Efferalgan rectal suppositories 150mg №5×2

Name:
Efferalgan.
Description:
Suppositories of white color with a smooth and shiny surface. The main active ingredient is Paracetamol. Release form Rectal suppositories. Dosage 150 mg. Pharmacological action Analgesics and antipyretics. PharmacodynamicsEfferalgan suppositories have analgesic and antipyretic effects. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulatory center in the hypothalamus. Pharmacokinetics Absorption of paracetamol with rectal administration is slower, but more complete than with oral administration. Peak plasma concentrations are reached 2-3 hours after ingestion. Paracetamol is rapidly distributed to 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. An insignificant part of paracetamol with the participation of cytochrome P450 is converted into a metabolite that enters into combination with glutathione and is excreted in the urine. With an overdose, the amount of this metabolite increases. In case of severe renal insufficiency (creatinine clearance below 10 ml / min), the excretion of paracetamol and its metabolites slows down. Indications for use Symptomatic treatment of mild to moderate pain and/or febrile conditions. Dosage and administration The drug is used rectally only in children from 6 months to 10 years. The recommended daily dose of paracetamol depends on the body weight of the child at the rate of 60 mg / kg / day, divided into 4 doses. A single dose is 15 mg / kg every 6 hours, receptions should be at regular intervals, including at night. In children, dosage should be observed in accordance with the body weight of the child. Age and corresponding body weight are approximate. Children weighing 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 to 10 years old) 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 appointment of a suppository is not recommended. Do not use more than 4 suppositories per day. In case of severe renal insufficiency (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 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. In the absence of a therapeutic effect, 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. In the case of the use of paracetamol during pregnancy and lactation, the expected benefit of therapy for the mother and the potential risk to the fetus and child should be carefully weighed. Precautions To avoid the risk of overdose, you should check the absence of paracetamol in other medicines. Maximum allowable doses: in children weighing up to 37 kg, the maximum daily dose of paracetamol should not exceed 80 mg / kg / day; in children weighing 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 body weight of the child, and depending on this, the appropriate dosage form should be selected (see section Dosage and Administration). If, when calculating the daily dose in accordance with the body weight of the child, the required single dosage is less than the contents of one suppository, then after consulting a doctor, it is recommended to use other dosage forms of paracetamol. In case of diarrhea, the appointment of suppositories is not recommended. When using suppositories, there is a risk of local toxicity, especially with frequent and prolonged use. The drug should be used with caution in impaired liver function, Gilbert’s syndrome, dehydration, hypovolemia. Before taking the drug, you should consult with 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 dosing regimen of anticoagulants should be adjusted during the use of paracetamol and after its withdrawal. Effects on laboratory test results At abnormally high concentrations, the use of paracetamol may affect blood glucose results through the glucose oxidase-peroxidase reaction. The use of paracetamol may affect the results of the determination of 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 a hepatotoxic syndrome increases. Paracetamol reduces the effectiveness of diuretics. Contraindications – hypersensitivity to paracetamol; – hepatocellular insufficiency; – severe violations of the liver, kidneys; – recent proctitis, anusitis or rectal bleeding; – blood diseases; – deficiency of the enzyme glucose-6-phosphate dehydrogenase; – children’s age up to 3 months. Composition 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 in terms of rhein. Overdose There is a risk of poisoning in the elderly and especially in young children, which can be life-threatening. Symptoms: nausea, vomiting, anorexia, pallor, abdominal pain, usually appearing on the first day. A single dose of more than 10 g of paracetamol in adults and a single dose of paracetamol in a child at a dose of more than 150 mg / kg of body weight can cause hepatocyte necrosis, leading to hepatocellular insufficiency, metabolic acidosis, encephalopathy and death. 12-48 hours after an overdose, there may be an increase in the level of hepatic transaminases, lactate dehydrogenase and bilirubin, as well as a decrease in the level of prothrombin. Treatment: if symptoms of poisoning appear, consult a doctor immediately. A blood test to determine the level of paracetamol in plasma, gastric lavage (if taken orally), N-acetylcysteine antidote intravenously or orally within 10 hours after taking the drug, symptomatic treatment is recommended. Side effect Very rarely: Allergic reactions: – anaphylaxis, pruritus, rash on the skin and mucous membranes (usually generalized rash, erythematous, urticaria), angioedema, erythema multiforme exudative (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. On the part of the hematopoietic organs: anemia, thrombocytopenia, leukopenia, neutropenia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), 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, stop using the drug and consult a doctor. Storage conditionsStore at a temperature not exceeding 30 °C. 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