Medicinal reference book geotar. Zalasta Ku-Tab: instructions for using tablets What does a torrent kutab tablet look like

Cough is an unpleasant symptom of various diseases. It is generally accepted that this sign is something bad that needs to be eliminated immediately. However, it is not always necessary to get rid of a cough. In many cases, it helps the patient more than it hurts.

Pharmacological production supplies a variety of cough medicines to pharmacy chains. Doctors recommend the latest drugs to their patients, forgetting about the old proven drugs. In recent years, it is rarely seen in the appointment of the drug Cough tablets. However, the drug is recognized as effective, safe and inexpensive.

The instructions for the drug "Cough Tablets" position it as a safe expectorant drug, based on the herbal composition. The active ingredient of the drug is thermopsis grass powder. Each tablet contains 6.7 mg of this component.

The principle of action of the active substance is based on the provocation of irritation. Once in the human body, thermopsis causes a reflex release of bronchial secretions. At the same time, muscle activity is increased. The mucus that collects in the bronchi and lungs is evacuated naturally.

Thermopsis has long been used in medicine. The plant has established itself as an effective remedy in the treatment of diseases of the respiratory system.

The second active ingredient of the drug is sodium bicarbonate. One tablet contains 250 mg of this remedy. It has a thinning effect on sputum, making it more liquid. In this form, mucus is excreted more easily.

Acting in a complex manner, the two substances of the drug help to easily evacuate thick sputum from the lower respiratory tract.

As secondary components, the manufacturer uses potato starch and talc. In medicine, cough tablets are positioned as a herbal remedy with an expectorant effect.

Release form

The medication is available in the form of flat white pills. Tablets are packed in blisters of 10 pieces.

Each pack contains one or two of these blisters. On the front of the package is the trade name "Cough Tablets".

Also, the medicine is available in paper packaging, 10 tablets each.

Due to its natural composition, the drug belongs to over-the-counter drugs. You can buy it at your nearest pharmacy.

The low cost makes the medicine affordable for every person. A pack of 10 tablets costs no more than 50 Russian rubles.

Shelf life and storage conditions

The manufacturer indicates that the drug is suitable for use within 4 years. During this time, it is necessary to store the pills in a dry place. The ambient temperature should not exceed 25 degrees. Tablets should be kept away from children.

Assignments to use

• tracheitis;
• bronchitis;
• pneumonia;
• chronic pathologies of the respiratory tract

The medicine is prescribed for dry and unproductive cough. Tablets are effective in the formation of thick, viscous, difficult to separate mucus and the absence of a cough reflex to remove it.

It is a mistake to believe that the medication will help relieve an annoying cough. The medicine, on the contrary, irritates the respiratory tract so that sputum is excreted from them.

If the mucus stagnates in the bronchi, then harmful microorganisms will begin to multiply in it, which is fraught with the occurrence of a secondary infection.

How to take cough tablets

In order for the treatment to be effective and short, you must first contact a specialist.

Only a doctor can reliably determine the cause of an unpleasant symptom and prescribe appropriate drugs.

If a person is categorical, then you must carefully read the instructions before using the drug and strictly follow the indicated algorithm.

Dosage

• Adult patients the medicine is recommended in a single dose of 1 tablet, three times a day. The duration of treatment is limited to five days. The maximum allowable single dose of the drug is 14 tablets, and the daily dose is 42.
• Children after 12 years the medication is prescribed in the amount of half the adult dose - 1/2 tablet. Multiplicity of application 2-3 times. The duration of use is 3-5 days.

The medicine is taken orally with a comfortable amount of water. In the treatment of dry cough, it is recommended to consume more fluids, as this will improve the thinning of the mucus and speed up the separation of sputum.

In such cases, the pulmonologist selects an individual dosage and establishes a separate regimen.

Interaction with other medicines and the possibility of complex use

Often, cough tablets are prescribed in complex treatment. The drug is combined in non-steroidal anti-inflammatory drugs that eliminate fever and pain. Often combined with antibiotics and immunomodulators.

If the patient is taking any medication prescribed by other specialists, then the doctor who recommends Cough Tablets should be informed.

If the doctor prescribes Cough Tablets with other medicines, then he will definitely talk about the possibility of their joint use. When using it yourself, you should read the important point from the instructions indicating the interaction.

• Astringents, enveloping the stomach, antacids and adsorbents reduce the effectiveness of the herbal remedy. Medicines used in diseases of the gastrointestinal tract disrupt the absorption of alkaloids. These medicines should be used at least 2 hours apart. In this case, the cough medicine should be used first.
• Medicines based on codeine or other substances that cause antitussive action should not be used simultaneously with thermopsis. Such drugs are called antagonists, they have the opposite effect.

Contraindications, precautions and adverse reactions

Despite the safe composition and a small number of components, the drug has its own contraindications. Under no circumstances should Cough Tablets be taken if:

1. The patient has hypersensitivity to the components or previously had an allergy to drugs with thermopsis;
2. The patient suffers from peptic ulcer of the stomach or intestines, which is in an acute stage.
3. With extreme caution Cough tablets should be taken by allergy sufferers, as well as patients with severe liver or kidney disease.
4. The drug is contraindicated for pregnant women, since the effect of the active substance on the fetus has not been thoroughly studied.

Thermopsis passes into breast milk, so you can not use this medication during lactation. If treatment is required for a nursing mother, then it is necessary to resolve the issue of temporarily stopping breastfeeding or picking up.

Unpleasant effects of therapy

Most of the patients taking the drug tolerate the treatment well. Only in some cases, thermopsis provokes side effects, expressed in allergies and dyspeptic disorders.

It is forbidden to use the medication in a dosage exceeding that established by the manufacturer, unless recommended by a doctor.

An overdose is accompanied by symptoms such as nausea, urge to vomit. In such cases, the patient is prescribed a gastric lavage, taking adsorbents and symptomatic agents that alleviate the condition.

If you feel worse during treatment, you should stop taking the medication and seek medical help.

Additionally

In recent decades, medicine has made tremendous strides forward. Modern cough medicines help quickly and effectively.

Most medicines have chemical components in their composition, which causes mistrust. Such drugs are expensive. Cough tablets have a lot of positive qualities:

• are inexpensive and sold without a prescription, available to every consumer, with the exception of persons with contraindications;
• have a safe composition, act quickly and effectively;
• have a long shelf life, do not require special storage conditions;
• in just 3-5 days, a dry and unproductive cough is transferred to a wet and light one.

In contact with

Cough tablets instructions for use describe how drugs that suppress the cough reflex, thin the bronchial secret (mucolytics / secretolytics), drugs that activate the ciliated epithelium of the bronchi and promote sputum discharge (expectorant / secretomotor agents).

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

1. according to the effect (softening, expectorant, sputum thinning, antitussive, etc.), often one drug has a whole set of therapeutic qualities;
2. by the ability to deal with different types of cough (used both for non-productive cough and for coughing with viscous sputum, with wet with copious secretion or allergic cough);
3. in form (dissolvable pop-up tablets, sucking tablets for coughing, for oral administration).

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

Choosing the right cough medicine

Good cough tablets are not always an expensive drug. When choosing a medication for treatment, one should first of all focus not on its cost, but on the characteristics of a productive (with sputum) or unproductive (dry) cough.

At the same time, the quality of sputum is an important criterion:

• viscous, difficult-to-separate sputum requires liquefaction and assistance with discharge;
• an abundant secret should be helped to remove the ciliated epithelium from the respiratory tract;
• dry excruciating cough requires the use of drugs that stop it.

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

Cough suppressants include:

• secretolitics / mucoliths - that is, thinning sputum;
• secretory drugs that promote its discharge;
• bronchodilators - this group of medicines works against bronchospasm, expanding the lumen of the bronchi, thanks to which sputum (viscous / thick / liquid) is excreted easier and faster.

Attention: remember that it is categorically not recommended to take funds from different pharmacological groups at the same time, referring them to the category of "cough pills"! Let us consider in more detail 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 means include a variety of tastes. Cough lozenges have much in common with lollipops and are easy to offer to children. Most funds can be absorbed every 2 hours. This allows you to effectively and quickly alleviate the condition. This group includes such popular products as (Sage, Doctor MOM, Lazolvan, Alex-Plus, Bronchicum, Geksoral tabs), made in the form of lozenges.

Effervescent tablets, for example, ACC, are not superior in efficiency to their coated counterparts. But it is more interesting to offer them to children and they begin to act faster. Therefore, in the subjective perception of the patient, these drugs seem to be more "advanced" and effective.

How to take cough tablets depends on the form of the drug. Effervescent tablets dissolve in water and drink, lozenges dissolve, coated pills are swallowed and washed down with water. Most medications are taken either before meals or with or without food.

Antitussive drugs

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

Dry cough tablets are shown to adults. It means that the funds of 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 old.

Mechanism of action

Medicines (drugs) that suppress cough affect:

• on the cough center in the brain (central action), such as Codeine, Dextromethorphan;
• or block the transmission of a nerve impulse to the muscles involved in the coughing act (peripherally acting, for example, Levodron propizine).

These medicines 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 means of symptomatic therapy, prescribed for an exhausting, unproductive cough. They are divided into:

1. Narcotic. This group includes, like Codeine (Nurofen Plus, Terkodin, Codelac), as well as Demorphan, Morphine and Hydrocodone. There are preparations from 87 rubles and above.
2. Non-narcotic. This includes Butamirate, Oxeladine (in the form of citrate) and others.

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

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

The second group can also cope with dry cough quite effectively. These medicines can be taken for a longer 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 absorbable cough tablets for children and adults (more precisely lozenges for resorption).

Application

Means of this group are prescribed to suppress the cough reflex when:

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

With respiratory infections of a 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 medicines

Among the tablets for dry cough, inexpensive, but effective, non-drug central action can be distinguished: Bromhexine from 15 rubles, Glaucin, Bronholitin, Kaffetin 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, Codterpin, Codelac) cost about 200-300 rubles.

Attention: Codelac Neo and Codelac Broncho preparations are not narcotic!

Secretolytics, secretomotor drugs and bronchodilators

If the cough is wet, drugs are required that can thin the secret and help remove it 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 drugs that differ in origin (natural / artificial) and pharmacological features. There are medicines:

• reflex action;
• resorptive;
• mucolytics;
• bronchodilators.

Each of the options presented involves one of the mechanisms for the production and release of bronchus mucosa.

Reflex means

This species 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, reflexively stimulate an increase in the production of bronchial secretions.

In this group of funds, there are many cough tablets that are inexpensive, but effective. First of all, these are cough tablets with thermopsis (tabletted herbal extract, Thermopsol), as well.

Mukaltin is a remedy with marshmallow root. Such tablets cost up to 10 rubles. Not forbidden to expectant mothers who are carrying a baby and children at an age when they can take a pill. The drug is taken 20 minutes before meals, three times a day, 1-2 things.

Thermopsol - cough tablets containing soda and thermopsis. Taken orally three times a day. The course is 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:

1. Dr. MOM (lozenges for resorption);
2. Fitolor;
3. Travesil.

All of these remedies contain licorice rhizome. Medicines with thyme/thyme are slightly more expensive. They cost from 200 rubles (Gelomirtol, Bronchopret). Easy to use cough lozenges with sage. They cost about 200 rubles. It can be absorbed by children from the age of 5, 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 medicines in tablet form are used on their own quite rarely (Amtersol, Sodium bicarbonate 0.25 grams). More often they are used in combination with reflex drugs (Termopsol).

To date, there is no urgent need for resorptive agents. Pharmacies are rich in cough tablets, inexpensive and quite effective, made from plant materials, with a minimum set of contraindications.

Mucus thinners

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

And means activating the production of pulmonary surfactant: Bromhexine and Ambroxol.

This group includes proteolytics Trypsin, Ribonuclease, Chymotrypsin, sulfur-containing compounds and derivatives of plant matter (visicin) that 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 the secret.

From this group, you can buy cough tablets at a price of at least 100-400 rubles and more:

• ACC for 288 rubles, Vicks - 135 rubles, Fluimucil - 144 rubles (based on acetylcesteine);
• Fluifort - 307 rubles, Fluditec - 350 rubles (based on carbocysteine).
• Ambrobene - 148 rubles, Flavamed - 150 rubles, -170 rubles (based on Ambroxol).

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

Bronchodilators

These drugs are good for the treatment of spasmodic paroxysms of coughing. They are effective to drink with allergic cough and bronchial asthma. These funds will also help with bronchial obstruction, due to the ability to fight bronchospasm. In this series, cough tablets are inexpensive:

• Eufillin - from 9 rubles;
• Salbutamol from 71 rubles.

A little more expensive is Berodual and Berotek from 270 rubles.

Application

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

If the cough is strong, tormenting, and sputum is secreted, funds from the ACC series, Ambroxol, Solvin are of little use.

If the cough is wet, the secret literally “squishes” in the bronchi, you need soda, Thermopsis preparations or Mukaltin. The reviews for these cough tablets are positive, although these are the simplest and cheapest remedies. They, as they say, have been tested for centuries. Even for small children, experienced pediatricians recommend purchasing a drug called "Cough Pills" 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. In order to prepare a simple medicine, baking soda, milk, and natural honey will suffice.

Cough tablets - official instructions for use

Check out another effective, inexpensive cough remedy that you will spend a minimum of time and money on preparing.

Popular related questions

Are there cough pills for pregnant women? Unfortunately, no one has developed special drugs for patients in this category. Direct prohibitions on taking medications are not contained in the annotation for:

• Mukaltin;
• preparations 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 benefit to the expectant mother "outweighs" the likely harm to her baby.

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

What are some good cough pills? Medicine does not operate with such concepts. She classifies drugs as effective and not, with a large number of side effects and not. The choice of medication is based on the patient's condition.

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

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

Ontime is an effective antisecretory drug used for the prevention and treatment of diseases of the digestive tract, caused, in particular, by hypersecretion of hydrochloric acid in the fundic glands of the stomach. The drug belongs to the group of inhibitors of the so-called. "proton pump".

Active ingredient and release form

Ontime is available in tablet form for oral administration. Each enteric-coated tablet contains 10 or 20 mg of the active ingredient, rabeprazole (as rabeprazole sodium). They are packaged in foil and PVC blisters of 10 pieces.

Pharmacological properties Ontime

Rabeprazole inhibits the activity of the H + -K + -ATPase enzyme, which ensures the supply of hydrogen ions to the parietal cells. Due to this, the process of HCl biosynthesis is blocked at the final stage, and the acidity of gastric juice decreases. Increasing the pH of the medium accelerates the regeneration of damaged mucous membranes of the digestive tract.

After taking the tablets, the active ingredient is released and absorbed in the small intestine. At a dose of 20 mg, the highest plasma concentration is recorded after 3.5 hours. The level of bioavailability - 52%; this indicator remains unchanged after repeated administration. Up to 97% of the substance is conjugated with plasma albumin. The process of biotransformation of rabeprazole occurs in the liver, and metabolites are excreted mainly in the urine (90%). The half-life is normally about 1 hour; it slightly increases in the elderly.

After the cancellation (completion of the course) of rabeprazole, the basal and stimulated secretory activity normal for the patient is restored only after 2-3 days.

Indications for use

• GERD();
• erosion of the esophagus associated with the reverse reflux of gastric contents;
• and 12 duodenal ulcer;
• Zollinger-Ellison syndrome (a symptom complex that occurs with gatrino-producing neoplasms);
• gastropathy caused by infection (as part of the "triple" eradication therapy).

With GERD, this drug is prescribed for both symptomatic and long-term maintenance therapy.

Contraindications

Ontime should not be taken by patients with intolerance to rebeprazole (and other substituted benzimidazoles), as well as hypersensitivity to the auxiliary ingredients of the drug.

Children and adolescents under 18 years of age should not take this proton pump inhibitor. discharged due to lack of experience of use in pediatric practice.

Dosing regimen

Tablets must not be crushed or chewed to avoid damage to the enteric coating.; the active ingredient is not sufficiently stable in a low pH environment. They must be swallowed whole with a sufficient amount of liquid (50-100 ml of boiled water).

A single dose is 10-20 mg. The frequency of admission and duration of treatment is determined by the gastroenterologist depending on the nosological form, the severity of clinical symptoms and the dynamics of the process.

At duodenal ulcers in the acute stage, 20 mg of rabeprazole is taken for 4 weeks, and for gastric - 6 weeks. If complete healing of defects does not occur, a second course is prescribed.

Duration of treatment GERD - 1-2 months. With symptomatic therapy, 10 mg per day is prescribed. With episodic manifestations of the disease, tablets are taken as needed.

Zollinger-Ellison Syndrome involves individual selection of the dosing regimen. Initial dose - 60 mg / day; if necessary, it is doubled, divided into 2 doses.

For eradication Helicobacter pylori appointed so-called. triple therapy. It involves the parallel administration of 20 mg of rabeprazole with two - Clarithromycin (0.5 g) and Amoxicillin (1 g) twice a day. The duration of the course is 1 week.

Side effects of Ontime

Most patients tolerate this drug well.

In case of hypersensitivity to rabeprazole or additional components, allergic reactions are not excluded - skin rashes and itching, bronchospasm and angioedema.

In rare cases, the following side effects may occur:

Overdose

No cases of acute overdose have been reported.

Interaction of Ontime with other pharmacological drugs

Proton pump inhibitors can reduce the absorption and bioavailability of antifungal drugs (Itraconazole and Ketoconazole).

With the simultaneous administration of Ontime and Digoxin, the concentration of cardiac glycoside in plasma may moderately increase.

Ontime tablets during pregnancy and lactation

Rabeprazole does not have embryotoxic, teratogenic and mutagenic effects, but there is not enough data on its absolute safety for the fetus. . In this regard, Ontime is contraindicated for pregnant women at any gestational age.. The substance is excreted in breast milk. If it is necessary to conduct course therapy during lactation, the question is raised about the temporary transfer of the child to artificial feeding.

Additional instructions

Before the start of the course, a comprehensive diagnosis is required in order to exclude oncological diseases of the digestive tract. An antiulcer agent can “lubricate” the clinical symptoms of malignant tumors (in particular, gastric carcinomas), which makes it difficult to detect them in a timely manner.

Ontime can cause dizziness, weakness and decreased visual clarity. Therefore, at the time of treatment, patients are strongly advised to refrain from driving and other activities that require increased concentration.

Caution should be exercised when prescribing drugs to patients with severe renal insufficiency.

Rules for storage and dispensing in pharmacies

Ontime is on the list of potent drugs (list B), so it is available by prescription.

Preparation: TORENDO® KU-TAB
The active substance of the drug: risperidone
ATX encoding: N05AX08
CFG: Antipsychotic drug (neuroleptic)
Registration number: LS-002602
Date of registration: 29.12.06
The owner of the reg. credit: KRKA d.d. (Slovenia)

Release form Torendo ku-tab, 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 hydroxypropyl cellulose LH-21), aspartame, crospovidone, iron oxide red (E172), mint and menthol flavor, calcium silicate, magnesium stearate.

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

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

Pharmacological action Torendo ku-tab

Antipsychotic drug (neuroleptic).

Risperidone is a selective monoaminergic antagonist with a pronounced affinity for serotonergic 5-HT2 receptors and dopaminergic D2 receptors, it also binds to 1-adrenergic receptors and, with a slightly lower affinity, to H1-histaminergic and 2-adrenergic receptors. It 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 of the mesolimbic and mesocortical systems.

The sedative effect is due to the blockade of adrenoreceptors of 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. It causes less suppression of motor activity and induces catalepsy to a lesser extent than classical antipsychotics (neuroleptics).

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

Risperidone can cause a dose-dependent increase in plasma prolactin concentration.

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 plasma concentration of risperidone 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 acid-1-glycoprotein. The plasma protein-bound fractions of risperidone and 9-hydroxy-risperidone are 88% and 77%, respectively.

Metabolism

Risperidone is metabolized with the participation of the isoenzyme of the cytochrome P450 IID6 system with the formation of 9-hydroxy-risperidone, which has a similar pharmacological effect.

Risperidone and 9-hydroxy-risperidone are an effective antipsychotic fraction. Further metabolism of risperidone is N-dealkylation. When administered 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 9-hydroxy-risperidone in most cases is achieved 3-4 days after the start of treatment.

breeding

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

Pharmacokinetics of the drug.

in special clinical situations

In elderly patients or patients with insufficient renal function, with a single use of the drug, high levels of active substance concentrations in plasma and their slow excretion are noted.

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 (arousal, delirium) or psychotic symptoms;

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

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

Dosage and method of application of the drug.

Torendo Ku-tab lozenges are fragile, they should not be squeezed through the packaging foil, as they may break. The package is opened by gently pulling on the edge of the blister foil, marked with a dot, and the tablet is removed, then it should be immediately put 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.

With schizophrenia

For adults and children over the age of 15 years, risperidone can be prescribed 1-2 times / 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 increase 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 at doses >16 mg / day has not been studied, doses above this level should not be used.

Information on the use of the drug for the treatment of schizophrenia in children under the age of 15 years is not available.

Patients with diseases of the liver and kidneys are recommended to use the drug at an initial dose of 0.5 mg 2 times / 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 / day (in an adequate dosage form). If necessary, the dose can be individually increased by 0.25 mg 2 times / day, no more than every other day. For most patients, the optimal dose is 0.5 mg 2 times / day. Some patients are shown the use of the drug 1 mg 2 times / day.

Upon reaching the optimal dose, it may be recommended to use the drug 1 time / day.

Mania in Bipolar Disorders

The recommended initial dose of the drug is 2 / 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

Patients weighing 50 kg are 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.

Patients weighing 50 kg are 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.

Prolonged use of the drug Torendo Ku-tab in adolescents should be carried out under the constant supervision of a physician.

Side effects of Torendo ku-tab:

From the side of 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), and hypervolemia (due to polydipsia or syndrome of inappropriate secretion of antidiuretic hormone), tardive dyskinesia (involuntary rhythmic movements predominantly of the tongue and / or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased levels of CPK), thermoregulatory disorders and epileptic seizures.

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

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

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

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

From the hemopoietic 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 under 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, myocardial infarction, cardiac muscle conduction disorders), dehydration and hypovolemia, cerebrovascular accident, Parkinson's disease, convulsions (including history), renal or severe liver failure, drug abuse or drug dependence, conditions predisposing to the development of torsades de pointes (bradycardia, electrolyte imbalance, concomitant use of drugs that prolong the QT interval), brain tumors, intestinal obstruction, cases of acute drug overdose, Reye's syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions).

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 intended benefit to the mother outweighs the potential risk to the fetus.

Since risperidone and 9-hydroxy-risperidone are excreted in breast milk, if necessary, the use of the drug during lactation should decide whether to stop breastfeeding.

Special instructions for the use of Torendo ku-tab.

In schizophrenia, at the beginning of treatment with risperidone, it is recommended to gradually withdraw previous therapy, if clinically warranted. If patients are transitioning from depot antipsychotic therapy, it is recommended that risperidone be initiated instead of the next scheduled injection. The need to continue therapy with anti-Parkinsonian drugs should be periodically assessed.

In connection with the β-adrenergic blocking effect of risperidone, orthostatic hypotension may occur, especially during the initial dose selection. If arterial hypotension occurs, dose reduction should be considered. In patients with diseases of the cardiovascular system, as well as dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually, according to the recommendations.

The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If signs and symptoms of tardive dyskinesia occur, consideration should be given to discontinuing all antipsychotics.

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

With the abolition of carbamazepine and other inducers of hepatic enzymes, the dose of risperidone should be reduced.

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

Pediatric use

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

Influence on the ability to drive vehicles and control mechanisms

During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, as well as from taking 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 free airway patency to ensure adequate oxygenation and ventilation, gastric lavage (after intubation if the patient is unconscious) and administration of activated charcoal in combination with laxatives. Symptomatic therapy aimed at maintaining the vital functions of the body.

For the timely diagnosis of possible cardiac arrhythmias, it is necessary to start ECG monitoring as soon as possible. Careful medical supervision and ECG monitoring is carried out until the symptoms of intoxication disappear completely. 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, there was a decrease in the concentration of the active antipsychotic fraction of risperidone in plasma. Similar effects may be seen with other hepatic enzyme inducers.

Phenothiazines, tricyclic antidepressants and some β-blockers can 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.

With the simultaneous use of risperidone with drugs that are highly bound to plasma proteins, there is no clinically significant displacement of any drug from the plasma protein fraction.

Antihypertensive drugs increase the severity of blood pressure reduction against the background of risperidone.

Conditions of sale in pharmacies.

The drug is dispensed by prescription.

Terms of the storage conditions of 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.

LS 002602 dated 12/29/2006
Trade name of the drug: Torendo ® Ku-tab

International non-proprietary name:

risperidone

Dosage form:

lozenges

Compound
1 tablet contains:
active substance: risperidone - 0.5 mg, 1 mg or 2 mg.
Excipients: mannitol, butyl methacrylate copolymer basic, povidone, microcrystalline cellulose, hyprolose (low-substituted hydroxypropyl cellulose, LH-21), aspartame, crospovidone, iron oxide red dye (E 172), mint flavor, menthol flavor, calcium silicate, magnesium stearate.

Description
Tablets 0.5 mg, 1 mg and 2 mg: round, slightly biconvex tablets of light pink color with visible patches.

Pharmacotherapeutic group:

antipsychotic (neuroleptic).
ATX CODE N05AX08.

Pharmacological properties
Pharmacodynamics
Risperidone is an antipsychotic agent, also has a sedative, antiemetic and hypothermic effect. Risperidone is a selective monoaminergic antagonist with a pronounced affinity for serotonergic 5-HT2 and dopaminergic D2 receptors, it also binds to alpha1-adrenergic receptors and, with a slightly lower affinity, to H1-histaminergic and alpha2-adrenergic receptors. It does not have tropism for cholinergic receptors.
The antipsychotic effect is due to the blockade of dopamine D2 receptors of the mesolimbic and mesocortical systems.
The sedative effect is due to the blockade of adrenoreceptors of the reticular formation of the brain stem; antiemetic action - blockade of dopamine D2 receptors of the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus.
Reduces productive symptoms (delusions, hallucinations), automatism. It causes less suppression of motor activity and induces catalepsy to a lesser extent than classical antipsychotics (neuroleptics).
Balanced central serotonin and dopamine antagonism may reduce the risk of extrapyramidal symptoms.
Risperidone can cause a dose-dependent increase in plasma prolactin concentration.

Pharmacokinetics
When taken orally, risperidone is completely absorbed (regardless of food intake) and maximum plasma concentrations are observed after 1-2 hours.
Risperidone is metabolized by cytochrome P-450 IID6 to form 9-hydroxy-risperidone, which has a similar pharmacological action. Risperidone and 9-hydroxy-risperidone are an effective antipsychotic fraction. Further metabolism of risperidone is N-dealkylation. When taken orally, risperidone is eliminated with an elimination half-life of about 3 hours. The half-life of 9-hydroxy-risperidone and the active antipsychotic fraction has been found to be 24 hours.
In most patients, the equilibrium concentration of risperidone is observed one day after the start of treatment. The equilibrium state of 9-hydroxy-risperidone is in most cases achieved within 3-4 days after the start of treatment.
The plasma concentration of risperidone is proportional to the dose of the drug (within therapeutic doses).
Risperidone is rapidly distributed in the body. The volume of distribution is 1-2 l/kg. In plasma, risperidone is bound to albumin and acidic alpha-1-glycoprotein. The plasma protein-bound fraction of risperidone is 88% and 77%, respectively, for 9-hydroxy-risperidone.
Excreted by the kidneys - 70% (of which 35-45% in the form of a pharmacologically active fraction) and 14% with bile. With a single dose, high levels of active plasma concentrations and slow excretion in elderly patients and patients with insufficient renal function are noted.

Indications for use

• schizophrenia (acute and chronic) 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 (arousal, delirium) or psychotic symptoms;
• as adjuvant therapy in the treatment of mania in bipolar disorders;
• as an adjunct therapy for behavioral disorders in adolescents from 15 years of age and adult patients with a reduced intellectual level or mental retardation, in cases where destructive behavior (aggressiveness, impulsivity, auto-aggression) is leading in the clinical picture of the disease.

Contraindications
Hypersensitivity to the components of the drug; lactation period, children under 15 years of age (efficacy and safety have not been established).
Carefully:

• Diseases of the cardiovascular system (chronic heart failure, myocardial infarction, conduction disorders of the heart muscle)
• dehydration and hypovolemia
• cerebrovascular accident
• Parkinson's disease
• convulsions (including history)
• severe renal or hepatic insufficiency (see dosage recommendations)
• drug abuse or drug dependence (see dosing recommendations)
• conditions predisposing to the development of pirouette-type tachycardia (bradycardia, electrolyte imbalance, concomitant use of drugs that prolong the QT interval)
• brain tumor, intestinal obstruction, cases of acute drug overdose, Reye's syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions)

Use during pregnancy and lactation. The safety of risperidone in pregnant women has not been studied. During pregnancy, it can be used only if the positive effect justifies the possible risk.
Since risperidone and 9-hydroxy-risperidone are excreted in breast milk, women using the drug should not breast-feed.

Dosage and administration
Torendo ® Ku-tab for resorption are fragile, they should not be squeezed out through the packaging foil, because. they may break. The package is opened by gently pulling on the edge of the blister foil, marked with a dot, and the tablet is removed, then it should be immediately put on the tongue. The tablet begins to dissolve in the mouth within seconds and can be swallowed without water and should not be mixed in the mouth with food. The tablet should not be crushed or chewed.
Schizophrenia.
Adults and children over 15 years old. Risperidone may be given once or twice a day. The initial dose is 2 mg per day. On the second day, the dose should be increased to 4 mg per day. From this point on, the dose can either be kept at the same level or individually adjusted if necessary. Usually the optimal dose is 4-6 mg per day. In some cases, a slower 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 should not be used.
Information on the use of the drug for the treatment of schizophrenia in children under 15 years of age is not available.
Elderly patients. An initial dose of 0.5 mg twice a day is recommended. The dosage can be individually increased by 0.5 mg twice a day to 1-2 mg twice a day.
Diseases of the liver and kidneys. The recommended starting dose is 0.5 mg twice a day. This dose can be gradually increased to 1-2 mg twice a day.
Drug abuse or drug dependence- The recommended daily dose of the drug is 2-4 mg.
Behavioral disorders in patients with dementia.
A starting dose of 0.25 mg twice daily is recommended (an adequate dosage form should be used). The dosage, if necessary, can be individually increased by 0.25 mg 2 times a day, no more than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, some patients are shown taking 1 mg 2 times a day.
Upon reaching the optimal dose, it may be recommended to take the drug once a day.
Mania in Bipolar Disorders
The recommended initial dose of the drug is 2 mg per day at a time. If necessary, this dose can be increased by 2 mg per day, no more than every other day. For most patients, the optimal dose is 2-6 mg per day. Behavioral disorders in patients with mental retardation
Patients weighing 50 kg or more- The recommended initial dose of the drug is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg per day, no more than every other day. For most patients, the optimal dose is 1 mg per day. However, for some patients, 0.5 mg per day is preferable, while some require an increase in dose to 1.5 mg per day.
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 per day, no more than every other day. For most patients, the optimal dose is 0.5 mg per day. However, for some patients, 0.25 mg per day is preferable, while others require an increase in dose to 0.75 mg per day.
Long-term use of Torendo ® Ku-tab in adolescents should be carried out under the constant supervision of a physician.
Use in children under 15 years of age is not recommended.

Side effect
From the 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 (either due to polydipsia or due to a syndrome of inappropriate antidiuretic hormone secretion), tardive dyskinesia (involuntary rhythmic movements predominantly of the tongue and/or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased levels of creatine phosphokinase), thermoregulatory disorders and epileptic seizures.
From the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of "liver" transaminases, dry mouth, hypo- or hypersalivation, anorexia and / or increased appetite, increase or decrease in body weight.
From the side of the cardiovascular system: sometimes orthostatic hypotension, reflex tachycardia or increased blood pressure.
From the side of the hematopoietic organs: neutropenia, thrombocytopenia.
From the endocrine system: galactorrhea, gynecomastia, menstrual disorders, amenorrhea, weight gain, hyperglycemia and exacerbation of pre-existing diabetes mellitus.
From the genitourinary system: priapism, erectile dysfunction, ejaculation disorder, anorgasmia, urinary incontinence.
Allergic reactions: rhinitis, rash, angioedema, photosensitivity.
From the side of the skin: dry skin, hyperpigmentation, itching, seborrhea.
Others: arthralgia.

Overdose
Symptoms: drowsiness, sedation, depression of consciousness, tachycardia, arterial hypotension, extrapyramidal disorders, in rare cases, prolongation of the QT interval, Treatment: it is necessary to ensure free airway patency to ensure adequate oxygenation and ventilation, gastric lavage (after intubation, if the patient is unconscious ) and the appointment of activated charcoal in combination with laxatives. Symptomatic therapy aimed at maintaining the vital functions of the body.
For the timely diagnosis of possible cardiac arrhythmias, it is necessary to start ECG monitoring as soon as possible. Careful medical supervision and ECG monitoring is carried out until the symptoms of intoxication disappear completely. There is no specific antidote.

Interaction 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 with alcohol.
Risperidone reduces the effectiveness of levodopa and other dopamine agonists.
Clozapine reduces the clearance of risperidone.
When using carbamazepine, there was a decrease in the concentration of the active antipsychotic fraction of risperidone in plasma. Similar effects may be seen with other hepatic enzyme inducers.
Phenothiazines, tricyclic antidepressants and some β-blockers can 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 using risperidone together with other drugs that are highly bound to plasma proteins, there is no clinically significant displacement of any drug from the plasma protein fraction.
Antihypertensive drugs increase the severity of lowering blood pressure against the background of risperidone.

special instructions
Switching from therapy with other antipsychotic drugs. In schizophrenia, at the beginning of treatment with risperidone, it is recommended to gradually withdraw previous therapy if clinically warranted. If patients are transitioning from depot antipsychotic therapy, it is recommended that risperidone be started instead of the next scheduled injection. The need to continue therapy with anti-Parkinsonian drugs should be periodically assessed. In connection with the a-adrenergic blocking effect of risperidone, orthostatic hypotension may occur, especially during the initial dose selection. If hypotension occurs, dose reduction should be considered. In patients with diseases of the cardiovascular system, as well as dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually, according to the recommendations (see Dosage and Administration).
The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If signs and symptoms of tardive dyskinesia occur, consideration should be given to discontinuing all antipsychotics. If a neuroleptic malignant syndrome occurs, characterized by hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness, and an increase in the level of creatine phosphokinase, all antipsychotic drugs, including risperidone, should be discontinued.
With the abolition of carbamazepine and other inducers of "liver" enzymes, the dose of risperidone should be reduced.
Patients should be advised to refrain from overeating due to the possibility of weight gain.
During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, as well as from drinking alcohol.

Release form
Lozenges of 0.5 mg, 1 mg and 2 mg. 10 tablets in a blister. 3 blisters in a cardboard box along with instructions for use.

Best before date
2 years.

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

Holiday conditions
On prescription.

Manufacturer
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

For all questions, please contact the representative office in the Russian Federation
123022, Moscow, st. 2nd Zvenigorodskaya, 13, building 41.

When packing and / or packaging at a Russian enterprise, it is indicated:
LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moscow,