Tsefekon d from. Cefecon d suppositories: instructions for use

Cefekon - suppositories with analgesic and antipyretic effects. That is, these are candles that can relieve pain and heat. They are most often used for symptomatic treatment... Trade name of suppositories: Tsefekon D. The medicine is intended for children, in particular for newborns.

Antipyretic suppositories have a significant advantage: they do not affect the water-salt balance, thereby, they do not provoke or aggravate dehydration with fever. In addition, the drug is quickly excreted from the body. The composition of the product is quite safe for babies, which is also a plus.

Composition and form of release

Cefekon for children is available only in the form of candles. Torpedo suppositories are creamy white or yellow-white in color. The drug is available in several variations:

• 50 mg;
• 100 mg;
• 250 mg.

The product contains paracetamol as an active substance. This is a well-known non-steroidal anti-inflammatory agent that can relieve pain and bring down the temperature.

There is only one auxiliary component - witepsol. This substance is the basis for the manufacture of suppositories. Therefore, we can say that only paracetamol "works" in Tsefekon D candles. The lightweight composition allows the drug to be effective and not injure the child's body.

Important! The drug takes effect 15-30 minutes after application. It gradually reduces fever to prevent fainting.

The description from the manufacturer says that the drug can be used to get rid of fever (temperature) after vaccination. Only in this situation are Tsefekon candles allowed for children under 3 months old. But you can use suppositories after vaccination only 1 time. Despite its safe composition, the drug is not used to treat newborns. What do suppositories help with?

General indications for use:

• diseases accompanied by elevated temperature (ARVI, flu, various infections);
• pain syndromes of low or moderate intensity.

Cefekon D for children can be used to relieve toothache or headache, with burns and severe injuries. The drug is also used to relieve muscle discomfort. It should be understood that this medicine is not able to cure the disease, it only fights the symptoms. Therefore, candles can be safely included in complex therapy viral and infectious pathologies.

Over time, the medication is able to completely stop the pain, which is also its great advantage.

Contraindications

The drug is prohibited for use in children with individual intolerance to the active substance, as well as in patients under 1 month of age. It should be used with caution by people with diseases of the organs of the excretory system (liver, kidneys). The medicine is not recommended for use in patients with glucose enzyme deficiency and blood diseases (leukopenia, anemia).

Important! Candles do not have any negative effect on duodenum and stomach, so they can be used for vomiting.

People with Gilbert's syndrome also need to use Cefecon with great caution.

Before using Cefekon candles for children, the instructions must be studied by the parents. You can use suppositories only after an enema or natural bowel movement.

For an enema, you can use plain warm water or a soothing solution with chamomile.

Tsefekon D instructions for use

Duration of treatment: 5 days as an anesthetic, 3 days to get rid of the temperature. If after a week does not come desired effect, then you need to contact a specialist. The course of treatment can also be extended on the advice of a doctor.

Important! Suppositories cannot be held in hand for a long time, they must be injected immediately after being removed from the package. Candles from body temperature begin to melt. Therefore, they also dissolve quickly in the rectum.

A small child (up to 3 months) can be administered 1 suppository in a minimum dose of 50 mg. After using the candle, you need to carefully monitor the baby's well-being, since there is a high risk of allergic reactions on the skin or mucous membranes.

Side effects

You need to be careful with Tsefekon candles, since many children experience side effects after using them. If the child does not feel well after the first use of suppositories, then the course of treatment should be suspended.

Common side effects that are normal:

• nausea;
• diarrhea;
• stomach ache.

It is not normal for a child to vomit or become anemic. You should also be on your guard if there are signs of allergies: itching, swelling, rashes. The manufacturer does not provide data on overdose, so you need to be careful.

Advice! Use suppositories correctly, carry out all hygiene procedures before the introduction of suppositories and observe the dosage.

Storage conditions, cost and analogues

It is imperative to follow the rules for storing Tsefekon candles. Keep them in a dry place out of the reach of children. Store no more than 2 years at a temperature not exceeding 20 degrees.

The price of the drug is budgetary, especially for antipyretics. The medicine can be purchased for 50-100 rubles at almost any pharmacy. It is also sold on the Internet. Before ordering a drug, you need to carefully look at its photo. Many virtual stores sell fake pacifiers.

Cefekon candles do not have many analogues:

• Paracetamol in the form of candles ( full analog drug for children Tsefekon) - from 40 rubles.
• Paracetamol-Alfarm (this remedy can be used for children, adolescents and adults) - from 45 rubles.
• Children's Panadol (candles for kids and adults) - from 70 rubles.

All analogs of cefekon candles have almost the same effect. They relieve pain syndromes and lower fever.

Cefekon D is a drug that really needs to be kept in the medicine cabinet if there are small children in the house. The tool has very good composition, mild effect and minimum contraindications.

Video

From the moment of birth, the baby's immune system is constantly tested. The fact is that the habitat of the crumbs is not sterile and, accordingly, the child encounters foreign bacteria and microorganisms every day. However, this is exactly how the formation immune system, which in the future will protect the entire body. In order to support the body's defenses, you can additionally give.

Unfortunately, not all pathogens are able to cope with immunity... Some pathogens still cause infection of the body, and then specific treatment is already needed. One of the body's reactions to inflammation is an increase in body temperature. Small child not yet able to take antipyretic tablets. Therefore, other forms come to the rescue. Cefekon in the form of suppositories perfectly copes with heat in the youngest patients. This drug is made on the basis of paracetamol. The rectal form of administration allows the use of an antipyretic from a very young age.

Cefekon comes in the form of suppositories for rectal administration... The color can range from white to cream. The shape is rounded, which makes the insertion less uncomfortable. It should be stored in a cool place to avoid deformation, which makes it difficult to use.

Composition

Cefekon - candles for children with an extremely simple composition. The basis for the formation of the suppository is the fatty base (solid). Each candle weighs 1.25 g. Paracetamol is used as an active ingredient. Various dosages are available: 50 mg, 100 mg and 250 mg.

Operating principle

It is very difficult to answer the question of how quickly Cefekon works - candles for children... The fact is that it depends not so much on the effect of paracetamol on the body itself, but on individual characteristics. For some, half an hour is enough for a pronounced effect to appear, while others will not have it at all.

This tool belongs to aspirin-like drugs. It has a pronounced antipyretic and analgesic effect. However, the anti-inflammatory effect is rather weak. The mechanism of action is associated with the inhibition of the synthesis of prostaglandins, as well as the effect on the centers of pain and thermoregulation in the hypothalamus. When it enters the focus of infection, a certain amount of the active substance is destroyed. First of all, this is what causes a weak anti-inflammatory effect.

The main positive point is the non-toxicity of the drug. It does not have a negative effect on the gastrointestinal tract, unlike many other non-steroidal anti-inflammatory drugs. The intestinal mucosa is not damaged, which makes the use safe for the little ones.

Absorption of paracetamol with rectal administration is slower than with oral administration. However, at the same time, it is complete. The maximum concentration in blood plasma is reached two to three hours after administration. This is the answer to the question of interest to many, how long does Cefekon - candles for children work.

The active ingredient is fairly evenly distributed in the body, because the concentration in saliva, blood plasma and intercellular fluid is approximately the same. The ability to bind to plasma proteins is rather weak.

Paracetamol metabolization occurs mainly in the liver with the formation of inactive compounds. Excretion from the body occurs through the kidneys. Moreover, ninety percent of the substance is excreted on the first day after ingestion. It is important to understand that with a serious degree renal failure elimination of the drug and its decay products can be significantly slowed down.

Indications

A rise in temperature to fairly high levels is not unusual for babies under three years old. The fact is that their thermoregulation is still imperfect, and therefore the slightest inflammatory process can cause fever.

The antipyretic effect is necessary in the case of:

• acute respiratory viral infections (in combination with);
• influenza conditions;
• unpleasant adverse reactions after vaccinations, especially in the case of complex vaccines;
• children's infectious diseases (chickenpox, rubella, etc.);
• period of teething.

An analgesic effect is necessary for:

• muscle pain;
• neuralgia;
• pain during teething;
• headaches caused by intoxication with an infectious or viral disease;
• trauma;
• burns.

At what age is it allowed to take

Tsefekon D - candles for children, the instruction is allowed to be used from one month of age. The main criterion is the weight of the small patient: it should not be lower than four kilograms.

For children from three months to twelve years old, the drug is used for the symptomatic treatment of diseases that are accompanied by an increase in temperature, as well as painful sensations low and medium intensity. For babies from one month to three, a single use is allowed immediately after vaccination.

Contraindications

A categorical contraindication to unauthorized use of the drug is the age of the crumbs up to a year, especially for newborns. For such small patients, a visit to the pediatrician is necessary, and only he can decide on the need for treatment.

The remedy is contraindicated for:

• diagnosed hypersensitivity to the main active ingredient - paracetamol;
• diseases associated with the process of hematopoiesis;
• severe renal failure, as well as impaired liver function;
• diabetes mellitus (paracetamol can affect insulin sensitivity and cause a drop in blood sugar);
• violation of the integrity of the rectal mucosa and problems with defecation;
• genetic diseases.

Side effects

The immune system

Anaphylactic shock, possibly the development of Quincke's edema, redness, rash, swelling skin, erythema, tissue necrolysis due to the action of the drug.

Hematopoietic organs

Leukopenia hemolytic anemia, sulfhemoglobinemia, neutropenia, thrombocytopenia, methemoglobinemia, characterized by shortness of breath, severe cyanosis and pain in the heart.

Respiratory system

Bronchospasm may develop if hypersensitivity to non-steroidal anti-inflammatory drugs.

Gastrointestinal tract

Nausea, gagging, pain in the stomach, abnormal liver function, usually without jaundice.

Endocrine system

In case of impaired glucose tolerance, hypoglycemia may develop, up to coma.

Local side effects

Irritation at the injection site (anus, rectum).

If any negative symptom occurs, you must immediately stop taking the drug and seek the advice of a pediatrician.

Instructions for use and dosage

First of all, it is important to understand that the drug is used only under the supervision of a pediatrician. It is necessary to approach this issue with extreme caution when the patient is less than a year old.

The tool is used rectally. Suppositories cannot be split to obtain the required dosage. If, when calculating the required amount of a substance per day in relation to body weight, a single dosage is less than what is contained in the suppository, then after consulting a specialist, another form of medicine should be chosen. For example, .

The recommended dose of paracetamol per day is 60 mg per kilogram of body weight. It must be evenly distributed over four doses. Thus, a single dose is 15 mg per kilogram of body weight, which must be taken after a six-hour break.

When treating a child, it is necessary to strictly follow the permissible dosage and maintain the required number of hours between doses. Cefekon 250 mg - candles for children, the instruction suggests using from a weight of 17 kg, 1 suppository four times a day. If the child's weight exceeds 30 kg, then the number of suppositories is increased to two at a time.

Suppositories Cefekon 100 mg for children, the instruction prescribes to use from three months to three years. At the same time, the minimum allowable weight must be no less than four kilograms. In view of the peculiarities of the dosage form, which suggests the risk of local toxicity, it is undesirable to use more than four suppositories per day. At the same time, the duration of use should be minimal.

With severe renal failure, the interval between the use of suppositories should be at least eight hours. In numerical terms, this condition is characterized by creatinine clearance less than 10 mg per minute. At the age of one to three months, a single injection of a suppository at a dosage of 50 mg is permissible immediately after vaccination in order to lower body temperature.

Overdose

To avoid overdose, do not use in parallel other drugs containing paracetamol. This is especially dangerous for babies, there are frequent cases of drug overdose, as well as accidental poisoning. It can even be fatal.

In patients whose weight is less than thirty-seven kilograms, the dose should not exceed 80 mg per kilogram of body weight per day. If the weight is from thirty-eight to fifty kilograms, then the daily dose of paracetamol should not exceed three grams. With a body weight over fifty kilograms, the maximum daily dose should be less than four grams.

A single dose of 150 mg per kilogram of mass can cause: liver failure, impaired glucose metabolism, metabolic acidosis, hemorrhage, hypokalemia, encephalopathy and even death. Wherein characteristic feature is an increase in the level of hepatic transaminase, bilirubin and lactate dehydrogenase.

During the day and a half after administration, the level of prothrombin decreases. Acute renal failure, characterized by tubular necrosis in acute form, can cause sharp pain in the lumbar region, hematuria, proteinuria and develop even in the absence of severe liver damage. In addition, there have been cases of arrhythmia and acute pancreatitis.

When long-term use the drug in high doses from the hematopoietic system can develop: aplastic anemia, pancytopenia, neuropenia, leukopenia and thrombocytopenia.

In patients with a tendency to liver disease, taking a daily dosage of more than 5 g can lead to toxic damage to this organ. The pathological condition can develop within 12 to 48 hours. In case of overdose, you must immediately go to the hospital, even if early signs the toxic effect of the agent on the body is still absent.

Interaction with other drugs

The maximum doses of paracetamol (4 g per day) enhance the effect of anticoagulants for four days after the end of their use.

The rate at which paracetamol is absorbed may be slightly increased by metroclopramide and domperidone, and decreased by cholestyramine. Barbiturates can significantly reduce the antipyretic effect of the drug. Anticonvulsants can increase the toxic effects of paracetamol on the liver. It also reduces the effectiveness of diuretics.

Analogs

The main analogues of Tsefekon:

• Paracetamol capsules 325 mg;
• Paramax suppositories 150 mg and 80 mg;
• Panadol suspension 120 mg in 5 ml;
• Rapidol rectal solution 125 mg in 2.5 ml.

Cefekon - antipyretic
and anesthetic.

Pharmacological action of Tsefekon

The drug belongs to the group of non-narcotic analgesics.

The active ingredient is paracetamol. Its mechanism of action is to block the enzyme cyclooxygenase at the level of the center of thermoregulation in the brain. This reduces the production of prostaglandins, substances that cause inflammation, and also returns the thermoregulatory threshold to normal levels. Due to this, Cefekon has an antipyretic and analgesic effect without changing normal temperature body. In tissues, cellular peroxidase enzymes destroy paracetamol, so its anti-inflammatory effect is insignificant.

The use of Cefekon does not retain excess water and sodium ions in the body, does not adversely affect the mucous membrane of the stomach and intestines.

From rectal suppositories, paracetamol is absorbed into the arterial network of the rectum. The maximum concentration of the drug in the blood accumulates after 0.5 - 1 hour. It is able to penetrate the blood-brain and placental barriers.

The transformation of the drug into inactive metabolites occurs in the liver. Compared with analogues of Cefekon for oral administration, with rectal intake, the first passage of paracetamol bypasses the liver. Due to this, the drug load on her with this method of administration is reduced. Excretion of drug metabolites occurs through the kidneys in the urine.

Release form

According to the instructions, Cefekon is produced in rectal suppositories containing 50, 100 or 250 mg of paracetamol.

Indications for the use of Cefekon

The drug is used in children aged 3 months to 12 years to lower body temperature in case of acute respiratory diseases and childhood infections (measles, chickenpox, scarlet fever), with fever in the post-vaccination period. It helps to eliminate such unpleasant accompanying symptoms like headache and muscle pain.

There are good feedback about Cefekon as a pain reliever during teething.

Contraindications

Do not use the drug in case of individual intolerance, inflammatory processes in the rectum or bleeding from it, in children under 1 month.

Use Cefekon with caution in the pathology of hematopoietic organs (anemia, neutropenia), congenital deficiency of glucose-6-phosphate dehydrogenase.

Despite the fact that the composition of Cefekon is safe for use in children from the very early age , to reduce the temperature after vaccinations at the age of 1 to 3 months, it is used only once under the supervision of a doctor.

Instructions for using Tsefekon

Suppositories are better
insert into the rectum after emptying it or a cleansing enema. The rectal form is especially convenient for young children who have difficulty swallowing medicines at a temperature or if the disease is accompanied by vomiting.

The dosage depends on the child's age and body weight. On average, it is 10-15 mg / kg / day, the interval between the use of suppositories is 4-6 hours.

Single dose: 50 mg suppositories are inserted for children from 1 to 3 months, rectal suppositories with a dosage of 100 mg are suitable for children from 1 to 3 months, from 1 to 3 years, 1 - 2 suppositories of 100 mg, from 3 to 10 years - 250 mg , from 10 to 12 years, 2 suppositories of 250 mg.

The maximum allowable dose is 60 mg / kg / day. It is impossible to divide the suppository due to the possible uneven distribution of paracetamol in its base.

As an antipyretic without consulting a doctor, Tsefekon is used according to instructions for no longer than 3 days, as an anesthetic - up to 5 days. The doctor can extend the course if necessary.

Cefekon is undesirable to use simultaneously with salicylates - toxic kidney damage is possible... The drug enhances the effect of indirect anticoagulants.

Side effects

According to reviews, Cefekon can cause allergic reactions, nausea, abdominal pain, a decrease in the content of hemoglobin, platelets and leukocytes in the blood.

Yours faithfully,

Antipyretic drugs should be present in every first-aid kit, especially when a newborn baby has appeared in the family. Sometimes it happens very quickly. This condition may be associated with colds, infection or. In such cases, an immediate antipyretic drug is needed. Cefekon - candles for children (instructions for use are below), can help out in this situation.

Suppositories are the most demanded and popular, but they are not suitable for all children. They will quickly relieve the child of fever, are cheap. The price ranges from 39 to 49 rubles. Let's find out if it is worth buying a rectal suppository called Cefekon.

Principle of action, composition and correct administration

Cefekon belongs to the group of analgesic not drugs... The active ingredient paracetamol blocks cyclooxygenase in the central nervous system... In turn, the central nervous system acts on the center from which pain emanates. The drug maintains body temperature within certain limits. The rectal suppositories contain an additional component of witepsol.

The medicine is sold in different dosages. Pharmaceutical companies release a product active substance which is dosed at 50,100 and 250 mg. This dosage is convenient to use, there is no need to cut the candle if you need a smaller amount of the active ingredient.

Attention! Cefekon is used only rectally.

How to light candles for newborns and adults? They are inserted into the anus. Before using the suppository, you should empty the intestines, it can be spontaneous or with an enema. After emptying, lay the child on one side, pull the legs to the stomach in such a way that it is convenient to inject the product. After the candle has already entered the anus, squeeze the baby's buttocks and ask them to lie down for a while in this position.

Dosage for newborns and children under 12 years of age

The dosage regimen depends on the child's body weight. In the annotation to the drug (instructions for use) it is written that it is used once or repeatedly.

Important! The action of Tsefekon lasts from 4 to 6 hours.

Suppositories, which I release at 50 mg, are prescribed for newborns from 1 to 3 months. Suppositories of 100 mg (1 pc.) Are prescribed at the age of 3 months to 1 year. A child 1-3 years old, weighing 11-16 kg is recommended to introduce 1-2 candles at a time.

At the age of 3 to 10 years, the maximum daily dose is 750 mg. That is, 3 candles are injected from a temperature of 0.25 g each, maintaining 6 hours between the next injection. Children from 10 to 12 years old, whose weight exceeds 30 kg, are prescribed 2 suppositories of 0.25 g (500 mg) each.

How often can Cefekon rectal suppositories be used? In a single dose, the agent is administered 2-3 times a day, every 4-6 hours. Maximum 60 mg / kg body weight can be used.

How long does Cefekon work? The effect of the drug begins to be felt 30 minutes after administration.

Indications and contraindications for use

Antipyretic suppositories are used for children under 12 years old. The remedy is taken for any viral and infectious diseasescausing the temperature. Indications for use:

• smallpox;
• acute respiratory infections;
• post-vaccination period;
• headache;

Cefekon D is effective for myalgia, lumbago, degenerative-dystrophic diseases of the musculoskeletal system. Rectal suppositories are contraindicated for newborns who are less than 1 month old. It should be taken with caution in anemia and neurotropenia. The drug reduces hemoglobin.

Also, candles from the temperature cannot be given to a child with intolerance to the main active substance, the presence inflammatory process in the rectum. You can not use Cefecon with congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Side effects after using rectal suppositories, they rarely occur. However, there have been cases allergic reaction, nausea and, pain in abdominal... manifests itself as a rash on the skin, itching and hives. Isolated cases of thrombocytopenia and neurotopenia.

Attention! Stop using the product if the child becomes drowsy and slow.

The use of drugs in high doses causes an overdose. In such a situation, a dyspeptic phenomenon or hepatotoxic effect is possible.

The hepatotoxic effect increases with simultaneous use with inducers of microsomal liver enzymes (Phenytoin, Ethanol, Phenylbutazone). Absorption of paracetamol decreases when anticholinergics are used with Cefecon, and increases when combined with Metoclopramide.

The activity of the drug is reduced by adsorbing agents. For example, activated carbon and atoxil. In the case of a combination of Tsefekon with anti-tuberculosis drugs, toxic damage to the body occurs.

Important! Rectal suppositories cannot be used simultaneously with salicylates, so as not to cause nephrotoxic effects.

Combination of Cefekon with Nurofen

Helps from high temperature and for various pains. The difference between the funds is active substance... Can Nurofen and Cefekon be given at the same time? To this question, most pediatricians will answer that it is impossible. Reception of drugs is alternated, but it is not recommended to give at the same time. The appearance of unwanted side effects and a sharp drop in temperature. Every parent should know how to alternate Nurofen and Cefekon. At least 4 hours should pass between taking one of the antipyretic drugs.

How long after Nurofen can you give Cefekon? These drugs based on ibuprofen and paracetamol can be alternated with a break of two hours. However, do not forget about daily rate each of them. Nurofen's action lasts up to 8 hours. It is given no more than 3 times a day. Between his receptions, you can give Cefekon.

Candles Cefekon or Nurofen: which is better? The body of each child is individual. For some, the first remedy is suitable, for others it is better to use the second remedy. If you choose between candles, then Cefekon is better, since it can be used from the first month, and Nurofen from the third.

Cefekon or Panadol

Suspension Panadol has a pleasant taste. However, not all children like him. Panadol -, therefore, it cannot be alternated with Tsefekon. An overdose may appear. They take either one or the other. At the same time prohibited.

Panadol or Tsefekon: which is better? Comparing the reviews of the two remedies, it is safe to say that parents are inclined to use Cefekon. Panadol does not help many children. They begin to gag, cough, or spit them out. Alternative way lowering the temperature - candles with paracetamol. The child will not spit them out, and they will surely help. Cefekon is not absorbed into the stomach and does not affect the liver or kidneys, unlike Panadol.

Attention! Rectal suppositories bring down the temperature faster than suspensions.

And if you choose between Panadol baby and Tsefekon candles, the first option is better, because its effect is stronger.

What can replace rectal suppositories (analogues)

Candles can be replaced medicines in various forms... Tsefekon's analogs in suppositories:

• Panadol;
• Mexalen;
• Nurofen;
• Apotel.

Children from one year old can be given suspensions. They come in a variety of flavors. For example, Calpol, Flukoldeks, Imifol, Tylenol for babies and others. For older children, pills are prescribed (Efferalgan, Paracetamol-S-Hemofarm, Apap, Coldfree, Saridon, Padeviks, Antigrippin).

Identification and classification

Registration number

International non-proprietary name

paracetamol

Dosage form

rectal suppositories (for children)

Composition

One suppository contains:

active substance- paracetamol 50 mg; 100 mg; 250 mg;

excipients: solid fat (Witepsol (brands H 15, W 35), Supposir (brands NA 15, NAS 50)) - until a suppository weighing 1.25 g is obtained.

Description

Torpedo-shaped suppositories, white or white with a yellowish or creamy shade. Appearance is allowed white bloom on the surface of the suppository.

Pharmacotherapeutic group

Analgesic non-narcotic drug

Pharmacological properties. Pharmacodynamics

Paracetamol has analgesic and antipyretic effects. The exact mechanism of action of paracetamol has not been established. Apparently, it includes central and peripheral components. It is known that the drug blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. The duration of the analgesic action is 4-6 hours, the antipyretic action is at least 6 hours. In the inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the absence of a significant anti-inflammatory effect.

The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues leads to the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacological properties. Pharmacokinetics

When administered rectally, paracetamol is well absorbed from the rectum (68-88%); the maximum concentration in blood plasma is reached after 2-3 hours. Paracetamol weakly binds to blood plasma proteins. Penetrates the blood-brain barrier.

It is metabolized mainly in the liver with the formation of glucuronides and sulfates. A small part (4%) of paracetamol is metabolized by cytochrome P450 to form an active intermediate metabolite (N-acetylbenzoquinone imine), which under normal conditions is quickly rendered harmless by reduced glutathione and excreted in the urine after binding with cysteine \u200b\u200band mercapturic acid. However, with a massive overdose, the amount of this toxic metabolite increases.

The half-life in adults is 2.7 hours, in children - 1.5-2 hours; total ground clearance 18 l / h. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60-80%) and sulfate (20-30%); less than 5% is excreted unchanged.

In severe renal failure (creatinine clearance<10-30 мл/мин) выведение парацетамола несколько замедляется, а период полувыведения составляет 2-5,3 ч. Скорость выведения глюкуронида и сульфата у пациентов с тяжелой почечной недостаточностью в три раза ниже, чем у здоровых добровольцев.

The pharmacokinetics of paracetamol in elderly patients does not change; in children, only the half-life from blood plasma differs, which is somewhat shorter than in adults. In addition, in children under 10 years of age, paracetamol is excreted to a greater extent in the form of sulfate, and not glucuronide, which is typical for adult patients. Moreover, the total excretion of paracetamol and its metabolites in patients of all age groups is the same.

Indications for use

Used in children from 3 months to 12 years old as:

• antipyretic agent for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
• pain reliever for pain syndrome of mild to moderate intensity, including: headache and toothache, muscle pain, neuralgia, pain in trauma and burns.

In children from 1 to 3 months, a single dose of the drug is possible to lower the temperature after vaccination, the use of the drug for all indications is possible only as directed by a doctor.

If necessary, please consult your doctor before using the medicinal product.

Contraindications

• hypersensitivity to paracetamol or other components of the drug;
• neonatal period (up to 1 month);
• severe liver dysfunction (9 or more points on the Child-Pugh scale);
• rectal inflammation, rectal bleeding;
• deficiency of glucose-6-phosphate dehydrogenase.

Carefully

Severe renal failure (creatinine clearance less than 10 ml / min), liver failure (less than 9 points on the Child-Pugh scale), benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, chronic alcoholism, pregnancy, the period of breastfeeding, the simultaneous administration of other paracetamol-containing drugs.

Care should be taken when using the drug in patients with dehydration, hypovolemia, anorexia, cachexia and bulimia.

Do not use this medicine if your child has diarrhea!

Application during pregnancy and during breastfeeding

The experience of use in humans indicates that paracetamol, when taken orally in therapeutic doses, does not adversely affect the course of pregnancy or the health of the fetus and newborn. Paracetamol overdose during pregnancy does not increase the risk of congenital malformations. Reproductive toxicity studies after oral administration have not revealed teratogenic or fetotoxic potential. After careful assessment of the benefits and risks, paracetamol can be used throughout pregnancy. Paracetamol should not be used during pregnancy for long periods of time, in high doses, or in combination with other drugs, since the safety of use in these circumstances has not been established. Paracetamol can be used during pregnancy, however, it is advisable to use the minimum effective dose and the shortest possible course.

Paracetamol in small amounts passes into human breast milk, however, when using the drug in therapeutic doses, the effect on newborns / breastfed children is not expected.

There is limited evidence that drugs that inhibit the synthesis of cyclooxygenase / prostaglandin, including paracetamol, can lead to a decrease in female fertility due to an effect on ovulation that is reversible after stopping treatment. Since paracetamol is believed to inhibit prostaglandin synthesis, this could potentially reduce fertility, although this has not been demonstrated.

Method of administration and dosage

Rectally. After spontaneous emptying of the intestine or a cleansing enema, the suppository is released from the contour cell packaging and injected into the rectum. The dosage of the drug is calculated depending on age and body weight, in accordance with the table. A single dose is 10-15 mg / kg of the child's body weight; the interval between each dose should be at least 6 hours. The maximum daily dose of paracetamol (including with the simultaneous use of other paracetamol-containing drugs) should not exceed 60 mg / kg of the child's body weight.

Age		Single dose
1-3 months. In children under 3 months of age this drug is used once (1 suppository) in case of developing a fever against the background of vaccinations that are carried out at the age of 2 months. A drug applies only as directed by a doctor!	4-6 kg	1 suppository, 50 mg once. Only by doctor's prescription!
3-12 months	7-10 kg	1 suppository of 100 mg
1-3 years	11-16 kg	1-2 suppositories of 100 mg
3-10 years	17-30 kg	1 suppository 250 mg
10-12 years old	31-35 kg	2 suppositories 250 mg each

Duration of treatment: 3 days as an antipyretic and up to 5 days as an analgesic. Prolongation of the course, if necessary, after consulting a doctor.

Patients with impaired renal function

In case of impaired renal function, the time interval between taking the drug should be at least 8 hours with creatinine clearance less than 10 ml / min, at least 6 hours with creatinine clearance more than 10 ml / min.

Patients with impaired liver function

In patients with chronic liver diseases, including compensated ones, especially in patients with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver) or dehydration, the daily dose of paracetamol should not exceed 3 g / day.

If after treatment there is no improvement or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicinal product.

You should see your doctor if symptoms worsen or do not improve after 2-3 days of treatment.

Side effect

From the digestive system:abdominal pain, diarrhea, nausea, vomiting, tenesmus.

From the liver and biliary tract:liver failure, liver necrosis, hepatitis, increased activity of liver enzymes.

From the side of the hematopoietic organs: thrombocytopenia, anemia, leukopenia, neutropenia.

On the part of the cardiovascular system: decrease or increase in prothrombin index, decrease in blood pressure (as a symptom of anaphylaxis).

On the part of the skin and subcutaneous tissue:allergic reactions (skin rash, pruritus, urticaria, Quincke's edema), acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the immune system: anaphylactic shock.

Local reactions:irritation of the rectal mucosa, irritation in the anal canal.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

The overdose threshold can be reduced in children, in patients suffering from malnutrition, the elderly, patients with liver diseases, chronic alcoholism, in patients taking inducers of microsomal liver enzymes. In such cases, overdose can be fatal.

In case of overdose, you should immediately consult a doctor, even if the patient's condition does not cause concern.

Symptoms: during the first 24 hours after an overdose - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; violation of glucose metabolism, metabolic acidosis (including lactic acidosis). Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In case of severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. The hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: the introduction of donors of SH-groups and precursors of the synthesis of glutathione - methionine and acetylcysteine \u200b\u200b- within 10 hours after overdose. The need for further therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration. Symptomatic treatment. Liver tests should be performed at the beginning of treatment and then every 24 hours.

Interaction with other medicinal products

Phenytoin reduces the effectiveness of paracetamol and increases the risk of developing hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially at high doses. Patients should be monitored to rule out hepatotoxicity.

Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. With simultaneous use, consideration should be given to reducing the dose of paracetamol.

Care should be taken with the simultaneous use of paracetamol and inducers of liver microsomal enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants).

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Salicylamide increases the half-life of paracetamol.

The international normalized ratio (INR) should be monitored during and after the end of the simultaneous use of paracetamol (especially in high doses and / or for a long time) and coumarins (for example, warfarin), since paracetamol, when taken at a dose of 4 g, does not less than 4 days can enhance the effect of indirect anticoagulants.

The attending physician should be informed about the use of paracetamol when conducting tests to determine uric acid and blood glucose levels.

special instructions

Read the instructions carefully before using the drug. Please keep the instructions in hand, you may need them again. If you have any questions, see your doctor. The medicine you are treating is intended for you personally and should not be passed on to others, as it may harm them even if they have the same symptoms as you.

If the fever continues for more than 3 days and the pain syndrome continues for more than 5 days, you should consult your doctor.

Paracetamol can cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, which can be fatal. If a skin rash or other signs of hypersensitivity reactions appear, stop taking the drug immediately and consult a doctor!

Simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this can cause an overdose of paracetamol.

There is a risk of overdose in patients suffering from liver disease, chronic alcoholism, chronic malnutrition (due to low levels of glutathione stores in hepatocytes) and in patients receiving inducers of liver microsomal enzymes.

The daily dose of paracetamol should not exceed 4 g in adult patients. For chronic liver diseases, including compensated ones, the daily dose of paracetamol should not exceed 3 g / day!

When using the drug for more than 5-7 days, the peripheral blood parameters and the functional state of the liver should be monitored. Paracetamol distorts laboratory tests in the quantitative determination of glucose and uric acid in plasma.

Long-term use of analgesic drugs in high doses in violation of the instructions for use (especially with the simultaneous use of several analgesics) can lead to the development of a headache that is not amenable to treatment with high doses of these drugs.