Levomycetin Actitab, 500 mg 10 pcs

Pharmacotherapeutic group: antibiotic

ATX code: J01BA01

Pharmacodynamics

Bacteriostatic broad spectrum antibiotic, disrupts the process of protein synthesis in the microbial cell at the stage of transfer of amino acids
t-RNA to ribosomes.

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

Active against the following microorganisms: Escherichia coli, Shigella dysenteria, Shigella flexneri spp., Shigella boydiispp., Shigellasonnei, Salmonellaspp. (including Salmonella typhi, Salmonella paratyphi), Staphylococcus spp, Streptococcus spp. (including Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, several strains of Proteus spp., Burkholderia pseudomallei, Rickettsia spp, Treponema spp., Leptospira spp., Chlamydia spp. (including Chlamydia trachomatis), Coxiella burnetii, Ehrlichia canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae.

It has no effect on acid-fast bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacterspp., Enterobacterspp., Serratiamarcescens, indole positive strains of Proteusspp., Pseudomonasaeruginosaspp., protozoa and fungi. Resistance of microorganisms develops slowly.

Pharmacokinetics

After administration the binding to plasma proteins is 50-60%. Time of reaching maximum concentration (TCmax) after administration – 1-3 hours. Volume of distribution – 0.6-1.0 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 in liver and kidneys. Up to 30% of the administered dose is found in bile. Maximal concentration (Cmax) in cerebrospinal fluid is determined 4-5 hours after a single dose and can reach 21-50% of Cmax in plasma in the absence of inflammation of the meninges and 45-89% – in the presence of inflammation of the meninges.

Passes through placental barrier, concentrations in fetal serum may be 30-80% of that in mother’s blood. It penetrates into breast milk. The main amount (90%) is metabolized in the liver. In the intestine it is hydrolyzed under the influence of intestinal bacteria with the formation of inactive metabolites.

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Indications

Infections of the urinary and biliary tract caused by sensitive microorganisms.

Pharmacological effect

Pharmacotherapeutic group: antibiotic

ATX code: J01BA01

Pharmacodynamics

A broad-spectrum bacteriostatic antibiotic that disrupts the process of protein synthesis in the microbial cell at the stage of amino acid transfer
tRNA to ribosomes.

Effective against strains of bacteria resistant to penicillin, tetracyclines, and sulfonamides.

Active against the following microorganisms: Escherichia coli, Shigella dysenteria, Shigella flexneri spp., Shigella boydiispp., Shigellasonnei, Salmonellaspp. (including Salmonella typhi, Salmonella paratyphi), Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, a number of strains of Proteus spp., Burkholderia pseudomallei, Rickettsia spp., Treponema spp., Leptospira spp., Chlamydia spp. (including Chlamydia trachomatis), Coxiella burnetii, Ehrlichia canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae.

Does not affect acid-fast bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratiamarcescens, indole-positive strains of Proteus spp., Pseudomonasaeruginosaspp., protozoa and fungi. Microbial resistance develops slowly.

Pharmacokinetics

After administration, the binding to plasma proteins is 50-60%. Time to reach maximum concentration (TCmax) after administration is 1-3 hours. Volume of distribution is 0.6-1.0 l/kg. Therapeutic concentration in the blood remains for 4-5 hours after administration. Penetrates well into body fluids and tissues. Its greatest concentrations are created in the liver and kidneys. Up to 30% of the administered dose is found in bile. The maximum concentration (Cmax) in the cerebrospinal fluid is determined 4-5 hours after a single dose and can reach 21-50% of the Cmax in plasma in the absence of inflammation of the meninges and 45-89% in the presence of inflammation of the meninges.

Passes through the placental barrier, concentrations in fetal blood serum can be 30-80% of those in maternal blood. 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 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 intestines – 1-3%. The half-life (T1/2) in adults is 1.5-3.5 hours, in case of impaired renal function – 3-11 hours. T1/2 in children is 3.0-6.5 hours. It is poorly excreted during hemodialysis.

Special instructions

Severe complications from the hematopoietic system are usually associated with the use of high doses for a long time.

When taking ethanol simultaneously, a disulfiram-like reaction may develop (facial hyperemia, spasm in the abdomen and stomach area, nausea, vomiting, headache, decreased blood pressure, tachycardia, shortness of breath).

Active ingredient

Chloramphenicol

Composition

1 tablet contains:

Active substances:

chloramphenicol – 500 mg.

Excipients: colloidal silicon dioxide (Aerosil), microcrystalline cellulose, povidone, crospovidone, calcium stearate, for a dosage of 250 mg – opadry II (series 85) [polyvinyl alcohol, macrogol, talc, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide], for a dosage of 500 mg – opadry II (series 85) [polyvinyl alcohol, macrogol, talc, titanium dioxide, quinoline yellow aluminum varnish, indigo carmine aluminum varnish].

Pregnancy

Infections of the urinary and biliary tract caused by sensitive microorganisms.

Contraindications

Hypersensitivity, suppression of bone marrow hematopoiesis, acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency, liver and/or kidney failure, skin diseases (psoriasis, eczema, fungal infections), pregnancy, lactation, children under 3 years of age and/or body weight less than 20 kg.

With caution:

Patients who have previously received treatment with cytotoxic drugs or radiation therapy.

Side Effects

From the digestive system: dyspepsia, nausea, vomiting (the likelihood of development is reduced when taken 1 hour after a meal), diarrhea, irritation of the oral mucosa and pharynx, dermatitis, dysbacteriosis (suppression of normal microflora).

From the hematopoietic organs: reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia; rarely – aplastic anemia, agranulocytosis.

From the nervous system: 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.

Interaction

It inhibits microsomal liver enzymes, therefore, when used simultaneously with phenobarbital, phenytoin, and indirect anticoagulants, there is a weakening of the metabolism of these drugs, a slower elimination and an increase in their concentration in plasma.

Reduces the antibacterial effect of penicillins and cephalosporins. When used simultaneously with erythromycin, clindamycin, lincomycin, a mutual weakening of the effect is observed 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.

Simultaneous administration with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), affecting metabolism in the liver, with radiation therapy increases the risk of side effects.

When prescribed with oral hypoglycemic drugs, an increase in their effect is observed (due to suppression of metabolism in the liver and an increase in their concentration in plasma).

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Overdose

Symptoms: nausea, vomiting.

Treatment: gastric lavage, symptomatic therapy, hemosorption.

Storage conditions

List B. Store in a dry place, protected from light, at a temperature not exceeding 25 oC

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date stated on the package.

Manufacturer

Alium JSC, Russia