Project Description
Levomycetin
capsules 0,25 g – Capsulae Laevomycetini 0,25
international nonproprietary name
Chloramphenicol.
Ref
BP-0070
Pharmacotherapeutic group
Antibioticofamphenicol group.
Composition of the preparation
1 capsule contains 250 mg of levomycetin (chloramphenicol).
Pharmacological action
Pharmacodynamics Levomycetin is antibiotic of vast gamma of antibacterial action, It is of bacteriostatic effect. Antibacterial mechanism of levomycetin is reoated to its inhibiting activity to peptidyl-transferase and breakage of protein bacterium synthesis in cells. It is effective against many gram-positive coccus (staphylococcus, streptococcus, pneumococcus, enterococcus) and gram-negative (gonococcus, meningococcus), salmonella, shigella, klebsiella, serracia, yersinia, protea, anaerobe, Rickettsia, spirochaeta and some other large viruses (trachoma, psittacosis, lymphogranuloma venerium and others). The drug resistance is developed slowly. It is antibiotic of the reserve and is administered if other antibiotics are ineffective. Pharmacokinetics Levomycetin is well tolerated and rapidly absorbed after oral intake. Max.blood concentration after oral intake is achieved in 2-3 h., therapeutic blood concentration in 4-5 h. after intake. The drug is well absorbed in organs, tissues and fluid of organism, asses through hematoencephalic barrier, well penetrated to cerebrospinal fluid (about 50% of blood). The drug penetrates through placenta, is detected in breast milk. Therapeutic concentration is revealed in vitreous body, cornea, iris, aqueous humor lens). It is mainly urine excreted, partially bile and feces excreted.
Indications
Levomycetin is administered for the treatment of typhoid/enteric fever, paratyphoid, generalized type of salmonellosis, dysentery, brucellosis, tularemia, ricketsiosis, clamidiosis, meningitis, cerebrum abscess, peritonitis.
Special indication
Avoid alcohol during levomycetin treatment.
Special warning
Not established
Dosage and method of administration
Levomycetinisadministeredfororalintake 30 min. beforemeals (incaseofnauseamvomit, 1 h. Aftermeals). Singledoseinadultsis0.25—0.5 g, dailydose— 2g, insevereconditions (typhoid/entericfever, peritonitis) inhospitalitispossibletoadministerlevomycetin 3 gadayunderseveremedicalcontrolandbloodandrenaltests. Dailydoseisdividedin 3-4 intakes. Single dose in children under 3 is 10-15 mg/kg of body weigh; 3-8 years old 0.15—0.2 g; after 8 years old 0.2—0.3 g. Intake 3—4 times a day. It is prohibited to exceed the indicated doses. Average course of treatment is 7—10 days. If it is well tolerated, the course under indications (severe diseases, repeated infections) may be prolonged to 2 weeks. Repeatedcoursesoflevomycetintreatmentarenotrecommended.
Overdosage
Not established
Safety measures
Administer with care in patients with cardiovascular diseases and allergic tendency.
Side effects
Oral usage of levomycetin may cause dyspepsia, nausea, vomit, liquid stool, irritation of tunica mucosa of mouth, fauces, dermatitis. The drug may cause inhibition of hematosis (reticulocytopenia, granulocytopenia, agarnulocytosis, reduction of erythrocytes) and even aplastic anemia. Possible pscycomotor disorder, hallucinations, eyeball paralysis, ear and eye acuity reduction, allergic reactions (skin eruption, urticaria, angioneurotic edema), possible myocardial depression. Levomycetin ausage may be accompanied by the development of dysbacteriosis, superinfections (candidal mycosis, staphylococcus infection, proteus infection). Infants are mostly sensitive to levomycetin, administration is under severe medical control of haemopoiesis system
Contraindications
Levomycetin is contraindicated in hypersensitivity, hemopoietic organ diseases, acute intermittent porphyria, marked liver and renal failure, deficiency of glucose-6-phosphatdehydrogenase enzyme, psoriasis, eczema, skin fungi diseases, pregnancy, lactation, in infants (the first months after birth).
Interactions with other medicinal preparations
Phenobarbitolacceleratesbiotransformation, decreaseslevomycetinactionduration. Concurrent administration of phenitoin, the concentration of levomycetin in serum increases and is potentially toxic. Levomycetin inhibits tolbutamide, chlorpropamide, oxycumarine derivative metabolism enhancing their activity. Erythromycin, oleandomycin, nystatin, levorin increases antibacterial activity of levomycetin, benzilpenicillin salts decrease its activity. Levomycetin toxicity increases under concurrent administration of cimetidine, cycloserine, ristomycine. It is not compatible with cytostatics, sulphanilamides, pyrasoline-derivatives, barbiturates, diphenylhydantoins.
The form of release
Capsules 250 mg. 10 or 20 capsulesinblisterorinjar.