, there is no clinically pronounced displacement of any drug from the plasma protein fraction.
Antihypertensive drugs increase the severity of blood pressure reduction on the background of risperidone.
Cimetidine and Ranitidine increase the concentration of risperidone in plasma, but the antipsychotic effect does not increase, because the cohesion of the active metabolites is reduced.
Simultaneous use of risperidone with furosemide in elderly patients with cerebrovascular dementia has been associated with high mortality.
The mechanism of this interaction has no clear explanation. It is necessary to evaluate the ratio of the potential benefits and the possible risks for these patients with simultaneous use of risperidone and diuretic agents, including furosemide.
Risperidone can increase blood pressure, reducing the effectiveness of phenoxybenzamine, labetalol, and other alpha-blocking sympathomimetics, reserpine, methyldopa, and other antihypertensive drugs of central action.
The lowering blood pressure effect of guanitidine is blocked.
The concomitant use of risperidone with drugs that prolong the QT interval, such as other APS, antiarrhythmic drugs IA, Class III, moxifloxacin, Erythromycin, methadone, mefloquin, tricyclic antidepressants, lithium preparations, and cisapride, requires attention and caution. You must be careful when taking concomitant risperidone with drugs that can cause electrolyte imbalance, such as thiazide diuretics (hypokalemia). This combination increases the risk of developing malignant arrhythmias.
The simultaneous use of ethanol and central nervous system depressants give additive suppression of the central nervous system function.

Pregnancy and breastfeeding

The safety of risperidone in pregnant women has not been studied. In pregnancy, it can only be used if a positive effect justifies a possible risk.
Since risperidone and 9-hydroxy-risperidone penetrate into breast milk, women who use the drug should not breastfeed.

Influence on ability to drive a car and other mechanisms

During treatment, it is necessary to refrain from practicing potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions, as well as from drinking alcohol.

Side effects

Nervous system disorders: insomnia, agitation, anxiety, headache, sometimes drowsiness, fatigue, dizziness, impaired concentration, blurred vision, rarely extrapyramidal symptoms (tremor, rigidity, hypersalivation, bradykinesia, akathisia, 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 antidiuretic hormone secretion), tardive dyskinesia (involuntary rhythmic Vision advantageously language and / or persons), neuroleptic malignant syndrome (hyperthermia, muscle stiffness, instability autonomous functions, impaired consciousness and awareness CPK), disorders of thermoregulation and seizures.

On the part of the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of liver transaminases, dry mouth, hypo or hypersalivation, anorexia and / or increased appetite, increased or decreased body weight. Since the cardiovascular system: sometimes orthostatic hypotension, reflex tachycardia, or increased blood pressure. From the side of blood-forming organs: neutropenia, thrombocytopenia.
On the part of the endocrine system: galactorrhea, gynecomastia, menstrual disorders, amenorrhea, weight gain, hyperglycemia and exacerbation of preexisting diabetes.
On the part of the urogenital system: priapism, erectile dysfunction, ejaculation disorders, anorgasmia, urinary incontinence.
Allergic reactions: rhinitis, rash, angioedema, photosensitization. On the part of the coat: dry skin, hyperpigmentation, itching, seborrhea. Others: arthralgia.

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 the free passage of airways to ensure adequate oxygenation and ventilation, gastric lavage (after intubation, if the patient is unconscious) and the appointment of Activated carbon in combination with laxatives.Symptomatic therapy aimed at maintaining the vital functions of the body.
In order to timely diagnose possible arrhythmias, it is necessary to start ECG monitoring as soon as possible. Careful medical observation and ECG monitoring is carried out until the symptoms of intoxication disappear. The specific antidote is absent.

Pharmacodynamics

Pharmacotherapeutic group: antipsychotic (neuroleptic). KODATH: N05AX08.

Pharmacological properties

Risperidone is an antipsychotic, has a sedative, antiemetic and hypothermic effect. Risperidone is a selective monoaminergic antagonist with a pronounced affinity for serotonergic 5-HT2 and dopaminergic D2 receptors, and is also associated with alpha 1-adrenergic receptors and with somewhat lower affinity for H1-histaminergic and alpha 2 adrenergic receptors. Does not have a tropism for cholinergic receptors

The antipsychotic effect is due to the blockade of the dopamine D2 receptors of the mesolimbic and mesocortical system.
The sedative effect is due to blockade of the adrenoreceptors of the reticular formation of the brain stem; antiemetic effect - blockade of dopamine D2-receptors of the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus.
Reduces productive symptoms (delusions, hallucinations), automatism.It causes less suppression of motor activity and to a lesser extent induces catalepsy than classical antipsychotics (neuroleptics).
Balanced central antagonism of serotonin and dopamine may reduce the risk of extrapyramidal symptoms.
Risperidone may cause a dose-dependent increase in plasma prolactin concentration.

Pharmacokinetics

When ingested, risperidone is completely absorbed (regardless of the meal) and maximum plasma concentration levels are observed after 1-2 hours. Risperidone is metabolized with the participation of P4502D6 cytochrome with the formation of 9-hydroxy-risperidone, which has a similar pharmacological action. Risperidone and 9-hydroxy-risperidone are an effective antipsychotic fraction. The further metabolism of risperidone is N-dealkylation. When taken internally, risperidone is eliminated with a half-life of about 3 hours. It is established that the half-life of 9-hydroxy-risperidone and the active antipsychotic fraction is 24 hours.
In most patients, the equilibrium concentration of risperidone is observed one day after the start of treatment. The equilibrium state of 9-hydroxy-risperidone in most cases is achieved 3-4 days after the start of treatment.
The plasma concentration of risperidone is proportional to the dose of the drug (within therapeutic doses).
Risperidone is rapidly distributed in the body. The volume of distribution is 1-2 l / kg.In plasma, risperidone is associated with albumin and acidic alpha-1-glycoprotein. The fraction of risperidone, which is bound to plasma protein, is 88% and 77%, respectively, in the case of 9-hydroxy-risperidone.
Excreted by the kidneys -70% (of which 35-45% in the form of a pharmacologically active fraction) and 14% with bile. With a single dose, there are high levels of active plasma concentrations and slow elimination in elderly patients and patients with insufficient kidney function.

List of excipients

Excipients: mannitol, butyl methacrylate, dimethylaminoethyl methacrylate and methyl methylate (1: 2: 1), povidone K-25, microcrystalline cellulose, hyprolose (hydroxy propyl low-substituted cellulose, LH-21), aspartame, crospovidone, red dyes ), mint flavor, menthol flavor, Calcium silicate, Magnesium stearate.

Special storage conditions

Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.