Universal reference book for medicines
Product name: CEFECON ® D (CEFECON D)

Active substance: paracetamol

Type: Analgesic-antipyretic

Manufacturer: NIZHFARM (Russia)
Composition, form of production and packaging
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Suppositories rectal for children white or white with a creamy or yellowish hue of color, torpedo-shaped.
1 supp.

paracetamol 50 mg

- "- 100 mg

- "250 mg

Excipients: Witepsol.

5 pieces.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Has 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 lack of significant anti-inflammatory effects.
The drug does not adversely affect the water-electrolyte metabolism (does not lead to a delay in sodium and water) and the mucosa of the gastrointestinal tract.

PHARMACOKINETICS

Suction and distribution

Quickly and highly absorbed from the digestive tract.
C max is reached in 30-60 minutes. Binding to plasma proteins - 15%. Penetrates through the BBB.
Metabolism and excretion

Metabolised in the liver;
80% reacts with glucuronic acid and sulfates to form inactive metabolites; 17% is hydroxylated to form active metabolites, which are then conjugated to glutathione and 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 cases

V d and bioavailability in children (including newborns) is similar to that 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 that is excreted in the urine.
INDICATIONS

The drug is intended for use in children aged 3 months to 12 years.

Children aged 1 to 3 months may receive a single dose of the drug to reduce the temperature after vaccination (the possibility of using the drug for other indications is decided by the doctor individually).

Applied as:

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

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

DOSING MODE

The drug is used rectally.
Suppositories are injected into the baby's rectum after a cleansing enema or spontaneous bowel movement.
The dosage regimen is set depending on the 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.
Age Body weight Single dose

1-3 months 4-6 kg 1 soup.
50 mg (50 mg)
3-12 months 7-10 kg 1 soup.
100 mg (100 mg)
from 1 year to 3 years 11-16 kg 1-2 soups.
100 mg (100-200 mg)
from 3 to 10 years 17-30 kg 1 soup.
250 mg (250 mg)
from 10 to 12 years 31-35 kg 2 soups.
250 mg (500 mg)
When the drug is used as an antipyretic agent, 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 EFFECT

On the part of the digestive system: nausea, vomiting, abdominal pain are possible.

Allergic reactions: a rash on the skin and mucous membranes, itching, urticaria, and Quincke's edema.

From the hemopoietic 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), hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

CONTRAINDICATIONS

- age up to 1 month;

- Hypersensitivity to paracetamol.

With caution apply the drug for violations of liver and kidney function, Gilbert syndrome, Dubin-Johnson, Rotor, diseases of the blood system (anemia, thrombocytopenia, leukopenia), deficiency of the enzyme glucose-6-phosphate dehydrogenase.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution apply the drug for violations of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution apply the drug for violations of liver function.

SPECIAL INSTRUCTIONS

The patient should be warned about the need to see a doctor if the fever lasts more than 3 days and the pain syndrome is more than 5 days.

It should avoid simultaneous application with other paracetamolosoderzhaschimi drugs, tk.
this can cause an overdose of paracetamol.
When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood and the functional state of the liver.
Paracetamol distorts the results of laboratory studies in the quantitative determination of glucose and uric acid in plasma.
OVERDOSE

Data on the overdose of Cefexon D are not available.

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 slight overdose.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.

When taking concomitantly with salicylates, the likelihood of developing a nephrotoxic effect increases.

When combined with paracetamol, the toxic effects of chloramphenicol are enhanced.

When combined with paracetamol, the effect of anticoagulants of indirect action increases and the effectiveness of uricosuric agents decreases.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry place inaccessible to children at a temperature not exceeding 20 ° C.
Shelf life - 2 years.
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