Cefecon D, rectal suppositories for children 100mg 10pcs

Composition

One suppository contains:  

Active ingredient:

Paracetamol — 50 mg,100 mg or 250 mg;

Basics for suppositories:  

Solid fat (vitepsol, supposir) — before receiving a suppository weighing 1.25 g.

Cefecon® D rectal suppositories for children of 50 mg,100 mg or 250 mg.

5 suppositories each in a contour cell package; 

two contour cell packages together with instructions for medical use of the drug are placed in a cardboard box.

Pharmacological action

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 cyclooxygenase, which explains the absence of a significant anti-inflammatory effect.

The absence of a blocking effect on prostaglandin synthesis in peripheral tissues causes it to have no negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics:

Absorption is high and rapidly absorbed from the gastrointestinal tract. The maximum concentration period is 30-60 minutes.

Penetrates the blood-brain barrier. The amount of bioavailability in children and newborns is similar to that in adults. It is metabolized in the liver.

The elimination 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

Used in children from 3 months to 12 years as:

• an antipyretic agent for acute respiratory diseases, flu, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;
• an analgesic agent for pain syndrome of mild and 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 prescribed by a doctor.

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 tract: nausea, vomiting, abdominal pain.

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

Hematopoietic disorders: anemia, leukopenia, agranulocytosis, thrombocytopenia.

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

Interaction

Stimulators 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 small overdose.

Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxic effects. 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. Increases the effect of indirect anticoagulants, reduces the effectiveness of uricosuric drugs.

How to take, course of use and dosage

Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of Cefecon D is calculated depending on age and body weight, in accordance with the table.

The average single dose is 10-15 mg/kg 2-3 times a day within 4-6 hours with a Maximum daily dose of acetaminophen should not exceed 60 mg/kg

1-3 months (4-6 kg) – 1 supp. 50 mg (50 mg);

3-12 months (7-10 kg) – 1 supp. 100 mg (100 mg);

from 1 to 3 years (11-16 kg) – 1-2 supp. 100 mg (100-200 mg);

from 3 to 10 years (17 to 30 kg) – 1 supp. 250 mg (250 mg);

from 10 to 12 years of age (31-35 kg) – 2 supp. 250 mg (500 mg).

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

If the fever persists for more than 3 days and the pain syndrome persists for more than 5 days, consult your doctor. Concomitant use of paracetamol 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.

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

Keep out of reach of children, at a temperature not exceeding 20°C.

Shelf life

3 years

Active ingredient

Paracetamol

Dosage form

rectal suppositories

Description

Children over 3 months of age

Indications

Neuritis, Arthritis, Flu, Cold, Burns, Osteoarthritis, Migraines