Cefekon d - instructions for use. Tsefekon d suppositories: instructions for use Tsefekon suppositories 250
Tsefekon-D candles
from 3 to 12 years
International patented name
Paracetamol
Package
Cefekon ® D rectal suppositories for children, 50 mg, 100 mg or 250 mg. 5 suppositories in a blister pack; two contour blister packs along with instructions for medical use the drug is placed in a cardboard box
Compound
One suppository contains: paracetamol as an active substance - 0.05 g, 0.01 g or 0.25 g; as excipient: vitepsol - a sufficient amount to obtain a suppository weighing from 1.19 to 1.31 g.
Description
Suppositories are white or white with a creamy or yellowish tint, torpedo-shaped.
Pharmacodynamics:
Paracetamol has analgesic and antipyretic effects. The drug blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxyginase, which explains the lack of a significant anti-inflammatory effect.
The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues causes it to lack negative influence on water-salt metabolism (sodium and water retention) and mucous membrane gastrointestinal tract.
Pharmacokinetics:
Absorption is high, quickly absorbed from the gastrointestinal tract. The period to achieve maximum concentration is 30-60 minutes. Penetrates the blood-brain barrier. The amount of bioavailability in children and neonates is similar to that in adults. Metabolized in the liver. The half-life is 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, unchanged - 3%. There is no significant age-related difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.
Indications for use
Used in children from 3 months to 12 years as: - an antipyretic for acute respiratory diseases, flu, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature; - painkiller for pain syndrome weak and moderate intensity, including: headache and toothache, muscle pain, neuralgia, pain from injuries and burns. In children from 1 to 3 months, a single dose of the drug can be taken to reduce fever after vaccination; the use of the drug for all indications is possible only as prescribed by a doctor.
Contraindications
Hypersensitivity to the components of the drug, age - up to 1 month of life. With caution: Impaired liver and kidney function, Gilbert, Dubin-Johnson and Rotor syndrome, diseases of the blood system (anemia, thrombocytopenia, leukopenia), genetic absence of glucose-6-phosphate dehydrogenase.
Directions for use and doses
Rectally. After spontaneous bowel movement or a cleansing enema, the suppository is released from the contour cell packaging and inserted into the rectum. The dosage of the drug is calculated depending on age and body weight, in accordance with the table. A single dose is 10-15 mg/kg of the child’s body weight, 2-3 times a day, every 4-6 hours. Maximum daily dose paracetamol should not exceed 60 mg/kg of the child’s body weight.
Age Tsefekon-d | Weight Tsefekon-d | Single dose of Cefekon-d |
1-3 months | 4 - 6 kg | 1 suppository of 0.05 g (50 mg) |
3-12 months | 7 - 10 kg | 1 suppository of 0.1 g (100 mg) |
1-3 years | 11 -16 kg | 1 - 2 suppositories of 0.1 g (100 mg) |
3-10 years | 17 - 30 kg | 1 suppository of 0.25 g (250 mg) |
10-12 years | 31 - 35 kg | 2 suppositories of 0.25 g (250 mg) |
Duration of treatment: 3 days as an antipyretic and up to 5 days as an anesthetic. Extending the course if necessary after consultation with a doctor
Allergic reactions(including skin rash).
Interaction with other drugs
Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic medicines increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications, even with a slight overdose. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity. When taken together with salicylates, the nephrotoxic effect of paracetamol increases. Combination with chloramphenicol leads to an increase in the toxic properties of the latter. Strengthens the effect of indirect anticoagulants, reduces the effectiveness of uricosuric drugs.
With ongoing febrile syndrome against the background of using paracetamol for more than 3 days, and pain syndrome for more than 5 days, a doctor’s consultation is required.
In an online pharmacy Tsefekon-d can be purchased with home delivery. The quality of all products in our online pharmacy, including Cefekon-d, undergo product quality control by our trusted suppliers. You can buy Cefekon-d on our website by clicking on the “Buy” button. We will be happy to deliver Cefekon-d to you completely free of charge to any address within our delivery area.
Suppositories are white or white with a yellowish or creamy tint, torpedo-shaped.
Active ingredients
Release form
Suppositories
Compound
One suppository contains: active substance- paracetamol - 50 mg, 100 mg or 250 mg, bases for suppositories: solid fat (vitepsol, supposir) - until a suppository weighing 1.25 g is obtained.
Pharmacological effect
Anti-inflammatory, antipyretic, analgesic
Pharmacokinetics
Absorption is high, quickly absorbed from the gastrointestinal tract. The period to achieve maximum concentration is 30-60 minutes. Penetrates the blood-brain barrier. The amount of bioavailability in children and neonates is similar to that in adults. Metabolized in the liver. The half-life is 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, 3% unchanged. There is no significant age-related difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.
Indications
Used in children from 3 months to 12 years as: an antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature, an analgesic for pain of mild and moderate intensity, including : headache and toothache, muscle pain, neuralgia, pain from injuries and burns. In children from 1 to 3 months, a single dose of the drug can be taken to reduce fever after vaccination; the use of the drug for all indications is possible only as prescribed by a doctor.
Contraindications
Hypersensitivity, neonatal period (up to 1 month).
Precautionary measures
Renal and liver failure, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, genetic absence of glucose-6-phosphate dehydrogenase, simultaneous administration other paracetamol-containing drugs.
Directions for use and doses
Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of the drug is calculated depending on age and body weight, in accordance with the table. A single dose is 10–15 mg/kg 2–3 times a day every 4–6 hours. The maximum daily dose of paracetamol should not exceed 60 mg/kg.
Side effects
Allergic reactions (including skin rash).
Overdose
Symptoms: during the first 24 hours after administration - pallor skin, nausea, vomiting, anorexia, abdominal pain, impaired glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In case of severe overdose - liver failure with progressive encephalopathy, coma, death, acute renal failure with tubular necrosis (including in the absence of severe liver damage), arrhythmia, pancreatitis. The hepatotoxic effect in adults occurs when taking 10 g or more. Treatment: administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine - after 12 hours. The need for further therapeutic measures (further administration of methionine, intravenous administration N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Interaction with other drugs
Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications, even with a slight overdose. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity. When taken together with salicylates, the nephrotoxic effect of paracetamol increases. Combination with chloramphenicol leads to an increase in the toxic properties of the latter. Strengthens the effect of indirect anticoagulants, reduces the effectiveness of uricosuric drugs.
special instructions
If fever persists for more than 3 days and pain persists for more than 5 days, you should consult your doctor. Should be avoided simultaneous use paracetamol with other paracetamol-containing drugs, as this may cause an overdose of paracetamol. When using the drug for more than 5-7 days, peripheral blood counts should be monitored and functional state liver. Paracetamol distorts indicators laboratory research at quantification glucose and uric acid in plasma.
Storage conditions
Keep out of the reach of children, at a temperature not exceeding 20°C.
Compound
One suppository contains
active substance: paracetamol - 50 mg or 100 mg, or 250 mg.
Base for suppositories: solid fat - a sufficient amount to obtain a suppository weighing 1.25 g.
Pharmacotherapeutic group
ATX code: . Other analgesic and antipyretic drugs. Aniline derivatives.
Description
Suppositories are white or white with a yellowish or brownish tint, torpedo-shaped in color.
Pharmacological properties
Pharmacodynamics
Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis and an effect on the thermoregulation center in the hypothalamus.
Pharmacokinetics
The absorption of paracetamol when administered rectally is slower than when administered oral administration, however more complete. The maximum concentration in blood plasma is achieved 2-3 hours after administration.
Paracetamol is quickly distributed in all tissues of the body. Concentrations in blood, saliva and plasma are comparable. Binding to blood 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 to form 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 is slowed down.
Indications for use
Symptomatic treatment mild to moderate pain and/or fever.
Directions for use and doses
Rectally. It is advisable that before using Cefekon® D suppositories, the child goes to the toilet or has a cleansing enema. Place your baby on his side. Release the suppository from the blister pack. Carefully insert the suppository into the baby's anus with the pointed end. After this, 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 to obtain the required dosage. In case of diarrhea, administration of a suppository is not recommended.
The dosage of the drug is calculated depending on age and body weight, in accordance with the table. Approximate ages of children based on body weight are provided as a guideline only. A single dose is 10-15 mg/kg of the child’s body weight. If necessary, this dose can be re-administered, 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 increased analgesic effect. The maximum daily dose of paracetamol (including with 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 child’s body weight, a single dosage is required less than the contents of one suppository, then after consultation with a doctor it is recommended to use others dosage forms paracetamol (for example, oral solution or suspension). When treating children, the dosage regimen should be calculated in accordance with the child’s body weight, and depending on this, the appropriate dosage form must 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 fever after vaccination. The use of the drug is possible only as prescribed by a doctor.
In case of severe renal failure (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. Extend the course if necessary after consulting a doctor.
Side effecttwee
Side effects at therapeutic doses occur very rarely.
From the respiratory system:
Very rarely ( From the gastrointestinal tract: often (from ≥ 1/100 to From the immune system: rare (from ≥ 1/10000 to For the skin and subcutaneous tissues: rare (from ≥ 1/10000 to From the liver and biliary tract: rare (from ≥ 1/10000 to Laboratory resultsate: rare (from ≥ 1/10000 to Local reactions:
Redness and soreness around anus, irritation of the rectum, anus.
There are isolated reports of the development of thrombocytopenia and agranulocytosis. However, a cause-and-effect relationship with paracetamol use has not been established.
Liver necrosis may occur after overdose.
If side effects occur, tell your doctor. This applies to everythingall possible side effects, includingundescribedin this leaflet.
Contraindications
Individual increased sensitivity to the components of the drug, severe dysfunction of the liver and kidneys, deficiency of glucose-b-phosphate dehydrogenase (possible development hemolytic anemia), childhood up to 1 month of 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.
Carefully
Paracetamol should be used with caution in the following cases:
Mild or moderate hepatocellular failure; renal failure; Gilbert's syndrome (non-hemolytic familial jaundice); chronic alcoholism, overuse alcohol (drinking 3 or more drinks of alcohol daily); anorexia, bulimia or cachexia; chronic malnutrition (low glutathione reserves in the liver); dehydration, hypovolemia.
When a patient is diagnosed with acute viral hepatitis treatment should be stopped.
Precautionary measures
There is a risk of local toxicity when using suppositories. Frequency of development and severity of this side effect increase with increasing duration of use of suppositories, frequency of their administration and dosage level.
Do not use the drug simultaneously with other medicines containing paracetamol, as this may cause an overdose of paracetamol.
When treated with paracetamol at a dose of 60 mg/kg/day, simultaneous use of another antipyretic is justified only if paracetamol is ineffective. Do not exceed recommended doses.
Do not use for diarrhea.
If hyperthermia continues for more than 3 days during treatment or your health condition worsens, you should consult a doctor.
Patients with moderate renal and/or hepatic impairment should consult a doctor before using paracetamol. Severe (severe) dysfunction of the liver and/or kidneys is 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 due to anorexia, low body mass index, chronic nutritional deficiency, chronic serious illness. In such patients, taking paracetamol may increase the risk of developing metabolic acidosis.
Use during pregnancy and lactation
Paracetamol penetrates the placental barrier and is excreted 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.
Impact on the ability to performdrive vehicles or other machinery
Paracetamol has no or negligible effect on the ability to drive vehicles or use other machinery.
Overdose
The risk of serious intoxication may be increased in the elderly, young children, patients with liver disease, chronic alcoholism, and malnourished patients taking inducers of microsomal liver enzymes. In such cases, an overdose can lead to fatal outcome. 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 - pale skin, nausea, vomiting, anorexia, malaise, sweating, abdominal pain. When administered simultaneously to adults of 10 g or more or to children of more than 150 mg/kg, 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 prothrombin content. Clinical symptoms Liver damage usually appears 1-2 days after a drug overdose and reaches a maximum on days 4-6.
Treatment
Immediate hospitalization.
Determination of the quantitative content of paracetamol in blood plasma before starting treatment as soon as possible early dates after an overdose. Administration of SH-group donors and precursors for glutathione synthesis - 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 acetylcystsine) is determined 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 normalizes within 1-2 weeks with full restoration liver functions. In very severe cases, a liver transplant may be required.
Interaction with other drugs
Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use paracetamol, especially in high doses. Patients should be monitored for hepatotoxicity.
Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. If used concomitantly, consider reducing the dose of paracetamol.
Salicylamide increases the half-life of paracetamol.
Caution should be exercised during 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 in 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 cessation of concomitant 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.
Effect on laboratory tests
The use of paracetamol may affect the results of determining uric acid in blood serum by reaction with a phosphorus-tungsten reagent and determining the concentration of glucose in the blood using the glucose oxidase/peroxidase method.
If currentlyIf you have taken other medications in the past or in the recent past, please tell your doctor
Release form
Cefekon® D rectal suppositories for children, 50 mg, 100 mg or 250 mg. 5 suppositories in a blister pack; two blister packs together with instructions for medical use of the drug are placed in a cardboard box.
Pharmacodynamics:
Paracetamol has analgesic and antipyretic effects. The drug blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of a significant 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 mucous membrane of the gastrointestinal tract.
Pharmacokinetics:
Absorption is high, quickly absorbed from the gastrointestinal tract. The period to achieve maximum concentration is 30-60 minutes. Penetrates the blood-brain barrier. The amount of bioavailability in children and neonates is similar to that in adults. Metabolized in the liver. The half-life is 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, unchanged - 3%. There is no significant age-related difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.
Indications
Cefekon D is used in children from 3 months to 3 years as:
antipyretic for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
analgesic for pain of mild to moderate intensity, incl. head and toothache, muscle pain, neuralgia, pain from injuries and burns.
Contraindications
Hypersensitivity to the components of Tsefekon D;
age up to 1 month of life.
Carefully:
liver and kidney dysfunction;
Gilbert's syndrome; Dubin-Johnson and Rotor;
diseases of the blood system (anemia, thrombocytopenia, leukopenia);
genetic absence of the enzyme glucose-6-phosphate dehydrogenase.
special instructions
If the febrile syndrome continues during the use of paracetamol for more than 3 days, and the pain syndrome continues for more than 5 days, a doctor’s consultation is required.
Compound
One suppository contains: active substance - paracetamol - 50 mg, 100 mg or 250 mg; bases for suppositories: solid fat (vitepsol, supposir) - until a suppository weighing 1.25 g is obtained.
Directions for use and doses
Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of Cefekon D is calculated depending on age and body weight, in accordance with the table. Average single dose is 10-15 mg/kg 2-3 times a day every 4-6 hours.
The maximum daily dose of paracetamol should not exceed 60 mg/kg.
1-3 months (4-6 kg) - 1 sup. 50 mg each (50 mg);
3-12 months (7-10 kg) - 1 sup. 100 mg each (100 mg);
from 1 year to 3 years (11-16 kg) - 1-2 supp. 100 mg each (100-200 mg);
from 3 to 10 years (17-30 kg) - 1 sup. 250 mg each (250 mg);
from 10 to 12 years (31-35 kg) - 2 supp. 250 mg (500 mg).
Side effects
From the gastrointestinal tract: nausea, vomiting, abdominal pain.
Allergic reactions: itching, rash on the skin and mucous membranes, urticaria, Quincke's edema.
From the hematopoietic organs: anemia, leukopenia, agranulocytosis, thrombocytopenia.
With long-term use in large doses- hepatotoxic and nephrotoxic effects (interstitial nephritis, papillary necrosis), hemolytic anemia.
Drug interactions
Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications, even with a slight overdose. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity. When taken together with salicylates, the nephrotoxic effect of paracetamol increases. Combination with chloramphenicol leads to an increase in the toxic properties of the latter. Strengthens the effect of indirect anticoagulants, reduces the effectiveness of uricosuric drugs.
Overdose
Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In case of severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. The hepatotoxic effect in adults occurs when taking 10 g or more.
Treatment: administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine - after 12 hours. The need for further therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Storage conditions
In a place protected from light, at a temperature of 2-25°C.
Best before date
2 years.
The appearance of the product may differ from the product shown in the photo.
Suction and distribution
Fast and in high degree absorbed from the gastrointestinal tract. Cmax is reached within 30-60 minutes. Plasma protein binding - 15%. Penetrates through the BBB.
Metabolism and excretion
Metabolized in the liver; 80% reacts with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form active metabolites, which are then conjugated with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. T1/2 - 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, unchanged - 3%.
Pharmacokinetics in special clinical situations
Vd and bioavailability in children (including newborns) are similar to those in adults. In newborns of the first 2 days of life and in children aged 3-10 years, the main metabolite of paracetamol is paracetamol sulfate, in children 12 years and older - conjugated glucuronide. There is no significant age-related difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.
Overdose
Data on overdose of the drug Cefekon D are not provided.
Storage conditions
The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 20°C.
Interaction with other drugs
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol, hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.
Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.
When taken simultaneously with salicylates, the likelihood of developing nephrotoxicity increases.
At joint use with paracetamol, the toxic effects of chloramphenicol are enhanced.
When used together with paracetamol, the effect of indirect anticoagulants is enhanced and the effectiveness of uricosuric drugs is reduced.
Side effect
From the outside digestive system: Possible nausea, vomiting, abdominal pain.
Allergic reactions: rash on the skin and mucous membranes, itching, urticaria, Quincke's edema.
From the hematopoietic system: rarely - anemia, thrombocytopenia, leukopenia, agranulocytosis.
With long-term use in high doses, the development of hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia is possible.
Compound
paracetamol 250 mg.
Directions for use and doses
The drug is administered rectally. Suppositories are introduced into the child’s rectum after a cleansing enema or spontaneous bowel movement.
The dosage regimen is set depending on age and body weight. The average single dose is 10-15 mg/kg of the child’s body weight. The drug in a single dose is administered 2-3 times a day, after 4-6 hours. The maximum daily dose of the drug should not exceed 60 mg/kg body weight.
Age Body weight Single dose
1-3 months 4-6 kg 1 sup. 50 mg each (50 mg)
3-12 months 7-10 kg 1 sup. 100 mg each (100 mg)
from 1 year to 3 years 11-16 kg 1-2 supp. 100 mg each (100-200 mg)
from 3 to 10 years 17-30 kg 1 sup. 250 mg each (250 mg)
from 10 to 12 years 31-35 kg 2 supp. 250 mg each (500 mg)
When using the drug as an antipyretic, the duration of treatment is 3 days; as a pain reliever - 5 days. If necessary, the doctor may extend the course of treatment.
Product description
Rectal suppositories for children are white or white with a creamy or yellowish tint, torpedo-shaped.
With caution (Precautions)
The drug is used with caution in cases of liver and kidney dysfunction, Gilbert, Dubin-Johnson, Rotor syndrome, diseases of the blood system (anemia, thrombocytopenia, leukopenia), deficiency of the enzyme glucose-6-phosphate dehydrogenase.
special instructions
The patient should be warned about the need to consult a doctor if fever persists for more than 3 days and pain persists for more than 5 days.
Concomitant use with other paracetamol-containing drugs should be avoided, because this may cause an overdose of paracetamol.
When using the drug for more than 5-7 days, peripheral blood counts and the functional state of the liver should be monitored. Paracetamol distorts laboratory results in the quantitative determination of glucose and uric acid in plasma.
Release form
Rectal suppositories for children are white or white with a creamy or yellowish tint, torpedo-shaped.
1 sup.
paracetamol 250 mg
Excipients: vitepsol.
Expiration date from date of manufacture
Indications for use
The drug is intended for use in children aged 3 months to 12 years.
In children aged 1 to 3 months, a single use of the drug is possible to reduce fever after vaccination (the possibility of using the drug for other indications is decided by the doctor individually).
Used as:
Antipyretic for acute respiratory viral infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
Analgesic for pain of mild to moderate intensity, including: headache, toothache, muscle pain, neuralgia, pain from injuries and burns.
Contraindications
Age up to 1 month;
Hypersensitivity to paracetamol.
pharmachologic effect
Has an analgesic and antipyretic effect. Blocks cyclooxygenase in the central nervous system, affecting pain and thermoregulation centers. At the site of inflammation, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of significant anti-inflammatory effect.
The drug does not have a negative effect on water-electrolyte metabolism(does not lead to sodium and water retention) and the gastrointestinal mucosa.