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

Active ingredient

Composition

Excipients: colloidal silicon dioxide (aerosil), microcrystalline cellulose, povidone, crosspovidone, calcium stearate, for dosage of 250 mg – opadray II (series 85) [polyvinyl alcohol, macrogol, talc, titanium dioxide, iron oxide yellow, Iron oxide red, iron oxide black], for 500 mg dosage – opadray II (series 85) [polyvinyl alcohol, macrogoal, talc, titanium dioxide, aluminum varnish based on quinoline yellow, aluminum varnish based on indigo carmine].

How to take, the dosage

Ingestion (30 min before a meal, and 1 hour after a meal in case of nausea and vomiting), 3-4 times a day. Single dose for adults is 0.25-0.5 g, daily dose – 2 g. In case of severe infections (under hospital conditions) the dose can be increased up to 3-4 g per day (under control of blood, kidney and liver function).

In children over 3 years old and/or with body weight more than 20 kg a dose of 12.5 mg/kg every 6 hours or 25 mg every 12 hours, in severe infections – up to 75-100 mg/kg/day (with control of serum concentrations of the drug).

The average duration of treatment is 8-10 days.

Interaction

Inhibits microsomal liver enzymes, therefore in concomitant use with phenobarbital, phenytoin, indirect anticoagulants weakened metabolism of these drugs, slowed excretion and increased their plasma concentrations.

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

The concomitant use with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), which affect metabolism in the liver, with radiation therapy increases the risk of side effects.

When administered with oral hypoglycemic drugs, it is noted that their effect is increased (due to the suppression of metabolism in the liver and increase of their concentration in the plasma).

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special Instructions

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

Disulfiram-like reactions (facial hyperemia, abdominal and stomach cramps, nausea, vomiting, headache, decreased blood pressure, tachycardia, shortness of breath) may occur if ethanol is taken simultaneously.

Contraindications

Hypersensitivity, suppression of medullary hematopoiesis, acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency, hepatic and/or renal insufficiency, skin diseases (psoriasis, eczema, fungal lesions), pregnancy, lactation, children under 3 years old and/or body weight less than 20 kg.

With caution:

Patients previously treated with cytostatic drugs or radiation therapy.

Side effects

Digestive system disorders: dyspepsia, nausea, vomiting (the probability of development is reduced if taken 1 hour after meals), diarrhea, irritation of the mucous membranes of the mouth and pharynx, dermatitis, 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.

Others: secondary fungal infection.

Overdose

Symptoms: nausea, vomiting.

Treatment: gastric lavage, symptomatic therapy, hemosorption.

Pregnancy use

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