Cefecon D for children, rectal 50 mg 10 pcs

It has analgesic and antipyretic effect. It blocks cyclooxygenase in CNS, 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 action.

The drug has no negative effect on water-electrolyte metabolism (does not lead to sodium and water retention) and gastrointestinal mucosa.

Pharmacokinetics

Intake and distribution

It is quickly and highly absorbed from the gastrointestinal tract. Cmax is reached after 30-60 min. Binding to plasma proteins is 15%. It penetrates through the HEB.

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 then conjugate with glutathione to form inactive metabolites.

In glutathione deficiency these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. T1/2 is 2-3 h. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys as glucuronides and sulfates, 3% is unchanged.

Pharmacokinetics in special clinical cases

Vd and bioavailability in children (including infants) are similar to those in adults. In infants 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 elimination rate 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 the drug may be used once to reduce the fever after vaccination (the possibility of using the drug for other indications is decided by the doctor individually).

It is used as:

Active ingredient

Composition

One suppository contains:

The active ingredient:

Paracetamol – 50 mg, 100 mg or 250 mg;

The bases for the suppositories:

Solid fat (vitepsol, souposir) – up to a suppository weight of 1.25 g.

How to take, the dosage

Rectally. After spontaneous bowel emptying or purging enema, the suppository is released from the contoured cell package and inserted into the rectum.

The dosage of the drug is calculated depending on age and body weight, according to the table. The 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 body weight of the child.

Treatment duration: 3 days as an antipyretic and up to 5 days as an analgesic. Extension of the course if necessary after consulting the doctor.

Interaction

The inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol, hepatotoxic drugs increase production of hydroxylated active metabolites, which causes the possibility of severe intoxication even with a small overdose.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

The risk of nephrotoxic effects increases when taken concomitantly with salicylates.

The toxic effects of chloramphenicol are increased when co-administered with paracetamol.

When used concomitantly with paracetamol the effects of indirect anticoagulants are increased and the effectiveness of uricosuric agents is reduced.

Special Instructions

The patient should be warned to seek medical attention if fever persists for more than 3 days and pain persists for more than 5 days.

Combined use with other paracetamol-containing drugs should be avoided because it may cause an overdose of paracetamol.

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

In impaired renal function

The drug is used with caution in impaired renal function.

In impaired liver function

The drug is used with caution in impaired liver function.

Contraindications

Side effects

Digestive system disorders: nausea, vomiting, abdominal pain are possible.

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

Hematopoietic system: rarely – anemia, thrombocytopenia, leukopenia, agranulocytosis.

In prolonged use in high doses hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) actions, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia may develop.

Overdose

Symptoms:

In the first 24 h after ingestion, skin pallor, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis.

The symptoms of hepatic dysfunction may appear 12-48 hours after overdose.

In severe overdose – hepatic 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 occurs when taking 10 g or more.

Treatment:

The administration of SH-group donators and precursors of glutathione synthesis – methionine in 8-9 hours after overdose and N-acetylcysteine in 12 hours.

The need for further therapeutic measures (further methionine administration, intravenous N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.

Pregnancy use

In pregnancy, breastfeeding and children under 3 months of age, use with caution.

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