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Instructions for use:
Efferalgan is a drug belonging to the group of analgesics-antipyretics.
Efferalgan is a non-narcotic analgesic that also has an antipyretic effect. Its therapeutic effect is based on the mechanism of blocking COX1 and COX2 in the central nervous system with a subsequent effect on the centers of thermoregulation and pain.
The lack of anti-inflammatory effect is explained by the neutralization of the effect of paracetamol on COX. Neutralization is carried out by cellular peroxidases in inflamed tissues.
The drug does not have a negative effect on the water-salt balance (does not retain water and Na+) and on the gastrointestinal mucosa due to the fact that Efferalgan does not block the synthesis of prostaglandins in peripheral tissues.
For ease of use of Efferalgan, there are various forms of release of the drug:
There are also special forms of medication intended for children:
According to the instructions for Efferalgan, the drug is recommended for use in the following cases:
Medical reviews about Efferalgan note the presence of a number of contraindications, the list of which should be read before starting to use the drug:
The instructions for Efferalgan prescribe taking the drug orally (unless otherwise indicated) with plenty of water. At least 1 hour, but no more than 2 hours, should pass between eating and taking the medicine.
The dosage varies depending on the patient's age:
The interval between doses of the medicine should be at least 4 hours. The duration of taking Efferalgan without medical advice cannot be more than 3 days (to reduce fever) and no more than 5 days if the drug is used as an analgesic.
Efferalgan should also be administered rectally, taking into account the patient’s age: the dosage for adults is 500 mg 1 to 4 times a day, the maximum single dose is 1 g, the daily dose is 4 g. For children from 12 to 15 years old, Efferalgan is recommended in the amount of 250-300 mg from 3 to 4 times a day; children aged 8 to 12 years should take the drug in the same dosage three times a day; from 6-8 years the required dosage is the same, the frequency is reduced to 2-3 times; from 4 to 6 years – 150 mg 3-4 times a day; for children from 2 to 4 years old, the dose is the same, frequency – up to 3 times; from one to two years - 80 mg 3 or 4 times a day; from six months to a year - the same dosage with a frequency of 2-3 times; from 3 months to six months, take 80 mg no more than 2 times daily.
The use of Efferalgan may lead to unwanted reactions. They are described below:
Medical reviews about Efferalgan note the likelihood of increasing the maximum permissible daily dose when taking the drug simultaneously with other drugs that contain paracetamol.
The absence of a therapeutic effect (presence of symptoms of fever for more than 3 days and pain for more than 5 days) is a reason to consult a doctor.
Patients with diabetes mellitus, as well as patients on a diet that excludes sugar, should keep in mind that 1 ml of the drug contains sugar in the amount of 0.335 g.
Efferalgan should be stored at a temperature not exceeding 30°C, away from children. The shelf life is 3 years.
Antipyretic drugs are always available in your home medicine cabinet. An important point in taking any of them is not to resort to medication until the temperature reaches 38 degrees. The body itself must learn to resist the virus and produce antibodies.
Efferalgan is one of the remedies that effectively and quickly combat high fever, is approved for children and is not addictive. It is sold without a prescription, so you should follow the instructions when using it.
Antipyretic syrup EfferalganEfferalgan UPSA is a modern antipyretic drug that allows you to quickly bring down a high temperature. It comes in three forms:
Efferalgan in syrup form is recommended for children. Its main active ingredient is paracetamol - 3 grams per 100 ml of product. The excipients included in the composition are the following (their quantitative content in grams per 100 ml is indicated in brackets):
The pharmacological effect of the drug can be described by three main properties:
Paracetamol affects the centers of pain and thermoregulation, blocking cyclooxygenase in the central nervous system (we recommend reading:). In tissues where the inflammatory process occurs, its effect 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. The distribution of the active component in tissues and liquids is good. The drug is excreted through the kidneys with a half-life of 1 to 2 hours.
Efferalgan syrup is prescribed to children from one month of age to 12 years with a body weight ranging from 4 to 32 kilograms. The main purpose of the drug is to relieve pain and reduce fever.
The drug is prescribed as an analgesic for such types of pain of mild to moderate intensity as:
In the second capacity, the solution is used for acute respiratory infections and infections that are provoked by the following pathogens:
The drug is contraindicated in cases of high sensitivity to the components and in children who are not yet 1 month old. In addition to age restrictions and individual intolerance, Efferalgan is prohibited from use if the child has:
In addition to strict restrictions, there are situations when the attending physician must prescribe the drug and monitor its use, since the regimen will differ from the instructions included in the package. This approach is applicable for Gilbert's syndrome and mild to moderate kidney and liver problems.
Children who do not yet know how to drink from a spoon are prescribed rectal suppositories with doses according to the child’s age. In most cases, they resort to the second, more popular form - syrup. The table below describes the dosages of Efferalgan recommended for children of different ages and with different body weights:
Age, years | Body weight, kg | Dose, ml (mg) |
3-5 months | 6-8 | 3 (90) |
5-12 months | 8-10 | 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, it is necessary to focus on body weight. Also, to avoid overdose, it is not advisable to use Efferalgan together with other drugs that contain paracetamol. The course of treatment should not exceed 5-7 days. If a child takes Efferalgan, he should be provided with plenty of fluids during this period, especially after taking the syrup.
The drug should be stored in a dark place at temperatures up to 30 degrees and kept away from children. The shelf life is 3 years. From the moment the bottle is opened, the solution is suitable for use for six months. It is forbidden to give the product to a child if it has expired.
The antipyretic and analgesic drug has established itself as an effective remedy that is well accepted by the child’s body. However, this does not exclude the occurrence of a negative reaction in children whose bodies cannot tolerate paracetamol or other components.
Among the side effects that may occur when taking Efferalgan, the following should be noted:
In rare cases, anemia, leukopenia, agranulocytosis, and thrombocytopenia may occur. With prolonged use, abdominal pain may become regular and blood pressure may become elevated. There is a risk of anaphylactic shock.
The threat is posed by uncontrolled long-term use without following the dosage. This causes changes in the composition of the blood, methemoglobinemia and pancytopenia, produces a hepatotoxic and nephrotoxic effect and leads to subsequent problems with the psychological health of the baby.
Regarding overdose in children, acute paracetamol poisoning can be identified by the appearance of symptoms including:
If, when the above symptoms occur, you 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 has been stopped and the child has been hospitalized, treatment is reduced to a number of measures, including:
One of the advantages of the antipyretic drug Efferalgan UPSA is its reasonable price. Despite its low cost, the product is highly effective and safe when used correctly. On the territory of the Russian Federation, a bottle of Efferalgan 90 mg can be purchased for 100 rubles. This price can vary in 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 of action, safety for children, minimal side effects and lack of addiction.
Despite all these advantages and availability, you should keep in mind alternative drugs with similar effects. The pharmacological market provides a huge selection of all kinds of medications with similar properties and characteristics, the main active component of which is paracetamol. Such drugs differ in the country where they were manufactured and the auxiliary elements in the composition.
Among the main analogues of Efferalgan it is worth noting.
◊ Syrup (for children) in the form of a slightly viscous solution of yellow-brown color, with a caramel-vanilla odor.
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, piperonal, amyl cinnamate, vanillin, acetyl vanillin) , purified water.
90 ml - plastic bottles (1) complete with measuring spoon - cardboard boxes.
Analgesic-antipyretic. 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 influence on the synthesis of prostaglandins in peripheral tissues.
Suction and distribution
Absorption of paracetamol is complete and rapid. Cmax in plasma is achieved 30-60 minutes after administration. The distribution of paracetamol in tissues occurs quickly. Comparable drug concentrations are achieved in blood, saliva and plasma. Plasma protein binding is low (10-25%). Penetrates through 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 conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme 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 excreted unchanged.
For children aged from 1 month to 12 years (with body weight from 4 to 32 kg):
- as an antipyretic for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
- as an analgesic for pain of mild or moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain from injuries and burns.
The average single dose depends on the child’s body weight and is 10-15 mg/kg body weight 3-4 times a 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. You should adhere to regular time intervals between taking the drug.
For convenience and accuracy of dosing, you should use a measuring spoon. The measuring spoon has divisions indicating the child’s body weight: 4, 6, 8, 10, 12, 14 or 16 kg. Unmarked divisions correspond to intermediate body weight: 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 that is closest in value to the child's body weight. For example, if the child's body weight is from 4 to 5 kg, fill the measuring spoon 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 to the 10 kg mark, then refill the measuring spoon 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 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 (creatinine clearance 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 an analgesic. If it is necessary to continue taking the drug, consult a doctor.
From the digestive system: possible - diarrhea, abdominal pain, nausea, vomiting, tenesmus; with long-term use in high doses, hepatotoxic effects are possible.
Allergic reactions: possible - skin rash, itching, urticaria, Quincke's edema, anaphylactic shock, decreased blood pressure (as a symptom of anaphylaxis).
From the hematopoietic system: rarely - anemia, thrombocytopenia, leukopenia, neutropenia.
Others: decrease or increase in prothrombin index; with long-term use in high doses, nephrotoxic effects are possible.
- severe liver dysfunction;
- severe renal dysfunction;
- blood diseases;
- deficiency of glucose-6-phosphate dehydrogenase;
- children up to 1 month;
- hypersensitivity to the components of the drug
WITH caution The drug should be used for mild to moderate liver or kidney dysfunction, or for Gilbert's syndrome.
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 monitor the peripheral blood picture and the functional state of the liver.
Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma.
If it is necessary to prescribe the drug to patients with diabetes mellitus or to patients on a low-sugar diet, it should be taken into account that 1 ml of the drug contains 0.335 g of sugar (0.67 g of sugar for each calibration division of the measuring spoon /indicated by marks in kg/).
Persons caring for a sick child should be warned about the need to discontinue the drug and consult a doctor if adverse reactions occur. Consultation with a doctor is also required in the absence of a therapeutic effect: continuation of fever for more than 3 days and pain for more than 5 days.
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 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 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 to stop taking the drug and immediate hospitalization. Blood samples should be taken for an initial determination of plasma paracetamol levels. Gastric lavage, enterosorbents (activated carbon, hydrolytic lignin) are administered, and the antidote acetylcysteine is administered (IV or orally) up to 10 hours after taking the drug. Acetylcysteine may be effective 16 hours after an overdose. Symptomatic treatment is also carried out.
With simultaneous use of Efferalgan with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin, ethanol, the risk of hepatotoxicity increases significantly.
When taken together with salicylates, the risk of nephrotoxicity increases significantly.
Salicylamide can prolong the half-life of paracetamol.
When used simultaneously with chloramphenicol, the toxicity of the latter increases.
Probenecid leads to an almost twofold decrease in the clearance of paracetamol due to suppression of binding to glucuronic acid.
Paracetamol enhances the effect of indirect anticoagulants.
Paracetamol reduces the effectiveness of uricosuric drugs.
The drug is approved for use as an over-the-counter product.
The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 3 years.
The drug is prescribed orally 1-2 hours after meals.
The average single dose depends on the child’s body weight and is 10-15 mg/kg body weight 3-4 times a 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 has divisions indicating a single dose (15 mg/kg) for children with body weight 4, 8, 12 or 16 kg respectively. Unmarked divisions correspond body weight 6, 10 or 14 kg.
Child's age | Child's body weight (kg) | Mark on measuring spoon (paracetamol content/ volume of solution) |
1-3 months | On doctor's recommendation. | |
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 | 16-20 | 16 (240 mg/8 ml) |
6-7 years | 20-22 | 16+4 (300 mg/10 ml) |
7-8 years | 22-24 | 16+6 (330 mg/11 ml) |
8-9 years | 24-26 | 16+8 (360 mg/12 ml) |
9-10 years | 26-28 | 16+10 (390 mg/13 ml) |
10-11 years | 28-30 | 16+12 (420 mg/14 ml) |
11-12 years old | 30-32 | 16+14 (450 mg/15 ml) |
The ratio of the child's age and body weight is given approximately.
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 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 the child's body weight is from 20 to 22 kg, then fill the measuring spoon to the 16 kg mark, then refill the measuring spoon 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 and up to 5 days when used as an analgesic. If it is necessary to take the drug for a longer period, consult a doctor.
On our website you will find detailed information about the drug EFFERALGAN (syrup) and its instructions for use in Russian. Instructions for use contain information about the composition, indications for use, contraindications, dosage, peculiarities of use in children, during pregnancy and breastfeeding, interactions with other drugs, side effects and overdose of EFFERALGAN. You can also familiarize yourself with the conditions and shelf life of the drug EFFERALGAN and its analogues.
Registration number:
Trade name: Efferalgan
International nonproprietary name: Paracetamol
Chemical rational name: N-(4-hydroxyphenyl)acetamide
Dosage form: oral solution (for children) 3% (complete with dosage spoon).
Compound
1 ml of the drug contains 30 mg of paracetamol.
excipients: macrogol 6000, sucrose solution, sodium saccharin, sorbic acid, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, caramel-vanilla flavor, water.
Description
A transparent, homogeneous, slightly viscous solution of yellow-brown color, with a caramel-vanilla taste and smell.
Pharmacotherapeutic group
Analgesic non-narcotic drug.
ATX code:
Pharmacological properties
Efferalgan contains paracetamol, which has an analgesic and antipyretic effect.
Indications for use
Efferalgan is used in children from 3 months to 12 years (with body weight from 6 to 32 kg) as an antipyretic for acute respiratory diseases, influenza, 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 of mild or moderate intensity, including: headaches and toothaches, muscle pain, neuralgia, pain from injuries and burns.
Contraindications
Do not use this medicine if your child has:
With caution– The drug should be used with caution in case of impaired liver or kidney function, with Gilbert's syndrome. Before taking the drug, you should consult your doctor.
To determine the dose and regimen of taking the drug in children aged 1 to 3 months, you should consult a doctor.
Directions for use and doses
The drug is taken orally with plenty of liquid 1-2 hours after eating.
The average single dose of Efferalgan depends on the child’s body weight and is 10-15 mg/kg body weight 3-4 times a 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. For convenience and accuracy of dosing, use a measuring spoon.
The measuring spoon has divisions indicating a single dose (15 mg/kg) for a child with the corresponding body weight: 4, 8, 12 or 16 kg. Unmarked divisions correspond to intermediate body weight: 6, 10 or 14 kg.
Children from 3 months to 6 years (6-20 kg): Fill the measuring spoon to the mark according to the table. For example, if your child weighs from 6 to 8 kg, fill the measuring spoon to the mark corresponding to 6 kg.
Children from 6 to 12 years old (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 your child weighs between 20 and 22 kg, fill the measuring spoon to the 16 kg mark, then refill the measuring spoon to the 4 kg mark.
The drug can be given to a child without dilution or after dilution with water or milk.
Duration of treatment:
3 days as an antipyretic and up to 5 days as an analgesic. If it is necessary to continue taking the drug, consult a doctor.
Side effect
Possible nausea, vomiting, abdominal pain, allergic reactions (skin rash, itching, urticaria, Quincke's edema).
Rarely – anemia, leukopenia, agranulocytosis, thrombocytopenia.
With long-term use in large doses, hepatotoxic and nephrotoxic effects are possible, as well as the occurrence of methemoglobinemia and pancytopenia. If adverse reactions occur, stop taking the drug and consult a doctor.
Overdose
Signs of acute paracetamol poisoning are nausea, vomiting, stomach pain, sweating, and pale skin. After 1-2 days, signs of liver damage appear - pain in the liver area, increased activity of “liver” enzymes in the blood, an increase in prothrombin time. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop. If symptoms of poisoning appear, stop using the drug and consult a doctor immediately. It is recommended to lavage the stomach, take enterosorbents (activated carbon, polyphepan), intravenous administration of the antidote N-acetylcysteine, and take methionine.
Interaction with other drugs
When using Efferalgan together with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), zyxorin, phenylbutazone, rifampicin and alcohol, the risk of hepatotoxicity increases significantly.
Taken together with salicylates significantly increases the risk of nephrotoxicity. When used simultaneously with chloramphenicol (chloramphenicol), the toxicity of the latter increases.
Paracetamol contained in Efferalgan enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Special instructions
Efferalgan contains paracetamol, therefore, in order to avoid exceeding the maximum daily dose, the drug should not be used simultaneously with other medications containing paracetamol.
When using the drug for more than 5-7 days, monitoring the peripheral blood picture and the functional state of the liver is necessary.
If the drug is taken by children suffering from diabetes or on a low-sugar diet, it should be taken into account that 1 ml of the drug contains 0.335 g of sugar.
Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma.
In the absence of a therapeutic effect: continued fever for more than 3 days and pain for more than 5 days, you should consult your doctor.
Release form
Oral solution in a 90 ml plastic bottle, sealed with a “push and pop” cap made of polyethylene. 1 bottle with measuring spoon and instructions for use in a cardboard box.
Storage conditions
Store at a temperature not exceeding 30°C, out of the reach of children.
Best before date
3 years.
Do not use the drug after the expiration date indicated on the packaging.
Conditions for dispensing from pharmacies
Over the counter.
Manufacturer
Bristol-Myers Squibb, France
304, avenue du Docteur Jean Bra 47000 AGEN – France
Moscow representative office:
123001, Russia, Moscow, Trekhprudny lane, building 9, building 1B.