Description
Pharmacological action
Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects.
The exact mechanism of analgesic and antipyretic effects of paracetamol has not been established. Apparently, it includes central and peripheral components. Paracetamol blocks cyclooxygenase (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 anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues leads to the absence of a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.
Indications
For children aged 1 month to 12 years (weighing 4 to 32 kg):
as an antipyretic for ARI, influenza, childhood infections, post-vaccination reactions and other conditions associated with an increase in
body temperature as an anesthetic for pain of mild or moderate intensity, including headache and toothache, muscle pain, neuralgia, pain from injuries and burns.
Contraindications
Do not use the drug if your child has:
hypersensitivity to paracetamol or other components of the drug, especially parabens (methyl and propyl parahydroxybenzoate)
severe hepatic impairment of kidney,
glucose deficiency age up to 1 month.
Caution – The drug should be used with caution in case of impaired liver or kidney function, in Gilbert’s syndrome. Before taking the drug, you must consult your doctor.
To determine the dose and regimen of the drug in children aged 1 to 3 months, consult a doctor.
Recommendations for use
The average single dose of the drug depends on the body weight of the child 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 doses of the drug.
Use a measuring spoon for convenient and accurate dosing. On the measuring spoon there are markings indicating the child s body weight: 4, 6, 8, 10, 12, 14 or 16 kg. Unmarked divisions correspond to an intermediate body weight: 5, 7, 9, 11, 13 or 15 kg.
Children with a body weight of 4 to 16 kg
Fill a measuring spoon with a mark corresponding to the child s body weight or the label closest in value to the child s body weight. For example, if the child s body weight is from 4 to 5 kg, fill a measuring spoon to the mark corresponding to 4 kg. If necessary, the drug should be taken every 4-6 hours.
Children with a body weight of 16 to 32 kg
Fill a measuring spoon to the mark corresponding to 10 kg, then refill the measuring spoon to the mark so that the total weight of the child is obtained. For example, if the child s body weight is from 18 to 19 kg, fill the measuring spoon to the mark corresponding to 10 kg, then refill the measuring spoon to the mark of 8 kg. If necessary, the drug should be taken every 4-6 hours.
The drug can be given to the child both without dilution and after dilution (with water, milk or juice).
Duration of treatment – 3 days as an antipyretic and up to 5 days as a painkiller. If you need to continue taking the drug, you need to consult a doctor.
For children aged 1 to 3 months, the drug can be given only as directed by a doctor.
In severe renal impairment, the time interval between doses of the drug should be at least 8 hours with CC less than 10 ml / min, at least 6 hours with CC 10-50 ml / min.
In patients with chronic or compensated active liver diseases, especially those associated with liver failure, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), Gilbert syndrome, dehydration or body weight less than 50 kg, the dose should be reduced or increased interval between receptions. The daily dose should not exceed 2 g.
Special instructions
Efferalgan contains paracetamol, therefore, in order to avoid exceeding the maximum daily dose, the drug should not be used simultaneously with other medicines containing paracetamol.
When using the drug for more than 5-7 days, monitoring of the picture of peripheral blood and the functional state of the liver is necessary.
In case of taking the drug by children suffering from diabetes mellitus or 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.
Paracetamol distorts the results of laboratory studies 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 should consult your doctor.
Composition of
1 ml of the preparation contains:
Active substances:
30 mg paracetamol.
Excipients:
macrogol 6000 – 20 g,
sugar syrup (sucrose, water) – 50 g,
sodium saccharin – 0.15 g,
potassium sorbate – 0.4 g,
caramel vanilla flavor * – 0.2 g,
citric acid – 0.107 g,
purified water – up to 100 ml.
* composition of caramel vanilla flavoring:
butanedione,
acetylmethylcarbinol,
benzaldehyde,
propylene glycol,
gamma-heptalactone,
benzyl alcohol,
trialkyldryl plylcyrindyl, srldklinlprindlrp, srldkylprylprindlrp, srldkylprylprindlrp
Side effects
Nausea, vomiting, abdominal pain, allergic reactions (skin rash, itching, urticaria, Quincke’s edema) are possible.
Rarely – anemia, leukopenia, agranulocytosis, thrombocytopenia.
With prolonged 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 of
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, increased activity of liver enzymes in the blood, increased 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.
Recommended gastric lavage, administration of enterosorbents (activated charcoal, polyphepan), intravenous administration of the antidote N-acetylcysteine, methionine.
Storage conditions
Store at a temperature not exceeding 30 ° C, out of the reach of children.
Expiration
3 years.
Do not use the drug after the expiration date indicated on the package.
Pharmacy conditions
without prescription
Dosage form
oral solution
