Levomycetin, pills 500 mg, 20 pcs.

Composition

Active ingredient:Levomycitin 500 mgsupport substances:potato starch, povidone (low molecular weight medical polyvinylpyrrolidone 12600 ± 2700), calcium stearate, talc, crospovidone (collidone CL-M).

Pharmacological action

pharmacodynamicabacteriostatic broad-spectrum antibiotic, disrupts the process of protein synthesis in the microbial cell. It is effective against bacterial strains resistant to penicillin, tetracyclines, and sulfonamides. Active against many gram-positive and gram-negative bacteria, pathogens of purulent infections, typhoid fever, dysentery, meningococcal infection, hemophilic 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, a number of 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-resistant bacteria (including Mycobacterium tuberculosis), Pseudomonas aeruginosa, Clostridium, methicillin-resistant strains of staphylococci, Acinetobacter, Enterobacter, Serratia marcescens, indole-positive strains of Proteus spp., Pseudomonas aeruginosa spp., protozoa and fungi. Microbial resistance develops slowly. Pharmacokineticabsorption — 90% (fast and almost complete). Bioavailability — 80%. The association with plasma proteins is 50-60%, in premature newborns-32%. Tmax after oral administration is 1-3 h. Vd is 0.6-1 l/kg. The therapeutic concentration in the blood is maintained for 4-5 hours after administration. Penetrates well into body fluids and tissues. The highest concentrations are created in the liver and kidneys. Up to 30% of the administered dose is detected in the bile. Cmax in the cerebrospinal fluid is determined 4-5 hours after a single oral administration and can reach 21-50% of Cmax in plasma in non-inflamed meninges and 45-89% in inflamed meninges. Passes through the placental barrier, fetal serum concentrations can be 30-80% of the concentration in the mother’s blood. Penetrates into breast milk. The main amount (90%) is metabolized in the liver. In the intestine, under the action of intestinal bacteria, it is hydrolyzed to form inactive metabolites. It is excreted within 24 hours, by the kidneys — 90% (by glomerular filtration — 5-10% unchanged, by tubular secretion in the form of inactive metabolites — 80%), through the intestine — 1-3%. T1/2 in adults — 1.5–3.5 hours, with impaired renal function — 3-11 hours. T1/2 in children (from 1 month to 16 years) — 3-6.5 hours, in newborns (from 1 to 2 days) — 24 hours or more (varies especially in children with low birth weight),10-16 days — 10 hours. It is poorly exposed to hemodialysis.

Indications

Diseases caused by sensitive microorganisms:brain abscess;typhoid fever;paratyphoid fever;salmonellosis (mainly generalized forms);dysentery;brucellosis;tularemia;Ku fever;meningococcal infection;rickettsiosis (including typhoid fever, trachoma, Rocky Mountain spotted fever);psittacosis;inguinal lymphogranuloma;chlamydia;yersiniosis;ehrlichiosis;urinary tract infections;purulent wound infection;pneumonia;purulent peritonitis;biliary tract infections;purulent otitis media.

Recommendations for use

Inside.30 minutes before meals, with the development of nausea and vomiting-1 hour after meals,3-4 times a day. The average duration of treatment is 8-10 days. For adults, a single dose is 250-500 mg, daily-2000 mg/day. In case of severe infections (including typhoid fever, peritonitis) in a hospital setting, it is possible to increase the dose to 3000-4000 mg / day. Children are prescribed under the control of serum concentrations of 12.5 mg / kg (base) every 6 hours or 25 mg / kg (base) every 12 hours, with severe infections (bacteremia, meningitis) – up to 75-100 mg/kg (base) per day.

Contraindications: non-acceptance of the active component and components of the drug; skin pathologies;eczema;depressed hematopoiesis; psoriasis; fungi on the skin;sore throat;acute respiratory infections; pregnancy;breastfeeding.

Side effects

From the digestive system: dyspepsia, nausea, vomiting (the probability of development decreases when taken 1 hour after eating), diarrhea, irritation of the oral and pharyngeal mucosa, dermatitis (including perianal dermatitis – with 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 of age).

Interaction

Concomitant administration with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), affect liver metabolism, as well as with radiation therapy, increases the risk of side effects. When taking ethanol at the same time, a disulfiram reaction may develop. When administered with oral hypoglycemic drugs, their effect is enhanced (due to suppression of metabolism in the liver and an increase in their concentration in plasma). When used concomitantly with erythromycin, clindamycin, lincomycin, there is a mutual weakening of the action due to the fact that chloramphenicol can displace these drugs from the bound state or prevent their binding to the 50S subunit of bacterial ribosomes. Reduces the antibacterial effect of penicillins and cephalosporins. Chloramphenicol suppresses the cytochrome P 450 enzyme system, so when used simultaneously with phenobarbital, phenytoin, and indirect anticoagulants, there is a weakening of the metabolism of these drugs, slowing down their excretion and increasing their concentration in plasma.

Overdose

Gray syndrome may occur in premature children and newborns when treated with high doses, 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, low body temperature, irregular breathing, lack of reactions, cardiovascular insufficiency. Lethality rate-up to 40%. Treatment: hemosorption, symptomatic therapy.

Special instructions

Due to its high toxicity, it is not recommended to use it unnecessarily for the treatment and prevention of banal infections, colds, flu, pharyngitis, and bacterial transmission. Severe complications from the hematopoietic system, as a rule, are associated with the use of high doses (more than 4 g / day) for a long time. In the course of treatment, systematic monitoring of the peripheral blood picture is necessary. In the fetus and newborns, the liver is not sufficiently developed to bind chloramphenicol, and the drug can accumulate in toxic concentrations and lead to the development of gray syndrome, so children in the first months of life are prescribed the drug only for vital indications. When taking levomycetin and ethanol at the same time, a disulfiram reaction may develop (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, convulsions).

Storage conditions

List B. In a place protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

5 years

Active ingredient

Chloramphenicol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 3 years of age

Indications

Urinary Tract Infections, Intestinal Infections, Biliary Tract

Infections Weight

Weight: 21 g.