Cefecon D rectal suppositories (for children) 50mg №5×2

Name:
Cefekon D supp.rect. (for children) 50mg in a box. No. 5х2
Description:
Suppositories of white or white color with a yellowish or brownish tint, torpedo-shaped. The main active ingredient Paracetamol Release form Suppositories Dosage 50 mg Pharmacological properties Pharmacodynamics Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis and influence on the thermoregulatory center in the hypothalamus. Pharmacokinetics Absorption of paracetamol with rectal administration is slower than with oral administration, but more complete. The maximum plasma concentration is reached 2-3 hours after administration. Paracetamol is rapidly distributed in all tissues of the body. Concentrations in blood, saliva and plasma are comparable to each other. Binding to plasma proteins is weak. Paracetamol is metabolized in the liver to form inactive compounds with glucuronic acid and sulfates. A small part of paracetamol is metabolized by cytochrome P450 with the formation of an active intermediate metabolite (N-acetylbenzoquinone imine), which under normal conditions is quickly neutralized by reduced glutathione and excreted in the urine after binding to cysteine and mercapturic acid. However, with a massive overdose, the amount of this toxic metabolite increases. Paracetamol is excreted mainly in the urine; 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60-80%) and sulfate (20-30%); less than 5% is excreted unchanged. The half-life is from 4 to 5 hours. In severe renal failure (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. Dosing and Administration Rectally. It is desirable that before using Cefekon® D suppositories, the child should go to the toilet or be given a cleansing enema. Lay the child on its side. Release the suppository from the blisters. Carefully insert the suppository into the child’s anus with the pointed end. After that, the child should not get up for 1-2 minutes. Only whole suppositories should be administered. Do not break suppositories before use. Do not use more suppositories than indicated in the instructions. Suppositories are not intended to be divided in order to obtain the required dosage. In case of diarrhea, the introduction of a suppository is not recommended. The dosage of the drug is calculated depending on the age and body weight, in accordance with the table. The approximate age of children, based on body weight, is given as a guide only. A single dose is 10-15 mg/kg of the child’s body weight. If necessary, this dose can be administered repeatedly, but not more than 4 times in 24 hours. The interval between each dose should be at least 4 hours. Do not exceed the recommended dose. Higher doses do not lead to an increase in the analgesic effect. The maximum daily dose of paracetamol (including with the simultaneous use of other paracetamol-containing drugs) should not exceed 60 mg / kg of the child’s body weight. If, when calculating the daily dose in accordance with the body weight of the child, a single dosage of less than the contents of one suppository is necessary, then after consulting a doctor, it is recommended to use other dosage forms of paracetamol (for example, a solution or suspension for oral administration). When treating children, the dose calculation regimen should be observed in accordance with the child’s body weight, and depending on this, the appropriate dosage form should be selected. The drug should be used under medical supervision, with extreme caution in children under 1 year of age. In children from 1 to 3 months (weighing at least 4 kg), a single use of the drug is possible to reduce the temperature after vaccination. The use of the drug is possible only on prescription. Due to the risk of local toxicity, it is not recommended to use suppositories more than 4 times a day; the duration of use with the rectal route of administration should be minimal. In case of severe renal insufficiency (creatinine clearance below 10 ml / min; the interval between the use of suppositories should be at least 8 hours. The duration of the course of treatment is 3 days. Prolongation of the course, if necessary, after consulting a doctor. Use during pregnancy and lactation Paracetamol penetrates through 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.PrecautionsWhen using suppositories, there is a risk of local toxicity.The incidence and severity of this side effect increase with an increase in the duration of the use of suppositories, the frequency of their administration and the dosage level.Do not use the drug simultaneously with other drugs containing paracetamol, as this may cause an overdose of paracetamol.In the treatment of paracetamol at a dose of 60 mg / kg /day the simultaneous use of another antipyretic is justified only in case of ineffectiveness of paracetamol. Recommended doses should not be exceeded. Do not use for diarrhea. If hyperthermia lasts more than 3 days during treatment or the state of health worsens, you should consult a doctor. Patients with moderate renal and / or hepatic insufficiency should consult a doctor before using paracetamol. Expressed (severe) violations of the liver and / or kidneys are a contraindication to the use of the drug. An overdose of paracetamol can lead to liver failure (see section “Overdose”). Cases of liver failure have been reported in patients with reduced glutathione levels in anorexia, low body mass index, chronic malnutrition, and chronic severe illness. In such patients, paracetamol may increase the risk of developing metabolic acidosis. Influence on the ability to drive vehicles or other mechanisms Paracetamol has no or little effect on the ability to drive vehicles or other mechanisms. Interaction with other drugs Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially at high doses. Patients should be monitored for hepatotoxicity. Probenecid almost halves the clearance of paracetamol by inhibiting the process of its conjugation with glucuronic acid. With simultaneous use, consideration should be given to reducing the dose of paracetamol. Salicylamide increases the half-life of paracetamol. Caution should be exercised with the simultaneous use of paracetamol and inducers of microsomal liver enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants) (see section “Overdose”). Paracetamol, when taken at a dose of 4 g for at least 4 days, may enhance the effect of oral anticoagulants. 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 anticoagulants (for example, warfarin); dose adjustment of the anticoagulant may be required. Influence on laboratory tests The use of paracetamol may affect the results of the determination of uric acid in the blood serum by reaction with a phosphorus-tungsten reagent and the determination of the concentration of glucose in the blood by the glucose oxidase / peroxidase method. If at present or in the recent past you have taken other medicines, tell your doctor about it. life, diseases of the blood system (anemia, thrombocytopenia, leukopenia), recent proctitis, anusitis or rectal bleeding, inflammation of the rectal mucosa and dysfunction of the anus; do not use for diarrhea. With caution Paracetamol should be used with caution in the following cases: mild or moderate hepatocellular insufficiency; kidney failure; Gilbert’s syndrome (non-hemolytic familial jaundice); chronic alcoholism, excessive alcohol consumption (drinking 3 or more doses of alcohol daily); anorexia, bulimia or cachexia; chronic malnutrition (low stores of glutathione in the liver); dehydration, hypovolemia. If a patient has acute viral hepatitis, treatment should be discontinued. Composition One suppository contains the active substance: paracetamol – 50 mg or 100 mg, or 250 mg. Suppository base: solid fat – sufficient to obtain a suppository weighing 1.25 g. liver enzymes. In such cases, an overdose can be fatal. In case of overdose, you should immediately consult a doctor, even if the patient’s condition does not cause concern. Symptoms During the first 24 hours after an overdose – pallor of the skin, nausea, vomiting, anorexia, malaise, sweating, abdominal pain. With the simultaneous administration of 10 g or more to adults or more than 150 mg / kg to children, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after the administration of paracetamol, there is an increase in the activity of “liver” transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in the content of prothrombin. Clinical symptoms of liver damage usually appear 1-2 days after an overdose of the drug and reach a maximum at 4-6 days. Treatment Immediate hospitalization. Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose. The introduction of donators of SH-groups and precursors of the synthesis of glutathione – methionine and acetylcysteine is most effective within 10 hours after an overdose. The need for further therapeutic measures (further administration of methionine, intravenous administration of acetylcystsin) is determined by ~ 1m * depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration. symptomatic treatment. Liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of “liver” transaminases is normalized within 1-2 weeks with full restoration of liver function. In very severe cases, a liver transplant may be required. Side effects Side effects at therapeutic doses are very rare. From the respiratory system: very rarely (<1/10000): bronchospasm in patients sensitive to aspirin and other NSAIDs; From the gastrointestinal tract: often (from ? 1/100 to < 1/10): hyperemia of the rectal mucosa; From the immune system: rarely (from? 1/10000 to <1/1000): allergic reactions (including skin rash); very rarely (<1/10000): anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis. On the part of the skin and subcutaneous tissues: rarely (from ≥ 1/10,000 to < 1/1,000): exanthema, urticaria, angioedema; From the side of the liver and biliary tract: rarely (from ≥ 1/10,000 to < 1/1,000): liver damage; Laboratory indicators: rarely (from ? 1/10,000 to < 1/1,000): increased creatinine levels (secondarily against the background of hepatorenal syndrome). Local reactions: Redness and soreness around the anus, irritation of the rectum, anus. There are isolated reports of the development of thrombocytopenia and agranulocytosis. However, a causal relationship with the use of paracetamol has not been established. Liver necrosis may occur after an overdose. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. Storage conditions In a place inaccessible to children, at a temperature not exceeding 20 ° C. Buy Cefekon D rectal suppositories (for children) 50 mg No. 5x2 ) 50mg №5x2