Efferalgan syrup for children: instructions for using the medicine, structure, Contraindications

Active material: paracetamol
When ATH: N02BE01
CCF: Analgesic-antipyretic
ICD-10 codes (testimony): J06.9, J10, K08.8, M79.1, M79.2, R50, R51, R52.0, R52.2
When CSF:
Manufacturer: BRISTOL-MYERS SQUIBB (France)

Efferalgan syrup for children: dosage form, composition and packaging

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

1 ml
paracetamol30 mg

Excipients: macrogol 6000, sugar syrup (sucrose, water), sodium saccharin, potassium sorbate, lemon acid, caramel-vanilla flavor (ʙutandion, aцetilmetilkarʙinol, benzaldehyde, propylene glycol, gamma geptalakton, benzyl alcohol, triacetine, pyperronal, amilцinnamat, vanillin, atsetilvanilin), Purified water.

90 ml – plastic bottles (1) complete with measuring spoon – cardboard boxes.
150 ml – plastic bottles (1) complete with measuring spoon – cardboard boxes.

Efferalgan syrup for children: pharmachologic effect

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

It has no negative impact on the water-salt metabolism (sodium and water retention) and gastrointestinal mucosa due to lack of effect on prostaglandin synthesis in peripheral tissues.

Efferalgan syrup for children: pharmacokinetics

Absorption and distribution

Absorption of paracetamol full and fast. Cmax plasma achieved through 30-60 minutes after administration. The distribution of paracetamol in the tissues occurs rapidly. Achieved comparable concentration of drug in the blood, saliva and plasma. Relationship to plasma proteins is low (10-25%). It penetrates through the BBB.

Metabolism and excretion

Metabolism occurs in the liver, 80% reacts conjugation with glucuronic acid and sulphates into inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolite, which is conjugated with glutathione to form inactive metabolites have. With a lack of glutathione, these metabolites may block the enzyme systems of hepatocytes and cause their death. The metabolism of the drug is also involved isoenzyme CYP2E1.

T1/2 is about 2 no (1-4 no). Excreted by the kidneys as metabolites, mainly conjugates. The unchanged output less 5%.

Efferalgan syrup for children: testimony

To children aged 1 months before 12 years (weighing from 4 to 32 kg):

  • as an antipyretic in acute respiratory infections, Flu, childhood infections, post-vaccination reactions and other conditions, accompanied by fever;
  • as an analgesic for mild to moderate pain, incl. headache and toothache, muscle aches, neuralgia, pain in trauma and burns.

Efferalgan syrup for children: dosing regimen

The average single dose depends on the body weight of the child and 10-15 mg / kg 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 no. It should adhere to regular time intervals between drug intake.

For convenience and accuracy of dosing should use measuring spoon. In measuring spoon marked division, indicating the body weight of the child: 4, 6, 8, 10, 12, 14 or 16 kg . Unmarked intermediate division of the body weight: 5, 7, 9, 11, 13 or 15 kg .

Children weighing from 4 to 16 kg: Fill the measuring spoon up to the mark, appropriate body weight of the child, or to a label, closest in meaning to the body weight of the child. For Example, if the weight of the child 4 to 5 kg fill the measuring spoon up to the mark, appropriate 4 kg . If necessary, the drug should be taken every 4-6 no.

Children weighing from 16 to 32 kg: Fill the measuring spoon up to the mark, appropriate 10 kg, then re-fill the measuring spoon up to the mark so, to get a total body weight of the child. For Example, if the weight of the child 18 to 19 kg fill the measuring spoon up to the mark, appropriate 10 kg, then re-fill the measuring spoon up to the mark 8 kg.

If necessary, the drug should be taken every 4-6 no. At impaired renal function (CC less than 10 ml / min) the time interval between doses of the drug should be at least 8 no.

The drug can be given as a child without dilution, and after dilution (water, milk or juice).

Duration of treatment – 3 days as an antipyretic and up 5 days as a painkiller. If you need to continue taking the drug requires medical consultation.

Efferalgan syrup for children: side effects

From the digestive system: possible – diarrhea, abdominal pain, nausea, vomiting, tenesmus; With prolonged use at high doses may hepatotoxic effects.

Allergic reactions: possible – skin rash, itch, hives, angioedema, anaphylactic shock, decrease in blood pressure (as a symptom of anaphylaxis).

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

Other: reduction or increase in prothrombin index; With prolonged use at high doses may nephrotoxicity.

Efferalgan syrup for children: Contraindications

  • severe liver;
  • severe renal dysfunction;
  • blood disease;
  • deficiency of glucose-6-fosfatdegidrogenazы;
  • Children up to age 1 of the month;
  • hypersensitivity to the drug

FROM caution use in patients with hepatic dysfunction or renal mild to moderate, when Gilbert's syndrome.

Efferalgan syrup for children: Special instructions

To avoid exceeding the maximum daily dose, Efferalgan not be used concurrently with other drugs, soderzhashtimi paracetamol.

In applying the drug more 5-7 days necessary to monitor patterns of peripheral blood and functional state of the liver.

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

The appointment of the drug to patients with diabetes or patients, located on a diet with low sugar content, should be considered, what in 1 ml of the product contains 0.335 g sugar (0.67 g of sugar per calibration division of the measuring spoon (marked labels in kg).

Persons, caring for a sick child, should be warned about the need to repeal the drug treatment and medical attention in the event of adverse reactions. Consultation is also required in the absence of therapeutic effect: continued fever more 3 days and more pain 5 days.

Efferalgan syrup for children: overdose

Symptoms acute paracetamol poisoning are nausea, vomiting, anorexia, epigastric pain, Sweating, pale skin, appearing in the first 24 h after administration. Intake of paracetamol at a dose of 140 mg / kg body weight in children causes destruction of liver cells, resulting in complete and irreversible gepatonekroz, hepatic insufficiency, metabolic acidosis, эncefalopatii, what, in turn, It can lead to coma and death.

Through 12-48 h after administration can be observed increase in liver transaminases, LDH and bilirubin levels while reducing prothrombin. The clinical picture of liver damage is usually detected through 1 or 2 days and reaches a maximum after 3-4 day.

Treatment: When symptoms of poisoning recommended discontinuation and immediate hospitalization. Blood samples should be taken for the initial determination of the level of paracetamol in plasma. Held gastric lavage, reception enterosorbents (Activated carbon, Lignin gidroliznyi), introduction antidote acetylcysteine (in / or orally) in time before the 10 h after dosing. Acetylcysteine ​​may be effective later 16 h after overdose. Also symptomatic treatment.

Efferalgan syrup for children: drug interaction

In an application with barbiturates Efferalgan, tricyclic antidepressants, anticonvulsants (phenytoin), flumetsinolom, phenylbutazone, rifampicin, ethanol significantly increased risk of hepatotoxicity.

When taken together with salicylates significantly increases the risk of nephrotoxicity.

Salicylamide can roll T1/2 Paracetamol.

While the use of chloramphenicol toxicity recent increases.

Probenecid causes an almost two-fold reduction in clearance of paracetamol by inhibiting binding to glucuronic acid.

Paracetamol intensifies the effect of indirect anticoagulants.

Paracetamol reduces the effectiveness of drugs urikozuricheskih.

Efferalgan syrup for children: terms of dispensing from pharmacies

The drug is resolved to application as an agent Valium holidays.

Efferalgan syrup for children: terms and conditions of storage

The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 3 year.

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