Levomycetinum

General characteristics. Structure:

Active ingredient: 250 mg or 500 mg of chloramphenicol.

Excipients: potato starch; PVP low-molecular medical (povidone); calcium stearate.

Antibiotic of a broad spectrum of activity.

Pharmacological properties:

Pharmacodynamics. The mechanism of antimicrobic action is connected with disturbance of protein synthesis of microorganisms. Has bacteriostatic action. It is active concerning gram-positive bacteria: Staphylococcus spp., Streptococcus spp.; gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Haemophilus influenzae, Salmonella spp., Shigella spp., Klebsiella spp., Serratia spp., Yersinia spp., Proteus spp., Rickettsia spp.; it is active also concerning Spirochaetaceae, some large viruses.

Chloramphenicol is active concerning the strains steady against penicillin, streptomycin, streptocides. Chloramphenicol resistance of microorganisms develops rather slowly.

Pharmacokinetics. After intake it is quickly and completely soaked up from a GIT. Bioavailability makes 80%. It is quickly distributed in an organism. Linkng with proteins of plasma makes 50-60%. It is metabolized in a liver. T1/2 makes 1.5-3.5 h. It is removed with urine, small amounts with a stake and bile.

Indications to use:

For intake: the infectious and inflammatory diseases caused by microorganisms, sensitive to chloramphenicol, including: typhoid, paratyphoid, dysentery, brucellosis, tularemia, whooping cough, sapropyra and other rickettsioses; trachoma, pneumonia, meningitis, sepsis, osteomyelitis.

For external use: purulent damages of skin, furuncles, it is long not healing trophic ulcers, burns of II and III degrees, nipple cracks at the feeding women.

For topical administration in ophthalmology: inflammatory diseases of eyes.

Route of administration and doses:

Individual. At intake a dose for adults - on 500 mg of 3-4 times/days. Single doses for children under 3 years - 15 mg/kg, 3-8 years - 150-200 mg; 8 years - 200-400 mg are more senior; frequency rate of use - 3-4 times/days. The course of treatment makes 7-10 days.

At external use apply on gauze tampons or directly on the struck area. From above apply a usual bandage, it is possible with parchment or compresseal paper. Bandagings make depending on indications in 1-3 days, sometimes in 4-5 days.

Locally apply in ophthalmology as a part of the combined drugs according to indications.

Features of use:

Chloramphenicol is not applied at newborns since development of "a gray syndrome" is possible (a meteorism, nausea, a hypothermia, gray-blue skin color, the progressing cyanosis, диспноэ, cardiovascular insufficiency).

With care apply at the patients receiving earlier treatment by cytostatic drugs or radiation therapy.

At a concomitant use of alcohol development of disulfiramopodobny reaction is possible (a hyperemia of integuments, tachycardia, nausea, vomiting, reflex cough, spasms).

In the course of treatment systematic control of a picture of peripheral blood is necessary.

Chloramphenicol is not applied at newborns since development of "a gray syndrome" is possible (a meteorism, nausea, a hypothermia, gray-blue skin color, the progressing cyanosis, диспноэ, cardiovascular insufficiency).

Side effects:

Co of the party of system of a hemopoiesis: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia.

From the alimentary system: nausea, vomiting, diarrhea, meteorism.

From TsNS and peripheral nervous system: peripheral neuritis, optic neuritis, headache, depression, confusion of consciousness, delirium, visual and auditory hallucinations.

Allergic reactions: skin rash, small tortoiseshell, Quincke's disease.

Local reactions: irritant action (at external or topical administration).

Interaction with other medicines:

At simultaneous use of chloramphenicol with peroral hypoglycemic drugs strengthening of hypoglycemic action due to suppression of metabolism of these drugs in a liver and increases in their concentration in a blood plasma is noted.

At simultaneous use with the drugs oppressing a marrowy hemopoiesis strengthening of the oppressing action on marrow is noted.

At simultaneous use with erythromycin, clindamycin, lincomycin mutual weakening of action is noted because chloramphenicol can force out these drugs from the connected state or interfere with their linkng with subunit 50S of bacterial ribosomes.

At simultaneous use with penicillin chloramphenicol counteracts manifestation of bactericidal effect of penicillin.

Chloramphenicol suppresses fermental system of P450 cytochrome therefore at simultaneous use with phenobarbital, Phenytoinum, warfarin note weakening of metabolism of these drugs, delay of removal and increase in their concentration in a blood plasma.

Contraindications:

Blood diseases, the expressed abnormal liver functions, deficit of enzyme glyukozo-6-fosfatdegidrogenazy, skin disease (psoriasis, eczema, fungus diseases); pregnancy, a lactation, children's age up to 4 weeks (newborns), hypersensitivity to chloramphenicol, a tiamfenikol, an azidamfenikol.

Overdose:

At use of the overestimated Levomycetinum doses for patients development of disturbances of a hemopoiesis which are followed by pallor of skin, a pharyngalgia, fervescence, weakness, increased fatigue internal bleedings and hematomas is noted. At patients with hypersensitivity and children at use of high doses of drug development of abdominal distention, nausea, vomiting, a dullness of integuments, a cardiovascular collapse, and also a respiratory distress with a metabolic acidosis is possible. Besides, high doses of chloramphenicol can cause development of vision disorders and hearing, delay of psychomotor reactions and a hallucination.

At overdose drug withdrawal is shown. At use of the overestimated drug doses in the form of tablets the gastric lavage and reception of enterosorbents is shown. At overdose also carry out symptomatic therapy.

Storage conditions:

In the place protected from light at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets on 250 mg or 500 mg in a paper strip packaging.