Description
Release form
Rectal suppositories
Packaging
12 pieces
Pharmacological action of
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 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.
Contraindications
severe liver dysfunction or decompensated active liver disease
severe renal dysfunction
blood disease
enzyme deficiency glucose-6-phosphate dehydrogenase
early chest infection (up to 3 months old, acute inflammation or infection) associated with the route of administration)
hypersensitivity to paracetamol, propacetamol hydrochloride (paracetamol prodrug) or other components of the drug.
The drug should be used with caution in case of impaired liver function, Gilbert syndrome, dehydration, hypovolemia, as well as anorexia, bulimia or cachexia (insufficient supply of glutathione in the liver).
Before taking the drug, consult your doctor.
In case of impaired renal function, the time interval between doses of the drug should be at least 8 hours with creatinine clearance (CC) of less than 10 ml / min, at least 6 hours with CC more than or equal to 10 ml / min.
The drug should not be used if the child has diarrhea.
Use during pregnancy and lactation
The drug should be used with caution during pregnancy and during breastfeeding.
Special instructions
Before taking the drug, consult your doctor.
When using the drug for more than a week, monitoring of the functional state of the liver and peripheral blood picture is necessary.
Reception of paracetamol in the doses exceeding recommended can lead to 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 in hepatocytes) and in patients receiving inducers of microsomal liver enzymes.
To avoid the risk of overdose, the simultaneous use of the drug Efferalgan ® 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.
Ingredients
1 suppository contains:
Active ingredient:
paracetamol 300 mg
Excipients:
semi-synthetic glycerides (solid fat) – 1000 mg.
Dosage and administration
The drug is administered rectally. Having released the suppository from the package, enter into the anus of the child (preferably after a cleansing enema or spontaneous bowel movement).
The average single dose of Efferalgan depends on the body weight of the child and is 15 mg / kg 4 times / day (every 4-6 hours). The maximum daily dose should not exceed 60 mg / kg.
Children with a body weight of 6 to 8 kg (age from 3 to 5 months) are given 1 suppository (80 mg) 4 times / day every 4-6 hours.
Children with a body weight of 10 to 14 kg (age from 6 months to 3 years), 1 suppository (150 mg) is administered 4 times / day every 4-6 hours.
Children with a body weight of 20 to 30 kg (age from 5 to 10 years) are administered 1 suppository (300 mg) 4 times / day every 4-6 hours.
Regular intervals between the use of suppositories should be observed – from 4 to 6 hours.
Do not use more than 4 suppositories / day.
Duration of treatment
In view of the possible local toxic effect, the use of suppositories more than 4 times / 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 an analgesic.
In the absence of a therapeutic effect, discontinue treatment and consult your doctor.
In patients with chronic or compensated active liver diseases, especially in patients with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver) and dehydration or body weight up to 50 kg, the dose should be reduced or the interval between doses should be reduced or increased. The daily dose should not exceed 2 g.
Side effects
From the digestive system: abdominal pain, diarrhea, nausea, vomiting, tenesmus.
From the side of the liver and biliary tract: liver failure, liver necrosis, hepatitis, increased activity of liver enzymes.
From the hemopoietic system: thrombocytopenia, anemia, leukopenia, neutropenia.
From the blood coagulation system: a decrease or increase in the prothrombin index.
From the skin and subcutaneous tissue: allergic reactions (skin rash, itching, urticaria, Quincke’s edema, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
On the part of the immune system: anaphylactic shock, decreased blood pressure (as a symptom of anaphylaxis).
Local reactions: irritation of the rectal mucosa, irritation in the anus.
If adverse reactions occur, stop taking the drug and consult a doctor.
Drug Interactions
Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses. Patients should be monitored to rule out hepatotoxicity.
Probenecid almost 2 times reduces the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. With simultaneous use, consideration should be given to reducing the dose of paracetamol.
Caution should be exercised while using paracetamol and inducers of microsomal liver enzymes (e.g. ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants).
Prolonged use of barbiturates reduces the effectiveness of paracetamol.
Salicylamide increases T1 / 2 of paracetamol.
Monitor the international normalized ratio (INR) during and after the simultaneous use of paracetamol (especially in high doses and / or for a long time) and coumarins (e.g. warfarin), as paracetamol when taken in a dose of 4 g for at least 4 days can enhance the effect of indirect anticoagulants.
The attending physician should be informed about the use of the drug Efferalgan ® when conducting tests to determine uric acid and blood glucose.
Overdose
Symptoms: symptoms of acute paracetamol poisoning are nausea, vomiting, anorexia, epigastric pain, sweating, paleness b kozhn h pokrovov, poyavlyayuschyesya in The first 24 hours after reception. Pryem paracetamol in dose of 140 mg / kg Fire-proof compounds pulmonary embolism in children v z vaet razrushenye cells liver, pryvodyaschee for is full and neobratymomu hepatonecrosis, hepatic failure, metabolic acidosis, encephalopathies, something in turn, can lead to coma and death.
Increased levels of liver transaminases (ALT, ACT), lactate dehydrogenase, and bilirubin may be observed 12-48 h after administration while reducing prothrombin levels. The clinical picture of liver damage is usually detected after 1 or 2 days and peaks in 3-4 days.
Treatment: If symptoms of poisoning appear, discontinuation and immediate hospitalization are recommended. Blood samples should be taken for the initial determination of paracetamol plasma levels. The gastric lavage is performed in case of oral administration of the drug, intersorbent intake (activated charcoal, lignin hydrolysis), administration of acetylcysteine antidote (in / or orally) within up to 8 hours after ingestion. Acetylcysteine can be effective even after 16 hours after overdose. They also conduct symptomatic treatment.
Liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of hepatic transaminases is normalized within 1-2 weeks. In very severe cases, a liver transplant may be required.
Hepatotoxic and nephrotoxic effects are possible with prolonged use at high doses.
Storage Conditions
At a temperature not exceeding 30 ° C.
shelf life
3 years
Deystvuyushtee substance
Paracetamol
Terms and conditions
without prescription
Dosage form
rectal suppositories
For prescription
Prescription
For children over 4 months old For nursing mothers prescribed for a doctor, Pregnant women prescribed for a doctor, Adults sflrd prd27 5 years old
UPSA CAC, France
