Cefekon D - instructions for use, dose, side effects, contraindications

Paracetamol has an analgesic and antipyretic effect. 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 absence 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 gastrointestinal mucosa.

Pharmacokinetics:

Absorption is high, rapidly absorbed from the gastrointestinal tract. 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 of adults. Metabolised in the liver. 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 that is excreted in the urine.

Indications:

Applied in children from 3 months to 12 years as:

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

- painkiller with pain syndrome of mild and moderate intensity, including: headache and toothache, muscle pain, neuralgia, pain in case of injuries and burns.

Children from 1 to 3 months is possible a single dose of the drug to reduce fever after vaccination, use of the drug in all indications can only be prescribed by a doctor.

Contraindications:

Hypersensitivity, the period of newborns (up to 1 month).

Carefully:

Renal and liver failure, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver disease, alcoholism, pregnancy, lactation, genetic absence of glucose-6-phosphate dehydrogenase, concomitant use of other drugs paratsetamolsoderzhaschih.

Dosing and Administration:

Rectally.

After a spontaneous bowel movement or enema, suppository, free from blisters and injected into the rectum.

The dosage of the drug is calculated according to age and body weight, according to 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.

Age	The weight	Single dose
1-3 months	4-6 kg	1 suppository of 50 mg
3-12 months	7-10 kg	1 suppository of 100 mg
1-3 years	11-16 kg	1-2 suppositories of 100 mg each
3-10 years	17-30 kg	1 suppository of 250 mg
10-12 years old	31-35 kg	2 suppositories 250 mg each

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

Side effects:

Allergic reactions (including skin rash).

Overdose:

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction 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. Hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine after 12 hours. The need for further therapeutic measures (further introduction 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:

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 causes the possibility of severe intoxication, even with a slight overdose.

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

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 anticoagulants of indirect action, reduces the effectiveness of uricosuric drugs.

Special instructions:

If the fever lasts more than 3 days and the pain syndrome is more than 5 days, you should consult your doctor.

Paracetamol should not be used concomitantly with other paracetamol-containing drugs, as 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.

Form release / dosage:Suppositories rectal [for children], 50 mg, 100 mg or 250 mg.

Packaging:

For 5 suppositories in a contiguous cell package; Two contour mesh packages along with the instruction for 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.

Shelf life:3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N001061 / 01

Date of registration:31.08.2007

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

NIZHFARM, JSC Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp10.01.2017

Illustrated instructions

Instructions

Cefexon® D (Cefecon® D)