Levomycetin, tablets 500 mg 20 pcs

Pharmacodynamics

Bacteriostatic broad spectrum antibiotic, disrupts the process of protein synthesis in the microbial cell.

It is effective against strains of bacteria resistant to penicillin, tetracyclines, sulfonamides.

Active against many Gram-positive and Gram-negative bacteria, causative agents of septic infections, typhoid, dysentery, meningococcal infection, Haemophilus influenzae bacteria, Escherichia coli, Shigella dysenteria spp, Shigella flexneri spp, Shigella boydii spp, Shigella sonnei spp., Salmonella spp. (including Salmonella typhi, Salmonella paratyphi), Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae), Neisseria meningitidis, several strains of Proteus spp, Pseudomonas pseudomallei, Rickettsia spp., Treponema spp., Leptospira spp., Chlamydia spp. (including Chlamydia trachomatis), Coxiella burnetii, Ehrlichia canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae.

He acts on acid-fast bacteria (including Mycobacterium tuberculosis), Pseudomonas aeruginosa spp., clostridia, methicillin-resistant strains of staphylococci, Acinetobacter, Enterobacter, Serratia marcescens, indole-positive strains of Proteus spp.

Microbial resistance develops slowly.

Pharmacokinetics

Absorption – 90% (fast and almost complete). Bioavailability – 80%. Binding to plasma proteins – 50-60%, in premature infants – 32%. Tmax after oral administration is 1-3 hours. Vd – 0.6-1 l/kg. Therapeutic concentration in blood is maintained for 4-5 hours after intake.

It penetrates well into body fluids and tissues. The highest concentrations are formed in the liver and kidneys. Up to 30% of the administered dose is found in bile. Cmax in cerebrospinal fluid is determined 4-5 hours after a single oral administration and can reach 21-50% of Cmax in plasma and 45-89% in inflamed cerebrospinal fluid. Passes through the placental barrier, fetal serum concentrations may be 30-80% of maternal blood concentrations. Passes into breast milk. The main amount (90%) is metabolized in the liver. In the intestine under the influence of intestinal bacteria it is hydrolyzed with the formation of inactive metabolites.

Indications

Diseases caused by susceptible microorganisms:

– brain abscess;

– typhoid fever;

– paratyphoid fever;

– salmonellosis (mainly generalized forms);

– dysentery;

– brucellosis;

– tularemia;

– Q fever;

– meningococcal infection;

– rickettsioses (including.ч. typhus, trachoma, Rocky Mountain spotted fever);

– psittacosis;

– inguinal lymphogranuloma;

– chlamydia;

– yersinioses;

– ehrlichiosis;

p> – urinary tract infections;

– purulent wound infection;

– pneumonia;

– purulent peritonitis;

– biliary tract infections;

– purulent otitis media.

Active ingredient

Composition

How to take, the dosage

Ingestion. 30 min before a meal, in case of development of nausea and vomiting – 1 hour after the meal, 3-4 times a day. The average duration of treatment course is 8-10 days.

In adults the single dose is 250-500 mg, the daily dose is 2000 mg/day. In case of severe forms of infections (including typhoid fever and peritonitis) the dose can be increased up to 3000-4000 mg/day under hospital conditions.

In children under control of the drug concentration in blood serum 12.5 mg/kg (base) every 6 hours or 25 mg/kg (base) every 12 hours, in severe infections (bacteraemia, meningitis) up to 75-100 mg/kg (base) daily.

Interaction

Simultaneous use with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), affect liver metabolism, as well as with radiation therapy increases the risk of side effects.

The simultaneous use of ethanol may cause a disulfiram reaction.

When administered with oral hypoglycemic agents, an increase in their effect has been noted (due to the suppression of metabolism in the liver and an increase in their plasma concentrations).

In concomitant use with erythromycin, clindamycin, lincomycin mutual weakening of action is noted due to the fact that chloramphenicol may displace these drugs from the bound state or prevent their binding to the 50S subunit of bacterial ribosomes.

Decreases the antibacterial effect of penicillins and cephalosporins.

Chloramphenicol inhibits cytochrome P450 enzyme system, therefore concomitant use with phenobarbital, phenytoin and indirect anticoagulants leads to decreased metabolism of these drugs, slower excretion and increased plasma concentrations.

Special Instructions

Due to high toxicity, it is not recommended for the treatment and prevention of trivial infections, colds, influenza, pharyngitis, bacteriuria without necessity.

Severe complications with the hematopoietic system are usually associated with the use of high doses (more than 4 g/day) over a long period of time.

A systematic monitoring of peripheral blood counts is necessary during treatment.

In fetus and newborn children the liver is not developed enough to bind chloramphenicol and the drug may accumulate in toxic concentrations and lead to gray syndrome, therefore in children in the first months of life the drug is prescribed only with vital signs.

The simultaneous use of levomycetin and ethanol may lead to disulfiram reaction (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, seizures).

Contraindications

– hypersensitivity;

– inhibition of medullary hematopoiesis;

– acute intermittent porphyria;

– glucose-6-phosphate dehydrogenase deficiency;

-hepatic insufficiency;

– renal insufficiency;

– skin diseases (psoriasis, eczema, fungal lesions);

– pregnancy;

– lactation period;

– childhood (under 2 years).

Patients who have previously been treated with cytostatic drugs or radiation therapy should use with caution.

Side effects

Digestive system disorders: dyspepsia, nausea, vomiting (possibility of development is reduced if taken 1 hour after a meal), diarrhea, irritation of the mucosa of the mouth and throat, dermatitis (including perianal dermatitis – in rectal use), dysbacteriosis (suppression of normal microflora).

Hematopoietic disorders: reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia; rarely – aplastic anemia, agranulocytosis.

Nervous system disorders: psychomotor disorders, depression, confusion, peripheral neuritis, optic neuritis, visual and auditory hallucinations, decreased visual and hearing acuity, headache.

Allergic reactions: skin rash, angioedema.

Other: secondary fungal infection, collapse (in children under 1 year).

Overdose

The occurrence of gray syndrome in premature infants and neonates when treated with high doses is possible, the cause of which is the accumulation of chloramphenicol due to immaturity of liver enzymes in children, as well as its direct toxic effect on the myocardium.

Symptoms: bluish-gray skin color, decreased body temperature, irregular breathing, lack of reactions, cardiovascular failure. Lethality is up to 40%.

Treatment: hemosorption, symptomatic therapy.

Similarities