How many mg in ml of efferalgan suspension. Efferalgan for children: instructions for use. Cost and storage

19.07.2020 Drugs

During an exacerbation viral infections many children have respiratory problems. This is due to the fact that the immune system the child is not fully formed and cannot resist pathogenic microorganisms. In most cases, the disease is accompanied by an increase in temperature. Fever and inflammation are the body's natural response to disease-causing bacteria and viruses.

At the same time, the human body produces a complex of specific substances that suppress their reproduction and development.

Drug manufacturers offer a wide variety of drugs to lower the temperature and relief of the baby's condition. One of the effective and safe drugs is Efferalgan, which has an analgesic effect and has a pleasant taste.

Efferalgan is non-steroidal drug, which is used to relieve heat and pain that accompany any cold.

An antipyretic agent is not recommended for use at temperatures below 38.5 degrees, because at this time in the human body there is the production of protective antibodies that help resist pathogenic microorganisms. The body must resist on its own. Using antipyretics for a long time can be addictive.

Efferalgan is a product that is of high quality and is often used in pediatric practice... The syrup has analgesic antipyretic properties and is practically safe for the child's body.

Composition and form of release

The composition of the drug includes an active active substance paracetamol and auxiliary components magrocol, sorbitic acid, sucrose, water, sodium saccharinate, propyl parahydroxybenzoate, methyl parahydroxybenzonate and flavorings.

For a long time, paracetamol has been used as a pain reliever, as well as a remedy for the treatment of diseases. gastrointestinal tract in children of different ages.

The manufacturer offers several forms of release of the drug Efferalgan:

  • suppositories;
  • effervescent tablets;
  • effervescent tablets with vitamin C;
  • syrup that is most often used to treat children. Dosage form is a yellowish-brown liquid, slightly viscous, sweet, with a caramel taste and smell.

How does it work

Efferalgan belongs to the group of non-steroidal drugs. The active substance, paracetamol, has analgesic, antipyretic and mild anti-inflammatory effects.

The mechanism of antipyretic and analgesic nature on the body has not been established. It probably has a peripheral and central component. As a result of the action of the active substance, blocking the centers of inflammation, pain and thermoregulation, which regulate the course of inflammatory processes in the body, fever and other signs colds... The small anti-inflammatory activity of the agent is due to the breakdown of the active component under the influence of enzymes in the bloodstream.

The medicine has no negative effect on water and salt metabolism and the state of the mucous surfaces of the stomach and intestines. When it enters the stomach, paracetamol is rapidly absorbed, evenly distributed in the tissues and reaches its maximum concentration within 40 minutes.

The disintegration of the drug occurs in the cells of the liver, then the remnants of the drug are excreted from the body by the kidneys.

Indications for use

Children's Efferalgan is a reliable and safe remedy which quickly and effectively lowers the temperature and reduces pain I'm with a child. The drug is recommended for use in the following cases:

Contraindications

Before using the drug, you should carefully read the instructions, since Efferalgan for children has a number of contraindications. You can not use the drug if the patient has:

  • increased intolerance to paracetamol and auxiliary components of the drug;
  • blood diseases and circulatory system;
  • children under one month old;
  • renal and hepatic impairment.

Instructions for use and dosage

Efferalgan syrup is intended for oral administration with plenty of water or other liquid after eating.

The dose of the drug is calculated taking into account the child's body weight and is 10 mg per kilogram of body weight. Maximum amount the agent used should not exceed 60 mg. The interval between doses of the medication is 6 hours.

For accurate dosing, use the measuring spoon that comes with each package. There are special divisions on the spoon, marking a single dose and dosage, taking into account the child's weight of 4, 8, 12 and 16 kilograms.

Children weighing from 4 to 16 kilograms should fill a measuring spoon to the appropriate division and use the drug following the instructions for use.

Children weighing 16 kilograms or more. The measuring spoon is filled to the division of 10 kilograms, then re-poured the lack of funds to add up to the child's body weight.

If there is no measuring spoon, then a regular teaspoon can be used for dispensing, which holds 5 ml of liquid or a tablespoon, the volume of which is 15 ml. The drug can be most accurately measured with a syringe.

If Efferalgan syrup is prescribed to a patient suffering from renal failure, then the interval of use should be at least 8 hours. For convenience, the medicine can be diluted with water, juice or milk. A course of treatment should not exceed three days if the syrup is used as an antipyretic agent and no more than five days for stopping pain syndrome... Longer use of the syrup is possible only as directed by a doctor.

Side effects and overdose

With prolonged use of Efferalgan syrup, some patients may develop an allergic reaction, which accompanied by urticaria, itchy skin, puffiness. The drug can cause nausea and vomiting, stool disturbance. A laxative effect is possible after the first use of the product.

Patients develop hyperhidrosis and pallor of the skin.

In childhood, there may be inflammation of the intestinal mucosa, frequent false urge to empty the intestines. Very rarely, anaphylaxis and falling may occur blood pressure.

If the dosage is violated in children, patients with hepatic insufficiency, malnutrition, it is possible development of intoxication and fulminant hepatitis, in a severe, fatal case. The consequences of an overdose develop within a day after the last use of the drug.

If the child shows signs of poisoning drug, you should immediately stop using the drug, rinse the stomach and use an adsorbing drug - activated charcoal or Polyphepan.

Analogs

If, for some reason, Efferalgan for children cannot be used, it can be replaced with drugs with a similar effect. Effective pain relievers and antipyretic drugs are Pentalgin, Ketonal, Tantum Verde, Viburkol, Melbek. The replacement should be carried out only after consultation with the attending physician, who will prescribe the dosage and determine the duration of the course of treatment.

Antipyretic drugs are always in the home medicine cabinet. An important point in taking any of them is not to resort to medication until the temperature indicator goes over 38 degrees. The body must learn to resist the virus itself and produce antibodies.

Efferalgan is one of the remedies that effectively and quickly fight high fever, are allowed for children and are not addictive. It is sold without a prescription, so you should follow the instructions when using it.

Antipyretic syrup Efferalgan

Composition and properties of Efferalgan syrup for children

Efferalgan UPSA is a modern antipyretic agent that allows you to quickly bring down high fever. It comes in three forms:

  1. Effervescent tablets. They are white, flat, round pills. There is a strip on one side. Sold in blister packs of 4. Upon contact with water, they begin to dissolve, while actively releasing gas bubbles.
  2. Syrup. It is dispensed in vials for 90 ml of solution. Usually, a special measuring spoon is included in the kit. The syrup itself is a viscous yellow-brown solution that smells of caramel and vanilla.
  3. Rectal suppositories. White, glossy and smooth. Released in blisters of 10 pieces.

Efferalgan in the form of a syrup is recommended for children. Its main active ingredient is paracetamol - 3 grams per 100 ml of product. The auxiliary substances included in the composition are as follows (their quantitative content in grams per 100 ml is indicated in brackets):

  • sugar solution consisting of sucrose and water (50);
  • macrogol 6000 (20);
  • citric acid (0.107);
  • sodium saccharinate (0.150);
  • potassium sorbate (0.400);
  • vanilla caramel flavor (0.200);
  • purified water.

In addition to syrup, Efferalgan is available in the form effervescent tablets and rectal suppositories

pharmachologic effect the drug can be described by three main properties:

  • antipyretic;
  • pain reliever;
  • anti-inflammatory.

Paracetamol acts on the centers of pain and thermoregulation by blocking cyclooxygenase in the central nervous system (we recommend reading :). In the fabrics where it goes inflammatory process, its action is neutralized by cellular peroxidases, which explains their minimal anti-inflammatory effect.

After administration, the drug is rapidly absorbed from the gastrointestinal tract. The highest concentration of the substance in the blood plasma is observed after 10 - 60 minutes. In tissues and fluids, the distribution of the active ingredient is good. The drug is excreted through the kidneys with a half-life of 1 to 2 hours.

Indications for use

Efferalgan syrup is prescribed for children starting from one month of age and up to 12 years old with a body weight ranging from 4 to 32 kilograms. The main purpose of the drug is to relieve pain and bring down the temperature.


Efferalgan is prescribed for children from one month of age to relieve pain and relieve fever.

As an anesthetic, the drug is prescribed for such types of pain of mild and moderate intensity as:

  • muscular;
  • head;
  • dental;
  • having a neuralgic character;
  • traumatic;
  • resulting from burns.

In the second quality, the solution is used for acute respiratory infections and infections that are provoked by the following pathogens:

  • staphylococci and streptococci;
  • rhinovirus, influenza A and B, parainfluenza;
  • staphylococcus aureus;
  • colibacillus;
  • Pneumococcus;
  • herpes types 1 and 2.

Efferalgan is used as an adjuvant after vaccination

When is the drug contraindicated?

The drug is contraindicated in case of high sensitivity to the constituents and in children who are not yet 1 month old. In addition to the age limit and individual intolerance, Efferalgan is prohibited to use if the child has:

  • malfunctions of the liver, which have turned into a severe form;
  • lack of the enzyme glucose-6-phosphate dehydrogenase in the body;
  • pathology of the circulatory system;
  • chronic diseases of internal organs;
  • impaired kidney function in a severe stage.

In addition to strict restrictions, there are situations when only the attending physician should prescribe the drug and monitor its intake, since the scheme will differ from the instructions attached to the package. This approach is useful for Gilbert's syndrome and kidney and liver problems with mild or medium severity.

Instructions for use

Children who do not yet know how to drink from a spoon are prescribed rectal suppositories with doses according to the age of the child. In most cases, they resort to the help of a second, more popular form - syrup. The table below lists the dosages of Efferalgan recommended for children of different ages and with different body weights:

Age, yearsBody weight, kgDose, ml (mg)
3-5 months6-8 3 (90)
5-12 months8-10 4 (120)
1-2 10-12 5 (150)
2-3 12-14 6 (180)
3-4 14-16 7 (210)
4-6 16-20 8 (240)
6-7 20-22 10 (300)
7-8 22-24 11 (330)
8-9 24-26 12 (360)
9-10 26-28 13 (390)
10-11 28-30 14 (420)
11-12 30-32 15 (450)

When calculating the dosage, you must focus on body weight. Also, in order to avoid an overdose, it is undesirable to use Efferalgan in conjunction with other drugs, which contain paracetamol. The course of treatment should not exceed 5-7 days. If a child is taking Efferalgan, during this period he should be provided with plenty of fluids, especially after taking the syrup.


Efferalgan comes with a convenient graduated false scale (15 mg per 1 kg of body weight)

Medicinal product should be stored in a dark place at temperatures up to 30 degrees and out of the reach of children. The shelf life is 3 years. From the moment the bottle is opened, the solution is usable for six months. It is forbidden to give a child a remedy if it has expired.

Possible side effects

Antipyretic and analgesic drug has established itself as effective remedy, which is well accepted by the child's body. However, this does not exclude the appearance of a negative reaction in children whose body does not tolerate paracetamol or other components.

Among side effects that may appear when taking Efferalgan, it should be noted:

  • abdominal pain;
  • bouts of nausea;
  • vomit;
  • diarrhea;
  • irritation of the rectum;
  • malfunctions of the digestive system;
  • an allergic reaction that can appear in the form of hives, angioedema, skin rashes and itching.

Efferalgan overdose may contribute to the development of urticaria

In rare cases, there may be anemia, leukopenia, agranulocytosis, thrombocytopenia. With prolonged use, abdominal pain can become regular, and blood pressure can become high. There is a risk of anaphylactic shock.

The threat is posed by uncontrolled long-term use without observing the dosage. This causes changes in the composition of the blood, methemoglobinemia and pancytopenia, produces hepatotoxic and nephrotoxic effects and leads to subsequent problems with the psychological health of the baby.

Consequences of an overdose

With regard to overdose in children, acute paracetamol poisoning can be determined by the onset of symptoms, including:

  • blanching of the skin;
  • lowering body temperature;
  • anorexia;
  • stomach pain;
  • sweating

If, when the above signs occur, do not seek help from specialists, irreversible processes begin to occur in the cells, which are fraught with the development of acidosis, liver failure, hepatonecrosis, encephalopathy and coma.

After the drug was discontinued and the child was hospitalized, treatment is reduced to a number of activities, including:

  • gastric lavage;
  • taking enterosorbents (Polyphepan or activated carbon);
  • intravenous injection of the antidote N-acetylcysteine;
  • methionine course;
  • symptomatic therapy.

The cost of the drug and analogues

One of the advantages of the antipyretic drug Efferalgan UPSA is its reasonable price. Despite its low cost, the product is characterized by high efficiency and safety when used correctly. In the territory Russian Federation a bottle of Efferalgan 90 mg can be purchased for 100 rubles. This price can vary within a range that depends on the city and pharmacy where the medicine is purchased.

Efferalgan is widely used in pediatric medicine due to its speed, safety for babies, minimum side effects and lack of addiction.

Despite all these advantages and availability, alternative drugs should be in mind. similar action... The pharmacological market provides a huge selection of all kinds medications with similar properties and characteristics, the main active ingredient which is paracetamol. Such drugs differ in the country where they were manufactured and in the auxiliary elements in the composition.

It is worth noting among the main analogues of Efferalgan.

Instructions for use

Efferalgan instructions for use

Dosage form

Slightly viscous brown solution with caramel-vanilla smell.

Compound

100 ml of the preparation contains:

Active ingredient: paracetamol 3,000 g

Excipients: macrogol-6000 - 20,000 g; sugar syrup (sucrose, water) - 50,000 g; sodium saccharinate - 0.150 g; potassium sorbate - 0.400 g; citric acid - 0.107 g; caramel-vanilla flavor * - 0.200 g; purified water - up to 100 ml.

* Composition of caramel-vanilla flavor: butanedione, acetylmethylcarbinol, benzaldehyde, propylene glycol, gamma-heptalactone, benzyl alcohol, triacetin, piperronal, amylcinnamate, vanillin, acetyl vanillin.

Pharmacodynamics

Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects. The exact mechanism of the analgesic and antipyretic effects of paracetamol has not been established. Apparently, it includes central and peripheral components. Paracetamol blocks cyclooxygenase 1 (COX) and COX2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of an anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (Na + and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics

Absorption of paracetamol after oral administration is complete and fast. The maximum plasma concentration is reached within 30-60 minutes after ingestion. The distribution of paracetamol in tissues is rapid. The volume of distribution in children is 0.7-1.01 l / kg.

Achieved comparable concentrations of paracetamol in blood, saliva and plasma. The connection with plasma proteins is low, 10-25%. Penetrates the blood-brain barrier.

Paracetamol is metabolized mainly in the liver to form 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 ​​and mercapturic acid. However, with massive intoxication, the amount of this toxic metabolite increases. The half-life in adults is 2.7 hours, in children - 1.5-2 hours, in newborns - 3.5 hours, the total clearance is 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 displayed unchanged. In severe renal failure (creatinine clearance below 10-30 ml / min), the excretion of paracetamol slows down somewhat. The rate of excretion of glucuronide and sulfate in patients with severe renal failure is lower than in healthy patients.

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.

Side effects

Possible diarrhea, abdominal pain, nausea, vomiting, tenesmus, decrease or increase in prothrombin index and international normalized ratio (INR), decrease in blood pressure (as a symptom of anaphylaxis), thrombocytopenia, leukopenia, neutropenia, allergic reactions on the part of the skin and subcutaneous tissue (skin rash, itching, urticaria, Quincke's edema, anaphylactic shock, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).

At long-term use in large doses, hepatotoxic and nephrotoxic effects are possible.

When the appearance adverse reactions stop taking the drug and see your doctor.

Selling features

Available without a prescription

Special conditions

The drug contains paracetamol, therefore, in order to avoid exceeding the maximum daily dose do not use the drug at the same time as other medicines (prescription and over-the-counter) containing paracetamol.

When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood picture and the functional state of the liver.

Paracetamol can cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, which can be fatal. At the first manifestation of a rash or other hypersensitivity reactions, the drug should be discontinued.

If the drug is taken by patients with diabetes mellitus or those who are with reduced content sugar, it should be borne in mind that 1 ml of the drug contains 0.335 g of sugar (0.67 g of sugar for each graduation division of a measuring spoon (indicated by marks in kg).

Paracetamol distorts the results of laboratory tests of the content of glucose and uric acid in the blood plasma.

Without therapeutic effect: Continuation of fever for more than 3 days and pain syndrome for more than 5 days, consult your doctor.

Indications

Efferalgan is used in children from 1 month to 12 years old (weighing from 4 to 32 kg) as an antipyretic agent in acute respiratory diseases, flu, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature.

The drug is also used as an analgesic for pain syndrome of mild to moderate intensity, including: headache and toothache, muscle pain, neuralgia, pain in trauma and burns.

Contraindications

Do not use this medicine if your child has:

Hypersensitivity to paracetamol, propacetamol hydrochloride (paracetamol prodrug) or other components of the drug;

Severe liver dysfunction or active decompensated liver disease;

Age up to 1 month;

Sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully:

Heavy renal failure(creatinine clearance< 30 мл/мин), печеночная недостаточность, хронический алкоголизм, анорексия, булимия, кахексия, гиповолемия, обезвоживание, дефицит глюкозо-6-фосфатдегидрогеназы.

Drug interactions

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.

Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid.

With the simultaneous appointment, consideration should be given to reducing the dose of paracetamol.

Care should be taken with the simultaneous use of paracetamol and inducers of microsomal liver 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.

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 for at least 4 days may enhance the effect of indirect anticoagulants.

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Mode of application

Dosage

Average single dose the drug depends on the child's body weight and is 10-15 mg / kg body weight.

The maximum daily dose should not exceed 60 mg / kg body weight. The minimum interval between doses of the drug should be 4 hours. You should adhere to regular time intervals between taking the drug. Use a measuring spoon for convenient and accurate dosing.

On the measuring spoon, there are divisions indicating the child's body weight: 4, b, 8, 10, 12, 14 or 16 kg.

Unmarked divisions correspond to intermediate body mass: 5, 7, 9, 11, 13 or 15 kg.

Children weighing 4 to 16 kg: Fill the measuring spoon to the mark for the child's weight or to the mark closest to the child's weight. For example, if your child weighs between 4 and 5 kg, fill the measuring spoon up to the 4 kg mark. If necessary, the drug should be taken every 4-6 hours.

Children weighing 16 to 32 kg: Fill the measuring spoon up to the 10 kg mark, then refill the measuring spoon up to the mark so that the total weight of the child is obtained. For example, if your child weighs between 18 and 19 kg, fill the measuring spoon up to the 10 kg mark, then refill the measuring spoon up to the 8 kg mark. If necessary, the drug should be taken every 4-6 hours.

The drug can be given to a child either without dilution or after dilution (with water, milk or juice).

Duration of treatment:

3 days as an antipyretic and up to 5 days as a pain reliever. If it is necessary to continue taking the drug, a doctor's consultation is required.

In severe renal impairment, the time interval between doses of the drug should be at least 8 hours with creatinine clearance less than 10 ml / min, at least 6 hours - with creatinine clearance of 10-50 ml / min.

In case of impaired liver function and in patients with chronic alcoholism, malnutrition (low supply of liver glutathione) or dehydration, the daily dose should not exceed 3 g.

Overdose:

In case of an overdose, intoxication is possible, especially in children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking inducers of microsomal liver enzymes, in which fulminant hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases - sometimes fatal.

The clinical picture of an acute overdose develops within 24 hours after taking paracetamol.

Symptoms: gastrointestinal upset (nausea, vomiting, loss of appetite, discomfort in abdominal cavity and / or abdominal pain), pallor of the skin. Simultaneous administration of 7.5 g or more to adults or more than 140 mg / kg to children results in cytolysis of hepatocytes with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after the introduction of paracetamol, there is an increase in the activity of "hepatic" transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in prothrombin content.

Clinical symptoms of liver damage appear 1-2 days after drug overdose and reach a maximum on 3-4 days.

Treatment:

Immediate hospitalization;

Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose;

Administration of SH-group donors and precursors for the synthesis of glutathione - methionine and acetylcysteine ​​within 10 hours after an overdose. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration;

Symptomatic treatment;

Liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, hepatic transaminase activity will return to normal within 1–2 weeks.

In very severe cases, a liver transplant may be required.

Bottle 90 ml

Paracetamol 30 mg per ml.
Excipients: macrogol 6000, sucrose solution, sodium saccharin, sorbic acid, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, caramel vanilla flavor, water.
Syrup (for children) 3% transparent, homogeneous, slightly viscous, yellow-brown in color, with a caramel-vanilla taste and smell.

pharmachologic effect

Analgesic antipyretic. It has an analgesic and antipyretic effect. Inhibits COX-1 and COX-2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of its anti-inflammatory effect.
It does not have a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa due to the lack of effect on the synthesis of prostaglandins in peripheral tissues. The possibility of methemoglobin formation is unlikely.

Indications for use

For children aged 3 months to 12 years (weighing 6-32 kg):
- increased body temperature, incl. with acute respiratory infections, influenza, childhood infections, post-vaccination reactions;
- moderate or mild pain syndrome, incl. headache, toothache, muscle pain, neuralgia, pain in trauma and burns.

Mode of application

The drug is administered orally 1-2 hours after a meal.
The average single dose depends on the child's body weight and is 10-15 mg / kg of body weight 3-4 times / day. The maximum daily dose is 60 mg / kg. The interval between doses is 4-6 hours.
For convenience and accuracy of dosing, use a measuring spoon. The measuring spoon contains divisions indicating a single dose (15 mg / kg) for children weighing 4, 8, 12 or 16 kg, respectively. Unmarked divisions correspond to a body weight of 6, 10 or 14 kg.
Child's age | Child's body weight (kg) | Measuring spoon mark (paracetamol content / solution volume)
1-3 months | On the recommendation of a doctor.
3-5 months | 6-8 | 6 (90 mg / 3 ml)
5 months-1 year | 8-10 | 8 (120 mg / 4 ml)
1-2 years | 10-12 | 10 (150 mg / 5 ml)
2-3 years | 12-14 | 12 (180 mg / 6 ml)
3-4 years | 14-16 | 14 (210 mg / 7 ml)
4-6 years old | 16-20 | 16 (240 mg / 8 ml)
6-7 years old | 20-22 | 16 + 4 (300 mg / 10 ml)
7-8 years old | 22-24 | 16 + 6 (330 mg / 11 ml)
8-9 years old | 24-26 | 16 + 8 (360 mg / 12 ml)
9-10 years old | 26-28 | 16 + 10 (390 mg / 13 ml)
10-11 years old | 28-30 | 16 + 12 (420 mg / 14 ml)
11-12 years old | 30-32 | 16 + 14 (450 mg / 15 ml)
The ratio of the age and body weight of the child is given roughly.
Children aged 3 months to 6 years (body weight 6-20 kg): fill the measuring spoon to the mark according to the table. For example, if the child's body weight is from 6 to 8 kg, then the measuring spoon should be filled up to the mark corresponding to 6 kg.
Children aged 6 to 12 years (body weight 20-32 kg): fill the measuring spoon to the 16 kg mark, then refill the measuring spoon to the mark according to the table. For example, if a child's body weight is between 20 and 22 kg, then fill the measuring spoon up to the 16 kg mark, then refill the measuring spoon up to the 4 kg mark.
The drug can be given to a child without dilution or after dilution with water or milk.
The duration of treatment is 3 days when used as an antipyretic agent and up to 5 days as an analgesic agent. If it is necessary to take the drug for a longer period, a doctor's consultation is required.

Interaction

With the simultaneous use of Efferalgan with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), zixorin, phenylbutazone, rifampicin, ethanol, the risk of developing hepatotoxic effects significantly increases.
When taken together with salicylates, the risk of nephrotoxic effects is significantly increased.
With simultaneous use with chloramphenicol (chloramphenicol), the toxicity of the latter increases.
Paracetamol enhances the effect of indirect anticoagulants.
Paracetamol reduces the effectiveness of uricosuric drugs.

Side effect

Allergic reactions: possible - skin rash, itching, Quincke's edema.
From the digestive system:
- possible - nausea, vomiting, abdominal pain;
- with prolonged use in high doses, a hepatotoxic effect is possible.
From the hematopoietic system:
- rarely - anemia, leukopenia, agranulocytosis, thrombocytopenia;
- with prolonged use in high doses, the development of methemoglobinemia and pancytopenia is possible.
Others: with prolonged use in high doses, a nephrotoxic effect is possible.

Contraindications

- severe liver dysfunction;
- severe renal dysfunction;
- blood diseases;
- deficiency of glucose-6-phosphate dehydrogenase;
- childhood up to 1 month;
- hypersensitivity to the components of the drug, especially parabens (methyl and propyl parahydroxybenzoate).
The drug should be used with caution in case of mild and moderate hepatic or renal dysfunction, with Gilbert's syndrome.

Overdose

Symptoms: nausea, vomiting, stomach pain, sweating, pallor of the skin. After 1-2 days, signs of liver damage appear - soreness in the liver, an increase in the activity of hepatic transaminases in the blood, an increase in prothrombin time. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop.
Treatment: cancel the drug, gastric lavage is recommended, intake of enterosorbents (activated carbon, polyphepan), intravenous administration of the antidote N-acetylcysteine, methionine intake, clinical monitoring of the patient's condition.

special instructions

To avoid exceeding the maximum daily dose, Efferalgan should not be used simultaneously with other drugs containing paracetamol.
When using the drug for more than 5-7 days, it is necessary to control the picture of peripheral blood and functional state liver.
Paracetamol distorts the results of laboratory tests of the content of glucose and uric acid in the blood plasma.
If it is necessary to prescribe the drug to patients with diabetes mellitus or to patients on a diet with a low sugar content, it should be borne in mind that 1 ml of the drug contains 0.335 g of sugar.
Persons caring for a sick child should be warned about the need to discontinue the drug and consult a doctor in case of adverse reactions. A doctor's consultation is also required in the absence of a therapeutic effect: continued fever for more than 3 days and pain for more than 5 days.

Syrup (for children) in the form of a slightly viscous solution of yellow-brown color, with a caramel-vanilla smell.

Excipients: macrogol 6000, sugar syrup (sucrose, water), sodium saccharinate, potassium sorbate, citric acid, caramel-vanilla flavor (butanedione, acetylmethylcarbinol, benzaldehyde, propylene glycol, gamma-heptalactone, benzyl alcohol, triacetin, piperronal, amylcinnamatil), acetylcinnamatil , purified water.

90 ml - plastic bottles (1) complete with a measuring spoon - cardboard boxes.

Clinical and pharmacological group

Analgesic antipyretic

pharmachologic effect

Analgesic antipyretic. It has an analgesic and antipyretic effect. Inhibits COX-1 and COX-2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of its anti-inflammatory effect.

It does not have a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa due to the lack of effect on the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics

Absorption and distribution

Absorption of paracetamol is complete and fast. C max in plasma is reached within 30-60 minutes after administration. The distribution of paracetamol in tissues is rapid. Comparable concentrations of the drug in blood, saliva and plasma are achieved. The connection with plasma proteins is low (10-25%). Penetrates the BBB.

Metabolism and excretion

Metabolism occurs in the liver, 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug.

T 1/2 is about 2 hours (1-4 hours). It is excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is displayed unchanged.

Indications for the use of the drug

For children aged 1 month to 12 years (weighing from 4 to 32 kg):

- as an antipyretic agent for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;

- as an anesthetic for pain syndrome of mild or moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain in trauma and burns.

Dosage regimen

The average single dose depends on the child's body weight and is 10-15 mg / kg of body weight 3-4 times / day. The maximum daily dose should not exceed 60 mg / kg body weight. The interval between doses of the drug should be 4-6 hours. Regular time intervals between taking the drug should be adhered to.

For convenience and accuracy of dosing, use a measuring spoon. The measuring spoon contains divisions indicating the child's body weight: 4, 6, 8, 10, 12, 14 or 16 kg. Unmarked divisions correspond to intermediate body mass: 5, 7, 9, 11, 13 or 15 kg.

Children weighing from 4 to 16 kg

Fill the measuring spoon to the mark corresponding to the child's body weight, or to the mark closest in value to the child's body weight. For example, if the child's body weight is between 4 and 5 kg, fill the measuring spoon up to the 4 kg mark. If necessary, the drug should be taken every 4-6 hours.

Children weighing from 16 to 32 kg

Fill the measuring spoon up to the 10 kg mark, then refill the measuring spoon up to the mark so that the total weight of the child is obtained. For example, if your child is between 18 and 19 kg, fill the measuring spoon to the 10 kg mark, then refill the measuring spoon to the 8 kg mark. If necessary, the drug should be taken every 4-6 hours.

At impaired renal function (CC less than 10 ml / min) the time interval between doses of the drug should be at least 8 hours.

The drug can be given to a child either without dilution or after dilution (with water, milk or juice).

The duration of treatment is 3 days as an antipyretic and up to 5 days as a pain reliever. If it is necessary to continue taking the drug, a doctor's consultation is required.

Side effect

From the digestive system: possible - diarrhea, abdominal pain, nausea, vomiting, tenesmus; with prolonged use in high doses, a hepatotoxic effect is possible.

Allergic reactions: possible - skin rash, itching, urticaria, Quincke's edema, anaphylactic shock, lowering blood pressure (as a symptom of anaphylaxis).

From the hematopoietic system: rarely - anemia, thrombocytopenia, leukopenia, neutropenia.

Others: decrease or increase in prothrombin index; with prolonged use in high doses, a nephrotoxic effect is possible.

Contraindications to the use of the drug

- severe liver dysfunction;

- severe renal dysfunction;

- blood diseases;

- deficiency of glucose-6-phosphate dehydrogenase;

- children's age up to 1 month;

- hypersensitivity to drug components

WITH caution the drug should be used in case of mild and moderate hepatic or renal dysfunction, with Gilbert's syndrome.

special instructions

To avoid exceeding the maximum daily dose, Efferalgan should not be used simultaneously with other drugs containing paracetamol.

When using the drug for more than 5-7 days, it is necessary to control the picture of peripheral blood and the functional state of the liver.

Paracetamol distorts the results of laboratory tests of the content of glucose and uric acid in the blood plasma.

If it is necessary to prescribe the drug to patients with diabetes mellitus or to patients on a diet with a low sugar content, it should be borne in mind that 1 ml of the drug contains 0.335 g of sugar (0.67 g of sugar for each graduation division of a measuring spoon / marked in kg /).

Persons caring for a sick child should be warned about the need to discontinue the drug and consult a doctor in case of adverse reactions. A doctor's consultation is also required in the absence of a therapeutic effect: continued fever for more than 3 days and pain for more than 5 days.

Overdose

Symptoms acute poisoning with paracetamol are nausea, vomiting, anorexia, pain in the epigastric region, sweating, pallor of the skin, appearing in the first 24 hours after administration. Taking paracetamol at a dose of 140 mg / kg of body weight in children causes destruction of liver cells, leading to complete and irreversible hepatonecrosis, liver failure, metabolic acidosis, encephalopathy, which, in turn, can lead to the development of coma and death.

12-48 hours after administration, an increase in the level of liver transaminases, LDH and bilirubin may be observed with a simultaneous decrease in the level of prothrombin. The clinical picture of liver damage is usually detected after 1 or 2 days and reaches a maximum after 3-4 days.

Treatment: if symptoms of poisoning appear, it is recommended that the drug be discontinued and immediately hospitalized. Blood samples should be taken for the initial determination of paracetamol plasma levels. Gastric lavage, intake of enterosorbents (activated carbon, hydrolytic lignin), administration of acetylcysteine ​​antidote (IV or oral) within 10 hours after taking the drug are performed. Acetylcysteine ​​can be effective 16 hours after overdose. Symptomatic treatment is also carried out.

Drug interactions

With the simultaneous use of Efferalgan with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin, ethanol, the risk of developing hepatotoxic effects significantly increases.

When taken together with salicylates, the risk of nephrotoxic effects is significantly increased.

Salicylamide can prolong the T 1/2 of paracetamol.

With simultaneous use with chloramphenicol, the toxicity of the latter increases.

Probenecid leads to an almost twofold decrease in the clearance of paracetamol due to the suppression of binding with glucuronic acid.

Paracetamol enhances the effect of indirect anticoagulants.

Paracetamol reduces the effectiveness of uricosuric drugs.

Conditions of dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life is 3 years.