Levomycetinum

General characteristics. Structure:

Active ingredient: chloramphenicol;
1 bottle contains levomycetinum of succinate of sodium salt sterile in terms of levomycetinum of 0,5 g or 1 g.

Pharmacological properties:

Pharmacodynamics. Antibiotic of a broad spectrum of activity. It is effective concerning many gram-positive (stafilokokk, streptococci, pneumococci, enterococci) and gram-negative bacteria: intestinal and hemophilic sticks, salmonellas, shigellas, клебсиелл, serration, iyersiniya, protea, gonokokk, meningokokk, anaerobe bacterias, rickettsiae, spirochetes, chlamydias, and also causative agents of trachoma, psittacosis, inguinal limfogranulomatoz; affects the strains of bacteria steady against penicillin, streptomycin, streptocides; слабоактивен concerning acid resisting bacteria, a pyocyanic stick, clostridiums and protozoa. In usual doses works bacteriostatically. Inhibits a peptidiltransferaza and breaks synthesis of protein in a bacterial cell. Medicinal drug resistance develops rather slowly, at the same time, as a rule, cross resistance to other chemotherapeutic means does not arise.

Pharmacokinetics. At intramuscular introduction high concentration of drug is quickly reached in
to blood plasma (in 5-10 minutes after intravenous, in 30-45 minutes after intramuscular introduction). The maximum concentration in blood is reached in 1 hour and remains in effective concentration in a blood plasma for 8-12 hours. A considerable part (60-80%) contacts plasma albumine. Easily gets into bodies and liquids of an organism, through a blood-brain barrier, through a placenta, into breast milk.  with bile is removed generally by kidneys in the form of inactive metabolites, partially.

Main physical and chemical properties: powder of color, white or white with a yellowish shade, hydroscopic.
Incompatibility. Not to use solvents which are not specified in the section "Route of Administration and Doses". Levomycetinum cannot be mixed in one syringe with vitamins of group B and ascorbic acid. Levomycetinum is incompatible in solutions from ampicillin sodium salt, Gentamycini sulfas, Kanamycinum sulfate and a hydrocortisone.

Indications to use:

Typhoid, paratyphoid, generalized forms of salmonellosises, dysentery, brucellosis, tularemia, meningitis, sapropyra and other rickettsioses, trachoma. The infectious processes caused by the activators sensitive to action of Levomycetinum in case of inefficiency of other chemotherapeutic drugs or when their use is impossible.

Route of administration and doses:

Levomycetinum the adult is applied intramusculary or intravenously. To children apply intramusculary. Solutions of drug prepare ex tempore. Before introduction it is necessary to carry out test on portability of drug on condition of lack of contraindications to their carrying out. For intramuscular introduction bottle contents (0,5 g or 1 g) are parted in 2-3 ml of sterile water for injections and entered deeply intramusculary. For intravenous jet administration the single dose of drug is dissolved in 10 ml
sterile water for injections or in 5%, or glucose solution also enter into 40% intravenously slowly within 3-5 minutes. A sick diabetes mellitus drug is dissolved in 0,9% chloride sodium solution. The daily dose of drug for adults at systemic infections makes from 1 to 3 g; enter 0,5-1 g 2-3 times a day with an interval of 8-12 hours; if necessary the daily dose is increased to 4 g. In ophthalmology drug is used for parabulbar injections and instillations. For parabulbar injections 1-2 times a day enter 0,2-0,3 ml of 20% of solution; for instillations dig in in a conjunctival sac 5% solution on 1-2 drops (drug is dissolved in sterile water for injections or in 0,9% chloride sodium solution) 3-5 times a day. Water 5% store solution for instillations no more than 2 days. Duration of use of  of 5 - 15 days. Levomycetinum is applied intramusculary in a daily dose: to children aged till 1 year of  of 25 - 30 mg/kg of body weight, to children 1 years of  of 50 mg/kg of body weight are aged more senior, having divided into 2 introductions with an interval of 12 hours.

Features of use:

Treatment by Levomycetinum should be carried out under control of a picture of blood and a functional condition of a liver and the patient's kidneys. At emergence of a leukopenia, thrombocytopenia, anemia or other pathological changes of blood Levomycetinum should be cancelled immediately. Because of possible development of oppression of marrow aplastic anemia, thrombocytopenia and a granulocytopenia are usually shown after the end of therapy. Therefore such symptoms as pallor of skin, a pharyngalgia, the increased body temperature, unusual bleedings, weakness (if they appear in several weeks or months after drug withdrawal), demand acute management. Use to patients with disturbances of functions of a liver and kidneys. At such patients it is desirable to define periodically concentration of drug in blood for a possibility of correction of dosing, and also it is necessary to carry out assessment of a functional condition of a liver and the patient's kidneys. Use to patients of advanced age. Taking into account age features of functions of kidneys, a liver, cardiovascular system, existence of associated diseases, uses of other medicines it is necessary to define a drug dose for patients of advanced age with care, beginning, as a rule, with the lower bound
dosing range. At patients who took a course of cytostatic or radiation therapy earlier it is necessary to estimate potential risks and the expected advantage of treatment by the drug Levomycetinum taking into account possible development of heavy side effects. As well as at use of other antibacterial drugs, treatment by Levomycetinum can cause Clostridium difficile overgrowth that is the main reason for developing of pseudomembranous colitis. Pseudomembranous colitis arises as directly during administration of drug, and within 2 months after the end of antibacterial therapy. About cases of development of pseudomembranous colitis from an easy form to posing a threat for life, it was reported at use of all antibacterial drugs, including chloramphenicol. Therefore it is important to specify the diagnosis at patients with diarrhea after reception of antibacterial drugs. At confirmation of this type of diarrhea it is necessary to cancel an antibioticotherapia which does not influence Clostridium difficile and to appoint the corresponding therapy and inspection. If there is no necessary treatment, toxic megacolon, peritonitis, shock can develop.
It is necessary to consider that development of colitis is most probable at a serious illness at people of advanced age, and also at the weakened patients. Use of antibacterial drugs can lead to the overgrowth of insensitive microorganisms, in particular mushrooms. If in the course of treatment the infections caused by insensitive microorganisms develop it is necessary
to take the appropriate measures. Patients need to appoint levomycetinum with care with tendency to allergic reactions. It is impossible to allow uncontrolled purpose of Levomycetinum and its use at easy forms of infectious processes, at acute respiratory diseases or as prophylactic for prevention of bacterial infections, especially in
to pediatric practice. It is necessary to avoid repeated courses of treatment chloramphenicol, treatment has to last not longer, than it is necessary for receiving positive takes without risk of development of complications or a recurrence of a disease. Ability to influence speed of response at control of motor transport or work with other mechanisms.
It is necessary to use with care drug to the persons managing motor transport or working with other mechanisms in connection with risk of development of possible undesirable reactions from a nervous system.

Side effects:

Co of the party of system of blood and lymphatic system: toxic influence on system of a blood formation and oppression of activity of marrow (including a granulocytopenia, a pancytopenia, an erythrocytopenia, anemia (reduction of level of hemoglobin in blood)), a leukopenia, thrombocytopenia, a reticulocytopenia, cytoplasmatic vacuolation of early erythrocyte forms, seldom in hard cases is possible development of hypoplastic anemia, an agranulocytosis.
From a digestive tract: stomatitis, glossitis, irritation of mucous membranes of a mouth and pharynx, nausea, vomiting, diarrhea, abdominal distention, oppression of normal intestinal microflora, dysbacteriosis, consecutive fungal infection, coloenteritis, abnormal liver function.
From the central and peripheral nervous system: visual and auditory hallucinations, reversible vision disorders, hearing, peripheral neuritis, an optic neuritis, psychomotor frustration, encephalopathy with confusion of consciousness and a delirium, a headache, a depression. Allergic reactions: skin rash (including a small tortoiseshell), dermatitis (including perianal dermatitis), a dermatosis, fever, it is very rare – a Quincke's disease, an anaphylaxis.
From cardiovascular system: seldom at children till 1 year development of a cardiovascular collapse is possible (heat - a syndrome).
Others: development of consecutive infection, reaction of a bacteriolysis (Yarisha-Gerksgeymer's reaction) is possible.
At use of Levomycetinum in the form of eye drops local allergic reactions are possible.

Interaction with other medicines:

Levomycetinum is not appointed together with the drugs oppressing a hemopoiesis (the streptocides derivative of pyrazyl ketone, cytostatics), and also with radiation therapy. As P450 cytochrome inhibitor Levomycetinum can slow down metabolism and elimination, to increase level in blood of dipheninum, Butamidum, barbiturates, Phenytoinum, indirect anticoagulants (for example warfarin, neodicoumarin). Cycloserinum strengthens a neurotoxicity, Ristomycinum – Levomycetinum gematotoksichnost. Levomycetinum oppresses metabolism of peroral hypoglycemic drugs (Tolbutamidum, Chlorproramidum) and oxycoumarin derivatives, increasing their hypoglycemic and anticoagulating properties. Barbiturates (phenobarbital), rifampicin, рифабутин accelerate Levomycetinum biotransformation, reduce concentration of drug in blood serum and its efficiency. Levomycetinum can reduce efficiency of estrogenosoderzhashchy oral contraceptives, weaken effects of iron preparations, folic acid, cyanocobalamine. Levomycetinum reduces antibacterial effect of penicillin and cephalosporins. Levomycetinum can reduce effect of macroleads (erythromycin), linkozamid (clindamycin, lincomycin). At simultaneous use of Levomycetinum with nystatin
and levorinum notes mutual weakening of antimicrobic action therefore it is necessary to avoid their simultaneous use. At simultaneous use with paracetamol extension of an elimination half-life of chloramphenicol can be observed.
At simultaneous use of Levomycetinum with cyclophosphamide the elimination half-life is extended the last from 7,5 to 11,5 hours. Levomycetinum can increase concentration of cyclosporine and a takrolimus in this connection the dose of the last needs to be korrigirovat.
It is incompatible with alcohol (at simultaneous use possibly development of disulfiramopodobny reaction: hyperemia of integuments, tachycardia, nausea, vomiting, reflex cough, spasms).

Contraindications:

The increased individual sensitivity to Levomycetinum (chloramphenicol) and other amfenikola. Oppression of a hemopoiesis, blood disease, acute porphyria. Skin diseases (psoriasis, eczema, fungal infections). The expressed abnormal liver functions and/or kidneys. Deficit glyukozo-6-fosfatdegidrogenazy. It is not necessary to appoint Levomycetinum for treatment and prevention of acute respiratory diseases, quinsy.

Use during pregnancy or feeding by a breast. There is no experience of use of drug during pregnancy or feeding by a breast.
Children. Use is authorized to children on condition of observance of the dosing specified in the section "Route of Administration and Doses". Appoint with care and only in the absence of alternative therapy.

Overdose:

Prolonged use of high doses (more than 3 g a day) Levomitsetina can cause psychomotor frustration, confusion of consciousness, visual and auditory hallucinations, decrease in auditory acuity and sight, an agranulocytosis, aplastic anemia, disturbance of sense of taste before its decrease, optical and peripheral neuritis (including paralysis of eyeglobes), pallor of integuments, a pharyngalgia, the increased temperature, unusual bleedings and hemorrhages, fatigue or weakness.
At overdose at children or especially sensitive people development "is possible heat - a syndrome": abdominal distention, vomiting, a respiratory distress with a heavy metabolic acidosis, gray skin color, a cardiovascular collapse.
Development of other side reactions, characteristic of Levomitsetin is also possible (see the section "Side reactions").
Treatment: drug withdrawal, gastric lavage, use of enterosorbents, symptomatic therapy.

Storage conditions:

Period of validity of 5 years. To store in original packaging at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 0,5 g or 1 g in a bottle.