Description
Release form
Cefecon ® D rectal suppositories for children of 50 mg, 100 mg or 250 mg. Five suppositories in blister packs two blister packs together with instructions for medical use of the drug are placed in a cardboard box.
Packing
10 pcs.
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 lack of a significant anti-inflammatory effect.
The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues causes it to have a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.
Pharmacokinetics:
Absorption is high, rapidly absorbed from the gastrointestinal tract. The period of reaching maximum concentration is 30-60 minutes. Penetrates through the blood-brain barrier. The bioavailability in children and infants is similar to that in adults. 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%. Significant age-related differences in the rate of elimination of paracetamol and in the total amount of the drug, which is excreted in the urine, no.
Indications
Used in children from 3 months to 12 years of age as:
antipyretic in acute respiratory infections, flu, childhood infections, post-vaccination reactions and other conditions accompanied by fever
painkiller and mild pain syndrome intensities, 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 directed by the doctor.
Contraindications
Hypersensitivity, neonatal period (up to 1 month).
Precautions
Renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, genetic absence of glucose-6-phosphate dehydrogenase, concomitant use of other paracetamol-containing drugs.
Special instructions
If you continue to have fever for more than 3 days and pain for more than 5 days, you should consult your doctor.
The simultaneous use of paracetamol with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol.
When using the drug for more than 5-7 days, peripheral blood counts and the functional state of the liver should be monitored. Paracetamol distorts the performance of laboratory tests in the quantitative determination of glucose and uric acid in plasma.
Composition
One suppository contains: the active substance is paracetamol – 50 mg, 100 mg or 250 mg of the basis for suppositories: solid fat (vitepsol, suppository) – until a suppository weighs 1.25 g.
Dosage and administration
Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of Cefecon D is calculated depending on age and body weight, according to the table. The average single dose is 10-15 mg / kg 2-3 times a day after 4-6 hours.
The maximum daily dose of paracetamol 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 year to 3 years (11-16 kg) – 1-2 supp. 100 mg (100-200 mg)
from 3 to 10 years (17-30 kg) – 1 supp. 250 mg (250 mg)
from 10 to 12 years (31-35 kg) – 2 supp. 250 mg (500 mg).
Side effects
Allergic reactions (including skin rash).
Drug interactions
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 can lead to the development of heavy metabolized active metabolites. Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxicity. When taken with salicylates, the nephrotoxic effect of paracetamol increases. The combination with chloramphenicol leads to an increase in the toxic properties of the latter. It enhances the effect of indirect anticoagulants, reduces the effectiveness of uricosuric drugs.
Overdose
Symptoms: during the first 24 hours after administration – 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. Hepatotoxic effect in adults is manifested when taking 10 g or more.
Treatment: administration of SH-group donors and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine 12 hours later. The need for further therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Storage conditions
In a place out of the reach of children, at a temperature not exceeding 20 ° C.
Expiration
3 years.
active substance
Paracetamol
Conditions for the drugstore from
Without a prescription
lekarstvennaja form
suppozytoryy rektaln e
Nizhpharm, Russia
