Cefecon^® D (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

N02BE01 (Paracetamol)

Active Substance

Paracetamol (Rec.INN registered by WHO)

Dosage Forms

	Cefecon^® D	Rectal suppositories for children 50 mg: 10 pcs.
		Rectal suppositories for children 100 mg: 10 pcs.
		Rectal suppositories for children 250 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories for children white or white with a yellowish or creamy tint, torpedo-shaped; the appearance of a white coating on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the cut are allowed.

	1 supp.
Paracetamol	50 mg

Excipients: solid fat (Witepsol (grades H15, W35), Suppocire (grades NA15, NAS 50)).

5 pcs. – contour cell packs (2) – cardboard packs.

	1 supp.
Paracetamol	100 mg

Excipients: solid fat (Witepsol (grades H15, W35), Suppocire (grades NA15, NAS 50)).

5 pcs. – contour cell packs (2) – cardboard packs.

	1 supp.
Paracetamol	250 mg

Excipients: solid fat (Witepsol (grades H15, W35), Suppocire (grades NA15, NAS 50)).

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Analgesic-antipyretic

Pharmacotherapeutic Group

Non-narcotic analgesic agent

Pharmacological Action

It has analgesic and antipyretic effects.

It blocks cyclooxygenase in the CNS, affecting the centers of pain and thermoregulation.

In the inflammation site, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of significant anti-inflammatory action.

The drug does not have a negative effect on water-electrolyte metabolism (does not cause sodium and water retention) and on the gastrointestinal mucosa.

Pharmacokinetics

Absorption and Distribution

It is rapidly and highly absorbed from the gastrointestinal tract. C_max is reached in 30-60 min. Plasma protein binding is 15%. It penetrates the blood-brain barrier.

Metabolism and Excretion

It is metabolized in the liver; 80% undergoes a reaction with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form active metabolites, which then conjugate with glutathione and form inactive metabolites.

With a deficiency of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. T_1/2 is 2-3 h. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys as glucuronides and sulfates, and 3% is excreted unchanged.

Pharmacokinetics in Special Clinical Cases

V_d and bioavailability in children (including newborns) are similar to those in adults.

In newborns during the first 2 days of life and in children aged 3-10 years, the main metabolite of paracetamol is paracetamol sulfate, while in children aged 12 years and older, it is the conjugated glucuronide.

There is no significant age-related difference in the rate of elimination of paracetamol and in the total amount of the drug excreted in the urine.

Indications

The drug is intended for use in children aged from 3 months to 12 years.

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

It is used as

An antipyretic for acute respiratory viral infections, influenza, childhood infections, post-vaccination reactions, and other conditions accompanied by fever;
An analgesic for mild to moderate pain, including: headache, toothache, muscle pain, neuralgia, pain from injuries and burns.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J06.9	Acute upper respiratory infection, unspecified
J10	Influenza due to identified seasonal influenza virus
K08.8	Other specified disorders of teeth and supporting structures (including toothache)
M79.1	Myalgia
M79.2	Neuralgia and neuritis, unspecified
R50	Fever of unknown origin
R51	Headache
R52.0	Acute pain
R52.2	Other chronic pain

ICD-11 code	Indication
1E30	Influenza due to identified seasonal influenza virus
8A8Z	Headache disorders, unspecified
8E4A.1	Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
CA07.0	Acute upper respiratory tract infection of unspecified site
DA0A.Z	Diseases of teeth and supporting structures, unspecified
FB56	Specified soft tissue diseases, not elsewhere classified
FB56.2	Myalgia
LA30.5Z	Anomalies of tooth resorption or loss, unspecified
MG26	Fever of other or unknown origin
MG30.Z	Chronic pain syndrome, unspecified
MG31.Z	Acute pain, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The drug is used rectally.

The suppositories are inserted into the child’s rectum after a cleansing enema or spontaneous bowel movement.

The dosage regimen is set depending on age and body weight.

The average single dose is 10-15 mg/kg of the child’s body weight.

The drug in a single dose is administered 2-3 times/day, every 4-6 hours.

The maximum daily dose of the drug should not exceed 60 mg/kg of body weight.

Age	Body Weight	Single Dose
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)

When using the drug as an antipyretic, the duration of the course of treatment is 3 days; when used as an analgesic – 5 days.

If necessary, the doctor may extend the course of treatment.

Adverse Reactions

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

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

From the hematopoietic system: rarely – anemia, thrombocytopenia, leukopenia, agranulocytosis.

With long-term use in high doses, the development of hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia is possible.

Contraindications

Age under 1 month;
Hypersensitivity to paracetamol.

With caution, the drug should be used in cases of impaired liver and kidney function, Gilbert’s syndrome, Dubin-Johnson syndrome, Rotor syndrome, blood system diseases (anemia, thrombocytopenia, leukopenia), deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Use in Hepatic Impairment

The drug should be used with caution in cases of impaired liver function.

Use in Renal Impairment

The drug should be used with caution in cases of impaired kidney function.

Special Precautions

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

Simultaneous use 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 indicators of laboratory tests in the quantitative determination of glucose and uric acid in plasma.

Overdose

Data on overdose of the drug Cefecon^® D are not provided.

Drug Interactions

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 determines the possibility of developing severe intoxication even with a small overdose.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action.

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

When used concomitantly with paracetamol, the toxic effects of chloramphenicol are enhanced.

When used concomitantly with paracetamol, the effect of indirect anticoagulants is enhanced and the effectiveness of uricosuric agents is reduced.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 20°C (68°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer