Torendo, pills 4mg, 20pcs

Composition

1 film-coated tablet contains:

Active ingredient:

risperidone 4 mg

. excipients:

cellactose*,

microcrystalline cellulose,

croscarmellose sodium,

colloidal anhydrous silicon dioxide,

sodium lauryl sulfate,

magnesium stearate.

shell:

Opadry STP 28785 white**, dye quinoline yellow E 104, dye Indigo Carmine E 132. * Cellactose is a spray-dried compound consisting of 75% alpha – lactose monohydrate and 25% cellulose powder, dry matter ** Opadry STP 28785 is a ready – mix these, titanium dioxide, talc, propylene glycol

Pharmacological action

Torendo is an antipsychotic (neuroleptic).

Pharmacodynamics

Risperidone is an antipsychotic agent that also has sedative, antiemetic and hypothermic effects. Risperidone is a selective monoaminergic antagonist with a pronounced affinity for serotonergic 5-HT2 and dopaminergic D2 receptors, also binds to alpha-1-adrenergic receptors and, with a slightly lower affinity, to H1-histaminergic and alpha-2-adrenergic receptors. It has no tropicity to cholinergic receptors. The antipsychotic effect is due to the blockade of dopamine D2-receptors of the mesolimbic and mesocortical systems.

Sedative effect is caused by blockade of adrenoreceptors of the reticular formation of the brain stem; antiemetic effect – blockade of dopamine D2-receptors of the trigger zone of the emetic center; hypothermic effect – blockade of dopamine receptors of the hypothalamus.

Reduces productive symptoms (delusions, hallucinations), automatism. It causes less suppression of motor activity and induces catalepsy to a lesser extent than classical antipsychotics (neuroleptics).

Balanced central antagonism to serotonin and dopamine may reduce the risk of extrapyramidal symptoms.

Risperidone may cause a dose-dependent increase in plasma prolactin concentrations.

Pharmacokinetics

When taken orally, risperidone is completely absorbed (regardless of food intake) and maximum plasma concentrations are observed after 1-2 hours.

Risperidone is metabolized by cytochrome P-450 IID6 to form 9-hydroxy-risperidone, which has a similar pharmacological effect. Risperidone and 9-hydroxy-risperidone represent an effective antipsychotic fraction. Further metabolism of risperidone involves N-dealkylation. When taken orally, risperidone is eliminated with a half-life of about 3 hours. The half-life of 9-hydroxy-risperidone and the active antipsychotic fraction was found to be 24 hours.

In most patients, the steady-state concentration of risperidone is observed one day after the start of treatment. In most cases, the equilibrium state of 9-hydroxy-risperidone is reached 3-4 days after the start of treatment. The concentration of risperidone in plasma 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 bound to albumin and acidic alpha-1-glycoprotein. The fraction of risperidone that is bound by plasma protein is 88% and 77%, respectively, in the case of 9-hydroxy-risperidone.

Excreted by the kidneys-70% (including 35-45% in the form of a pharmacologically active fraction) and 14% with bile. With a single dose, high levels of active plasma concentrations and slow elimination are observed in elderly patients and patients with insufficient renal function.

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 violence), with disorders of mental activity (agitation, delirium) or psychotic symptoms. – As an adjunct therapy in the treatment of mania in bipolar disorders. – As an adjunctive 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 leading in the clinical picture of the disease.

Use during pregnancy and lactation

The safety of using 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, discontinuation of breast-feeding should be considered if it is necessary to use the drug during lactation.

Contraindications

– Lactation period. – Children and adolescents under 15 years of age (efficacy and safety have not been established). – Hypersensitivity to the components of the drug.

With caution, the drug should be used in diseases of the cardiovascular system (chronic heart failure, myocardial infarction, cardiac muscle conduction disorders), dehydration and hypovolemia, impaired cerebral circulation, Parkinson’s disease, convulsions (including in the anamnesis), severe renal or hepatic insufficiency, drug abuse or drug dependence, conditions predisposing to the development of tachycardia of the “pirouette” type (bradycardia, impaired blood flow). electrolyte balance, concomitant use of medications that prolong the QT interval), brain tumors, intestinal obstruction, cases of acute drug overdose, Reye’s syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions).

Side effects

Nervous system disorders: insomnia, agitation, anxiety, headache, sometimes drowsiness, increased 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 secretion of antidiuretic hormone), tardive dyskinesia (involuntary rhythmic movements mainly of the tongue and/or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomous functions, impaired consciousness and increased creatine phosphokinase levels), thermoregulation disorders and epileptic seizures.

From 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.

From the cardiovascular system: sometimes orthostatic hypotension, reflex tachycardia or increased blood pressure.

Hematopoietic disorders: neutropenia, thrombocytopenia.

From the endocrine system: galactorrhea, gynecomastia, menstrual disorders, amenorrhea, weight gain, hyperglycemia and exacerbation of pre-existing diabetes mellitus.

From the genitourinary system: priapism, erectile dysfunction, ejaculation disorder, anorgasmia, urinary incontinence.

Allergic reactions: rhinitis, rash, angioedema, photosensitization.

From the skin: dry skin, hyperpigmentation, itching, seborrhea.

Other: arthralgia.

Interaction

Since risperidone primarily affects the central nervous system, it should be used with caution in combination with other centrally acting drugs and ethanol. Risperidone reduces the effectiveness of levodopa and other dopamine agonists. Clozapine reduces the clearance of risperidone.

When using carbamazepine, a decrease in the concentration of the active antipsychotic fraction of risperidone in plasma was noted. Similar effects can be observed with the use of other inducers of liver enzymes. Phenothiazines, tricyclic antidepressants, and certain A-blockers may increase plasma concentrations of risperidone, but this does not affect the concentration of the active antipsychotic fraction.

Fluoxetine may increase the plasma concentration of risperidone, but to a lesser extent the concentration of the active antipsychotic fraction, so risperidone doses should be adjusted.

When risperidone is co-administered with 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.

How to take, course of administration and dosage

of Schizophrenia.

Adults and children over 15 years of age. Risperidone can be given 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 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 increase in the dose and lower initial and maintenance doses may be justified.

Doses higher than 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 doses above 16 mg per 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.

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 twice daily is recommended. This dose can be gradually 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 twice daily 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, no more than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, some patients are shown to take 1 mg 2 times a day.

When the optimal dose is reached, it may be recommended to take the drug once a day.

Mania in bipolar disorders

The recommended starting dose of Torendo is 2 mg per day in one dose. If necessary, this dose can be increased by 2 mg per day, no more than every other day. For most patients, the optimal dose is 2-6 mg per day. Behavioral disorders in patients with intellectual disability

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 in the dose to 1.5 mg per day.

Patients weighing less than 50 kg – The recommended initial dose of Torendo 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, some patients prefer to take 0.25 mg per day, while others need to increase the dose to 0.75 mg per day.

Long-term use of Risperidone in adolescents should be carried out under the constant supervision of a doctor. Use in children under 15 years of age is not recommended.

Overdose

Symptoms: drowsiness, sedation, depression of consciousness, tachycardia, hypotension, extrapyramidal disorders, in rare cases prolongation of the QT interval.

Treatment: it is necessary to ensure free airway patency 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 body functions. For timely diagnosis of possible cardiac arrhythmias, it is necessary to start ECG monitoring as soon as possible. Careful medical monitoring and ECG monitoring are performed until the symptoms of intoxication completely disappear. There is no specific antidote.

Special instructions

In patients with schizophrenia, it is recommended to gradually cancel the previous therapy at the beginning of treatment with risperidone, if this is clinically justified. If patients are being transferred from therapy with depo-forms of antipsychotic drugs, it is recommended to start using risperidone instead of the next scheduled injection.

Periodically, the need to continue therapy with anti-Parkinsonian drugs should be evaluated. Orthostatic hypotension may occur due to the A-adrenoblocking effect of risperidone, especially during the initial dose selection period. If hypotension occurs, a dose reduction should be considered. In patients with diseases of the cardiovascular system, as well as with dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually, according to the recommendations. The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia.

If signs and symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered. If a neuroleptic malignant syndrome occurs, characterized by hypertension, muscle rigidity, instability of autonomous functions, impaired consciousness, and increased CPK levels, all antipsychotic medications, including risperidone, should be discontinued.

When carbamazepine and other inducers of liver enzymes are discontinued, the risperidone dose should be reduced. Patients should refrain from overeating due to the possibility of weight gain.

The use of the drug in children under 15 years of age is not recommended.

During treatment, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as well as from taking alcohol (ethanol).

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Risperidone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Schizophrenia, Psychiatric disorders, Alzheimer’s disease, Manic-depressive psychosis