Composition and release form
Efferalgan
Syrup for children | 100 ml |
paracetamol | 3 g |
excipients: macrogol 6000; sugar syrup (sucrose, water); sodium saccharinate; potassium sorbate; lemon acid; caramel-vanilla flavoring*; purified water | |
*flavor composition: butanedione; acetylmethylcarbinol; benzaldehyde; propylene glycol; gamma-heptalactone; benzyl alcohol; triacetin; piperonal; amyl cinnamate; vanillin; acetylvanillin |
in polyethylene phthalate bottles of 90 ml (complete with measuring spoon); 1 bottle in a cardboard pack.
Suppositories for rectal use | 1 sup. |
paracetamol | 80 mg |
150 mg | |
300 mg | |
excipients: semi-synthetic glycerides - up to a weight of 1 g |
in contour cell packages 5 pcs.; in a cardboard pack 2 packs.
Effervescent tablets | 1 table |
paracetamol | 0.5 g |
excipients: anhydrous citric acid; sodium carbonate anhydrous; sodium bicarbonate; sorbitol; soluble saccharin; sodium docusate; povidone; sodium benzoate |
in strips of 4 pcs.; There are 4 or 25 strips in a box.
Efferalgan with vitamin C
Effervescent tablets | 1 table |
paracetamol | 330 mg |
ascorbic acid | 200 mg |
excipients: potassium bicarbonate; sodium bicarbonate; sorbitol; anhydrous citric acid; sodium benzoate; sodium docusate; povidone |
in tubes of 10 pcs., in a box 1 tube.
Description of the dosage form
Efferalgan
Syrup: a slightly viscous solution of yellow-brown color with a caramel-vanilla aroma.
Suppositories: smooth, glossy white suppositories.
Tablets: round, flat with beveled edges and a notch on one side, white. When dissolved in water, intense release of gas bubbles is observed.
Efferalgan with vitamin C
Tablets: flat, white, with beveled edges and notches, when dissolved in water they give an effervescent reaction.
Pharmacodynamics
Efferalgan, syrup, suppositories, tablets
Efferalgan contains paracetamol, which blocks COX-1 and -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 anti-inflammatory effect. The absence of a blocking effect on the synthesis of PG in peripheral tissues determines the absence of a negative effect on water-salt metabolism (retention of Na+ and water) and the mucous membrane of the gastrointestinal tract.
Suppositories have analgesic, antipyretic and weak anti-inflammatory effects.
Additionally for tablets: the possibility of methemoglobin formation is unlikely.
Efferalgan with vitamin C
Efferalgan with vitamin C is a combination drug that contains paracetamol and, therefore, has an analgesic and antipyretic effect. Ascorbic acid, which is part of Efferalgan with vitamin C, takes part in the regulation of redox processes, reduces vascular permeability and increases the body's resistance to infections.
Efferalgan
We say “Efferalgan”, we mean “paracetamol” - this is the international non-proprietary name of this well-promoted global pharmaceutical brand, and it is paracetamol that is the main “weapon” of Efferalgan, giving it an analgesic and antipyretic effect. Paracetamol blocks cyclooxygenase, an enzyme responsible for the synthesis of inflammatory mediators, prostaglandins, and affects pain and thermoregulation centers. But paracetamol has almost no anti-inflammatory effect: its effect on cyclooxygenase is neutralized by the main cellular oxidizing enzymes - peroxidases. Inhibition of prostaglandin synthesis occurs mainly in the central nervous system, and not in peripheral tissues, which also plays a positive role, expressed in the absence of efferalgan’s negative effect on the mucous membrane of the digestive tract and water-salt metabolism.
Today in Russia there are three dosage forms of efferalgan in use: effervescent tablets, suppositories (suppositories) and syrup for children. There is nothing complicated in taking the tablets: 1 piece per 200 ml of water 2-3 times a day with 4-hour intervals between doses. To prepare the solution, you can use no more than 2 tablets with a maximum daily dose of 8 tablets. The drug can be used for self-medication without medical advice, but only for a limited amount of time: 5 days as an analgesic and 3 days as an antipyretic.
Efferalgan rectal suppositories are used in pediatric patients. Ideally, it is better to administer the suppository after a bowel movement or cleansing enema. The average single and maximum daily dose is determined by the child’s weight: 10-15 mg per kg 3-4 times a day with a maximum daily dose of 60 mg per kg. The duration of self-treatment is the same as for tablets. Syrup for children should be taken 1-2 hours after meals, washed down with plenty of water. To facilitate dosing of the drug, a measuring spoon is included in the package. The amount of syrup per dose is calculated based on the child’s age and body weight according to the table given in the package insert.
Considering that Efferalgan contains paracetamol, during the period of taking the drug it is necessary to refrain from using other medications containing this substance in order to avoid exceeding its daily dose. Paracetamol is not the most harmless substance, especially with long-term use, so if the period of its use exceeds 5-7 days, it is recommended to monitor the functional state of the liver and blood picture.
Pharmacokinetics
Absorption of paracetamol is complete and rapid. Peak plasma concentrations are reached 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 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. T1/2 - 1-4 hours. Excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is excreted unchanged.
Indications for the drug Efferalgan
Efferalgan
Syrup - for children from 1 month to 12 years (with a body weight of 4–32 kg); suppositories 80 mg - for children from 3 months to 5 months (with body weight from 6-8 kg); suppositories 150 mg - for children 6 months to 3 years old (with a body weight of 10–14 kg); suppositories 300 mg - for children 5–10 years old (with a body weight of 20–30 kg) for the following diseases and conditions:
as an antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by an increase in body temperature;
as an analgesic for pain of mild or moderate intensity (including headaches, toothaches, muscle pain, neuralgia, pain from injuries and burns).
Efferalgan
Efferalgan with vitamin C
moderate or mild pain syndrome (headache, toothache, migraine pain, neuralgia, muscle pain, lower back pain, pain from injuries and burns, sore throat, painful menstruation);
elevated body temperature due to colds (acute respiratory infections, flu, etc.) and other infectious and inflammatory diseases.
Efferalgan solution for oral administration 30 mg/ml 90 ml No. 1
Name
Efferalgan solution for oral administration 30 mg/ml in bottle 90 ml in pack No. 1
Description
Syrup (for children) 3% transparent, homogeneous, slightly viscous, yellow-brown in color, with a caramel-vanilla taste and smell.
Main active ingredient
Paracetamol
Release form
Syrup (for children) 3% transparent, homogeneous, slightly viscous, yellow-brown in color, with a caramel-vanilla taste and smell. 1 ml paracetamol 30 mg Excipients: macrogol 6000, sucrose solution, sodium saccharin, sorbic acid, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, caramel-vanilla flavor, water. 90 ml - plastic bottles (1) complete with measuring spoon - cardboard boxes.
Dosage
30 mg/ml in bottle 90 ml in pack No. 1
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 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 or patients on a low-sugar diet, it should be taken into account 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 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.
pharmachologic effect
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. The possibility of methemoglobin formation is unlikely.
Pharmacokinetics
Data on the pharmacokinetics of the drug Efferalgan are not provided.
Indications for use
For children aged 3 months to 12 years (body weight 6-32 kg): - increased body temperature, incl. for acute respiratory infections, influenza, childhood infections, post-vaccination reactions; - moderate or mild pain syndrome, incl. headache, toothache, muscle pain, neuralgia, pain from injuries and burns.
Directions for use and doses
Orally, both without dilution and after dilution (with water, milk or juice). The average single dose of Efferalgan depends on the child’s body weight and is 10–15 mg/kg 3–4 times a day. The maximum daily dose should not exceed 60 mg/kg. 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 must 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 weighs from 4 to 5 kg, you should fill the measuring spoon to the mark corresponding to 4 kg. For children weighing from 16 to 32 kg: fill the measuring spoon to the 10 kg mark, then again so as to obtain the total body weight of the child. For example, if the child’s weight is from 18 to 19 kg, you should fill the measuring spoon to the 10 kg mark, then again to the 8 kg mark. 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.
Precautionary measures
The use of the drug is contraindicated in severe liver dysfunction. The drug should be used with caution in cases of mild to moderate liver dysfunction and Gilbert's syndrome. The use of the drug is contraindicated in severe renal impairment. The drug should be used with caution in cases of mild to moderate renal dysfunction. The use of the drug in children under 1 month of age is contraindicated.
Interaction with other drugs
With simultaneous use of Efferalgan with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), zyxorin, phenylbutazone, rifampicin, ethanol, the risk of hepatotoxicity increases significantly. When taken together with salicylates, the risk of nephrotoxicity increases significantly. When used simultaneously with chloramphenicol (chloramphenicol), the toxicity of the latter increases. Paracetamol enhances the effect of indirect anticoagulants. Paracetamol reduces the effectiveness of uricosuric drugs.
Contraindications
- 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, especially parabens (methyl and propyl parahydroxybenzoate). The drug should be used with caution in case of mild to moderate liver or kidney dysfunction, or Gilbert's syndrome.
Compound
1 ml paracetamol 30 mg Excipients: macrogol 6000, sucrose solution, sodium saccharin, sorbic acid, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, caramel-vanilla flavor, water. 90 ml - plastic bottles (1) complete with measuring spoon - cardboard boxes.
Overdose
Symptoms: nausea, vomiting, stomach pain, sweating, pale skin. After 1-2 days, signs of liver damage appear - pain in the liver area, increased activity of liver transaminases in the blood, increased prothrombin time. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop. Treatment: discontinue the drug, gastric lavage is recommended, taking enterosorbents (activated carbon, polyphepan), intravenous administration of the antidote N-acetylcysteine, taking methionine, clinical monitoring of the patient's condition.
Side effect
Allergic reactions: possible - skin rash, itching, angioedema. From the digestive system: possible - nausea, vomiting, abdominal pain; with long-term use in high doses, hepatotoxic effects are possible. From the hematopoietic system: rarely - anemia, leukopenia, agranulocytosis, thrombocytopenia; with long-term use in high doses, the development of methemoglobinemia and pancytopenia is possible. Other: with long-term use in high doses, nephrotoxic effects are possible.
Storage conditions
The drug should be stored out of reach of children, in a dry place at a temperature not exceeding 30°C.
Contraindications
Efferalgan, suppositories, syrup
hypersensitivity to paracetamol;
severe dysfunction of the liver and kidneys;
blood diseases;
deficiency of the enzyme glucose-6-phosphate dehydrogenase;
age up to 1 month (for syrup), up to 3 months (for suppositories of 80 mg);
recent inflammation or bleeding in the rectum (contraindication related to the route of administration - for suppositories).
Carefully:
with impaired liver or kidney function due to Gilbert's syndrome. Before taking, you should consult your doctor;
in case of impaired renal function (Cl creatinine less than 10 ml/min), the time interval between doses of Efferalgan in the form of syrup should be at least 8 hours;
Efferalgan should not be used in the form of suppositories for diarrhea (diarrhea).
Efferalgan, tablets
hypersensitivity to paracetamol or any other component of the drug;
alcoholism;
deficiency of glucose-6-phosphate dehydrogenase;
pregnancy (I and III trimesters) and lactation period;
children under 15 years of age (body weight - at least 50 kg).
With caution - renal and/or liver failure, congenital hyperbilirubinemia (Gilbert, Dubinin-Johnson and Rotor syndromes), viral hepatitis, alcoholic liver damage, old age.
Efferalgan with vitamin C
hypersensitivity to paracetamol and other components of the drug;
children up to 8 years old.
With caution: renal and liver failure, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, old age, glucose-6-phosphate dehydrogenase deficiency.
Efferalgan syrup for children 30mg/ml 90ml bottle in Dzerzhinsk
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.
In case of 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.
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.
Side effects
Efferalgan
Common to all dosage forms: in rare cases, nausea, vomiting, allergic reactions (skin rash, itching, urticaria, Quincke's edema), irritation of the rectal mucosa, tenesmus are possible; extremely rarely - anemia, thrombocytopenia, methemoglobinemia, leukopenia, neutropenia.
With long-term use in large doses, hepatotoxic and nephrotoxic effects are possible.
Additional syrup: possible diarrhea, abdominal pain, allergic reactions (anaphylactic shock), decrease or increase in prothrombin index, decrease in blood pressure (as a symptom of anaphylaxis).
Additional tablets: the drug is well tolerated in recommended doses. With long-term use in doses significantly higher than recommended, monitoring of the peripheral blood picture is necessary.
Efferalgan with vitamin C
From the skin: itching, rash on the skin and mucous membranes (usually erythematous or urticarial), Quincke's edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Disorders of the central and peripheral nervous system (usually develops when taking high doses): dizziness, psychomotor agitation and disorientation.
From the gastrointestinal tract: nausea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the hematopoietic organs: anemia (cyanosis), sulfohemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency).
With long-term use in large doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.
From the urinary system (when taking large doses): nephrotoxicity (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).
Interaction
When using Efferalgan together with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxicity increases significantly.
Taken together with salicylates significantly increases the risk of nephrotoxicity.
Salicylamide can prolong T1/2 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 contained in Efferalgan enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Paracetamol may interfere with laboratory test results for determining uric acid and blood glucose levels.
Paracetamol reduces the effectiveness of uricosuric drugs.
Efferalgan with vitamin C (optional)
Concomitant use of paracetamol in high doses increases the effect of anticoagulant agents (reduced synthesis of procoagulant factors in the liver).
Long-term combined use of paracetamol and other NSAIDs increases the risk of developing nephropathy and renal papillary necrosis, and the risk of end-stage renal failure.
Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.
Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.
Vitamin C increases the absorption of penicillin and iron, reduces the effect of heparin and indirect anticoagulants, and increases the risk of crystalluria when treated with salicylates. The absorption of vitamin C is reduced when used simultaneously with oral contraceptives.
Vitamin C slows down the excretion of acids by the kidneys and reduces the reabsorption of drugs that have an alkaline reaction (including alkaloids).
Vitamin C in combination with deferoxamine increases the toxic effect of iron on tissue (especially on the heart, causing the development of heart failure); the prescription of drugs containing ascorbic acid is carried out after determining the concentration of deferoxamine and determining iron excretion, no earlier than 1–2 hours after the infusion of deferoxamine .
Directions for use and doses
Efferalgan
Syrup: orally, both without dilution and after dilution (with water, milk or juice).
The average single dose of Efferalgan depends on the child’s body weight and is 10–15 mg/kg 3–4 times a day. The maximum daily dose should not exceed 60 mg/kg. 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 must 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 weighs from 4 to 5 kg, you should fill the measuring spoon to the mark corresponding to 4 kg.
For children weighing from 16 to 32 kg: fill the measuring spoon to the 10 kg mark, then again so as to obtain the total body weight of the child. For example, if the child’s weight is from 18 to 19 kg, you should fill the measuring spoon to the 10 kg mark, then again to the 8 kg mark.
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.
Suppositories: rectally. Having freed the suppository from the package, insert it into the child's anus (preferably after a cleansing enema or spontaneous bowel movement).
The average single dose of Efferalgan depends on the child’s body weight and is 10–15 mg/kg 3–4 times a day. The maximum daily dose should not exceed 60 mg/kg.
Children from 3 to 5 months (with a body weight of 6–8 kg) - 1 suppository (80 mg); 6 months - 3 years (body weight 10-14 kg) - 1 suppository (150 mg); 5–10 years (with a body weight of 20–30 kg) - 1 suppository (300 mg) 3–4 times a day every 4–6 hours. You should not use more than 4 suppositories per day.
Duration of treatment - 3 days as an antipyretic and up to 5 days as an analgesic.
When using the drug for more than a week, monitoring the functional state of the liver and the picture of peripheral blood is necessary.
Pills. Inside, after dissolving in a glass of water (200 ml). Usually 1 - 2 tablets are used. 2-3 times a day at intervals of at least 4 hours.
The maximum single dose is 2 tablets. (1 g), daily - 8 tablets. (4 g).
In patients with impaired liver or kidney function and in elderly patients, the interval between doses of the drug should be at least 8 hours and the daily dose should be reduced.
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.
Efferalgan with vitamin C
Inside, after dissolving in a glass of water (200 ml).
For children. The average single dose of Efferalgan with vitamin C depends on the child’s body weight and is 10–15 mg of paracetamol per 1 kg of body weight 3–4 times a day. The maximum daily dose should not exceed 60 mg/kg.
The dosage of the drug depending on the age and body weight of the child is presented in the table.
Table
Child's age, years | Child's body weight, kg | Number of tablets per dose | Maximum number of tablets per day |
8–12 | 25–33 | 1 | 3–4 |
12–15 | 33–50 | 1,5 | 4–6 |
The ratio of the child's age and body weight is given approximately.
Without medical supervision, the maximum duration of treatment for children should not exceed 3 days.
Adults and children over 15 years of age (weighing 50 kg or more):
Usually - 2-3 tablets. 2–3 times a day. The maximum single dose is 3 tablets. (990 mg paracetamol); the maximum daily dose is 12 tablets. (3960 mg paracetamol.).
The interval between individual doses of the drug should be at least 4 hours. In patients with impaired liver or kidney function, with Gilbert's syndrome and in elderly patients, the interval between doses of the drug should be at least 8 hours, and the daily dose should be reduced.
The duration of treatment without medical supervision should not exceed 3 days when prescribed as an antipyretic and 5 days when prescribed as an analgesic.
Efferalgan syrup for children 30mg/ml 90ml bottle in Moscow
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.
In case of 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.
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.
Overdose
Efferalgan, syrup, suppositories
Symptoms: signs of acute paracetamol poisoning are nausea, vomiting, anorexia, pain in the epigastric region, sweating, pale skin, appearing in the first 24 hours after administration. Taking paracetamol at a dose of 140 mg/kg 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, lactate dehydrogenase and bilirubin may be observed with a simultaneous decrease in the level of prothrombin. The clinical picture of liver damage usually becomes apparent after 1 or 2 days and peaks after 3–4 days.
Treatment: stop taking the drug, immediately hospitalize the patient. Blood samples should be taken for an initial determination of plasma paracetamol levels. Gastric lavage is carried out in case of oral administration of the drug, intake of enterosorbents (activated carbon, hydrolytic lignin), administration of the antidote acetylcysteine (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.
Efferalgan, tablets.
Symptoms: pale skin, anorexia, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose). Toxic effects in adults are possible after taking more than 10–15 g of paracetamol: increased activity of liver transaminases, increased PT (12–48 hours after administration); a detailed clinical picture of liver damage appears after 1–6 days. Rarely, liver dysfunction develops at lightning speed and can be complicated by renal failure (tubular necrosis).
Treatment: in the first 6 hours after an overdose - gastric lavage, administration of SH-group donors and precursors for the synthesis of glutathione - methionine - 8-9 hours after an overdose and 14-acetylcysteine - after 12 hours. The need for additional therapeutic measures (further administration of methionine , intravenous administration of 14-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
Efferalgan with vitamin C
Symptoms of acute overdose: gastrointestinal disorders (diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or abdominal pain), increased sweating. The clinical picture of acute overdose develops within 6–14 hours after taking paracetamol.
Symptoms of chronic overdose: a hepatotoxic effect develops, characterized by general symptoms (pain, weakness, adynamia, increased sweating) and specific ones characterizing liver damage. As a result, hepatonecrosis may develop. The hepatotoxic effect of paracetamol can be complicated by the development of hepatic encephalopathy (impaired thinking, depression of higher nervous activity, agitation and stupor), convulsions, respiratory depression, coma, cerebral edema, bleeding disorders, development of disseminated intravascular coagulation syndrome, hypoglycemia, metabolic acidosis, arrhythmia, collapse. Rarely, liver dysfunction develops at lightning speed and can be complicated by renal failure (tubular necrosis). Symptoms appear 2–4 days after increasing the dose of the drug.
Treatment: administration of SH-group donors and precursors for the synthesis of glutathione-methionine 8-9 hours after an overdose and 14-acetylcysteine - after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of 14-acetylcysteine) is determined in depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
Efferalgan oral solution 3% 90ml N1
Efferalgan International nonproprietary name Paracetamol Release form Oral solution Composition 1.0 ml of the drug contains the active substance: paracetamol 30 mg, excipients: macrogol-6000, sugar syrup, sodium saccharin E954, potassium sorbate, anhydrous citric acid, caramel-vanilla flavoring *, purified water. *composition: gamma-octalactone, gamma-hexalactone, diacetyl, acetylmethylcarbinol, isoammyl cinnamate, gamma-heptalactone, vanillin, propylene glycol, triacetin, caramel coloring. DESCRIPTION Slightly viscous solution of brown color with a caramel-vanilla odor. Pharmacotherapeutic group: Other analgesics-antipyretics. Anilides. ATX code: N02BE01
Pharmacological properties Pharmacokinetics Absorption of paracetamol when taken orally occurs quickly and completely. Peak plasma concentrations are achieved 30-60 minutes after administration. Paracetamol is quickly distributed in all tissues. Concentrations in blood, saliva and plasma are comparable. Plasma protein binding is weak. Paracetamol is predominantly metabolized in the liver and excreted in the urine. 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide conjugates (60-80%), as well as sulfate conjugates (20-30%). Less than 5% is excreted unchanged. The half-life is 2 hours. A small part of paracetamol, with the participation of cytochrome P450, is converted into a metabolite that combines with glutathione and is excreted in the urine. In case of overdose, the amount of this metabolite increases. In case of severe renal failure (creatinine clearance below 10 ml/min), the elimination of paracetamol and its metabolites is slowed down. Pharmacodynamics Efferalgan contains paracetamol, which has an analgesic and antipyretic effect.
Indications for use: Symptomatic treatment of mild to moderate pain and/or febrile conditions.
Method of administration and dosage This dosage form is a solution, intended for children weighing from 4 to 32 kg (approximately 1 month - 12 years). The solution can be taken orally undiluted or diluted in a small amount of liquid (for example, water, milk, juice). In children, dosage should be observed in accordance with the child's body weight. Age and corresponding body weight are given approximately. The recommended daily dose of paracetamol is about 60 mg/kg/day. The average single dose depends on the child’s body weight and is 10-15 mg/kg body weight every 6 hours 4 times a day. For convenience and accuracy of dosing, it is necessary to use the graduated measuring spoon included with the drug. The measuring spoon has divisions indicating a single dose for a child with the corresponding body weight: 4, 6, 8, 10, 12, 14, 16 kg. Unmarked divisions correspond to intermediate body weight: 3, 5, 7, 9, 11, 13, 15 kg. The measuring spoon is filled according to the child’s body weight and the liquid level is adjusted by divisions. For a child weighing from 4 to 16 kg: fill the measuring spoon according to the division corresponding to the child's body weight, or use the division closest 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 division corresponding to 4 kg. If necessary, the drug can be repeated after 6 hours. For a child weighing 16 to 32 kg: First fill the measuring spoon to the specified division, and then refill the measuring spoon to the division required to obtain the child's desired body weight. For example, if the child’s body weight is from 18 to 19 kg, first fill the measuring spoon to the 10 kg graduation, and then fill it a second time to the 8 kg graduation. If necessary, the drug can be repeated after 6 hours. Regular use avoids fluctuations in pain intensity or temperature levels. In children, a regular interval between doses should be observed day and night, preferably 6 hours. In case of severe renal failure (creatinine clearance below 10 ml/min), the interval between doses of the drug should be at least 8 hours. Duration of treatment: 3 days - as an antipyretic, 5 days - as an analgesic.
Side effects Possible diarrhea, abdominal pain, nausea, vomiting, allergic reactions (skin rash, itching, urticaria, Quincke's edema, anaphylactic shock), tenesmus, decrease or increase in prothrombin index, decrease in blood pressure (as a symptom of anaphylaxis). Rarely - anemia, thrombocytopenia, leukopenia, neutropenia. With long-term use in large doses, hepatotoxic and nephrotoxic effects are possible. If adverse reactions occur, stop taking the drug and consult a doctor.
Contraindications Do not use the drug if your child has: - hypersensitivity to paracetamol or other components of the drug; - severe dysfunction of the liver and kidneys; - blood diseases; - deficiency of the enzyme glucose-6-phosphate dehydrogenase; - age up to 1 month. With caution The drug should be taken with caution in case of impaired liver function, Gilbert's syndrome. Before taking the drug, you should consult your doctor.
Interactions with other medicinal products Oral anticoagulants When taking maximum doses of paracetamol (4 g/day) for at least 4 days, there is a risk of increased effect of the oral anticoagulant and an increased risk of bleeding. Therapy should be monitored using the INR (international normalized ratio) at regular intervals. If necessary, the dose of the oral anticoagulant should be adjusted during treatment with paracetamol and after discontinuation of paracetamol. Effect on laboratory test results At abnormally high concentrations, taking paracetamol may affect the results of blood glucose determinations through the glucose oxidase-peroxidase reaction. The use of paracetamol may affect the results of determining blood urea by a method that uses phosphotungstic acid. When Efferalgan is used together with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxicity increases significantly. Taken together with salicylates significantly increases the risk of nephrotoxicity. Salicylamide may prolong the half-life (TL) 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.
Precautions To avoid the risk of overdose, before using the drug, you must check that other medications used together do not contain paracetamol. Maximum recommended doses: - in children weighing up to 37 kg, the total dose of paracetamol should not exceed 80 mg/kg/day; - in children weighing from 38 to 50 kg, the total dose of paracetamol should not exceed 3 g/day; - in adults and children weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g/day.
Precautions When treating a child with paracetamol at a dose of 60 mg/kg/day, the concomitant use of another antipyretic drug is justified only if paracetamol is ineffective. Patients suffering from diabetes or following a low-carbohydrate diet should take into account the sugar contained in the drug when calculating their daily sugar intake: 0.67 g of sugar per dose of the drug per 4 kg of body weight, according to the graduation on the measuring spoon.
Pregnancy and lactation Paracetamol penetrates the placental barrier and is excreted in breast milk. When using paracetamol during pregnancy and lactation, the expected benefits of therapy for the mother and the potential risk for the fetus and child should be carefully weighed. Peculiarities of the drug's influence on the ability to drive a vehicle and potentially dangerous mechanisms. Does not affect.
Overdose Signs of acute poisoning with paracetamol are nausea, vomiting, anorexia, pain in the epigastric region, sweating, pale skin, appearing in the first 24 hours after administration. Taking paracetamol at a dose of 150 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, lactate dehydrogenase and bilirubin may be observed with a simultaneous decrease in the level of prothrombin. The clinical picture of liver damage usually becomes apparent after one or two days and reaches a maximum after 3-4 days. If symptoms of overdose 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 is carried out in case of oral administration of the drug, intake of enterosorbents (activated carbon, hydrolytic lignin), administration of the antidote N-acetylcysteine intravenously or orally within 10 hours after taking the drug. Acetylcysteine may be effective 16 hours after an overdose. Symptomatic treatment is also carried out.
Packaging 90 ml of solution for oral administration in a bottle made of polyethylene terephthalate, sealed with a lid with a child protection system made of low-density polyethylene. 1 bottle along with a polystyrene measuring spoon and instructions for medical use are placed in a cardboard box.
Storage conditions Store at a temperature not exceeding 25C. Keep out of the reach of children!
Shelf life: 3 years. Do not use after expiration date.
Dispensing conditions Without a prescription.
Manufacturer: Bristol-Myers Squibb, 304 Avenue du Doctor Jean Bru, 47000 Agen, France. Marketing authorization holder: 3 Bristol-Myers Squibb, rue Joseph Monnier, PO Box 325, 92506 Rueil-Malmaison Cedex, France.
special instructions
Common to all dosage forms.
When using the drug for more than 5–7 days, monitoring of the peripheral blood picture and the functional state of the liver is necessary.
Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma.
Efferalgan
Syrup (optional). Contains paracetamol, therefore, in order to avoid exceeding the maximum daily dose, the drug should not be used simultaneously with other medications containing paracetamol.
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 (0.67 g of sugar for each calibration division of the measuring spoon (indicated by marks in kg).
Tablets (optional). To avoid toxic liver damage, paracetamol should not be combined with alcoholic beverages, or taken by persons prone to chronic alcohol consumption.
Efferalgan contains 412.4 mg of sodium per tablet, which should be taken into account by patients on a strict low-salt diet. Since the drug contains sorbitol, it should not be used in cases of fructose intolerance, poor absorption of glucose and galactose, or isomaltase deficiency.
Common to Efferalgan tablets and Efferalgan with vitamin C
The risk of developing liver damage increases in patients with alcoholic hepatosis.
With prolonged use of the drug, monitoring of the peripheral blood picture and the functional state of the liver is necessary.
Efferalgan with vitamin C (optional)
Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor renal function and blood pressure. With long-term use of large doses of vitamin C, inhibition of the function of the insular apparatus of the pancreas is possible.
In patients with high iron levels in the body, ascorbic acid should be used in minimal doses.
Prescribing drugs containing ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors can aggravate the process.
Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity, lactate dehydrogenase).
This drug contains 330 mg of sodium per tablet, which should be taken into account by people on a strict low-salt diet. Since the drug contains sorbitol, it should not be used in cases of fructose intolerance, poor absorption of glucose and galactose, or isomaltase deficiency.
Efferalgan syrup for children 30mg/ml 90ml bottle in Tambov
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.
In case of 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.
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.