Torendo kutab instructions for use. Maxicold tablets. Instructions for use. Interaction with other drugs

Some facts about the product:

Instructions for use

Price in online pharmacy website: from 302

Some facts

The active component of the drug is risperidone. It belongs to the group of antipsychotic drugs and is a benzisoxazole derivative. His chemical formula consists of twenty-three carbon molecules, twenty-seven hydrogen molecules, one fluorine molecule, four nitrogen molecules and two oxygen molecules.

Torendo Ku-tab is used in the symptomatic treatment of polymorphic mental disorder, including acute psychosis and chronic schizophrenia.

Pharmacological properties

Torendo Ku-tab exhibits antipsychotic effects. It is an antagonist of D2 receptors. The medicine is effective in the treatment of relapses and the treatment of behavioral disorders. The drug is used to treat mental illnesses that manifest themselves in the form of aggression, hallucinations, social withdrawal and thought disorders. The medicine is well tolerated by organisms without serious consequences. The active substance is able to bind to one or more receptors at once, such a connection helps in the treatment of schizophrenia. After use, the medicine enters the digestive tract where it undergoes metabolic processes. The first metabolic process begins in the hepatic system. The liver absorbs the medication well. The drug is easily absorbed, the maximum concentration of the drug occurs after two hours. Decomposition products are easily removed from the body. They have little activity and no pharmacological significance. Medicine is excreted from the body only in the form of breakdown products. The minimum half-life is twenty-four hours. The main part is excreted in feces and bile, a small amount is excreted in urine. The concentration of the drug in people with liver pathology remains normal.

Composition and release form

Torendo Ku-tab is available in the form of sublingual tablets. The dose is 0.5 milligrams, one or two milligrams. The composition includes the active component risperidone and auxiliary components. The dosage of risperidone is 0.5 or 1 or 2 milligrams. The medicine is packaged in a box with instructions for use, the number of tablets is thirty.

Indications for use

Indications Torendo Qu-tab is a treatment mental disorders. The medicine is indicated for acute and chronic schizophrenia, affective disorders, behavioral disorders, disorders with increased aggression and anger, and a tendency to violence. Prescribed to patients with delusional ideas and for the treatment of mania. Can be used for the treatment of adults with intellectual disabilities, and children over fifteen years of age with behavioral disorders.

Side effects

Side effects of Torendo Ku-tab manifest themselves in the form of the following disorders: the appearance of drowsiness and sleep disturbances, trembling of the hands, dizziness, decreased performance, the appearance of confused consciousness, increased panic disorders. Undesirable effects may affect the organs of vision and impair clarity. Some people experience weight gain and increased appetite. Rarely, muscle soreness and urinary disturbances, including urinary retention, occur. On the part of the reproductive system, there is a violation of sexual desire, a decrease in the amount of seminal fluid, and the appearance of discharge in the mammary glands (like colostrum). The medicine may have an adverse effect on gastrointestinal tract. Nausea, increased sweating, decreased appetite, constipation and liver pain occur. There is a decrease in platelets in the blood. Some patients experience allergies when they start taking it. It manifests itself in the form of rashes on the skin, redness, and itching. In some cases, prolonged allergies can trigger Quincke's edema. When the first signs of a change in general health or obvious symptoms appear side effect you need to seek help from your doctor.

Contraindications

Contraindications for the tablets are as follows: pregnancy and lactation, children under fifteen years of age, increased sensitization or allergies, mania in children under eighteen years of age, schizophrenia in children under eighteen years of age, affective disorders in children under fifteen years of age.

Use during pregnancy

The use of antipsychotic drugs during pregnancy is not recommended. The active substance easily penetrates the placental barrier and affects the growth and development of the unborn baby. You should not take pills during lactation. The medicine passes into breast milk. Therefore, during therapy, you should discuss the issue of stopping lactation with your doctor.

Method and features of application

The drug is sublingual (taking the medication by placing it under or on the tongue). The tablet has a brittle structure, so you need to print the medicine out of the foil, following the instructions on the package. The tablet is placed on the tongue and dissolves in a couple of minutes and is swallowed. The medicine can be washed down with water, but it is not recommended to take it with food. Food affects pharmacological properties. The duration of use and additional information about the medication are determined by the attending physician.

Alcohol compatibility

Interaction with other drugs

The medicine is not compatible with all medications. The medicine reduces the effectiveness of dopamine agonists. Carbamezepine and clozapine reduce the concentration of the active substance in the blood plasma. Inducers of liver enzymes reduce the bioavailability and concentration of the drug. And fluoxetine increases drug concentrations in plasma. If two drugs that are maximally bound to plasma proteins are used simultaneously, then the drugs do not displace each other and do not affect the binding to proteins. The medicine, while taking antihypertensive drugs, lowers blood pressure; adjustment of antihypertensive therapy is required. Cimetidine increases the concentration of the drug, but does not improve the pharmacological properties. It is not advisable to combine the drug with antiarrhythmic or other antipsychotic drugs; if the combination is unavoidable, monitoring of the blood condition is required. It is undesirable to combine the active component with diuretics; they reduce the level of potassium in the blood and lead to disruption of the heart. If the patient is seen by another doctor in addition to the psychiatrist, then it is required to inform the psychiatrist about all medications taken.

Overdose

If the dosage or instructions for use are violated, an overdose may occur. It manifests itself in the form of drowsiness, impaired consciousness, decreased breathing and heart rate, changes in blood pressure, nausea and indigestion. If an overdose occurs, the patient needs to seek help from a doctor. The doctor will prescribe symptomatic therapy. Therapy includes gastric lavage, administration of absorbents, and laxatives. In severe cases, therapy is prescribed to maintain vital functions.

Analogues

Torendo Ku-tab has several analogues, the constituent components of which are also risperidone. These are Rispolept, Leptinorm, Rezalen, Speridan. Medicines are used for the treatment of mental disorders only on the recommendation of a doctor.

Terms of sale

Torendo Ku-tab is available for sale by prescription.

Storage conditions

Torendo Ku-tab is stored at a temperature of no higher than thirty degrees in a place protected from children. The medicine retains its beneficial pharmacological properties for thirty-six months. After the shelf life has expired, the medicine must not be used.

Drug: TORENDO® KU-TAB
Active substance of the drug: risperidone
ATX encoding: N05AX08
CFG: Antipsychotic drug (neuroleptic)
Registration number: LS-002602
Registration date: 12/29/06
Owner reg. cert.: KRKA d.d. (Slovenia)

Torendo ku-tab release form, drug packaging and composition.

Lozenges are round, biconvex, light pink in color with visible inclusions.

1 tab.
risperidone
500 mcg
-«-
1 mg
-«-
2 mg

Excipients: mannitol, basic butyl methacrylate copolymer, povidone, microcrystalline cellulose, hyprolose (low-substituted hydroxypropylcellulose LH-21), aspartame, crospovidone, red iron oxide (E172), mint and menthol flavoring, calcium silicate, magnesium stearate.

10 pieces. - blisters (3) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Torendo ku-tab

Antipsychotic drug (neuroleptic).

Risperidone is a selective monoaminergic antagonist with pronounced affinity for serotonergic 5-HT2 receptors and dopaminergic D2 receptors, also binds to 1-adrenergic receptors and, with slightly lower affinity, to H1-histamine and 2-adrenergic receptors. Does not have tropism for cholinergic receptors. It also has a sedative, antiemetic and hypothermic effect.

The antipsychotic effect is due to the blockade of dopamine D2 receptors in the mesolimbic and mesocortical systems.

The sedative effect is due to the blockade of adrenergic receptors in the reticular formation of the brain stem.

The antiemetic effect is due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

The hypothermic effect is due to the blockade of dopamine receptors in the hypothalamus.

Reduces productive symptoms (delusions, hallucinations), automatism. Causes less suppression of motor activity and induces catalepsy to a lesser extent 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 concentrations.

Pharmacokinetics of the drug.

Suction

When taken orally, risperidone is completely absorbed (regardless of food intake) and Cmax in blood plasma is observed after 1-2 hours.

Distribution

The concentration of risperidone in plasma is proportional to the dose of the drug (within therapeutic doses).

Risperidone is rapidly distributed in the body. Vd is 1-2 l/kg. In plasma, risperidone binds to albumin and acidic -1-glycoprotein. The fractions of risperidone and 9-hydroxy-risperidone bound by plasma proteins are 88% and 77%, respectively.

Metabolism

Risperidone is metabolized by the cytochrome P450 IID6 isoenzyme to form 9-hydroxy-risperidone, which has a similar pharmacological effect.

Risperidone and 9-hydroxy-risperidone are an effective antipsychotic fraction. Further metabolism of risperidone involves N-dealkylation. When taken orally, risperidone is eliminated with a T1/2 of about 3 hours. T1/2 of 9-hydroxy-risperidone and the active antipsychotic fraction is 24 hours.

In most patients, CSS of risperidone is observed 1 day after the start of treatment. Css of 9-hydroxy-risperidone is in most cases achieved 3-4 days after the start of treatment.

Removal

70% is excreted in urine (of which 35-45% is in the form of a pharmacologically active fraction) and 14% in bile.

Pharmacokinetics of the drug.

in special clinical cases

In elderly patients or patients with insufficient renal function, high concentration levels are observed with a single dose of the drug. active substances in plasma and their slow elimination.

Indications for use:

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), mental disorders (agitation, delirium) or psychotic symptoms;

As an adjuvant therapy in the treatment of mania in bipolar disorders;

As an adjuvant therapy for behavioral disorders in adolescents over 15 years of age and in adult patients with reduced intellectual level or delay mental development, in cases where destructive behavior (aggression, impulsivity, auto-aggression) is leading in the clinical picture of the disease.

Dosage and method of administration of the drug.

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 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

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 per 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.

Side effects of Torendo ku-tab:

From the central nervous system and peripheral nervous system: 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 (due to polydipsia or syndrome of inappropriate secretion of antidiuretic hormone), 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 CPK levels), thermoregulation disorders and epileptic seizures.

From the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of liver transaminases, dry mouth, hyposalivation or hypersalivation, anorexia and/or increased appetite, increased or decreased body weight.

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

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

From the outside reproductive system: priapism, erectile dysfunction, ejaculation disorder, anorgasmia.

From the hematopoietic system: neutropenia, thrombocytopenia.

Dermatological reactions: dry skin, hyperpigmentation, itching, seborrhea.

Allergic reactions: rhinitis, rash, angioedema, photosensitivity.

Other: arthralgia, urinary incontinence.

Contraindications to the drug:

Lactation period;

Children and adolescents up to 15 years of age (efficacy and safety have not been established);

Hypersensitivity to the components of the drug.

The drug should be used with caution in diseases of the cardiovascular system (chronic heart failure, previous myocardial infarction, conduction disorders of the heart muscle), dehydration and hypovolemia, cerebrovascular accident, Parkinson's disease, seizures (including a history), renal or severe liver failure, drug abuse or drug dependence, conditions predisposing to the development of pirouette-type tachycardia (bradycardia, electrolyte imbalance, concomitant use medicines, prolonging 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).

Use during 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 expected benefit to the mother outweighs the potential risk to the fetus.

Since risperidone and 9-hydroxy-risperidone are excreted in breast milk, if it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be considered.

Special instructions for the use of Torendo ku-tab.

In schizophrenia, when starting treatment with risperidone, it is recommended to gradually withdraw previous therapy if clinically justified. If patients are transitioning from depot antipsychotic therapy, it is recommended that risperidone be started instead of the next scheduled injection. The need for continued therapy with antiparkinsonian drugs should be periodically assessed.

Due to the β-adrenergic blocking effect of risperidone, orthostatic hypotension may occur, especially during the initial dose titration 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, as recommended.

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.

When a neuroleptic malignant syndrome characterized by hypertension, muscle rigidity, instability of autonomic functions, impaired consciousness and increased CPK levels, all antipsychotic drugs, including risperidone, should be discontinued.

When carbamazepine and other liver enzyme inducers are discontinued, the dose of risperidone should be reduced.

Patients should refrain from overeating due to the possibility of weight gain.

Use in pediatrics

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

Impact on the ability to drive vehicles and operate machinery

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

Drug 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 administration activated carbon 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.

Interaction of Torendo ku-tab with other drugs.

Since risperidone acts primarily on 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 observed. Similar effects may be observed with other liver 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 may increase the plasma concentration of risperidone, but to a lesser extent the concentration of the active antipsychotic fraction, so the dose of risperidone should be adjusted.

When risperidone is used simultaneously with drugs that are highly bound to plasma proteins, no clinically significant displacement of any drug from the plasma protein fraction is observed.

Antihypertensive drugs increase the severity of the decrease in blood pressure caused by risperidone.

Terms of sale in pharmacies.

The drug is available with a prescription.

Storage conditions for the drug Torendo ku-tab.

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 2 years.

Instructions for use describe cough tablets as drugs that suppress the cough reflex, dilute bronchial secretions (mucolytics/secretolytics), drugs that activate the ciliated epithelium of the bronchi and promote the discharge of sputum (expectorants/secretomotor drugs).

Additionally, these drugs may have anti-inflammatory, antibacterial or emollient effects. The drugs can be roughly divided:

according to the effect it provides (emollients, expectorants, sputum thinners, antitussives, etc.), often one drug has a whole range of therapeutic qualities;
according to the ability to fight different types of cough (used both for non-productive cough and for cough with viscous sputum, for wet cough with copious secretions or allergic cough);
according to the form (soluble “fizzy” tablets, sucking cough tablets, for oral administration).

Each version of cough tablets is described in the instructions taking into account age indications, the possibility of taking by pregnant women, dosing rules and duration of therapy. In addition to these drug options, there are also combination drugs. They are the ones most often used in practice.

Choosing the right cough medicine

Good cough tablets are not always an expensive drug. When choosing a medication for treatment, you need to focus primarily not on its cost, but on the characteristics of the cough: productive (with sputum) or unproductive (dry).

In this case, the quality of sputum is also an important criterion:

viscous, difficult-to-separate sputum requires liquefaction and assistance with discharge;
the abundant secretion must be helped to remove the ciliated epithelium from the respiratory tract;
a dry, painful cough requires the use of drugs that stop it.

According to this principle, all tablets can be divided into 2 large groups: antitussives and others that do not suppress cough.

Non-cough suppressants include:

secretolytics/mucolitis - that is, thinning sputum;
secretomotor drugs that promote its discharge;
bronchodilators - this group of medications works against bronchospasm, expanding the lumen of the bronchi, thanks to which sputum (viscous/thick/thin) is eliminated easier and faster.

Attention: remember that it is strictly not recommended to take drugs from different pharmacological groups at the same time, classifying them as “cough tablets”! Let's take a closer look at what cough tablets are: the composition of drugs, the rules for their use and the pricing policy of pharmacies.

Advantages of dosage forms

The advantages of sucking/chewing products include a variety of tastes. Cough lozenges have a lot in common with lollipops and are easy to offer to children. Most products can be absorbed every 2 hours. This allows you to effectively and quickly relieve the condition. This group includes such popular products as (Sage, Doctor MOM, Lazolvan, Alex-Plus, Bronchicum, Hexoral Tabs), made in the form of lozenges.

Effervescent tablets, for example, ACC, are no more effective than their film-coated counterparts. But they are more interesting to offer to children and they begin to act faster. Therefore, in the subjective perception of the patient, these medications seem more “advanced” and effective.

How to take cough tablets depends on the form of the drug. Effervescent tablets are dissolved in water and drunk, lozenges are dissolved, film-coated pills are swallowed and washed down with water. Most medications are taken either before meals or regardless of meals.

Antitussives

This group of medications works well if the patient has a dry, painful cough. They are especially valuable for coughs of an allergic nature with bronchospasm.

Tablets for dry cough are indicated for adults. This means that the drugs in this group, with the exception of the drug Bromhexine and some sucking lozenges (Alex Plus), are usually not prescribed to children under 7-10 years of age.

Mechanism of action

Medicines that suppress cough affect:

on the cough center in the brain (central action), for example Codeine, Dextromethorphan;
or block the transmission of nerve impulses to the muscles involved in the coughing act (peripheral action, for example, Levodronpropizine).

These medications do not fight the cause of the cough. They suppress the cough reflex, the person stops coughing, but the disease develops as before.

Kinds

These are symptomatic treatments prescribed for an exhausting, non-productive cough. They are divided into:

Narcotic. This group includes, like Codeine (Nurofen Plus, Tercodin, Codelac), as well as Demorphan, Morphine and Hydrocodone. The drugs cost from 87 rubles and above.
Non-narcotic. This includes Butamirate, Oxeladin (in citrate form) and others.

The first group is the most effective, but is addictive and a large amount side effects. These drugs are allowed to be taken for no more than one week in a row. For cough, tablets of this category can be prescribed for adults; they are not recommended for children.

The narcotic group is effective, but it is addictive and has a large number of side effects (Demorphan, Morphine, Hydrocodone, Nurofen Plus) and is not recommended for children.

The second group can also cope with dry cough quite effectively. These medications can be taken over long time. The most famous drug from this group is Libexin. But it’s hard to call it cheap. The medicine costs about 450-500 rubles.

It is convenient to use dissolving cough tablets (or rather lozenges) for children and adults.

Application

Drugs in this group are prescribed to suppress the cough reflex when:

BA (asthma);
bronchospasm;
allergic cough;
emphysema;
inflammatory processes in the pleura.

For respiratory infections bacterial and viral nature(for example, with scarlet fever and whooping cough) in the acute period of the disease, when sputum is not yet produced, and a sharp, hacking cough literally tears the airways, making it difficult to rest, these drugs can also be prescribed. But in this case it is better to choose non-narcotic drugs.

List of medications

Among the inexpensive but effective tablets for dry cough, one can highlight centrally acting drugs that are not related to drugs: Bromhexine from 15 rubles, Glaucine, Bronholitin, Caffetin Cold, Codelac Neo (costing about 100-150 rubles).

Non-peripheral drugs are effective, but not cheap and cost from 450 rubles. Drugs with a central mechanism of action (Codeine, Codterpine, Codelac) cost about 200-300 rubles.

Attention: the drugs Codelac Neo and Codelac Broncho are not narcotic!

Secretolytics, secretomotor drugs and bronchodilators

If the cough is wet, you need drugs that can dilute the secretions and help remove them from the respiratory system. At the same time, they should not suppress the cough reflex, or this effect should be mild. This group includes a huge list of medications that differ in origin (natural/artificial) and pharmacological characteristics. There are medications:

reflex action;
resorptive;
mucolytics;
bronchodilators.

Each of the presented options involves one of the mechanisms for the production and release of secretions from the bronchial mucosa.

Reflex remedies

This type includes many herbal remedies (thyme, licorice, ivy, marshmallow, plantain, thermopsis, wild rosemary, cyanosis, coltsfoot, violet, istod, elecampane, pine) and drugs of artificial origin (Guaifenesin). These drugs irritate the mucous lining of the gastrointestinal tract, the cough center in the brain, and reflexively stimulate an increase in the production of bronchial secretions.

This group of remedies includes many cough tablets that are inexpensive but effective. First of all, these are cough tablets with thermopsis (tableted herbal extract, Thermopsol), as well as.

Mucaltin is a remedy with marshmallow root. Such tablets cost up to 10 rubles. Not prohibited for expectant mothers carrying a baby and children of an age when they can take the pill. The medicine is taken 20 minutes before meals, three times a day, 1-2 pieces.

Thermopsol - cough tablets containing soda and thermopsis. Taken orally three times a day. A course of 3-5 days. Allowed for pregnant women. These tablets cost about 30 rubles.

Effective cough tablets can be bought a little more expensive in the range of 90-150 rubles:

Doctor MOM (lozenges);
Fitolor;
Travesil.

All these products contain licorice rhizome. Medicines with thyme/thyme are a little more expensive. They cost from 200 rubles (Gelomirtol, Bronchopret). Cough lozenges with sage are easy to use. They cost about 200 rubles. They can be absorbed by children from 5 years old, but they are not recommended for pregnant women.

Directly affecting bronchial receptors

Resorptive, having a direct effect on the receptors of the lining of the bronchi (soda, potassium iodide).

These medications in tablet form are used independently quite rarely (Amtersol, Sodium bicarbonate 0.25 grams). More often they are used in combination with reflex drugs (Thermopsol).

Today, there is no urgent need for resorptive agents. Pharmacies are stocked with cough tablets that are inexpensive and quite effective, made from herbal raw materials, with a minimum set of contraindications.

Mucus thinners

These are synthetic drugs developed on the basis of 2 active substances: acetylcestine and carbocysteine.

And agents that activate the production of pulmonary surfactant: Bromhexine and Ambroxol.

This group includes proteolytics Trypsin, Ribonuclease, Chymotrypsin, sulfur-containing compounds and derivatives of plant matter (visicin), which destroy sputum protein and its mucopolysaccharide chains. These same substances stimulate the cilia of the epithelium of the respiratory tract to work more actively, removing secretions.

From this group you can purchase cough tablets for at least 100-400 rubles and more:

ACC for 288 rubles, Vicks - 135 rubles, Fluimucil - 144 rubles (based on acetylcesteine);
Fluifort - 307 rubles, Fluditek - 350 rubles (based on carbocisteine).
Ambrobene - 148 rubles, Flavamed - 150 rubles, -170 rubles (based on ambroxol).

Cheap cough tablets from this series are Ambroxol itself for 22 rubles, Bronchorus for 17 rubles and the already mentioned Bromhexine for 15 rubles.

Bronchodilators

These drugs are good for the treatment of spasmodic cough paroxysms. It is effective to drink them for allergic cough and bronchial asthma. These drugs will also help with bronchial obstruction, thanks to their ability to fight bronchospasm. In this series, cough tablets are inexpensive:

Eufillin - from 9 rubles;
Salbutamol from 71 rub.

Berodual and Berotek cost a little more, starting from 270 rubles.

Application

Tablets for dry cough for adults can be recommended from any group, from Bromhexine to Codeine (with the exception of pregnant women). Provided that the cough is without sputum, or accompanies allergies or asthma.

If the cough is severe, tormenting, and little sputum is produced, products from the ACC, Ambroxol, Solvin series will be suitable.

If the cough is wet, secretions literally “squish” in the bronchi, you will need soda, Thermopsis or Mucaltin preparations. The reviews for these cough tablets are positive, although they are the simplest and cheapest remedies. They, as they say, have been tested for centuries. Even for young children, experienced pediatricians recommend purchasing a drug called “Cough Tablets” and dividing them into several parts. Depending on the age of the baby.

Find out from the video a proven excellent remedy with which you can cure a dry and chronic cough. To prepare a simple medicine, it will be enough baking soda, milk, and natural honey.

Cough tablets - official instructions for use

Check out another effective, inexpensive cough remedy that will cost you a minimum of time and money to prepare.

Popular questions on the topic

Are there cough tablets for pregnant women? Unfortunately, no one has developed special medications for patients in this category. There are no direct prohibitions on taking medications in the annotation for:

Mukaltin;
drugs containing guaifenesil and/or dextromethorphan are prescribed with caution (Tussin Plus)
Bromhexine and its analogues can be prescribed if, in the eyes of the doctor, the benefits for the expectant mother “outweigh” the likely harm to her baby.

Do not take cough pills on your own during pregnancy, even if you think they are harmless. Consult a specialist.

What are some good cough tablets? Medicine does not operate with such concepts. She classifies drugs as effective and not, with the presence large quantity there are no side effects. The choice of medication is based on the patient's condition.

How to take cough tablets? According to the annotation for a specific drug. Most often, you can take the medicine regardless of food intake.

The information presented above is provided for informational purposes only. Before taking any medications, consult your doctor.

Zalasta Ku-tab
Buy Zalasta Qu-tab in pharmacies
Zalasta Ku-tab in the medicine directory

DOSAGE FORMS
lozenges 10 mg

MANUFACTURERS
Krka Polska Sp.zo.o (Poland)

GROUP
Neuroleptics - dibenzodiazepine derivatives

COMPOUND
The active substance is olanzapine.

INTERNATIONAL NON-PROPENTED NAME
Olanzapine

SYNONYMS
Zalasta, Zyprexa, Zyprexa Zidis, Olanzapin-Teva, Parnasan, Egolanza

PHARMACHOLOGIC EFFECT
Antipsychotic drug (neuroleptic) with a wide pharmacological spectrum of action. The antipsychotic effect is due to the blockade of dopamine D2 receptors of the mesolimbic and mesocortical systems; sedative effect - blockade of adrenergic receptors of the reticular formation of the brain stem; antiemetic effect - blockade of dopamine D2 receptors in the trigger zone of the vomiting center; hypothermic effect - blockade of dopamine receptors of the hypothalamus. In addition, it affects muscarinic, adrenergic, histamine H1 receptors and some subclasses of serotonin receptors. Reduces productive (delusions, hallucinations) and negative symptoms (hostility, suspicion, emotional and social autism) of psychosis. Rarely causes extrapyramidal disorders. Absorption of the active substance is high and does not depend on food intake. Tmax in blood plasma after oral administration is 5-8 hours. Metabolized in the liver, no active metabolites are formed, the main circulating metabolite is a glucuronide, does not penetrate the BBB. It is excreted mainly by the kidneys (60%) in the form of metabolites. Smoking, gender and age affect half-life and plasma clearance. In persons over 65 years of age - 51.8 hours and plasma clearance - 17.5 l/h, in persons under 65 years of age - 33.8 hours and plasma clearance - 18.2 l/h.

INDICATIONS FOR USE
For the treatment of schizophrenia (the drug effectively supports the improvement of clinical symptoms with long-term treatment in patients with an initial positive reaction to the drug); for the treatment of moderate or severe episodes of mania; for the prevention of relapses of mania in bipolar disorder (in patients with manic episodes with a good effect of therapy).

CONTRAINDICATIONS
Angle-closure glaucoma; children under 18 years of age (efficacy and safety have not been established); lactation period; galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption; hypersensitivity to olanzapine or other components of the drug. With caution: renal failure, liver failure, prostatic hyperplasia, paralytic ileus, epilepsy, history of convulsive syndrome, leukopenia and/or neutropenia of various origins, myelosuppression of various origins, incl. myeloproliferative diseases, hypereosinophilic syndrome, cardiovascular and cerebrovascular diseases or other conditions predisposing to hypotension, congenital prolongation of the QT interval on the ECG (increased QTc on the ECG), or in the presence of conditions that can potentially cause prolongation of the QT interval (for example, concomitant use of drugs prolonging the QT interval, congestive heart failure, hypokalemia, hypomagnesemia), old age, as well as concomitant use of other centrally acting drugs; immobilization, pregnancy.

SIDE EFFECT
From the central nervous system and peripheral nervous system: very often - drowsiness; often - dizziness, akathisia, parkinsonism, dyskinesia; rarely - convulsive syndrome (usually against the background of a history of convulsive syndrome); very rarely - malignant neuroleptic syndrome , dystonia (including oculogyric crisis) and tardive dyskinesia. When olanzapine is abruptly discontinued, symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting are very rarely observed. From the cardiovascular system: often - arterial hypotension (including orthostatic); infrequently - bradycardia with or without collapse; very rarely - an increase in the QTc interval on the ECG, ventricular tachycardia/fibrillation and sudden death, thromboembolism (including pulmonary embolism and deep vein thrombosis). From the digestive system: often - transient anticholinergic effects, incl. constipation and dry mouth, transient, asymptomatic increase in the level of liver transaminases (ALT, AST), especially at the beginning of treatment; rarely - hepatitis (including hepatocellular, cholestatic or mixed liver damage); very rarely - pancreatitis, increased levels of alkaline phosphatase and total bilirubin. Metabolism: very often - weight gain; often - increased appetite; very rarely - hyperglycemia and/or decompensation of diabetes mellitus, sometimes manifested by ketoacidosis or coma, including fatal outcome; hypertriglyceridemia, hypercholesterolemia, hypothermia. From the hematopoietic organs: often - eosinophilia; rarely - leukopenia; very rarely - thrombocytopenia, neutropenia. From the musculoskeletal system: very rarely - rhabdomyolysis. From the genitourinary system: very rarely - urinary retention, priapism. From the skin and subcutaneous tissue: rarely - photosensitivity reactions. Allergic reactions: rarely - skin rash; very rarely - anaphylactoid reactions, angioedema, itching or urticaria. Other: often - asthenia, peripheral edema; very rarely - alopecia. Laboratory indicators: very often - hyperprolactinemia, but clinical manifestations (for example, gynecomastia, galactorrhea and breast enlargement) are rare. In most patients, prolactin levels spontaneously normalized without discontinuation of therapy. Uncommon: increased levels of creatine phosphokinase (CPK). In older patients with dementia, studies have shown a higher incidence of death and cerebrovascular events (stroke, transient ischemic attacks). Very often, this category of patients experienced gait disturbances and falls. Pneumonia, fever, lethargy, erythema, visual hallucinations, and urinary incontinence were also common. Among patients with drug-induced (while taking dopamine agonists) psychoses associated with Parkinson's disease, worsening of parkinsonian symptoms and the development of hallucinations were often recorded. There is evidence of the development of neutropenia (4.1%) during combination therapy with valproic acid in patients with bipolar mania. Long-term therapy (up to 12 months) to prevent relapses in patients with bipolar disorder was accompanied by an increase in body weight.

INTERACTION
Metabolized by the enzyme CYP1A2, therefore inhibitors or inducers of cytochrome P450 isoenzymes that exhibit specific activity against CYP1A2 may affect the pharmacokinetic parameters of olanzapine. CYP1A2 inducers: The clearance of olanzapine may be increased in patients who smoke or when taking carbamazepine concomitantly, resulting in decreased plasma concentrations. Clinical observation is recommended because some cases require increasing the dose of the drug. CYP1A2 inhibitors: fluvoxamine, a specific CYP1A2 inhibitor, significantly reduces clearance. The average increase in maximum concentration after taking fluvoxamine in non-smoking women was 54%, and in smoking men - 77%. The average increase in AUC in these patient categories was 52% and 108%, respectively. In patients taking fluvoxamine or any other CYP1A2 inhibitor (eg, ciprofloxacin), it is recommended that olanzapine therapy be initiated at lower doses. A dose reduction may also be required if CYP1A2 inhibitors are added to therapy. Activated charcoal reduces oral absorption by 50-60% and should be taken at least 2 hours before or after dosing. Fluoxetine (a CYP450 inhibitor), single doses of magnesium or aluminum-containing antacids, or cimetidine do not affect the pharmacokinetics of olanzapine. May weaken the effect of direct and indirect dopamine agonists. In vitro, olanzapine does not inhibit major CYP450 isoenzymes (eg, 1A2, 2D6, 2C9, 2C19, 3A4). In vivo, no inhibition of the metabolism of the following active substances was found: tricyclic antidepressants (CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) and diazepam (CYP3A4 and 2C19). No interaction was detected when used simultaneously with lithium or biperiden. Therapeutic monitoring of plasma valproic acid levels showed that no changes in valproic acid doses are required when administered concomitantly with olanzapine. Caution should be exercised when using other centrally acting drugs simultaneously. Although a single dose of alcohol (45 mg/70 kg) does not have a pharmacokinetic effect, taking alcohol with olanzapine may be accompanied by an increased depressive effect on the central nervous system.

METHOD OF APPLICATION AND DOSAGE
The drug is prescribed orally, 1 time per day. For schizophrenia, the recommended initial dose of the drug is 10 mg per day. For episodes of mania, the initial dose is 15 mg in 1 dose with monotherapy or 10 mg as part of combination therapy. To prevent relapses in bipolar disorder, the recommended initial dose of the drug in remission is 10 mg per day. The daily dose of the drug for the treatment of schizophrenia, a manic episode or the prevention of relapses of bipolar disorder can be 5-20 mg, depending on the clinical condition of the patient.

OVERDOSE
Symptoms: very common in 10% are: tachycardia, agitation/aggression, dysarthria, various extrapyramidal symptoms, decreased level of consciousness from lethargy to coma; in less than 2% of cases the following occur: delirium, convulsions, coma, neuroleptic malignant syndrome, respiratory depression, aspiration, increased or decreased blood pressure, cardiac arrhythmias; in very rare cases - cardiopulmonary failure. The minimum dose for an acute overdose with a fatal outcome is 450 mg; the maximum dose for an overdose with a favorable outcome (survival) is 1500 mg. Treatment: There is no specific antidote. It is not recommended to induce vomiting. It is necessary to perform gastric lavage, taking activated charcoal (reduces the bioavailability of olanzapine by 60%), symptomatic treatment under the control of vital functions, including treatment of arterial hypotension and vascular collapse, maintaining respiratory function. The use of epinephrine, dopamine or other sympathomimetics with beta-adrenomimetic activity is not recommended, because the latter can aggravate arterial hypotension. To identify possible arrhythmias, monitoring of cardiovascular activity is necessary. The patient should be under continuous medical supervision until complete recovery.

SPECIAL INSTRUCTIONS
There are very rare reports of the development of hyperglycemia and/or decompensation of diabetes mellitus, sometimes accompanied by the development of ketoacidosis or ketoacidotic coma, incl. there are reports of several fatal cases. In some cases, there was an increase in body weight preceding decompensation, which could become a predisposing factor. In patients with diabetes mellitus and risk factors for the development of this disease, regular clinical monitoring and monitoring of blood glucose levels is recommended. If lipid levels change, therapy adjustments are required. If you abruptly stop taking the drug, very rarely (less than 0.01%) the following symptoms may develop: sweating, insomnia, tremor, anxiety, nausea or vomiting. When discontinuing the drug, a gradual dose reduction is recommended. Since clinical experience with the use of the drug in people with concomitant diseases is limited, the drug should be prescribed with caution to patients with prostatic hyperplasia and paralytic ileus. Experience with the use of olanzapine in patients with psychosis in Parkinson's disease caused by taking dopaminomimetics. Not recommended for the treatment of psychosis in Parkinson's disease caused by dopaminomimetics. Symptoms of parkinsonism and hallucinations increase. At the same time, the effectiveness of treating psychosis was not superior to placebo. Not indicated for the treatment of psychosis and/or behavioral disorders in dementia, due to increased mortality and increased risk of cerebrovascular disorders (stroke, transient ischemic attacks). The increase in mortality is independent of dose or duration of therapy. Risk factors predisposing to increased mortality include: age over 65 years, dysphagia, sedation, malnutrition and dehydration, lung diseases (for example, pneumonia, including aspiration), concomitant use of benzodiazepines. However, the increased incidence of death in the olanzapine groups compared with placebo was independent of these risk factors. With antipsychotic therapy, improvement in the patient's clinical condition occurs within a period of several days to several weeks. During this period, the patient needs careful monitoring. At the beginning of therapy, an asymptomatic increase in liver transaminases (ALT and AST) is possible. In patients with initially increased levels AST and/or ALT, with liver failure and conditions that potentially limit liver function, as well as those taking hepatotoxic drugs, caution should be exercised when prescribing the drug. If ALT and/or AST increase during drug therapy, medical monitoring of the patient and, possibly, a reduction in the dose of the drug are recommended. When diagnosing hepatitis (including hepatocellular, cholestatic or mixed), the drug must be discontinued. The drug should be used with caution in patients with leukopenia and/or neutropenia of any origin, myelosuppression of drug origin, as well as during radiation or chemotherapy, due to concomitant diseases, in patients with hypereosinophilic conditions or myeloproliferative diseases. Neutropenia has often been observed with concomitant use of olanzapine and valproic acid. NMS is a potentially life-threatening condition associated with treatment with antipsychotic drugs (neuroleptics), incl. olanzapine. Clinical manifestations of NMS: fever, muscle rigidity, impaired consciousness, autonomic disorders (unstable pulse or labile arterial pressure, tachycardia, increased sweating, arrhythmias). Additional symptoms of NMS: increased CPK, myoglobinuria (against the background of rhabdomyolysis) and acute renal failure. If symptoms of NMS develop, as well as an increase in body temperature for no apparent reason, it is necessary to discontinue all antipsychotics, incl. olanzapine. It should be used with caution in patients with a history of seizures or the presence of factors that lower the seizure threshold. Seizures were rarely reported while taking olanzapine. Therapy was accompanied by a significantly lower incidence of tardive dyskinesia compared with haloperidol. The risk of developing tardive dyskinesia increases with increasing duration of treatment. If signs of this condition occur in a patient taking olanzapine, the drug should be discontinued or the dose reduced. Symptoms of dyskinesia may temporarily increase after discontinuation of the drug. Caution should be exercised when using other centrally acting drugs and alcohol simultaneously. Postural hypotension is uncommon in older adults. In patients over 65 years of age, it is recommended to periodically monitor blood pressure. Caution should be used in patients with an established increase in the QTc interval, especially the elderly, with congenital long QT syndrome, congestive heart failure, myocardial hypertrophy, hypokalemia and hypomagnesemia. When taking the drug, very rarely (less than 0.01%) cases of venous thromboembolism have been reported. A cause-and-effect relationship between therapy and venous thrombosis has not been established. Because patients with schizophrenia often have acquired risk factors for venous thrombosis, all possible other factors (eg, immobilization) should be identified and preventive measures taken. The tablets contain lactose. The drug should not be taken by patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. Influence on the ability to drive vehicles and operate machinery. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

STORAGE CONDITIONS
The drug should be stored out of the reach of children, at a temperature not exceeding 30 C.

Dosage form: Orally dispersible tablets Compound:

1 tablet, dispersible in the oral cavity, 0.5 mg/1 mg/2 mg contains:

Active substance:

Risperidone 0.50 mg/1.00 mg/2.00 mg

Excipients: mannitol, butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer, povidone-K25, microcrystalline cellulose, low-substituted hyprolose, aspartame, crospovidone, red iron oxide dye (E172), mint flavor 1, menthol flavor 2, calcium silicate, magnesium stearate

1 Mint flavoring: corn maltodextrin, acacia gum, sorbitol, mint oil, levomenthol.

2 Menthol flavoring: corn maltodextrin, flavoring components.

Description:

Round, slightly biconvex tablets, light pink in color with visible inclusions.

Pharmacotherapeutic group:Antipsychotic (neuroleptic) ATX:

N.05.A.X Other antipsychotic drugs

N.05.A.X.08 Risperidone

Pharmacodynamics:

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT 2 and dopamine D 2 receptors. also binds to alpha 1 -adrenergic receptors and, to a lesser extent, to H 1 -histamine and alpha 2 -adrenergic receptors.

Has weak affinity for 5-HT 1 A -, 5-HT 1 C -, 5-HT 1 D - serotonergic, D 1 - dopaminergic receptors and haloperidol-sensitive sigma receptor binding sites, with little affinity for 5-HT 1 B - And 5-HT 3 receptors. Does not have the ability to interact with m-cholinergic and beta 1 -, beta 2 -adrenergic receptors.

Risperidone reduces the productive symptoms of schizophrenia, causes less suppression of motor activity and induces catalepsy to a lesser extent than classical antipsychotics.

Balanced central antagonism to serotonin and dopamine reduces the likelihood of developing extrapyramidal disorders and expands the therapeutic effect of the drug to cover negative and affective symptoms of schizophrenia.

Pharmacokinetics:

Suction

Risperidone is completely absorbed after oral administration, reaching maximum plasma concentrations after 1-2 hours. The absolute bioavailability of risperidone after oral administration is 70%. The relative bioavailability after oral administration of risperidone in tablet form is 94% when compared with risperidone in solution form.

Eating does not affect the absorption of the drug, so it can be used regardless of the time of meal.

The equilibrium concentration of risperidone in the body is achieved within 1 day in most patients. The equilibrium concentration of 9-hydroxyrisperidone is achieved within 4-5 days.

Distribution

Risperidone is rapidly distributed in the body. The volume of distribution is 1-2 l/kg. In blood plasma it binds to albumin and alpha 1-acid glycoprotein. 90% bound to plasma proteins, 9-hydroxyrisperidone - 77%.

Metabolism and excretion

Risperidone is metabolized in the liver with the participation of the CYP 2D 6 isoenzyme. The main metabolite is 9-hydroxyrisperidone, which has similar pharmacological activity to risperidone. and 9-hydroxyrisperidone constitute the active antipsychotic fraction.

The CYP 2D 6 isoenzyme is subject to genetic polymorphism. In patients who are extensive metabolizers of the CYP 2D 6 isoenzyme, this process is rapidly converted to 9-hydroxyrisperidone, while in patients who are poor metabolizers of the CYP 2D 6 isoenzyme, this process occurs much more slowly. Although extensive metabolizers have lower risneridone concentrations and higher 9-hydroxyrisperidone concentrations than poor metabolizers, the pharmacokinetics of the active antipsychotic fraction after single or multiple doses is similar in the two patient groups.

Another route of metabolism for risperidone is N-dealkylation. Research in conditions invitro on human liver microsomes showed that at clinically significant concentrations it does not significantly inhibit metabolism medicines, biotransformed under the influence of isoenzymes of the cytochrome P450 system, including CYP 1A2, CYP 2A 6, CYP 2C 8/9/10, CYP 2D 6, CYP 2E 1, CYP 3A 4 and CYP 3A 5.

A week after starting to take risneridone, 70% of the dose is excreted by the kidneys (while the excretion of risperidone and 9-hydroxyrisneridone by the kidneys is 35-45% of the dose taken, the rest is inactive metabolites) and 14% through the intestines.

After oral administration in patients with psychosis, the half-life (T 1/2) of risperidone is about 3 hours, T 1/2 of 9-hydroxyrisperidone and the active antipsychotic fraction is 24 hours.

Linearity

Plasma concentrations of risperidone are directly proportional to the dose administered over the therapeutic dose range.

Pharmacokinetics in selected patient groups

Elderly patients, patients with impaired liver and kidney function

After a single dose of risperidone in elderly patients, the concentration of the active antipsychotic fraction in the blood plasma increased by an average of 43%, T1/2 by 38%, and clearance decreased by 30%.

In patients with renal failure, an increase in plasma concentration and a decrease in clearance of the active antipsychotic fraction was observed by an average of 60 %.

In patients with hepatic impairment, plasma risperidone concentrations did not change, but the mean free risperidone concentration increased by 35%.

Children

The pharmacokinetics of risperidone, 9-hydroxyrisperidone and the active antipsychotic fraction in children is comparable to that in adult patients.

Gender, race, smoking

Population pharmacokinetic analysis revealed no apparent influence of gender, race, or smoking on the pharmacokinetics of risperidone and the active antipsychotic fraction.

Indications:

- Treatment of schizophrenia in adults and children over 13 years of age.

- Treatment of moderate to severe manic episodes associated with bipolar disorder in adults and children over 10 years of age.

- Short-term (up to 6 weeks) treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia that is not amenable to non-pharmacological treatment and where the patient is at risk of causing harm to himself or others.

- Short-term (up to 6 weeks) symptomatic treatment of persistent aggression in the structure of conduct disorder in children aged 5 years and older with mental retardation diagnosed according to DSM-IV criteria, in which the severity of aggression or other destructive behavior requires drug treatment. Pharmacotherapy should be part of a comprehensive treatment program, including psychological and educational interventions. should be prescribed by a specialist in child neurology and child psychiatry or a physician knowledgeable in the treatment of conduct disorders in children and adolescents.

Contraindications:

- Hypersensitivity to risperidone or any other components of the drug.

- Phenylketonuria.

- Congenital fructose intolerance.

Carefully:

Diseases of the cardiovascular system (chronic heart failure, previous myocardial infarction, cardiac muscle conduction disorders);

Hypotension (dose adjustment required);

Dehydration and hypovolemia;

Cerebrovascular accidents;

Parkinson's disease;

Convulsions (including history);

Severe renal and/or liver failure (see section "Method of administration and dosage");

Drug abuse or drug dependence;

Conditions predisposing to the development of tachycardia of the "pirouette" type (bradycardia, electrolyte imbalance, simultaneous use drugs that prolong the QT interval);

Metabolic disorders, including hyperglycemia, dyslipidemia (patient weight control is required);

Hyperprolactinemia;

Leukopenia, neutropenia, agranulocytosis;

Brain tumor, intestinal obstruction, cases of acute drug overdose, Reis' syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions):

Risk factors for the development of venous thromboembolism;

Diffuse Lewy body disease;

Use in elderly patients with cerebrovascular dementia;

Pregnancy;

Simultaneous use with furosemide.

Pregnancy and lactation:

Pregnancy

There are no controlled studies of the use of risperidone in pregnant women. In animal studies it was not teratogenic, but other types of toxic effects on the reproductive system were observed.

The potential risk of using risperidone in humans is unknown.

When antipsychotics (including risperidone) were used during the third trimester of pregnancy, the newborn developed reversible extrapyramidal symptoms and/or withdrawal symptoms that varied in severity and duration. Cases of agitation, hypertension, hypotension, tremor, somnolence, respiratory distress and malnutrition have been reported. Therefore, newborns should be closely monitored.

The use of Torendo® Ku-tab® during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to discontinue therapy during pregnancy, the drug should be discontinued gradually.

Breastfeeding period

In animal studies, 9-hydroxyrisperidone was excreted into breast milk. It has also been demonstrated that 9-hydroxyrisperidone passes into human breast milk in small quantities. There is no data on the development of side effects in infants with breastfeeding. Therefore, the issue of breastfeeding should be decided taking into account possible risk for a child.

Fertility

Like other drugs that are antagonists of dopamine D 2 receptors, it increases the concentration of prolactin in the blood plasma. Hyperprolactinemia can suppress the secretion of hypothalamic gonadotropin-releasing hormone, which leads to decreased secretion of pituitary gonadotropin. This, in turn, can cause suppression of reproductive function due to impaired steroidogenesis in the gonads in male and female patients. No significant effects were observed in preclinical studies.

Directions for use and dosage:

Torendo® Ku-tab® can be used as an alternative to Torendo® in patients who have difficulty swallowing tablets.

Due to the fact that the tablets are fragile, they should not be squeezed through the foil packaging, as they may break. Do not take the tablet with wet hands, as the tablet may melt.

Remove the tablet as follows:

1.Take the blister, bend it along the tear line and tear it off.

2.Open the blister by carefully pulling the edge of the foil.

3.Carefully shake the tablet into your palm.

4.Then it should be immediately placed on the tongue.

The tablet should be held in the mouth for a few seconds until completely dissolved (to facilitate swallowing), then washed down with liquid. Do not mix the tablet in your mouth with food.

You can also place the tablet in a full glass of water and drink immediately.

Schizophrenia

Adults

The drug Torendo® Ku-tab® can be used 1 or 2 times a day.

The initial dose of Torendo® Qu-tab® 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 increase and lower initial and maintenance doses may be justified.

Doses above 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

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.

Moderate to severe manic episodes associated with bipolar disorder

Adults

The recommended starting dose of Torendo® Ku-tab® is 2 mg once a day. If necessary, this dose can be increased at least after 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 Torendo® Kutab® should be regularly assessed and confirmed.

Elderly patients

The recommended starting 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. Experience in elderly patients is limited and caution should be exercised.

Children from 10 years old

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.

Incessant aggression at patients with moderate to severe Alzheimer's dementia

For most patients, the optimal dose is 0.5 mg 2 times a day. In some patients, however, the effective dose may be 1 mg twice daily.

Torendo® Qu-tab® should not be used for more than 6 weeks for persistent aggression in patients with dementia due to Alzheimer's disease.

During treatment with Torendo® Qu-tab®, frequent and regular assessment of the patient's condition is necessary to decide whether to continue therapy.

Continuous aggression in the structure of conduct disorder in children aged 5 years and older with mental retardation

Children from 5 to 18 years old

For patients weighing 50 kg or more, the recommended initial dose of Torendo® Ku-tab® is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg 1 time per day at least after 24 hours.

For most patients, the optimal dose is 1 mg once daily. However, for some patients, 0.5 mg per day is preferable, while some require an increase in dose to 1.5 mg per day.

For 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 1 time per day in less than 24 hours.

For most patients, the optimal dose is 0.5 mg once daily. 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 other symptomatic therapy, the advisability of continuing treatment with Torendo® Qu-tab® should be regularly assessed and confirmed.

Application in children under 5 years of age not recommended due to lack of data.

Special patient groups

Patients with impaired renal function have a reduced ability to eliminate the active antipsychotic fraction compared to other groups of patients.

In patients with impaired liver function, an increased concentration of the free fraction of risperidone in the blood plasma is observed.

The initial and maintenance dose, in accordance with the indications, should be reduced by 2 times; the dose increase in patients with impaired liver and kidney function should be carried out more slowly.

The drug Torendo® Ku-tab® should be used with caution in this category of patients.

Mode of application

Inside, regardless of meal time.

At the beginning of dosing and when increasing the dose, as well as if it is necessary to take a dosage of risperidone 0.25 mg, adequate dosage forms of risperidone should be used with the possibility of dosing but 0.25 mg.

The drug Torendo® Ku-tab® should be discontinued gradually. When abruptly stopping the use of antipsychotic drugs in high doses, including risperidone, in very rare cases, the development of a “withdrawal” syndrome (nausea, vomiting, increased sweating and insomnia) was observed, relapses of psychotic symptoms and the appearance of involuntary movements (such as akathisia, dystonia) were observed. and dyskinesia).

Switching from therapy with other antipsychotic drugs

When starting to use Torendo® Qu-tab®, it is recommended to gradually discontinue previous therapy if clinically justified.

In case of previous therapy with depot forms of antipsychotic drugs, it is recommended to start therapy with Torendo® Qu-tab® instead of the next scheduled injection.

The need to continue current antiparkinsonian drug therapy should be periodically assessed.

Side effects:

The most commonly observed adverse reactions (incidence ≥ 5%) were insomnia, anxiety, headache, upper respiratory tract infection, and parkinsonism.

Dose-dependent adverse reactions are parkinsonism and akathisia.

Side effects of risperidone noted in clinical studies of risperidone in dosage forms for oral administration and in long-acting injection form, as well as those obtained during post-registration surveillance, are given with a distribution by frequency and organ system.

The frequency of side effects was classified as follows: very often (≥ 1/10 cases), often (from ≥ 1/100 to<1/10 случаев), нечасто (от ≥ 1/1000 до < 1/100 случаев), редко (от ≥ 1/10000 до < 1/1000 случаев), очень редко (< 1/10000 случаев), частота неизвестна (частоту возникновения нельзя оценить на основании существующих данных). В каждой частотной группе побочные действия представлены в порядке уменьшения важности.

often: pneumonia, flu, bronchitis, upper respiratory tract infections, urinary tract infections, sinusitis, ear infections;

uncommon: viral infections, tonsillitis, inflammation of the subcutaneous fat, otitis media, eye infections, localized infections, akarodermatitis, respiratory tract infections, cystitis, onychomycosis;

rarely: lower respiratory tract infections, chronic otitis media, infections, subcutaneous abscess.

Disorders of the blood and lymphatic system :

uncommon: neutropenia, decreased white blood cell count, anemia, thrombocytopenia, decreased hematocrit, decreased eosinophil count, decreased hemoglobin;

rarely: granulocytopenia, agranulocytosis.

Immune system disorders :

uncommon: hypersensitivity reactions to the components of the drug;

Rare: drug hypersensitivity, anaphylactic reaction.

Endocrine system disorders :

Often: increased prolactin levels 1;

rarely: impaired production of antidiuretic hormone, glucosuria.

Metabolic and nutritional disorders :

often: weight gain, increased appetite, decreased appetite;

uncommon: weight loss, diabetes mellitus 3, anorexia, polydipsia, hyperglycemia, increased concentration of cholesterol in blood plasma;

rarely: hypoglycemia, water intoxication, increased insulin, increased concentration triglycerides in blood plasma;

very rare: diabetic ketoacidosis.

Mental disorders :

very often: insomnia;

often: restlessness, agitation, sleep disturbances, anxiety, depression;

uncommon: confusion, mania, decreased libido, lethargy, nervousness, nightmares;

rarely: anorgasmia, flattening of affect.

Nervous system disorders :

very often: parkinsonism 2, headache, drowsiness, sedation;

often: akathisia 2, dizziness 2, tremor 2, dystonia 2, lethargy, dyskinesia 2;

Uncommon: lack of response to stimuli, loss of consciousness, decreased level of consciousness, syncope, impaired consciousness, stroke, transient ischemic attack, dysarthria, impaired attention, gynersomnia, postural vertigo, imbalance, tardive dyskinesia, speech impairment, coordination impairment, kinesthesia, disorder taste sensations, taste perversion, convulsions, cerebral ischemia, movement disorders, psychomotor agitation, paresthesia;

rarely: neuroleptic malignant syndrome (NMS), diabetic coma, cerebrovascular disorders, head tremor;

frequency unknown: stuttering.

Visual disorders :

often: blurred vision, conjunctivitis;

uncommon: conjunctival hyperemia, blurred vision, eye discharge, periorbital edema, dry eyes, increased lacrimation, photophobia;

rarely: decreased visual acuity, impaired eye movement, involuntary rotation of the eyeballs, formation of crusts on the edge of the eyelid, glaucoma, intraoperative floppy iris syndrome (IFIS), retinal artery occlusion.

Hearing and labyrinth disorders :

Infrequently: vertigo, ear pain, tinnitus.

Heart disorders :

often: tachycardia;

uncommon: atrioventricular block, right or left bundle branch block, atrial fibrillation, palpitations, cardiac conduction disturbances, prolongation of the QT interval on the ECG, bradycardia, abnormalities on the ECG;

rarely: sinus arrhythmia, sinus bradycardia;

frequency unknown: first degree atrioventricular block.

Vascular disorders :

often: arterial hypertension;

uncommon: hypotension, orthostatic hypotension, hot flashes;

rarely: pulmonary embolism, deep vein thrombosis.

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.

Digestive system disorders :

often: vomiting, diarrhea, constipation, nausea, abdominal pain, dyspepsia, dry oral mucosa, abdominal discomfort, hypersalivation, toothache;

uncommon: dysphagia, gastritis, fecal incontinence, fecaloma, gastroenteritis, flatulence;

Rarely: intestinal obstruction, pancreatitis, swelling of the lips, swelling of the tongue, cheilitis;

very rarely: ileus.

Disorders of the liver and biliary tract :

infrequently: increased activity of transaminases, gamma-glutamyltransferase, liver enzymes (in particular, increased level of alanine aminotransferase activity) in blood plasma;

rarely: jaundice.

Disorders of the track and subcutaneous tissues :

often: skin rash, erythema;

uncommon: urticaria, skin lesions, disruption of the integrity of the skin, itching, acne, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, eczema;

rarely: drug rash, dandruff;

very rare: Quincke's edema.

Musculoskeletal and connective tissue disorders :

often: muscle spasms, musculoskeletal pain, arthralgia, back pain, pain in the extremities, pain in the buttocks;

uncommon: increased activity of creatine phosphokinase in blood plasma, muscle weakness, myalgia, neck pain, swollen joints, poor posture, stiffness in the joints, muscle pain in the chest;

rarely: rhabdomyolysis.

Renal and urinary tract disorders :

often: enuresis, urinary incontinence;

uncommon: urinary retention, dysuria, pollakiuria.

Pregnancy , postpartum and perinatal conditions :

rarely: withdrawal syndrome in newborns.

Disorders of the genital organs and breast :

uncommon: amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, galactorrhea, gynecomastia, menstrual disorder, vaginal discharge, pain in the breast area, discomfort in the breast area;

rarely: priapism, delayed menstruation, engorgement of the mammary glands, enlarged mammary glands, discharge from the mammary glands.

General and administration site disorders :

often: edema, pyrexia, fatigue, peripheral edema, generalized edema, asthenia, chest pain, pain;

Uncommon: facial swelling, gait disturbance, feeling unwell, slowness, flu-like condition, malaise, thirst, chest discomfort, chills, fever, discomfort;

rarely: hypothermia, decreased body temperature, withdrawal syndrome, cold snap limbs, induration.

Injuries, intoxications and complications of manipulations :

often: falling;

uncommon: pain during procedures.

1 - hyperprolactinemia in some cases can lead to gynecomastia, menstrual irregularities, amenorrhea and galactorrhea.

2 - extrapyramidal disorders can manifest as parkinsonism (hypersalivation, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, mask-like face, muscle tension, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, disturbances of the glabellar reflex, parkinsonian rest tremor), akathisia (akathisia, restlessness, hyperkinesia and restless legs syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis and myoclonus), dystonia.

The term "dystonia" includes dystonia, muscle spasms, muscle hypertension, torticollis, involuntary muscle contractions, muscle contracture, blepharospasm, eye movements, tongue paralysis, facial spasm, laryngospasm. myotonia, opisthotonus, oropharyngeal spasm, pleurototonus, tongue spasm and trismus. Tremors include tremor and parkinsonian resting tremor.

It should also be noted that there is a wider range of symptoms that are not always of extrapyramidal origin. Insomnia includes a sleep disorder and sleep disorder. Seizures include a grand mal seizure. Menstrual disorders include irregular menstruation, oligomenorrhea. Edema includes generalized edema, peripheral edema, and mild edema.

3 - in placebo-controlled studies, diabetes mellitus was observed in 0.18% of patients taking , compared to 0.11% of patients in the placebo group. In all clinical studies, in general, the incidence of diabetes mellitus in patients taking was 0.43%.

Undesirable effects when using paliperidone

Paliperidone is an active metabolite of risperidone, therefore the adverse reaction profiles of risperidone and paliperidone are interrelated.

In addition to the above, the following adverse reactions have been reported with the use of paliperidone, which may also occur with the use of risperidone:

From the cardiovascular system : postural orthostatic syndrome tachycardia.

Class effects

As with other antipsychotic drugs, very rare cases of prolongation of the interval have been observed.QTin the post-marketing observation period.

Other cardiovascular class effects observed with interval-prolonging antipsychoticsQT: ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and polymorphic ventricular tachycardia of the "pirouette" type.

Venous thromboembolism

Cases of venous thromboembolism, including pulmonary embolism and cases of deep vein thrombosis, have been observed with the use of antipsychotic drugs (frequency unknown).

Weight gain

In placebo-controlled studies in patients with schizophrenia, an increase in body weight of at least 7% after 6-8 weeks was observed in 18% of patients taking and in 9% of patients taking placebo.

In placebo-controlled clinical trials in patients with manic episodes, the incidence of weight gain of 7% or more after 3 weeks of treatment was comparable in the treatment group (2.5%) and placebo group (2.4%). %), and in the active control group it was slightly higher (3.5%).

In long-term clinical studies, children with conduct disorders increased body weight by an average of 7.3 kg after 12 months of therapy. The expected increase in body weight in children 5-12 years old with normal development is 3-5 kg per year, from 12-16 years old - 3-5 kg per year for girls and about 5 kg per year for boys.

Special patient groups

Side effects that were reported with greater frequency in elderly patients with dementia and in children than in adult patients are described below.

Elderly patients with dementia

Transient ischemic attacks and stroke were observed in clinical studies with an incidence of 1.4% and 1.5%, respectively, in elderly patients with dementia.

In addition, the following side effects have been reported in elderly patients with dementia with a frequency of≥ 5% and with an incidence at least 2 times higher than that in other patient populations: urinary tract infections, peripheral edema, lethargy and cough.

Children

The following side effects were observed in children (from 5 to 17 years of age) with a frequency≥ 5% and with an incidence at least 2 times higher than in other patient populations during clinical trials: somnolence/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain , dizziness, cough, pyrexia, tremor, diarrhea, enuresis.

Overdose:

Symptoms : drowsiness, sedation, depression of consciousness, tachycardia, arterial hypotension, extrapyramidal disorders, in rare cases, prolongation of the intervalQTand seizures. In case of overdose in patients simultaneously taking and, the development of polymorphic ventricular tachycardia of the “pirouette” type has been described.

In case of acute overdose, it is necessary to consider the possibility of overdose from taking several drugs.

Treatment : ensure a clear airway for adequate oxygenation and ventilation. Gastric lavage should be performed (after intubation, if the patient is unconscious), as well as laxatives should only be used if they were taken no more than 1 hour ago.

To timely diagnose a possible heart rhythm disorder, it is necessary to begin ECG monitoring as soon as possible.

There is no specific antidote; appropriate symptomatic therapy must be carried out.

When blood pressure decreases and vascular collapse, intravenous administration of infusion solutions and/or sympathomimetic drugs is recommended.

If acute extrapyramidal symptoms develop, anticholinergic drugs should be prescribed.

Careful medical observation and ECG monitoring are carried out until the symptoms of intoxication completely disappear.

Interaction:

Interactions,related With pharmacodynamics of the drug

Drugs that prolong the intervalQT

As with other antipsychotic drugs, caution should be exercised when using Torendo® Qu-tab® simultaneously with drugs that prolong the QT interval, for example, with antiarrhythmic drugs (disopyramide, etc.), tricyclic antidepressants (etc.) , tetracyclic antidepressants (and others), some antihistamines, other antipsychotics, some antimalarials (quinine, etc.), drugs that cause electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia or inhibit the hepatic metabolism of risperidone.

This list is not exhaustive.

Centrally acting drugs and alcohol

The drug Torendo® Ku-tab® should be used with caution in combination with other drugs and substances of central action, especially alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.

Levodopa and dopamine receptor agonists

The drug Torendo® Qu-tab® may reduce the effectiveness of levodopa and other dopamine receptor agonists. If this combination is necessary, especially in end-stage Parkinson's disease, the lowest effective dose of each drug should be prescribed.

Antihypertensive drugs

When risperidone was used concomitantly with antihypertensive drugs in the post-registration period, clinically significant arterial hypotension was observed.

Paliperidone

It is not recommended to use the drug Torendo® Ku-tab® and at the same time, since it is an active metabolite of risperidone. Concomitant use of a combination of risperidone and paliperidone may lead to increased concentrations of the active antipsychotic fraction.

Interactions, related With pharmacokinetics of the drug

Eating does not affect the absorption of risperidone.

Risperidone is primarily metabolized by CYP2D6 and to a lesser extent by CYP3A4. and its active metabolite 9-hydroxyrisperidone are P-glycoprotein (P-gp) substrates. Drugs that affect the activity of the CYP2D6 isoenzyme and drugs that significantly inhibit or induce the activity of the CYP3A4 isoenzyme and/or P-gp may affect the pharmacokinetics of the active antipsychotic fraction of risperidone.

Potent isoenzyme inhibitorsCYP2 D6

With simultaneous use of risperidone and potent inhibitors of the CYP 2D 6 isoenzyme, the plasma concentration of risperidone and, to a lesser extent, the active antipsychotic fraction may increase. Higher doses of a strong CYP2D6 inhibitor may increase the concentration of the active antipsychotic fraction of risperidone (eg, see below).

It is expected that other inhibitors of the CYP2D6 isoenzyme, such as , may have a similar effect on the concentration of risperidone in blood plasma.

When initiating or discontinuing therapy with a combination of risperidone and paroxetine, quinidine or another strong inhibitor of the CYP2D6 isoenzyme, especially at higher doses, the dose of Torendo® Qu-tab® should be adjusted.

Isoenzyme inhibitorsCYP3 A4 and/or R-gP

The simultaneous use of the drug Torendo® Ku-tab® and potent inhibitors of the CYP 3A 4 and/or P-gp isoenzyme can significantly increase the concentration of the active antipsychotic fraction of risperidone in the blood plasma. When initiating or discontinuing therapy with a combination of risperidone and itraconazole or another potent inhibitor of the CYP3A4 and/or P-gp isoenzyme, the dose of Torendo® Qu-tab® should be adjusted.

Inducers of the isoenzyme CYP 3A 4 and/or P- gr

Concomitant use of the drug Torendo® Qu-tab® with a powerful inducer of the CYP 3A 4 and/or P-gp isoenzyme may reduce the concentration of the active antipsychotic fraction of risperidone in the blood plasma.

When initiating or discontinuing therapy with a combination of risperidone and carbamazepine or another strong inducer of the CYP3A4 and/or P-gp isoenzyme, the dose of Torendo® Qu-tab® should be adjusted.

The effect of CYP 3A 4 isoenzyme inducers occurs over time, so it may take up to 2 weeks to achieve maximum effect after starting treatment. Accordingly, when discontinuing an inducer of the CYP 3A 4 isoenzyme, it may take up to 2 weeks until the effect disappears.

Drugs that bind tightly to plasma proteins

With the simultaneous use of the drug Torendo® Ku-tab® with drugs that are highly bound to blood plasma proteins, there is no clinically significant displacement of the drug from the complex with blood plasma proteins.

When using concomitant treatment, you should refer to the instructions for use of the corresponding drug and, if necessary, adjust the dosage of the drugs taken.

Psychostimulants

When psychostimulants (eg, methylphenidate) and risperidone are used concomitantly, changing the order of administration of one or both drugs may lead to extrapyramidal symptoms (see section "Special Instructions").

Children

Drug interaction studies were conducted only in adult patients. The relevance of these studies in children is unknown.

The simultaneous use of psychostimulants (for example, methylphenidate) and the drug Torendo® Qu-tab® in children does not change the pharmacokinetic parameters and effectiveness of risperidone.

Effect of other drugs on the pharmacokinetics of risperidone

Antibacterial drugs

Erythromycin, a moderate inhibitor of the CYP3A4 and P-gp isoenzymes, does not affect the pharmacokinetics of risperidone and the active antipsychotic fraction.

Rifampicin, a powerful inducer of the CYP 3A 4 and P-gp isoenzymes, causes a decrease in the concentration of the active antipsychotic fraction in the blood plasma.

Anticholinesterase drugs

Parkinson's disease and dementia with Lewy bodies

The use of antipsychotic drugs, including the drug Torendo® Qu-tab®, in patients with Parkinson's disease or dementia with Lewy bodies should be carried out with caution, since both groups of patients have an increased risk of developing NMS and increased sensitivity to antipsychotic drugs (including dulling of pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms). Parkinson's disease may worsen when taking risperidone.

Hyperglycemia and diabetes mellitus

Cases of the development of hyperglycemia, diabetes mellitus and aggravation of diabetes mellitus have been described. In some cases, there was an increase in body weight preceding therapy, which can be regarded as a predisposing factor. In very rare cases, the development of ketoacidosis and rarely - diabetic coma were observed.

As with any antipsychotic, patients should be monitored for symptoms of hyperglycemia (such as polydipsia, polyuria, polyphagia, and weakness). In patients with diabetes mellitus, blood glucose concentrations should be regularly monitored.

Weight gain

There is a significant increase in body weight. It is necessary to regularly monitor patients' body weight.

Hyperprolactinemia

Based on research results invitro It has been suggested that the growth of mammary tumor cells can be stimulated by prolactin. Although clinical and epidemiological studies have not shown a clear association of hyperprolactinemia with antipsychotic medications, caution should be exercised when using risperidone in patients with a history of this. The drug Torendo® Qu-tab® should be used with caution in patients with existing hyperprolactinemia and in patients with possible prolactin-dependent tumors.

QT prolongation

In very rare cases, prolongation of the QT interval has been observed in the post-marketing period. As with other antipsychotics, caution should be exercised when using Torendo® Qu-tab® in patients with cardiovascular disease, family history of QT interval prolongation, bradycardia, electrolyte imbalance (hypokalemia, hypomagnesemia), as this may increase the risk of arrhythmogenic effects or when used simultaneously with drugs that prolong the QT interval.

Convulsions

The drug Torendo® Qu-tab® should be used with caution in patients with a history of seizures or in conditions accompanied by a decrease in the threshold of seizure activity.

Priapism

Since it has an α-adrenergic blocking effect, priapism may develop when used.

Dysregulation of body temperature

When using antipsychotic drugs, such an undesirable effect as impaired thermoregulation is described. Caution must be exercised when using the drug Torendo® Qu-tab® in patients who may be exposed to factors that cause an increase in body temperature, such as intense physical activity, dehydration, high ambient temperature, and simultaneous use with drugs that have anticholinergic activity.

Antiemetic effect

In preclinical studies of risperidone, an antiemetic effect was observed. This effect, when occurring in humans, may mask signs and symptoms of overdose of some drugs or diseases such as intestinal obstruction, Reye's syndrome, and brain tumors.

Impaired kidney and liver function

In patients with impaired renal function, the ability to eliminate the active antipsychotic fraction is lower than in adult patients with normal renal function. In patients with impaired liver function, the concentration of the free fraction of risperidone in the blood plasma increases.

Venous thromboembolism

Cases of venous thromboembolism have been described with the use of antipsychotic drugs. It is necessary to identify all possible risk factors for the development of thromboembolic complications before and during therapy with Torendo® Ku-tab® and take preventive measures.

Intraoperative floppy iris syndrome (ISID)

ISDR was observed during cataract surgery in patients receiving drugs that antagonize alpha 1 -adrenergic receptors, including the drug Torendo® Qu-tab®. ISDR may increase the risk of visual complications during and after surgery. It is necessary to inform the ophthalmologist in advance about the use of drugs that antagonize alpha 1-adrenergic receptors currently or in the past.

The potential benefit of discontinuing therapy with drugs that antagonize alpha 1 -adrenergic receptors before cataract surgery has not been established. It is necessary to assess the benefit/risk ratio of discontinuing antipsychotic therapy.

Children and teenagers

Before using Torendo® Qu-tab® in children or adolescents with mental retardation, it is necessary to carefully assess their condition for the presence of physical or social causes of aggressive behavior, such as pain or inadequate demands of the social environment.

The sedative effect of risperidone should be carefully monitored in this population due to the possible effect on learning ability. Changing the timing of risperidone administration may reduce the effects of sedation on alertness in adolescents and children.

Risperidone use was associated with increases in mean body weight and body mass index. Height changes in longitudinal studies were within expected age-related norms. The effects of long-term use of risperidone on sexual development and growth have not been fully studied.

Due to the possible impact of prolonged hyperprolactinemia on growth and sexual development in children and adolescents, regular clinical assessment of hormonal status should be carried out, including measurement of height, body weight, monitoring of sexual development, menstrual cycle and other possible prolactin-dependent effects.

During risperidone therapy, regular assessment should be carried out to identify extrapyramidal symptoms and other movement disorders.

Special information on excipients

The composition of the drug Torendo® Ku-tab® includes, and therefore its use is contraindicated in patients with phenylketonuria, and, therefore, its use is contraindicated in patients with congenital fructose intolerance.

Impact on the ability to drive vehicles. Wed and fur.:

The drug Torendo® Ku-tab® may have a small or moderate effect on the ability to drive vehicles and machines. Patients should be advised not to drive a car or operate machinery until their individual sensitivity to the drug is determined.

Release form/dosage:

Oral dispersible tablets, 0.5 mg, 1 mg and 2 mg.

Package:

10 tablets per blister made of combined material OPA/Al/PVC, PET/Al foil(OPA/ Al/ PVC, RET/A lpeelofffoil).

3 blisters per cardboard pack along with instructions for use.

Storage conditions:

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of the reach of children.

Best before date:

3 years.

Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies: