PARATSETAMOL-ALTFARM

General characteristics. Structure:

Acting substance: Suppository contains paracetamol - 0,05 g, 0,1 g, 0,25 g or 0,5 g and a suppozitorny basis витепсол H15 to weighing suppository of 0,8 g, 1 g or 1,1 g, respectively.
Description: Suppositories from color, white to white with a creamy or yellowish shade, a torpedo-shaped form without visible impregnations on a slit.

Pharmacological properties:

Pharmacodynamics. The paracetamol which is contained in suppositories possesses the febrifugal and anesthetizing action. Drug blocks cyclooxygenase in TsNS, influencing the centers of pain and thermal control. Loss of heat a body at feverish states increases in result of vasodilatation and increase in a peripheral blood-groove. In the inflamed fabrics cellular peroxidases neutralize influence of paracetamol on cyclooxygenase that explains almost total absence of antiinflammatory effect of drug.

Pharmacokinetics. Paracetamol, at intake bystry and is almost completely absorbed from a digestive tract. The maximum level of concentration in blood is reached in 30-60 minutes. At rectal administration of paracetamol completeness of its absorption can be lower, than after intake.
Paracetamol is quickly and evenly distributed on body tissues. 10-15% of the accepted dose contact proteins of plasma. Sizes of volume of distribution and a biodostpnost at children and adults significantly do not differ. Drug gets through a placental barrier. Less than 1% of the accepted dose come to breast milk of nursing mothers.
Paracetamol is metabolized by microsomal enzymes of a liver, about 80% form conjugates with glucuronic acid and sulfates, to 17% is exposed to a hydroxylation with formation of active metabolites which conjugate with glutathione. At overdose or a lack of glutathione these metabolites can cause a necrosis of hepatocytes.
In an elimination half-life of paracetamol makes 1,5-2,5 hours. It can increase at patients with the expressed abnormal liver function and elderly patients. In 24 hours after reception of 85-90% of paracetamol 3% in an invariable look are removed with urine in the form of glyukoronid and sulfates, and.
At children up to 10-12 years formation of conjugates with sulfates is the main way of metabolism and removal of paracetamol. The probability of hepatotoxic effect at children is lower, than at adults. Other pharmacokinetic parameters of adults and children do not differ.

Indications to use:

Paratsetamol-Altfarm suppositories are applied at adults and children from 3 months of life (at children from 1 to 3 months of life - only on doctor's orders):
- as an antipyretic at the acute respiratory diseases, flu, children's infections, post-inoculative reactions and other infectious and inflammatory diseases which are followed by fervescence.
- as anesthetic at a pain syndrome of weak or moderate intensity, including: head and a dentagra, muscle pain, neuralgia, pain at injuries and burns.

Route of administration and doses:

Drug is used rektalno (enter into a rectum). Before suppository use, it is recommended to release intestines.

Dosage for adults:
Average single dose of 500 mg 2-4 times a day; the maximum single dose - 1 g (2 suppositories on 500 mg); the maximum daily dose - 4 g.
Duration of a course of treatment paracetamol without consultation of the doctor - 3-5 days.

Dosage for children:
Depends on age and the body weight of the child. The recommended single dose of paracetamol makes 10-15 mg/kg of body weight of the child. Drug is used 3-4 times a day with an interval of 4-6 hours. The maximum daily dose - no more than 60 mg/kg of body weight of the child.

The approximate scheme of dosing of suppositories at children depending on age:

Age of the child	Single dose
	mg	suppositories
1-3 months.	50 mg	1 soup. on 50 mg (according to the recommendation of the doctor)
3-5 months.	75 mg	1,5 soup. on 50 mg
5-12 months.	100 mg	1 soup. on 100 mg
1-3 years	100-150 mg	1-1,5 soup. on 100 mg
3 years - 6 years	150-250 mg	1,5 soup. on 100 mg - 1 soup. on 250 mg
6 years - 11 years	250-375 mg	1-1,5 soup. on 250 mg
11 years - 14 years	375-500 mg	1,5 soup. on 250 mg - 1 soup. on 500 mg

Duration of treatment is no more than 3 days, at appointment as an antipyretic and no more than 5 days as anesthetic. Further treatment by drug perhaps only after consultation with the doctor.

Features of use:

Prneparat of "Paratsetamol-Altfarm" suppositories rectal should not be appointed along with other drugs containing paracetamol.
At drug use more than 7 days control of a functional condition of a liver and a picture of peripheral blood is necessary.
If the condition of the patient does not improve within 3-5 days, consult with the doctor.

Side effects:

Nausea, pains in epigastriums, allergic reactions - skin rash, an itch, a small tortoiseshell, a Quincke's disease are possible. Abnormal liver functions, kidneys, and also system of a hemopoiesis (anemia, an agranulocytosis, thrombocytopenia) are in rare instances noted. At prolonged use in high doses - a hepatotoxic action, hemolitic anemia, aplastic anemia, a methemoglobinemia, a pancytopenia; nephrotoxicity (intersticial nephrite, papillary necrosis). At emergence of side effects it is necessary to stop administration of drug and to consult with the doctor.

Interaction with other medicines:

At a concomitant use the patient of other medicines it is necessary to consult with the doctor.
Reception together with salicylates considerably increases risk of nephrotoxic action.
At a concomitant use of paracetamol and barbiturates, anticonvulsants (Phenytoinum), tricyclic antidepressants, rifampicin, Butadionum, and also alcohol, the risk of a hepatotoxic action of drug increases. Inhibitors of a microsomal oxidation (including Cimetidinum) reduce risk of a hepatotoxic action.
Paracetamol strengthens effect of anticoagulants and reduces efficiency of uricosuric drugs.
When using drug together with levomycetinum, toxicity of the last increases.

Contraindications:

Drug should be used with care at the broken function of a liver or kidneys, at patients of advanced age, at alcoholism, during feeding by a breast.
To children to 3-month age suppositories are appointed only according to the recommendation of the doctor.
It is not necessary to use drug at patients with diarrhea.

Overdose:

Symptoms. At overdose or hypersensitivity to drug pallor, lack of appetite, nausea, vomiting, pains in epigastriums are noted. Increase in level of liver enzymes, increase in a prothrombin time, later - morbidity in a liver. In hard cases the liver failure, гепатонекроз, coma and encephalopathy develops.

Treatment. In these cases the gastric lavage within the first four hours, reception of eneterosorbent, intravenous administration of an antidote - N-Acetylcysteinum, appointment in methionine is recommended. At emergence of symptoms of poisoning to stop administration of drug and to see a doctor.

Storage conditions:

In the dry place protected from light at a temperature not higher than 25 S. Hranit in the place, unavailable to children.

Period of validity 2 years. After a period of validity not to use drug.

Issue conditions:

Without recipe

Packaging:

Suppositories on 50 mg, 100 mg, 250 mg and 500 mg on 5 pieces in a blister strip packaging from a film polyvinyl chloride. Two planimetric packagings together with the application instruction in a pack cardboard.