Efferalgan rectal suppositories. 150 mg package No. 10

Efferalgan rectal suppositories 80 mg No. 5x2

Name

Efferalgan.

Description

Suppositories are white in color with a smooth and shiny surface.

Main active ingredient

Paracetamol.

Release form

Rectal suppositories.

Dosage

80 mg.

pharmachologic effect

Analgesics and antipyretics.

Pharmacodynamics

Efferalgan suppositories have an analgesic and antipyretic effect. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Pharmacokinetics

Absorption of paracetamol when administered rectally is slower, but more complete than when administered orally. Maximum plasma concentrations are achieved 2-3 hours after administration. Paracetamol is quickly distributed into 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%) and sulfate conjugates (20-30%). Less than 5% is excreted unchanged. The half-life is 4-5 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.

Indications for use

Symptomatic treatment of mild to moderate pain and/or fever.

Directions for use and doses

The drug is used rectally only in children from 3 months to 10 years. The recommended daily dose of paracetamol depends on the child's body weight at the rate of 60 mg/kg/day, divided into 4 doses. A single dose is 15 mg/kg every 6 hours, doses should be taken at equal intervals, including at night. In children, dosage should be observed in accordance with the child's body weight. Age and corresponding body weight are given approximately. Children weighing from 4 to 10 kg (from 3 to 6 months) are administered 1 suppository (80 mg) no more than 4 times a day every 6 hours, not exceeding 4 suppositories per day. Children weighing from 10 to 14 kg (from 6 months to 4 years) are administered 1 suppository (150 mg) no more than 4 times a day every 6 hours, not exceeding 4 suppositories per day. Children weighing from 14 to 24 kg (from 4 years to 10 years) are administered 1 suppository (300 mg) no more than 4 times a day every 6 hours, not exceeding 4 suppositories per day. In case of diarrhea, the use of a suppository is not recommended. You should not use more than 4 suppositories per day. In case of severe renal failure (creatinine clearance below 10 ml/min), the interval between two doses should be at least 8 hours. Due to the risk of local toxicity, rectal administration of paracetamol should be kept as short as possible. The duration of use should be as short as possible: up to 3 days as an antipyretic and up to 5 days as an analgesic. If there is no therapeutic effect, you should stop treatment and consult a doctor.

Use during pregnancy and lactation

The drug is intended for use only in children from 3 months to 10 years of age. Paracetamol crosses 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.

Precautionary measures

To avoid the risk of overdose, you should check the absence of paracetamol in other medicines. Maximum permissible doses: in children weighing up to 37 kg, the maximum daily dose of paracetamol should not exceed 80 mg/kg/day; in children weighing from 38 to 50 kg, the maximum daily dose of paracetamol should not exceed 3 g/day; in adults and children weighing more than 50 kg, the maximum daily dose of paracetamol should not exceed 4 g/day. When treating children, the dosage regimen should be followed in accordance with the child’s body weight, and depending on this, the appropriate dosage form should be selected (see section Method of administration and dosage). If, when calculating the daily dose in accordance with the child’s body weight, the required single dosage is less than the contents of one suppository, then after consultation with a doctor it is recommended to use other dosage forms of paracetamol. In case of diarrhea, the use of suppositories is not recommended. There is a risk of local toxicity when using suppositories, especially with frequent and prolonged use. The drug should be used with caution in case of impaired liver function, Gilbert's syndrome, dehydration, hypovolemia. Before taking the drug, you should consult your doctor.

Interaction with other drugs

Oral anticoagulants Paracetamol enhances the effect of oral anticoagulants and increases the risk of bleeding when taken in maximum doses (4 g/day) for at least 4 days, so regular monitoring of the prothrombin index is necessary. If necessary, the dosage regimen of anticoagulants should be adjusted during the use of paracetamol and after its discontinuation. Effect on laboratory test results At abnormally high concentrations, taking paracetamol may affect blood glucose results 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. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, may increase the toxic effects of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With the simultaneous use of paracetamol with isoniazid, the risk of developing hepatotoxic syndrome increases. Paracetamol reduces the effectiveness of diuretics.

Contraindications

- hypersensitivity to paracetamol; - hepatocellular failure; - severe dysfunction of the liver and kidneys; - recent proctitis, anusitis or rectal bleeding; - blood diseases; - deficiency of the enzyme glucose-6-phosphate dehydrogenase; - children up to 3 months of age.

Compound

1 suppository contains the active substance: paracetamol 80 mg, 150 mg or 300 mg, respectively; excipient: solid fat. 1 tablet contains an average of 12.6 mg of anthranoids calculated as rhein.

Overdose

There is a risk of poisoning in the elderly and especially young children, which can be life-threatening. Symptoms: nausea, vomiting, anorexia, pallor, abdominal pain, usually appearing in the first day. A single dose of more than 10 g of paracetamol by an adult and a single dose of more than 150 mg/kg body weight by a child can cause necrosis of hepatocytes, leading to hepatocellular failure, metabolic acidosis, encephalopathy and death. 12-48 hours after an overdose, an increase in the level of liver transaminases, lactate dehydrogenase and bilirubin, as well as a decrease in the level of prothrombin, may be observed. Treatment: If symptoms of poisoning occur, consult a doctor immediately. A blood test to determine the level of paracetamol in plasma, gastric lavage (if taken orally), taking the antidote N-acetylcysteine ​​intravenously or orally within 10 hours after taking the drug, and symptomatic treatment are recommended.

Side effect

Very rare: Allergic reactions: - anaphylaxis, skin itching, rash on the skin and mucous membranes (usually a generalized rash, erythematous, urticaria), angioedema, exudative erythema multiforme (including Stevenson-Johnson syndrome), toxic epidermal necrolysis ( Lyell's syndrome). From the digestive system: nausea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice. From the endocrine system: hypoglycemia, up to hypoglycemic coma. From the hematopoietic organs: anemia, thrombocytopenia, leukopenia, neutropenia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia. From the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs. Local reactions: irritation of the rectum and anus. If any adverse reactions occur, you should stop using the drug and be sure to consult a doctor.

Storage conditions

Store at a temperature not exceeding 30 °C.

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Instructions for use for Efferalgan rectal suppositories 80 mg No. 5x2

Efferalgan candles for children

First aid kit

(much may not be useful, but if you go somewhere where there is no pharmacy nearby or abroad, then it is a “must have”) ALWAYS CONSULT WITH A PEDIATRIC!!! Xeroform powder - diaper rash, skin irritations bepanten (or panthenol) - diaper rash Nurofen or Panadol - temperature cefekon or analdim (in suppositories) - temperature reabal syrup - abdominal pain, in addition to the treatment of high fever (like no-spa for adults) smecta - diarrhea, allergy nifuroxazide susp. - diarrhea, any probiotic such as bifiorma - diarrhea, as a preventive measure during climate change / water Viferon suppositories - ARVI tests for acetone - monitoring the level of acetone in urine during vomiting, diarrhea, fever, etc. soda (regular, baking soda) - for inhalations for laryngitis or enemas for high acetone dimexide - compress on Gordo for laryngitis (hoarseness, “barking” cough.” Dilution 1:4. Possible compress for insect bites. nasal drops (nazivin) - runny nose, stuffy nose drops in the eyes (sodium sulfacyl, etc.) - conjunctivitis drops in the ears (Sofradex, etc.) - pain in the ears Erius or Claritin in syrup - allergies dexamethasone a couple of ampoules - for severe allergies, IM or together with dimexide for a compress for laryngitis, baralgetas, a couple of ampoules - high temperature i.m. Bandage, cotton wool, plaster, sterile wipes, alcohol, brilliant green, peroxide, furacillin in a tab, potassium permanganate

Addition: For diaper rash - desitin, sudocrem. Temperature - eferalgan suspension and suppositories, paracetamol suspension and Riabal suppositories at a temperature in cases where the periphery is spasmodic (cold arms and legs), which makes it difficult to reduce the temperature. Sorbents in addition to smecta - enterosgel, atoxyl ARVI, also laferobion suppositories Eye drops - sofradex, oculochel, chloramphenicol Ear drops - otipax, otizol (from 6 months). Allergy - zodak, fenistil. Erius from 6 months, Claritin from 2 years. Trauma, bruises, sprains, contusions - TraumeelS, children's rescuer Burn - panthenol Dehydration (with diarrhea, vomiting, temperature) - electrolyte (Humana), rehydron Enterol for diarrhea. You can add drugs that were mentioned for ARVI as prevention and treatment. I would call this list not a first aid kit, but drugs that are more often used in children. If you are creating a first aid kit for travel, then you need to proceed from what you are more susceptible to. For example, for active children who often fall - brilliant green, traumeel, peroxide, bandages. Etc.

Another first aid kit option: 1. Vibrukol 2. Viferon or laferobion in suppositories 3. Umkolor - a herbal antibiotic 4. Engystol or gripphel (aflubin) 5. Aquamaris 6. Efferalgan (paracetamol), analdim suppositories 7. Nurofen syrup 8. Baralgetas a couple of ampoules ( bring down the temperature) 9. Riabal - antispasmodic 10. Infacol for colic 11. Normaze or Duphalac 12. Glycerin suppositories 13. Smecta 14. Creon 15. Traumeel or lifesaver 16. Syringes 17. Hydrogen peroxide 18. Bandage 19. Zelenka 20. Plasters 21 Alcohol 22. Enema 23. Lactovit or bifi-form or other bacterial preparation 24. Dormikind for poor sleep, irritability 25. Dentokind for teething 26. Dentol or other gel for gum pain relief 27. Bepaten, sudocrem, desitin 28. tests for acetone 29. Vata 30. Furacilin 31. Humana Electrolyte or rehydron 32. A couple of ampoules of dexamethasone (hormone, good for emergency conditions such as allergies, laryngeal stenosis, obstructive bronchitis) 33. A couple of ampoules of citrarginine (with acetone) 34. Something antihistamine (fenistil, zodak, erius) in syrup drops and gel (fenistil, psilobalm) 35. Otipax (for ears) 36. Something for the throat (bioparox, chlorophyllipt, givalex, etc.) 37. Eye drops ( at least banal chloramphenicol or tobrex, okulohel) 38. Vasoconstrictor drops for the nose (otrivin). 39. Burn spray (panthenol) may be needed 40. Dimexide 41. Nifroxazide