Cefecon D, rectal suppositories for children 50mg 10pcs

Composition

One suppository contains:  

Active ingredient:  

Paracetamol — 50 mg,100 mg or 250 mg;

Basics for suppositories:  

Solid fat (vitepsol, supposir) – until receiving a suppository weighing 1.25 g

Pharmacological action

It has analgesic and antipyretic effects. 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.

Suction and distribution

It is rapidly and highly absorbed from the gastrointestinal tract. Cmax is reached in 30-60 minutes. Binding to plasma proteins is 15%. Penetrates through the BBB.

Metabolism and elimination

It is 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.

When glutathione is deficient, 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 cases

of 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 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.

In children aged from 1 to 3 months, it is possible to use the drug once to reduce the temperature after vaccination (the possibility of using the drug for other indications is decided by the doctor individually).

Used as:

• antipyretic agent for acute respiratory viral infections, flu, children’s infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
• analgesic agent for pain syndrome of mild to moderate intensity, including: headache, toothache, muscle pain, neuralgia, pain from injuries and burns.

Use during pregnancy and lactation

Use with caution during pregnancy, lactation and children under 3 months of age.

Contraindications

Hypersensitivity, neonatal period (up to 1 month). With caution: Renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, genetic absence of glucose-6-phosphate dehydrogenase, simultaneous use of other paracetamol-containing drugs.

Side effects

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

Allergic reactions:  rash on the skin and mucous membranes, pruritus, 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) effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

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 causes the possibility of severe intoxication even with a small overdose.

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

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

When combined with paracetamol, the toxic effects of chloramphenicol increase.

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

How to take, course of use and dosage

Rectally. After spontaneous bowel emptying 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, 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 analgesic. Prolongation of the course if necessary after consultation with your doctor.

Overdose

Symptoms:  

during the first 24 hours after use — 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:  

use of SH-group donors and glutathione — methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine-12 hours later.

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

Special instructions

The patient should be warned to consult a doctor if the fever persists for more than 3 days and the pain syndrome persists for more than 5 days.

Concomitant use with other paracetamol-containing medications 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 laboratory tests in the quantitative determination of glucose and uric acid in plasma.

With impaired renal function

Use the drug with caution in cases of impaired renal function.

With impaired liver function

The drug is used with caution in cases of liver function disorders.

Product

form Cefecon® D rectal suppositories for children of 50 mg,100 mg or 250 mg. 5 suppositories in a contour cell package; two contour cell packages together with instructions for medical use of the drug are placed in a cardboard box.

Storage conditions

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

Shelf life

3 years

Active ingredient

Paracetamol

Dosage form

rectal suppositories

Purpose

Children over 1 month of age

Indications

Burns, Flu, Neuritis, Migraines, Colds