Efferalgan suppositories 300mg, No. 12

• In children, as an antipyretic agent 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 anesthetic for pain syndrome of mild to moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain in trauma and burns.

80 mg suppositories are used in children weighing 6 to 8 kg (aged 3 to 5 months), 150 mg suppositories are used in children weighing 10 to 14 kg (aged 6 months to 3 years) , 300 mg suppositories are used in children weighing 20 to 30 kg (aged 5 to 10 years).

The drug is used rectally. Having released 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 15 mg / kg 4 times / day (every 4-6 hours). The maximum daily dose should not exceed 60 mg / kg.

Children weighing from 6 to 8 kg (age from 3 to 5 months) are administered 1 suppository (80 mg) 4 times / day every 4-6 hours.

Children weighing from 10 to 14 kg (age from 6 months to 3 years) are administered 1 suppository (150 mg) 4 times / day every 4-6 hours.

Children weighing from 20 to 30 kg (age from 5 to 10 years) are administered 1 suppository (300 mg) 4 times / day every 4-6 hours.

It is necessary to observe regular intervals between the use of suppositories - from 4 to 6 hours.

Do not use more than 4 suppositories per day.

Duration of treatment

In view of the possible local toxic effect, the use of suppositories more than 4 times a day is not recommended, the duration of use should be as short as possible: 3 days as an antipyretic and up to 5 days as a pain reliever.

In the absence of a therapeutic effect, treatment should be discontinued and the attending physician should be consulted.

In patients with chronic or compensated active liver diseases, especially accompanied by liver failure, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), Gilbert's syndrome, dehydration, or weighing up to 50 kg, the dose of the drug should be reduced or the interval increased between receptions. The daily dose should not exceed 2 g.

Rectal suppositories are white, smooth, glossy.

1 supp.

paracetamol 300 mg

Excipients: semi-synthetic glycerides (solid fat) - 1000 mg.

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

• severe liver dysfunction or decompensated liver disease in the active stage;

• severe renal dysfunction;

• blood diseases;

• deficiency of the enzyme glucose-6-phosphate dehydrogenase;

• early infancy (up to 3 months);

• recent inflammation or bleeding in the rectum (contraindication associated with the route of administration).

With caution: the drug should be used with caution in case of impaired renal function, liver function, Gilbert's syndrome, dehydration, hypovolemia, as well as anorexia, bulimia, cachexia or chronic nutritional deficiency (insufficient supply of glutathione in the liver).

Before taking the drug, you should consult your doctor.

In case of impaired renal function, 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 more than or equal to 10 ml / min.

Do not use the drug if the child has diarrhea.

pharmachologic effect

Efferalgan suppositories contain paracetamol, which 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 the 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 (sodium and water retention) and the gastrointestinal mucosa.

Side effect

From the digestive system: abdominal pain, diarrhea, nausea, vomiting, tenesmus.

From the liver and biliary tract: hepatic failure, liver necrosis, hepatitis, increased activity of liver enzymes.

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

From the side of the blood coagulation system: a decrease or increase in the prothrombin index.

Skin and subcutaneous tissue disorders: allergic reactions (skin rash, itching, urticaria, Quincke's edema, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).

From the immune system: anaphylactic shock, lowering blood pressure (as a symptom of anaphylaxis).

Local reactions: irritation of the rectal mucosa, irritation in the anal canal.

If any adverse reactions occur, you should stop taking the drug and consult a doctor.

Application for violations of liver function

The use of the drug is contraindicated in severe liver dysfunction or decompensated liver disease in the active stage.

The drug should be used with caution in case of impaired liver function, Gilbert's syndrome.

Application for impaired renal function

The use of the drug is contraindicated in severe renal impairment.

Application in children

The use is contraindicated in early infancy (up to 3 months).

special instructions

Before taking the drug, you should consult your doctor.

When using the drug for more than a week, it is necessary to monitor the functional state of the liver and the picture of peripheral blood.

Taking more paracetamol than recommended can cause serious liver damage.

There is a risk of overdose in patients suffering from liver disease, chronic alcoholism, chronic malnutrition (due to low levels of glutathione stores in hepatocytes) and in patients receiving inducers of liver microsomal enzymes.

To avoid the risk of overdose, the simultaneous administration of EfferalganЃ and other drugs containing paracetamol is not recommended.

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 use of the drug should be discontinued.

Overdose

Symptoms: signs of acute paracetamol poisoning are nausea, vomiting, anorexia, epigastric pain, 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, there may be an increase in the level of liver transaminases (ALT, ACT), lactate dehydrogenase and bilirubin 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: when 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 is performed in the case of oral administration of the drug, intake of enterosorbents (activated carbon, hydrolytic lignin), administration of the antidote acetylcysteine ??(IV or oral) within 8 hours after taking the drug. Acetylcysteine ??can be effective even 16 hours after an overdose. Symptomatic treatment is also carried out.

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 1Ц2 weeks. In very severe cases, a liver transplant may be required.

With prolonged use in high doses, hepatotoxic and nephrotoxic effects are possible.

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. Patients should be monitored to exclude hepatotoxicity.

Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. With simultaneous use, you should consider reducing the dose of paracetamol.

Care should be taken with the simultaneous use of paracetamol and inducers of liver microsomal 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 T1 / 2 of paracetamol.

The international normalized ratio (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), because paracetamol, when taken in a dose of 4 g for at least 4 days, can enhance the effect of indirect anticoagulants.

Caution should be exercised with the simultaneous use of paracetamol and flucloxacillin, which is associated with an increased risk of metabolic acidosis with a high anionic difference, especially in patients with a risk factor for the development of glutathione deficiency (including patients with severe renal failure, sepsis, malnutrition and chronic alcoholism). Careful monitoring is recommended in order to detect signs of acid-base imbalance, namely metabolic acidosis with a high anion difference, including the determination of 5-oxoproline in urine.

The attending physician should be informed about the use of EfferalganЃ when performing tests to determine uric acid and blood glucose levels.