Cefekon d suppositories: instructions for use. Cefecon d - instructions for use Cefecon suppositories for children 250 mg


Compound

One suppository contains

active substance: paracetamol - 50 mg or 100 mg, or 250 mg.

The basis for suppositories: solid fat - a sufficient amount to obtain a suppository weighing 1.25 g.

Pharmacotherapeutic group

ATX Code: . Other analgesics and antipyretics. Aniline derivatives.

Description

Suppositories are white or white with a yellowish or brownish tint, torpedo-shaped.

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 feverish conditions.

Dosage 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.

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. Extension of the course if necessary after consulting a doctor.

Side actionyours

Side effects at therapeutic doses are very rare.

From the respiratory system:

Very rarely ( From the gastrointestinal tract: often (from ≥ 1/100 to From the immune system: rarely (from ≥ 1/10000 to From the skin and subcutaneous tissues: rarely (from ≥ 1/10000 to From the side of the liver and biliary tract: rarely (from ≥ 1/10000 to Laboratory indicationsate: rarely (from ≥ 1/10000 to 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 allex possible side effects, includingundescribedin this leaflet.

Contraindications

Individual hypersensitivity to the components of the drug, severe violations of the liver and kidneys, deficiency of glucose-β-phosphate dehydrogenase (possible development of hemolytic anemia), children under 1 month of age, 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 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.

Precautionary measures

When using suppositories, there is a risk of local toxicity. The frequency of development 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.

When treating with paracetamol at a dose of 60 mg / kg / day, the simultaneous use of another antipyretic is justified only if paracetamol is ineffective. 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.

Use during pregnancy and lactation

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.

Influence on the ability todrive motor vehicles or other mechanisms

Paracetamol has no or little effect on the ability to drive vehicles or operate other mechanisms.

Overdose

The risk of serious intoxication may be increased in the elderly, young children, patients with liver disease, chronic alcoholism, malnourished patients taking inducers of microsomal 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.

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.

Impact 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 presentYou have taken other medicines at some time or in the recent past, tell your doctor

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, suppository) - until a suppository weighing 1.25 g is obtained.

Pharmacological effect

Anti-inflammatory, antipyretic, analgesic

Pharmacokinetics

Absorption is high, rapidly absorbed from the gastrointestinal tract. The period of reaching the maximum concentration is 30-60 minutes. Penetrates through the blood-brain barrier. The magnitude of bioavailability in children and newborns 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 difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.

Indications

It is used in children from 3 months to 12 years of age 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 syndrome of mild and moderate intensity, including : headache and toothache, muscle pain, neuralgia, pain in injuries and burns. In children from 1 to 3 months, a single dose of the drug is possible to reduce the temperature after vaccination, the use of the drug for all indications is possible only as directed 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, concomitant use of other paracetamol-containing drugs.

Dosage and administration

Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of the drug is calculated depending on the age and body weight, in accordance with the table. A single dose is 10-15 mg / kg 2-3 times a day after 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 ingestion - pallor of the skin, nausea, vomiting, anorexia, abdominal pain, impaired glucose metabolism, metabolic acidosis. Symptoms of impaired liver function may appear 12-48 hours after an overdose. In 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 is manifested when taking 10 g or more. Treatment: the introduction of donators of SH-groups and precursors of the synthesis of glutathione - methionine 8-9 hours after an overdose and N-acetylcysteine ​​- 12 hours later. 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.

Interaction with other drugs

Stimulants 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 small overdose. Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxicity. When taken together with salicylates, the nephrotoxic effect of paracetamol increases. The combination with chloramphenicol leads to an increase in the toxic properties of the latter. Enhances 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 contact your doctor. The simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol. When using the drug for more than 5-7 days, peripheral blood parameters and the functional state of the liver should be monitored. Paracetamol distorts the performance of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

Storage conditions

In a place inaccessible to children, at a temperature not exceeding 20 ° C.

INSTRUCTIONS
on the medical use of the drug

Registration number:

R N001061/01-310807

Trade name of the drug:

Cefekon ® D

International non-proprietary name:

paracetamol

Dosage form:

rectal suppositories for children

Compound

One suppository contains: active substance - paracetamol - 50 mg, 100 mg or 250 mg; bases for suppositories: solid fat (vitepsol, suppository) - until a suppository weighing 1.25 g is obtained.

Description

Suppositories are white or white with a yellowish or creamy tint, torpedo-shaped.

Pharmacotherapeutic group

Analgesic non-narcotic agent

ATX code: N02BE01

Pharmacological properties

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 have no negative effect on water-salt metabolism (sodium and water retention) and the mucosa of the gastrointestinal tract.
Pharmacokinetics:
Absorption is high, rapidly absorbed from the gastrointestinal tract. The period of reaching the maximum concentration is 30-60 minutes. Penetrates through the blood-brain barrier. The magnitude of bioavailability in children and newborns 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 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:
- antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;
- an analgesic for pain syndrome of mild to 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 is possible to reduce the temperature after vaccination, the use of the drug for all indications is possible only as directed by a doctor.

Contraindications

Hypersensitivity, neonatal period (up to 1 month).

Carefully

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, concomitant use of other paracetamol-containing drugs.

Dosage and administration

Rectally. After spontaneous bowel movement or cleansing enema, the suppository is released from the blister pack and injected into the rectum. The dosage of the drug is calculated depending on the 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, after 4-6 hours. The maximum daily dose of paracetamol should not exceed 60 mg/kg of the child's body weight.

Duration of treatment: 3 days as an antipyretic and up to 5 days as an anesthetic. Extension of the course if necessary after consulting a doctor.

Side effect

Allergic reactions (including skin rash).

Interaction with other drugs

Stimulants 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 small overdose. Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxicity. When taken together with salicylates, the nephrotoxic effect of paracetamol increases. The combination with chloramphenicol leads to an increase in the toxic properties of the latter. Enhances 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 contact your doctor.
The simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol.
When using the drug for more than 5-7 days, peripheral blood parameters and the functional state of the liver should be monitored. Paracetamol distorts the performance of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

Overdose

Symptoms: during the first 24 hours after ingestion - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of impaired liver function may appear 12-48 hours after an overdose. In 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 is manifested when taking 10 g or more.
Treatment: the introduction of donators of SH-groups and precursors of the synthesis of glutathione-methionine 8-9 hours after an overdose and N-acetylcysteine ​​- 12 hours later. 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.

Release form

Cefekon ® D rectal suppositories for children 50 mg, 100 mg or 250 mg. 5 suppositories in a blister pack; two blisters, together with instructions for the medical use of the drug, are placed in a cardboard box.

Storage conditions

In a place inaccessible to children, at a temperature not exceeding 20 ° C.

Best before date

3 years. Do not use after the expiration date.

Terms of dispensing from pharmacies

Over the counter.

Manufacturer

Consumer claims should be sent to:
OAO NIZHFARM, Russia
603950, Nizhny Novgorod
GSP-459, st. Salganskaya, 7
Internet: http//www.nizhpharm.ru

Analgesic-antipyretic

Active substance

Release form, composition and packaging

Rectal suppositories for children white or white with a creamy or yellowish tint, torpedo-shaped.

Excipients: Witepsol.

5 pieces. - cellular contour packings (2) - packs of cardboard.

pharmachologic effect

It has an analgesic and antipyretic effect. It blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. In the focus of inflammation, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the absence of a significant anti-inflammatory effect.

The drug does not adversely affect the water-electrolyte metabolism (does not lead to sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics

Suction and distribution

Rapidly and highly absorbed from the gastrointestinal tract. C max is reached in 30-60 minutes. 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. T 1 / 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

V d 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 difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.

Indications

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 to reduce temperature after vaccination is possible (the possibility of using the drug for other indications is decided by the doctor individually).

Used as:

- antipyretic for ARVI, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;

- analgesic for pain syndrome of mild and moderate intensity, including: headache, toothache, neuralgia, pain in injuries and burns.

Contraindications

- age up to 1 month;

- Hypersensitivity to paracetamol.

WITH caution use the drug for violations of the liver and kidneys, Gilbert's syndrome, Dubin-Johnson, Rotor, diseases of the blood system (anemia, thrombocytopenia, leukopenia), deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Dosage

The drug is used 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 / day, after 4-6 hours. The maximum daily dose of the drug should not exceed 60 mg / kg of body weight.

When using the drug as an antipyretic, the duration of the course of treatment is 3 days; as an anesthetic - 5 days. If necessary, the doctor can extend the course of treatment.

Side effects

From the digestive system: possible nausea, vomiting, abdominal pain.

Allergic reactions: rash on the skin and mucous membranes, itching, urticaria, angioedema.

From the hematopoietic system: rarely - anemia, thrombocytopenia, leukopenia, agranulocytosis.

With prolonged use in high doses, it is possible to develop hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) action, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Overdose

Data on overdose of the drug Cefecon D are not provided.

drug interaction

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 small overdose.

Microsomal oxidation inhibitors () reduce the risk of hepatotoxicity.

When taken simultaneously with salicylates, the likelihood of developing a nephrotoxic effect increases.

  • G43 Migraine
  • J06 Acute infections of the upper respiratory tract, multiple and unspecified
  • K08.8.0* Toothache
  • M79.1 Myalgia
  • M79.2 Neuralgia and neuritis, unspecified
  • R50 Fever of unknown origin
  • R51 Headache
  • R52.0 Acute pain
  • T94.1 Sequelae of injuries, unspecified
  • T95.9 Sequelae of unspecified thermal and chemical burns and frostbite

Composition and form of release

in a blister pack 5 pcs.; in a pack of cardboard 2 packs.

Description of the dosage form

Suppositories are white or white with a creamy or yellowish tint, torpedo-shaped.

pharmachologic effect

Pharmacological action - analgesic, antipyretic, anti-inflammatory.

Pharmacodynamics

Paracetamol has analgesic and antipyretic effects. 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 drug does not adversely affect the water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics

Absorption is high, rapidly absorbed from the gastrointestinal tract. The period of reaching Cmax is 30-60 minutes, plasma protein binding is 15%. Penetrates through the BBB. The magnitude of the volume of distribution and bioavailability in children and newborns is similar to those in adults.

Metabolized in the liver: 80% - enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% - undergoes hydroxylation with the formation of active metabolites, which conjugate with glutathione and form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In newborns of the first two days of life and in children 3-10 years old, the main metabolite of paracetamol is paracetamol sulfate, in children 12 years and older - conjugated glucuronide.

T 1 / 2 - 2-3 hours. Within 24 hours, 85-88% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, unchanged - 3%. There is no significant age difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.

Indications for Cefecon ® D

Used in children from 3 months to 12 years as:

antipyretic for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;

painkiller for pain syndrome of mild and moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain in injuries and burns.

In children from 1 to 3 months, a single dose of the drug is possible to reduce the temperature after vaccination.

Contraindications

hypersensitivity to the components of the drug;

age up to 1 month of life.

Carefully:

dysfunction of the liver and kidneys;

Gilbert's syndrome; Club-Johnson and Rotor;

diseases of the blood system (anemia, thrombocytopenia, leukopenia);

genetic absence of the enzyme glucose-6-phosphate dehydrogenase.

Side effects

From the digestive tract: nausea, vomiting, abdominal pain.

Allergic reactions: itching, rash on the skin and mucous membranes, urticaria, angioedema.

From the side of the hematopoietic organs: anemia, leukopenia, agranulocytosis, thrombocytopenia.

With prolonged use in high doses - hepatotoxic and nephrotoxic effects (interstitial nephritis, papillary necrosis), hemolytic anemia.

Interaction

Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), 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 (including cimetidine) reduce the risk of hepatotoxicity.

When taken together with salicylates, the nephrotoxic effect of paracetamol increases dramatically.

The combination with chloramphenicol leads to an increase in the toxic properties of the latter.

Enhances the effect of indirect anticoagulants, reduces the effectiveness of uricosuric agents.

Dosage and administration

rectally, after a cleansing enema or spontaneous bowel movement. The dosage of the drug is calculated depending on the age and body weight, in accordance with the table. A single dose is 10-15 mg / kg 2-3 times a day after 4-6 hours. The maximum daily dose of paracetamol should not exceed 60 mg / kg.

Dosage of the drug for children of different ages

special instructions

If fever persists for more than 3 days and pain persists for more than 5 days, you should contact your doctor.

The simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol.

When using the drug for more than 5-7 days, peripheral blood parameters and the functional state of the liver should be monitored. Paracetamol distorts the performance of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

Manufacturer

OAO Nizhpharm (Russia).

Storage conditions of the drug Cefecon ® D

In a dry place, at a temperature not exceeding 20 °C.

Keep out of the reach of children.

Shelf life of the drug Cefecon ® D

Do not use after the expiry date stated on the packaging.