Chloramphenicol

Composition and release form of the drug

Pills white or white with a yellowish tint, round, biconvex shape.

Excipients: potato starch - 18.5 mg, K-25 - 3.75 mg, stearic acid - 2.75 mg.

10 pieces. - contour cellular packaging (1) - cardboard packs.
10 pieces. - contour cell packaging (2) - cardboard packs.
10 pieces. - contour cell packaging (3) - cardboard packs.
10 pieces. - contour cell packaging (4) - cardboard packs.
20 pcs. - contour cellular packaging (1) - cardboard packs.
20 pcs. - contour cell packaging (2) - cardboard packs.
20 pcs. - contour cell packaging (3) - cardboard packs.
20 pcs. - contour cell packaging (4) - cardboard packs.
30 pcs. - contour cellular packaging (1) - cardboard packs.
30 pcs. - contour cell packaging (2) - cardboard packs.
30 pcs. - contour cell packaging (3) - cardboard packs.
30 pcs. - contour cell packaging (4) - cardboard packs.
10 pieces. - cans (1) - cardboard packs.
20 pcs. - cans (1) - cardboard packs.
30 pcs. - cans (1) - cardboard packs.
40 pcs. - cans (1) - cardboard packs.
70 pcs. - cans (1) - cardboard packs.
80 pcs. - cans (1) - cardboard packs.

pharmachologic effect

Broad-spectrum antibiotic. The mechanism of action is associated with a violation of the synthesis of microbial proteins. Has a bacteriostatic effect. Active against gram-positive bacteria: Staphylococcus spp., Streptococcus spp.; gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Haemophilus influenzae, Salmonella spp., Shigella spp., Klebsiella spp., Serratia spp., Yersinia spp., Proteus spp., Rickettsia spp.; also active against Spirochaetaceae and some large viruses.

Chloramphenicol is active against strains resistant to penicillin and sulfonamides.

Resistance of microorganisms to chloramphenicol develops relatively slowly.

Pharmacokinetics

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Bioavailability is 80%. Quickly distributed in the body. Protein binding is 50-60%. Metabolized in the liver. T1/2 is 1.5-3.5 hours. It is excreted in the urine, small amounts in feces and bile.

Indications

For oral administration: infectious inflammatory diseases caused by microorganisms sensitive to chloramphenicol, including: paratyphoid fever, dysentery, brucellosis, tularemia, whooping cough, typhus and other rickettsioses; trachoma, pneumonia, meningitis, sepsis, osteomyelitis.

For external use: purulent skin lesions, boils, long-term non-healing trophic ulcers, burns II and III degree, cracked nipples in nursing women.

For local use in ophthalmology: inflammatory eye diseases.

Contraindications

Blood diseases, severe liver dysfunction, deficiency of the enzyme glucose-6-phosphate dehydrogenase, skin diseases (psoriasis, eczema, fungal diseases); pregnancy, lactation, children up to 4 weeks of age (newborns), hypersensitivity to chloramphenicol, thiamphenicol, azidamphenicol.

Dosage

Individual. When taken orally, the dose for adults is 500 mg 3-4 times a day. Single doses for children under 3 years of age - 15 mg/kg, 3-8 years - 150-200 mg; over 8 years old - 200-400 mg; frequency of use - 3-4 times/day. The course of treatment is 7-10 days.

For external use, apply to gauze pads or directly to the affected area. Apply a regular bandage on top, possibly with parchment or compress paper. Dressings are performed depending on the indications after 1-3 days, sometimes after 4-5 days.

Used locally in ophthalmology as part of combination drugs in accordance with indications.

Side effects

From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia.

From the outside digestive system: nausea, vomiting, diarrhea, flatulence.

From the central nervous system and peripheral nervous system: peripheral neuritis, neuritis optic nerve, headache, depression, confusion, delirium, visual and auditory hallucinations.

Allergic reactions: skin rash, urticaria, angioedema.

Local reactions: irritating effect (for external or local use).

Drug interactions

With the simultaneous use of chloramphenicol with oral hypoglycemic drugs, an increase in the hypoglycemic effect is observed due to the suppression of the metabolism of these drugs in the liver and an increase in their concentration in the blood plasma.

When used simultaneously with drugs that inhibit bone marrow hematopoiesis, there is an increased inhibitory effect on the bone marrow.

When used simultaneously with clindamycin, lincomycin, a mutual weakening of the effect is noted 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.

When used simultaneously with penicillins, chloramphenicol counteracts the bactericidal effect of penicillin.

Chloramphenicol inhibits the cytochrome P450 enzyme system, therefore, when used simultaneously with phenytoin, warfarin, there is a weakening of the metabolism of these drugs, a slower elimination and an increase in their concentration in the blood plasma.

special instructions

Chloramphenicol is not used in newborns, because the development of “gray syndrome” is possible (flatulence, nausea, hypothermia, gray-blue skin color, progressive cyanosis, dyspnea, cardiovascular failure).

Use with caution in patients who have previously received treatment with cytotoxic drugs or radiation therapy.

With simultaneous intake of alcohol, a disulfiram-like reaction may develop (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, convulsions).

Description

Tablets are white or white with a yellowish tint, with a score* and a bevel.

*The score is intended to divide the tablet to make it easier to swallow.

Compound

Each tablet contains:

active substance: chloramphenicol – 500 mg;

Excipients: povidone K-25, calcium stearate, potato starch.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Amphenicols.

ATS code: J01BA01.

pharmachologic effect

A broad-spectrum bacteriostatic antibiotic that disrupts the process of protein synthesis in a microbial cell at the stage of transfer of t-RNA amino acids to ribosomes. Effective against strains of bacteria resistant to penicillin, tetracyclines, and sulfonamides. Active against many gram-positive and gram-negative bacteria, pathogens of purulent and intestinal infections, meningococcal infection: Escherichia coli, Shigella dysenteria, Shigella flexneri spp., Shigella boydii spp., Shigella sonnei, Salmonella spp.(incl. Salmonella typhi, Salmonella paratyphi), Staphylococcus spp., Streptococcus spp.(incl. Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, a number of strains Proteus spp., Burkholderia pseudomallei, Rickettsia spp., Treponema spp., Leptospira spp., Chlamydia spp.(incl. Chlamydia trachomatis), Coxiella burnetii, Ehrlichia canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae. Does not affect acid-fast bacteria (incl. Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter, Enterobacter, Serratia marcescens,indole positive strains Proteus spp., Pseudomonas aeruginosa spp., protozoa and fungi. Microbial resistance develops slowly. Refers to reserve antibiotics and is used when other antibiotics are ineffective.

Indications for use

Heavy, life threatening infections caused by microorganisms sensitive to choramphenicol, especially Haemophilus influenzae, and typhoid fever.

Used as a reserve antibiotic when other antibacterial agents are ineffective or impossible to use.

- Typhoid fever ( Salmonella typhi);

– Paratyphoid A and B;

– Sepsis caused by salmonella;

– Meningitis caused by Salmonella;

– Meningitis caused by Haemophilus influenzae;

– Purulent bacterial meningitis;

– Rickettsial diseases.

Directions for use and doses

Doses:

Adults (inclincluding elderly patients): The usually recommended dose is 500 mg every 6 hours (50 mg/kg body weight per day in 4 divided doses). Treatment should be continued for another 2 or 3 days after body temperature normalizes. For severe infections (meningitis, sepsis), this dose may initially be doubled, but it should be reduced as soon as clinical improvement occurs.

Children over 6 years old: 50.0–100.0 mg/kg/day in 4 divided doses.

In children and elderly patients, it is necessary to monitor the concentration of chloramphenicol in the blood plasma. Recommended peak plasma concentration of chloramphenicol (approximately 2 hours after dosing): 10–25 mg/L; . "residual" concentration in blood plasma before next step should not exceed 15 mg/l.

Mode of application: orally, 30 minutes before meals.

If you missland taking the medicine, you must take the missed dose as soon as this omission is noticed. However, ifdThis time of administration coincides with the next dose, do not take the missed dose nextdvet. Take the drug according to the recommended regimendozation without doubling the dose to compensate for the missed dose.

Tablet of the drug Levomycetin is notdsplits into pieces, so when neobthe need to use chloramphenicol in a dose of less than 500 mg, it is recommended to use a medicinal solutiondqualitydother productsddriver, providing the possibility of such aOPS

Side effect

Like all drugs, chloramphenicol can cause unwanted side effects.bny reactions, aboutdHowever, they do not occur in everyone.

The incidence of side effects isdena next yeardations:

Rarely - May occur in up to 1 in 1000 people: reversible dose-dependent suppression of bone marrow functions and irreversible aplastic anemia, hypoplastic anemia, agranulocytosis.

Frequency unknown – outgoingdI'm fromthemeatingddata, frequency of occurrence of certaindit is impossible to eat: secondary fungal infection, reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia, pancytopenia, increased bleeding time, hypersensitivity reactions (including allergic skin reactions), angioedema, when treating patients with typhoid fever, the Jarisch-Herxheimer reaction may occur, psychomotor disorders, depression, confusion, peripheral neuritis, headache, optic neuritis, visual and auditory hallucinations, decreased visual and hearing acuity, acidotic cardiovascular collapse, dyspepsia, nausea, vomiting (the likelihood of development is reduced when taken 1 hour after meals) , diarrhea, irritation of the oral mucosa and pharynx, glossitis, stomatitis, enterocolitis, dysbacteriosis (suppression of normal microflora), paroxysmal nocturnal hemoglobinuria, fever, collapse (in children under 1 year), “gray syndrome” of newborns *.

* “Gray syndrome” of newborns is accompanied by vomiting, bloating, respiratory distress, and cyanosis. Later, vasomotor collapse, hypothermia, and acidosis occur. The cause of the development of “gray syndrome” of chloramphenicol, due to the immaturity of liver enzymes, is a toxic effect on the myocardium. Mortality reaches 40%.

If you experience any unwanted reactions, consult your doctor. Thisrecommendationapplies to any possible adverse reactions, including those not listed in the leaflet.treasurehigher. You can also report tendernesseadverse reactions to the Adverse Reactions Database (DaysTviyam) on medications, including reports of drug ineffectivenessnny drugs. By reporting side effects, you can help provide more information about the safety of the drug.

Contraindications

Hypersensitivity to the active and auxiliary components of the drug, a history of toxic reactions to chloramphenicol, active immunization, suppression of bone marrow hematopoiesis, acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency, hepatic and/or renal failure, psoriasis, eczema, fungal skin diseases, prevention and treatment of mild infections, children under 6 years of age, pregnancy, lactation.

Chloramphenicol is contraindicated in patients taking medications that may suppress bone marrow function.

Overdose

Chloramphenicol levels above 25 mcg/ml are considered toxic.

If more than 6 tablets are taken, you should rinse your stomach and continue symptomatic treatment. In case of severe overdose, for example, "gray syndrome" in children, it is necessary to quickly reduce the concentration of chloramphenicol in the blood plasma using hemoperfusion through ion exchange resins, which will significantly increase the clearance of chloramphenicol.

Most severe consequences Chloramphenicol poisoning can occur in children early age. With long-term (exceeding recommended periods) use in high doses - bleeding (due to depression of hematopoiesis or disruption of the synthesis of vitamin K by intestinal microflora).

Treatment: there is no specific antidote. In case of a serious overdose of the drug, symptomatic therapy is recommended - the use of activated carbon, hemoperfusion. In case of massive overdose, discuss the issue of replacement blood transfusion.

Precautionary measures

During treatment with chloramphenicol, alcohol intake is prohibited: with simultaneous intake of alcohol, the development of a disulfiram reaction (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, convulsions) is possible.

Severe complications from hematopoietic system associated with the use of large doses of chloramphenicol (more than 4000 mg/day) for a long time.

The use of the drug is contraindicated during the period of active immunization.

Clostridiumdifficile-associated diarrhea (CDAD) has been reported to occur with the use of virtually all antibacterial agents, including chloramphenicol, and can range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal microflora of the colon, leading to excessive growth WITH. difficile.

WITH. difficile produces toxins A and B, which contribute to the development of diarrhea. Hypertoxin-producing strains WITH. difficile are associated with increased morbidity and mortality, as these infections may be refractory to antibacterial therapy, and colectomy may be required, CDAD should be suspected in all patients with diarrhea following antibiotic use.

A careful history is necessary, as diarrhea may occur within 2 months after the use of antibacterial drugs.

If CDAD is suspected or confirmed, continued use of non-targeted antibiotics WITH. difficile, must be stopped. It is necessary to use appropriate fluids and electrolytes, protein supplements, antibiotics against WITH. difficile, surgical evaluation must be performed. Repeated courses of treatment with chloramphenicol should be avoided. Treatment should not be carried out before the start of treatment and more than is really necessary.

Excessively high level of the drug in the blood may be observed in patients with impaired liver or kidney function. In such patients, the use of the drug is contraindicated.

The use of chloramphenicol, like other antibiotics, can lead to overgrowth of non-susceptible microorganisms, including fungi. If infections caused by non-susceptible microorganisms occur during drug therapy, appropriate measures must be taken.

The use of chloramphenicol can cause severe blood disorders (aplastic anemia, bone marrow hypoplasia, thrombocytopenia, granulocytopenia). There are two types of bone marrow depression associated with chloramphenicol use. Usually observed mild depression bone marrow, dose-dependent and reversible, which can be detected by early changes in blood tests. Sudden fatal bone marrow hypoplasia without previous symptoms occurs very rarely. Basic Research blood tests should be performed before starting treatment and approximately every two days during drug therapy. Chloramphenicol should be discontinued if reticulocytopenia, leukopenia, thrombocytopenia, anemia, or any other blood laboratory changes occur. However, it should be noted that such studies do not exclude the possible subsequent occurrence of irreversible bone marrow suppression. Concurrent use of other drugs that inhibit red bone marrow function with chloramphenicol is contraindicated.

When using the drug in patients with diabetes mellitus, false positive results are possible in tests for the presence of glucose in the urine.

Dentistry. The use of the drug leads to an increase in the frequency of microbial infections of the oral cavity, slower healing processes and bleeding gums, which may be a manifestation of myelotoxicity. Dental interventions should, if possible, be completed before starting therapy.

Previous treatment with cytostatics or radiation therapy. Possible accumulation of chloramphenicol and toxic reactions in the form of bone marrow suppression and liver dysfunction.

Geriatric use. Features of use in elderly people have not been sufficiently studied due to the small number of people aged 65 years and older who took part in clinical trials. Eat clinical researches, showing no difference in therapeutic response to drug treatment between elderly and young patients. However, dose selection for elderly patients should be cautious, generally starting at the lower end of the dosing range. The drug is significantly excreted through the kidneys and the risk of toxic reactions may be higher in patients with impaired renal function. Since decreased renal function is more likely in elderly patients, caution should be exercised in dose selection and renal function should be monitored.

Use during pregnancy and perioddlactation

Adequate, well-controlled studies on the use of the drug during pregnancy have not been conducted. Chloramphenicol crosses the placental barrier, but it is unknown whether it has toxic effects on the fetus. The use of the drug during pregnancy is contraindicated.

The drug is excreted in mother's breast milk. Due to the possibility of developing severe adverse reactions In a child, breastfeeding must be stopped during treatment with the drug. The development of “gray syndrome” is possible: toxic reactions, including fatal cases, have been described in newborns; the signs and symptoms associated with these reactions have been called "gray syndrome". Cases of "gray syndrome" have been described in newborns born to a mother who received chloramphenicol during pregnancy. Cases up to 3 months of life have been described. In most cases, chlorifenicol therapy was initiated within the first 48 hours of life. Symptoms appeared 3 to 4 days after continuous treatment with high doses of chloramphenicol. The symptoms appeared in the following order:

– bloating with or without vomiting;

– progressive pale cyanosis;

– vasomotor collapse, often accompanied by irregular breathing;

– death within a few hours after the onset of these symptoms.

Progression of symptoms is associated with high doses. Preliminary serum studies showed unusually high concentrations of chloramphenicol (more than 90 mcg/ml with repeated doses). Measures of assistance: exchange blood transfusion or hemosorption. Cessation of therapy in the early stages often led to reverse symptoms until complete recovery.

Impact on the ability to drive vehiclesddangers and potential dangersWithnew mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous species activities that require increased concentration and speed of psychomotor reactions.

Interaction with other drugs

Chloramphenicol suppresses the cytochrome P450 enzyme system, therefore, when used simultaneously with phenobarbital, phenytoin, indirect anticoagulants, and tolbutamide, a weakening of the metabolism of these drugs, a slower elimination and an increase in their concentration in plasma are observed. Dose adjustment may be required anticonvulsants and anticoagulants if they are used concomitantly with chloramphenicol.

When used simultaneously with phenobarbital, a decrease in the concentration of chloramphenicol is possible (it is necessary to monitor the concentration of chloramphenicol in the blood). Reduces the antibacterial effect of penicillins and cephalosporins.

When used together with penicillins and rifampicin, complex effects (including decrease/increase in plasma concentrations) have been reported, requiring monitoring of chloramphenicol plasma concentrations.

When used with rifampicin, a decrease in the concentration of chloramphenicol is possible.

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, their effect is enhanced (by suppressing metabolism in the liver and increasing their concentration in plasma).

Calcineurin inhibitors (cyclosporine and tacrolimus): Chloramphenicol therapy may increase plasma concentrations of calcineurin inhibitors (cyclosporine and tacrolimus).

Barbiturates: The metabolism of chloramphenicol is accelerated by barbiturates such as phenobarbital, resulting in a decrease in its plasma concentration.

Estrogens: There is a small risk that chloramphenicol may reduce the contraceptive effect of estrogens.

Paracetamol: Concomitant use of chloramphenicol in patients receiving paracetamol should be avoided as the half-life of chloramphenicol is significantly prolonged.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. Chloramphenicol is contraindicated in patients receiving drugs known to cause agranulocytosis. These include: carbamazepine, sulfonamides, phenylbutazone, penicillamine, cytotoxic agents, some antipsychotics, including clozapine and especially depot antipsychotics, procainamide, nucleoside reverse transcriptase inhibitors, propylthiouracil.

Best before date

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

Vacation conditions

On prescription.

Manufacturer:

RUE “Belmedpreparaty”,

Republic of Belarus, 220007, Minsk,

st. Fabricius, 30, t./f.: (+375 17) 220 37 16,

e-mail: [email protected]

25.02.2012 4596

Levomycetin. Description, instructions.

Diseases caused by sensitive microorganisms, incl. brain abscess, typhoid fever, paratyphoid fever, salmonellosis (mainly generalized forms), dysentery, brucellosis, tularemia, Q fever, meningococcal infection...

International name:
Chloramphenicol

Description of the active substance (INN):
Chloramphenicol

Dosage form:
capsules, powder for preparing a solution for intravenous and intramuscular administration, powder for preparing a solution for intramuscular administration, tablets, film-coated tablets, extended-release tablets, aerosol for external use, liniment, solution for external use, solution for external use [alcohol], eye drops, eye ointment.

Pharmachologic effect:
A broad-spectrum bacteriostatic antibiotic that disrupts the process of protein synthesis in a microbial cell at the stage of transfer of t-RNA amino acids to ribosomes. Effective against strains of bacteria resistant to penicillin, tetracyclines, and sulfonamides. Active against many gram-positive and gram-negative bacteria, pathogens of purulent, intestinal infections, meningococcal infections: Escherichia coli, Shigella dysenteria, Shigella flexneri spp., Shigella boydii spp., Shigella sonnei, Salmonella spp. (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, Enterobacter, Serratia marcescens, indole-positive strains of Proteus spp., Pseudomonas aeruginosa spp., protozoa and fungi. Microbial resistance develops slowly.

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

Contraindications:
Hypersensitivity, suppression of bone marrow hematopoiesis, acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency, liver and/or renal failure, pregnancy, lactation. With caution. The neonatal period (up to 4 weeks) and early childhood.

Side effects:
From the digestive system: dyspepsia, nausea, vomiting (the likelihood of development is reduced when taken 1 hour after meals), diarrhea, irritation of the oral mucosa and pharynx, dermatitis (including perianal - with rectal use), 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, collapse (in children under 1 year). Overdose. Symptoms: “gray syndrome” (cardiovascular syndrome) in premature and newborns when treated with high doses (the cause of development is the accumulation of chloramphenicol due to the immaturity of liver enzymes and its direct toxic effect on the myocardium) - bluish-gray skin color, low body temperature, irregular breathing, lack of reactions, cardiovascular failure. Mortality - up to 40%. Treatment: hemosorption, symptomatic therapy.

Directions for use and dosage:
IM, IV or orally (30 minutes before meals, and if nausea and vomiting develop - 1 hour after meals), extended-release tablets - 2 times a day, other types of tablets and capsules - 3-4 times per day. A single dose for adults is 0.25-0.5 g, a daily dose is 2 g. For severe forms of infections (including typhoid fever, peritonitis) in a hospital setting, it is possible to increase the dose to 3-4 g/day. If it is impossible to administer orally (persistent vomiting), it is prescribed rectally, 4 times a day at a dose 1.5 times higher than the dose indicated for this patient for oral administration. Children are prescribed under the control of the concentration of the drug in the blood serum depending on age: premature and full-term newborns under 2 weeks of age - orally or intravenously, 6.25 mg/kg (base) every 6 hours; infants 2 weeks. and older - orally, 12.5 mg/kg (base) every 6 hours or 25 mg/kg (base) every 12 hours, for severe infections (bacteremia, meningitis) - up to 75-100 mg/kg (base)/ days Average duration treatment - 8-10 days.

Interaction:
It suppresses the enzyme system of cytochrome P450, therefore, when used simultaneously with phenobarbital, phenytoin, and indirect anticoagulants, a weakening of the metabolism of these drugs is observed, 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.

Levomycetin is a drug (tablets) that corresponds to the group of antimicrobial drugs for systemic use. Important features of the drug from the instructions for use:

• Sold only with a doctor's prescription
• During pregnancy: contraindicated
• When breastfeeding: contraindicated
• IN childhood: contraindicated
• For liver dysfunction: contraindicated

Package

Compound

The active substance of Levomycetin in all its forms is chloramphenicol - a substance that belongs to the amphenicol group of antibiotics.

Eye drops contain chloramphenicol at a concentration of 2.5 mg/ml.

Possible dosages active substance for capsules and tablets - 250 and 500 mg, for prolonged-release tablets - 650 mg (tablets have 2 layers - the outer contains 250, the inner - 400 mg of chloramphenicol).

An alcohol solution of Levomycetin is available in a concentration of 0.25; 1, 3 and 5%. Levomycetin ointment can have a concentration of 1 or 5%.

Drugs different manufacturers have different composition auxiliary components.

All versions of the same product produced by pharmaceutical companies in post-Soviet countries differ slightly, since they use the same technology for producing chloramphenicol. Thus, eye drops Levomycetin DIA is no different from the drops produced, for example, by the Belmedpreparaty company.

Release form

• eye drops 0.25% (ATC code S01AA01);
• liniment 1%, 5%;
• alcohol solution 1%, 3%, 5% and 0.25% (ATC code D06AX02);
• tablets and capsules 250 and 500 mg, extended-release tablets 650 mg (ATC code J01BA01).

pharmachologic effect

Antibacterial. The drug relieves inflammation and cures infections of any tissues and organs, provided that they are caused by microflora sensitive to chloramphenicol.

Pharmacodynamics and pharmacokinetics

Is Levomycetin an antibiotic or not? An antibiotic of synthetic origin, which is identical to the product produced by the microorganisms Streptomyces venezuelae during their life.

Chloramphenicol is destructive to most gram (+) and gram (-) bacteria (including strains that are resistant to sulfonamides, streptomycin and penicillin), spirochetes, rickettsia, and certain large viruses.

Shows low activity against Clostridium, Pseudomonas aeruginosa, acid-fast bacteria and protozoa.

The mechanism of action of the drug is associated with the ability of chloramphenicol to disrupt the synthesis of proteins of microorganisms. The substance blocks the polymerization of activated amino acid residues that are associated with m-RNA.

Resistance to chloramphenicol in microbes develops relatively slowly; cross-resistance to other chemotherapeutic drugs, as a rule, does not occur.

When applied topically, the required concentration is created in the aqueous humor, vitreous fibers, cornea and iris. The drug does not penetrate the lens.

Pharmacokinetic parameters when taking chloramphenicol orally:

• absorption - 90%;
• bioavailability - 80%;
• degree of binding to plasma proteins - 50-60% (in prematurely born
• term infants - 32%);
• Tmax - from 1 to 3 hours.

Therapeutic concentration in the bloodstream remains for 4-5 hours after oral administration. About a third of the dose taken is found in bile; the highest concentration of Levomycetin is created in the kidneys and liver.

The drug is able to cross the placental barrier, its serum concentration in the fetus can reach 30-80% of the serum concentration in the mother. Penetrates into milk.

Biotransformed mainly in the liver (90%). Under the influence of normal intestinal flora, it undergoes hydrolysis with the formation of inactive metabolites.

Elimination time - 24 hours. Excreted mainly by the kidneys (90%). From 1 to 3% is excreted with the intestinal contents. T1/2 for an adult - from 1.5 to 3.5 hours, in children 1-16 years old - from 3 to 6.5 hours, in children 1-2 days after birth - 24 hours or more (with low weight longer body), on days 10-16 of life - 10 hours.

Hemodialysis is weak.

Indications for use: what are tablets, eye solution and external therapy (liniment and alcohol solution) used for?

What does the medicine help with? Levomycetin is prescribed for diseases that are provoked by antibiotic-sensitive microbes: Shigella, Salmonella, Streptococcus, Staphylococcus, strains of Proteus, Neisseria, Rickettsia, Chlamydia, Leptospira, Klebsiella and a number of other microorganisms.

The drug is available in several dosage forms. This allows chloramphenicol to be delivered directly to the lesion and in the concentration required for treatment.

Indications for use of Levomycetin in the form of liniment and solution:

• bacterial skin infections, provided that they are caused by microflora sensitive to chloramphenicol;
• trophic ulcers;
• bedsores;
• boils;
• wounds;
• infected burns;
• arising from breastfeeding nipple cracks.

An alcohol solution is prescribed to be administered into the ears for purulent otitis media.

What is Levomycetin in tablets for?

Tablet forms are advisable to use for infections of the biliary and urinary tract caused by drug-sensitive microflora, generalized forms of salmonellosis, paratyphoid fever, typhoid fever, yersiniosis, rickettsiosis, brucellosis, dysentery, tularemia, meningococcal infection, brain abscess, chlamydia, trachoma, purulent wound infection, inguinal lymphogranuloma, purulent peritonitis, ehrlichiosis.

What are Levomycetin drops from?

Levomycetin (eye drops) is prescribed to treat the following types of bacterial eye infections:

• scleritis and episcleritis;
• conjunctivitis and keratoconjunctivitis;
• blepharitis;
• keratitis

The use of the drug is ineffective if these diseases are caused by fungi, viruses and microbes that are immune to the action of chloramphenicol.

Contraindications

The annotation states that contraindications to the use of Levomycetin are:

• hypersensitivity;
• depression of bone marrow hematopoiesis;
• acute intermittent (intermittent) porphyria;
• G6PD enzyme deficiency;
• renal/liver failure.

External therapy agents are not applied to large granulating wound surfaces, as well as to skin affected by fungal infection, eczemoy or psoriasis.

For patients who have previously received cytostatic drugs or undergone radiation therapy, pregnant women, and young children (especially the first 4 weeks of life), the medicine is prescribed for health reasons.

Side effects

Systemic side effects of Levomycetin:

• disorders of the digestive system - nausea, diarrhea, dyspepsia, vomiting, irritation of the mucous membrane of the pharynx and oral cavity, dysbacteriosis;
• disorders of hemostasis and hematopoiesis - reticulocytopenia, leukemia and thrombocytopenia, agranulocytosis, hypohemoglobinemia, aplastic anemia;
• disorders of the sensory organs and nervous system - depression, optic neuritis, mental and motor disorders, headache, disturbance of consciousness and/or taste, hallucinations (auditory or visual), delirium, decreased visual/hearing acuity;
• hypersensitivity reactions;
• addition of a fungal infection;
• dermatitis;
• cardiovascular collapse (usually in children of the first year of life).

When using eye drops, liniment and alcohol solution local allergic reactions are possible.

Instructions for use of Levomycetin

Levomycetin eye drops: instructions for use

Levomycetin eye drops (DIA, Akri, AKOS, Ferein) are applied into the conjunctival sac of each eye, one 3-4 times a day. The course of treatment usually lasts from 5 to 15 days.

When using the drug, you should tilt your head back, gently pull the lower eyelid towards the cheek so that a cavity is formed between the skin and the surface of the eye, and, without touching the eyelid and the surface of the eye with the tip of the dropper bottle, add 1 drop of the medicine into it.

After instillation, press the outer corner of the eye with a finger and do not blink for 30 seconds. If you cannot avoid blinking, you need to do this as carefully as possible so that the solution does not spill out of the eye.

For children during the neonatal period (the first 28 days after birth), the drug is used for health reasons.

At purulent otitis the drug is injected into the ear 1-2 times/day. 2-3 drops each. In case of significant discharge from ear canal, which wash off the applied solution, Levomycetin can be used up to 4 times a day.

Eye drops for stye

The use of chloramphenicol in combination with boric acid, which is included in the solution as an auxiliary component, for barley, helps prevent infection of the conjunctiva and the development of complications after opening the abscess, accelerates the ripening of barley, partially relieves redness and reduces the intensity of pain, reduces the time by 2-3 days recovery.

Treatment is carried out simultaneously for both the patient and the healthy eye. The product should be instilled 1-2 drops 2-6 times a day. In case of severe pain, Levomycetin can be instilled every hour.

Levomycetin tablets: instructions for use

Tablets and capsules are taken depending on the indications 3-4 times a day. A single dose of Levomycetin in tablets/capsules for an adult is 1-2 tablets. 250 mg. The highest dose is 4 tablets. 500 mg per day.

In particularly severe cases (for example, with peritonitis or typhoid fever), the dose can be increased to 3 or 4 g/day.

Duration of use - no more than 10 days.

Levomycetin is often used for diarrhea that occurs due to food poisoning, as well as in cases where intestinal disorder is a consequence of a bacterial infection.

Levomycetin tablets for diarrhea are taken before meals, one every 4-6 hours. The highest dose is 4 g/day. If after taking the first 500 mg tablet the disorder has stopped, you should not take the second one.

How to take Levomycetin for cystitis

For cystitis, tablets are usually used. In especially severe cases, the doctor may recommend injections of chloramphenicol (to prepare a solution, the powder is dissolved in water for injection or novocaine) or a jet infusion of chloramphenicol with glucose into a vein.

Unless otherwise indicated, cystitis tablets should be taken in a standard dosage every 3-4 hours.

Instructions for alcohol solution

The solution is intended for lubricating the affected skin surface or for use under an occlusive dressing.

The duration of treatment depends on the course of the pathological process, its severity and the effectiveness of therapeutic measures.

Cracked nipples should be treated with a 0.25% solution after each feeding. Treatment is continued for no more than 5 days.

Instructions for liniment

Liniment is applied to burned skin or wound surface after purulent exudate and dead tissue have been removed. Before treatment, the wound should also be washed with an antiseptic: 0.01% miramistin solution, 0.05% chlorhexidine bigluconate solution, 3% hydrogen peroxide solution or aqueous solution furatsilin 0.02%.

The ointment is applied to the affected area in a thin layer and then covered with a sterile bandage. You can also soak a sterile piece of gauze with the drug and fill the wound with it or cover the burn surface.

When treating wounds, liniment is used 1 r./day, when treating burns - 1 r./day. or 2-3 rubles/week, depending on how abundantly the purulent exudate is released.

When treating bacterial skin infections, Levomycetin is applied to the affected areas (after they have been pre-treated) 1 or 2 times a day, in a thin layer and without a bandage, if possible, rubbing the medicine until completely absorbed into the affected skin and while capturing small areas of healthy skin around the pathological focus.

Dry wet areas with a gauze cloth before using the product.

In cases where Levomycetin is used under a bandage, it is applied 1 r./day.

Single dose - 250-750 mg, daily dose - 1-2 g of chloramphenicol. A course of treatment for a patient weighing 70 kg should require up to 3 kg of the drug.

Apply a thick layer of ointment to cracked nipples on a sterile napkin.

Levomycetin for acne

What is Levomycetin? Antibacterial drug. The ability to quickly suppress infectious and inflammatory processes allows the use of a remedy (tablets and alcohol solution) for acne.

For skin problems, it is usually recommended to use a 1% solution. The medicine is applied pointwise so as not to dry out the skin and not provoke the appearance of chloramphenicol-resistant microbes, which in the future may cause the appearance of purulent acne that is difficult to treat.

The solution is used from the moment the pimple appears until it disappears. It is important to remember that the product is not intended for prophylactic use.

To treat acne and red, inflamed pimples, chloramphenicol is often used in combination with other medications.

The most popular are the following acne pills with Levomycetin:

• Aspirin, Levomycetin and calendula tincture. Acetylsalicylic acid(aspirin) and chloramphenicol, take 4 tablets each and, crushing them into powder, pour in 40 ml of calendula tincture.
• Boric acid, Levomycetin, salicylic acid and ethanol. To prepare the medicine, the ingredients are mixed in the following proportion: 5 ml of a two percent solution salicylic acid, boric acid and alcohol - 50 ml each, Levomycetin - 5 g.
• Salicylic acid, streptocide, camphor alcohol, Levomycetin in the following proportion: 30 ml (2% solution)/10 tablets/80 ml/4 tablets.

Reviews allow us to conclude that these remedies are very effective if acne is isolated, but if the problem is larger, it is necessary to first eliminate its cause from the inside.

Overdose

Severe complications from hematopoiesis are usually associated with long-term use of doses exceeding 3 g/day. Symptoms of chronic intoxication: pale skin, hyperthermia, sore throat, hemorrhages and bleeding, fatigue or weakness.

Treatment with high doses of newborns can provoke the development of cardiovascular (“gray”) syndrome, the main symptoms of which are:

• change in skin color to bluish-gray;
• hypothermia;
• bloating;
• vomit;
• lack of nervous reactions;
• breathing rhythm disturbance;
• acidosis;
• circulatory collapse;
• cardiovascular failure;
• coma.

In 2 out of 5 cases the patient dies. Reason fatal outcome is the accumulation of the drug in the body due to the immaturity of liver enzymes and the direct toxic effect of floramphenicol on the myocardium.

Cardiovascular syndrome occurs when plasma concentrations of chloramphenicol exceed 50 mcg/ml.

Treatment involves gastric lavage, the use of saline laxatives, enterosorbents, and a cleansing enema. In severe cases, hemosorption and symptomatic therapy are indicated.

Increased doses of eye drops may cause temporary visual impairment. If the dose is exceeded, rinse your eyes with running water.

An overdose of external therapy may be accompanied by irritation of the skin and mucous membranes, as well as local hypersensitivity reactions.

Interaction

Interaction with topical application has not been described.

Chloramphenicol enhances the effect of hypoglycemic drugs (by increasing their plasma concentration and suppressing their metabolism in the liver), as well as the effect of drugs that inhibit bone marrow hematopoiesis.

The drug prevents the manifestation of the bactericidal effect of penicillin. Weakens the metabolism of warfarin, phenobarbital and phenytoin, increasing their concentration in the blood plasma and slowing their elimination.

In combination with clindamycin, erythromycin and lincomycin, the drugs mutually weaken each other's effects.

To prevent an increase in the inhibitory effect on hematopoiesis, chloramphenicol should not be used together with sulfonamide drugs.

Terms of sale

Liniment and alcohol solution belong to the group of over-the-counter products. To purchase tablets and eye drops, you need a prescription from a doctor.

Storage conditions

Eye drops, alcohol solution, tablet forms should be stored at a temperature of up to 25°C, liniment - at a temperature of 15-25°C.

Best before date

For tablet forms - 5 years, for liniment - 2 years, for alcohol solution - 1 year, for eye drops - 2 years (within 15 days after opening the original packaging).

special instructions

The State Pharmacopoeia states that chloramphenicol is a white/white with a greenish-yellow tint, bitter in taste and odorless crystalline powder. The substance is poorly soluble in water and easily dissolves in 95% alcohol. Almost insoluble in chloroform.

The gross formula of the substance is C₁₁H₁₂N₂O₅Cl₂.

Can I use drops in the nose and ear?

In practice, eye drops in the nose are used for bacterial rhinitis, and in the ear for purulent otitis media.

Despite the fact that using the drug for other purposes cannot be considered correct, such treatment does help in some cases.

Most often, ophthalmic forms for a runny nose are prescribed to children who do not yet know how to blow their nose on their own: a large amount of mucus with bacteria, if it gets into various sinuses, can provoke complications such as sinusitis or sinusitis.

Despite the fact that the use of Levomycetin drops in infants can dry out the mucous membrane and reduce the flow of snot, it has been proven that local use of antibiotics often does not effectively combat bacterial infection.

If we talk about the treatment regimen based on the “off-label prescription” principle (not for the intended purpose), then Levomycetin is instilled in the ear, 3-4 drops, in the nose - 1-2 drops. Treatment lasts from 5 to 10 days. The frequency of procedures is 1-2 per day.

Before applying the drug into the nose, it is necessary to first instill a vasoconstrictor. Before inserting into the ear, the external auditory canal should be cleared of pus.

Application in veterinary medicine

In veterinary practice, Levomycetin is used for colibacillosis, salmonellosis, leptospirosis, dyspepsia, colienteritis, coccidosis and pullorosis of chickens, infectious laryngotracheitis and mycoplasmosis of birds, urinary tract infections and bronchopneumonia.

The dose for farm animals, as well as for cats and dogs, is selected depending on the weight and severity of the disease.

How to give the drug to chickens? To avoid mass death of chickens from intestinal infection, they are given 1 tablet of Levomycetin along with food for 3-5 days, 2 times a day. This dosage is calculated for 15-20 chicks.

Analogs

Preparations with the same active ingredient: Levomycetin Actitab, Levomycetin sodium succinate.

Analogues by mechanism of action:

• for Levomycetin tablets - Fluimucil;
• for solution and ointment Levomycetin - aerosol Levovinisol (generic), Bactroban, Baneocin, Gentamicin, Linkomycin, Syntomycin, Fucidin, Fusiderm, Neomycin.

Levomycetin eye drops can be replaced with the following drugs: Levomycetin-DIA, Levomycentin-AKOS, Levomycentin-Acri.

What is better - Levomycetin or Albucid?

Wikipedia states that Albucid (sulfacetamide) is an antimicrobial bacteriostatic agent from the sulfonamide group.

The drug is used in ophthalmology for the treatment of bacterial keratitis, purulent ulcers cornea, blepharitis, conjunctivitis, chlamydial and gonorrheal diseases in adults, as well as blenorrhea in newborn infants.

Albucid, unlike Levomycetin, causes severe eye irritation.

Use of Levomycetin for children

Use of Levomycetin tablets in pediatrics

Tablet forms of the drug are used in pediatrics under constant monitoring of the serum concentration of chloramphenicol. Depending on age, the dose of Levomycetin tablets for children ranges from 25 to 100 mg/kg/day.

For newborn infants under 2 weeks of age (including premature infants), the formula for calculating the daily dose is as follows: 6.25 mg/kg per dose with a frequency of applications up to 4 times per day.

For infants over 14 days old, 12.5 mg/kg is prescribed per dose every 6 hours or 25 mg/kg every 12 hours.

For severe infections (for example, meningitis), the dose is increased to 75-100 mg/kg/day.

How to take Levomycetin for diarrhea?

The drug is a fairly serious drug and therefore must be prescribed by a doctor. However, it is often given to children when it is necessary to relieve an intestinal disorder.

As a rule, the dose for children 3-8 years old is from 375 to 500 mg/day. (125 mg per 1 dose), for children 8-16 years old - 750-1000 mg (250 mg per 1 dose).

For diarrhea, a single use of the medicine is allowed. If the child’s condition does not improve, and symptoms persist 4-5 hours after taking the pill, you should consult a physician.

Levomycetin eye drops for children

Eye drops for newborns (in the first 4 weeks after birth) are used only for health reasons.

Levomycetin eye drops for infants are also used with caution. As a rule, 1 drop of antibiotic is instilled into the conjunctival sac of each eye every 6-8 hours.

The use of external therapy in children

The solution is not intended for the treatment of children under 1 year of age; liniment is not used for the treatment of premature and newborn infants.

Levomycetin and alcohol

Alcohol and chloramphenicol are incompatible. When used simultaneously with ethanol, there is a high risk of developing a disulfiram-like effect, which is manifested by tachycardia, skin hyperemia, nausea and vomiting, reflex cough, and convulsions.

Levomycetin during pregnancy

Levomycetin for external and systemic use is contraindicated during pregnancy. If the drug is prescribed to a nursing woman, the child must be switched to artificial feeding for the duration of treatment.

If indicated, eye drops can be used in pregnant women and during lactation, however, provided that the dosage recommended by the instructions is not exceeded.

Levomycetin contains the active substance chloramphenicol, which belongs to the broad-spectrum antibacterial agents of the amphenicol group. In established dosages, Levomycetin has a pronounced bacteriostatic effect. The antibiotic affects the processes of protein synthesis in the bacterial cell, thereby disrupting their division and reproduction, as well as the production of bacterial toxins. The drug is different low level tolerance to it in most strains of bacteria. But the indications for use and justification for using the drug also take into account the high toxicity of Levomycetin, which determines its side effects.

Release form and composition

The medicine is available in different forms, which allow it to be used both externally and internally to achieve local or systemic antibacterial action.

Levomycetin powder for the preparation of solution for injection, 0.5 g in bottles - each bottle contains the active substance: an amount of sterile chloramphenicol sodium succinate equivalent to 0.5 g of chloramphenicol.

Levomycetin powder for the preparation of solution for injection, 1 g in bottles - each bottle contains the active substance: an amount of sterile chloramphenicol sodium succinate equivalent to 1 g of chloramphenicol.

Levomycetin tablets 250 mg, 10 tablets in a blister - each tablet contains the active ingredient: chloramphenicol (chloramphenicol) - 250 mg; excipients: stearic acid, potato starch, hydroxypropylcellulose (additive E463).

Levomycetin tablets 500 mg, 10 tablets in a blister - each tablet contains the active ingredient: chloramphenicol (chloramphenicol) - 500 mg; excipients: stearic acid, potato starch, hydroxypropylcellulose (additive E463).

Levomycetin solution for external use, alcohol 0.25%, 25 or 40 ml in a bottle - 100 ml of solution contains the active ingredient: chloramphenicol 250 mg; excipients: ethyl alcohol 70% up to 100 ml.

Levomycetin solution for external use, alcohol 1%, 25 ml in a bottle - 100 ml of solution contains the active ingredient: chloramphenicol 1 g; excipients: ethyl alcohol 70% up to 100 ml.

Levomycetin solution for external use, alcohol 3%, 25 or 40 ml in a bottle - 100 ml of solution contains the active substance: chloramphenicol 3 g; excipients: ethyl alcohol 70% up to 100 ml.

Levomycetin solution for external use, alcohol 5%, 25 or 40 ml in a bottle - 100 ml of solution contains the active substance: chloramphenicol 5 g; excipients: ethyl alcohol 70% up to 100 ml.

Levomycetin eye drops 0.25%, 10 ml in a bottle - 1 ml of the drug contains the active ingredient: chloramphenicol 2.5 mg; excipients: boric acid, sterile water for injection up to 1 ml.

pharmachologic effect

Pharmacodynamics

Levomycetin in therapeutic dosages has a bacteriostatic effect, which can become bactericidal with an increase in single and course dose, if necessary indications are available. The active substance chloramphenicol has the ability to penetrate the cell wall of bacteria due to the chemical ability to be freely transported through the bilipid layer of bacterial membranes. After this, it binds to the large 50S subunit of the bacterial ribosome, which is involved in elongation - the formation of the polypeptide chain, which is the basis of protein synthesis. Blocking the large subunit prevents it from contacting the small one, which inhibits the synthesis of protein molecules. Also, chloramphenicol inhibits the enzyme peptidyltransferase, which transfers protein monomers to the site of their final formation.

Active against gram-positive and gram-negative flora, including: Escherichia coli, Shigella dysenteria spp., Shigella flexneri spp., Shigella boydii spp., Shigella sonnei spp., Salmonella spp., Salmonella typhi, Streptococcus spp., Streptococcus pneumoniae, Neisseria gonorrhoeae, Neisseria meningitidis, some strains of Proteus spp., Pseudomonas aeruginosa; Ricketsia spp., Treponema spp., Chlamydia spp., Chlamydia trachomatis. It is active against strains that are resistant to the use of drugs from the sulfonamide, penicillin, and tetracycline groups. Resistance to chloramphenicol in microorganisms develops slowly.

The drug does not have a bacteriostatic effect against acid-fast bacteria (including Mycobacterium tuberculosis), Pseudomonas aeruginosa (Pseudomonas aeruginosa), certain strains of Acinetobacter, Enterobacter, Serratia marcescens, Proteus spp., Pseudomonas aeruginosa spp., methicillin-resistant Staphylococcus aureus (MRSA), mushrooms

Pharmacokinetics

Forms of the drug for internal use are effectively absorbed in the gastrointestinal tract, especially in the intestines - there the absorption of the drug reaches 90%. Injection forms enter the systemic circulation immediately. The bioavailability of tablet forms is 80%; for the injection solution it is much higher.

The protein binding coefficient of Levomycetin reaches 60%; the drug binds most completely to the albumin fraction. The maximum concentration of the drug in the blood plasma is achieved 2-3 hours after oral administration. Concentration at which it remains therapeutic effect the drug can be maintained in the blood for up to 6 hours.

The drug not only circulates in the blood, but infiltrates tissues, easily permeable barriers of the body. Levomycetin is found in cerebrospinal fluid, urine, bile, it accumulates in meninges and liver and kidney tissue. Easily penetrates the placental barrier into breast milk.

Metabolism almost completely (90% of the incoming dose) occurs in the liver with the participation of cytochrome P450 and other biotransformation enzymes - thereby chloramphenicol inhibits the action of these enzymes, especially with long-term use. The remaining 10% turns into inactive metabolites under the influence of the environment and the intestinal microbiome. Elimination of metabolites is carried out by the kidneys (90%) and intestines.

Indications for use

The drug is indicated for oral and parenteral use in infectious and inflammatory diseases caused by bacteria sensitive to the drug: typhoid fever, paratyphoid fever, yersiniosis, brucellosis, shigellosis, salmonellosis, tularemia, rickettsiosis, chlamydia, purulent peritonitis, bacterial meningitis, biliary tract infections.

Externally - for burns, cuts, skin cracks, skin diseases accompanied by purulent-inflammatory lesions.

The dose of the drug is calculated individually and depends on the characteristics of the disease and the body, in particular the age, weight of the patient, as well as the condition of the organs in which the drug is converted.

It is recommended to take the drug 30 minutes before meals, this will ensure better absorption of Levomycetin in the intestine. If you have nausea or vomiting, you should take the medicine 1 hour after eating to minimize the risk of removing the tablet with vomit.

For adults, the maximum daily dose of Levomycetin for oral administration is 2 g (2000 mg), which should be distributed into 3-4 doses for better absorption. Thus, a single dose of Levomycetin is 250-500 mg (one tablet of 0.25 or 0.5), which is taken 3-4 times a day. The course of treatment lasts on average 7-10 days, after which liver and kidney function must be monitored due to the toxic properties of the drug in relation to these organs.

In case of a severe somatic condition of the patient caused by infections, which are accompanied by profuse diarrhea, hyperthermia, generalization of the pathological process, the daily dose can be increased to 4 g (4000 mg) under strict control of liver and kidney function, provided that the drug is fully tolerated throughout the course of treatment. If necessary and if there are medical indications, you can extend the course of treatment to 14 days, but no more.

Children aged 3 to 8 years are prescribed 125 mg of Levomycetin 3-4 times a day, and children from 8 years old are prescribed 250 mg of the drug 3-4 times a day during a course of treatment of 7-10 days.

Injectable forms of Levomycetin can be administered intramuscularly and intravenously. To prepare a solution for injection, add 3 mg of Levomycetin powder into a bottle with 1 g sterile water for injections, stir thoroughly until completely dissolved, and, changing the needle, inject deeply intramuscularly. For pain relief, it is recommended to also draw a 0.25% or 0.5% solution of novocaine into the syringe, having previously tested the tolerance of this analgesic.

To prepare a solution for intravenous administration, the contents of the bottle should be dissolved in 10 ml of water for injection or 5% glucose solution, and then slowly injected into a vein. You can also prepare a solution for intravenous drip administration, for which you need to dissolve the contents of the bottle in 500 ml of 0.9% NaCl and connect the dropper to the vein.

For cystitis and sinusitis caused by flora sensitive to Levomycetin, systemic therapy is prescribed in a dose of 1 to 3 g per day. The dosage is achieved by administering 0.5-1 g of the drug every 8-10 hours three times a day. If the infection is generalized or the patient has a severe somatic condition, it is allowed to increase the dose to 4 g of the drug per day.

Children under one year of age should use the drug only if there are valid medical indications at the rate of 25 mg/kg body weight; for children over 1 year of age, the dosage increases to 50 mg/kg body weight twice a day, with a 12-hour break between doses.

In the treatment of ophthalmological pathology - from barley, conjunctivitis - the injection solution is used for tissue instillation with an antibiotic, injection into the parabulbar fatty tissue or surrounding tissues. For injections, use a 20% solution of Levomycetin in an amount of up to 0.3 ml twice a day. Instillation is possible with a 5% solution up to 5 times a day.

There is also a ready-made solution of Levomycetin in the form of eye drops - it has a concentration of the active substance of 0.25% and is applied 1 drop into the conjunctival sac three times a day. The duration of treatment for conjunctivitis is 5-15 days with subsequent monitoring of curability.

The solution for external use can be used for local bacteriostatic action on affected areas of the skin, burns, wounds, and acne. To do this, you can moisten the affected area of ​​the skin, apply it under an occlusive dressing or bandages, applying the medicine 4-5 times a day.

Contraindications

• Hypersensitivity to the components of the drug Levomycetin with the development anaphylactic reactions or a history of episodes of such reactions;
• Diseases that are accompanied by inhibition of hematopoiesis;
• Severe renal or liver failure;
• Congenital enzymopathies, in particular deficiency of glucose-6-phosphate dehydrogenase of erythrocytes, which can lead to hemolysis;
• Skin diseases(eczema, psoriasis, fungal infection skin);
• Pregnancy, lactation and breastfeeding;
• Acute porphyria;
• Age up to 3 years (for tablet forms);
• Angina

The drug should be prescribed with caution to patients who have signs of mild to moderate renal or hepatic failure, as well as those who have undergone radiation or chemotherapy, taking into account clinicians' feedback about the increased risk of side effects in these groups of patients.

Side effects

Side effects to be most concerned about include hypoplastic anemia, inhibition of all germ layers of the bone marrow and loss or ability to effectively divide and proliferate, as well as “gray syndrome” in newborns and children under 3 months, which is caused by liver enzyme deficiency when prescribing chloramphenicol - it is manifested by vomiting, respiratory distress, hypothermia, acidosis, vasomotor collapse and is emergency. In addition, to side effects include:

• From the skin and subcutaneous tissue: allergic reactions in the form of fever, skin rash, dermatoses, perianal dermatitis.
• From the immune system: anaphylaxis reactions, urticaria, angioedema, facial edema, Quincke's edema, itching.
• From the nervous system and psyche: psychomotor disorders, moderate depression, confusion, headache, insomnia, encephalopathy, delirium, peripheral neuritis, paralysis of the eyeballs.
• From the sensory systems: impaired sense of taste, decreased hearing and visual acuity, development of visual and auditory hallucinations
• From the outside gastrointestinal tract: dyspeptic manifestations, bloating, nausea, vomiting, diarrhea, dysbacteriosis, enterocolitis, stomatitis, glossitis, liver dysfunction.
• From the blood and lymphatic system: inhibition of the plastic abilities of the bone marrow, reticulocytopenia, anemia (aplastic or hypoplastic), leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, agranulocytosis.
• General: dysbiosis, fungal infection, hyperthermia, decreased blood pressure up to collapse, local allergic reactions when using forms of the drug for external use.

Overdose

If the permissible therapeutic dose is exceeded, a bone marrow suppression reaction may develop, which will affect laboratory blood parameters and also cause a number of symptoms, including: increased risk of bleeding, the presence of pinpoint hemorrhages and hematomas, pallor due to anemia, pathological weakness, sore throat.

The main sign of a drug overdose is the “gray syndrome”, which is caused by the toxic effects of metabolites on the myocardium with absolute or relative immaturity of liver biotransformation enzymes. There is a disturbance in the rhythm of breathing and heartbeat, a gray-blue color of the skin appears, a decrease in body temperature, and a decrease in reflexes due to impaired neuromuscular conduction are possible. The terminal stages are acidosis and severe hypothermia. “Gray syndrome” develops not only in children, but also in patients with renal failure.

There is no specific antidote. You should immediately stop taking the drug, prescribe carrier agents, sorbents ( Activated carbon), having previously cleaned the stomach contents.

Interaction

The complex distribution at the stages of pharmacokinetics and pharmacodynamics makes this drug unpredictable when used simultaneously and interacts with other drugs.

When taking Albucid, which belongs to the group of sulfonamides, and Levomycetin simultaneously, the risk of suppression of the proliferative abilities of the bone marrow increases significantly. Both drugs have an inhibitory effect and can significantly slow down cell division in the bone marrow, as well as their subsequent maturation. Therefore, taking Levomycetin with Albucid is not recommended. The same applies to sodium sulfacyl, phthalazole and other sulfonamides, cytostatics, and ristomycin.

The use of Levomycetin eye drops simultaneously with interferon preparations, which have immunomodulatory and immunostimulating, as well as antiviral effects, is possible. Such drugs include Ophthalmoferon, which will act locally on viral particles, while Levomycetin will affect the bacterial pathogen. But we need to take into account the possibility of developing local allergic reaction for each drug separately.

Antibiotics from the tetracycline group have the same mechanism of action as Levomycetin. Their simultaneous use can lead to competition for the binding site on the transfer RNA during protein synthesis. Because of this, none of the above drugs will work until competitive inhibition stops when the concentration of one of them decreases.

Levomycetin significantly involves cytochromes of the P450 family, so simultaneous use of it with antiepileptic drugs increases their toxicity.

Levomycetin neutralizes or significantly reduces the antibacterial effect of penicillins and cephalosporins.

Concomitant use with estrogen-containing oral contraceptives reduces the effectiveness of contraception.

Analogs

Drugs that are analogues of Levomycetin may differ in price and medical indications, which are indicated in the instructions for a particular drug. They may have similar indications, but the validity of use for a particular pathology must be determined by a specialist.

Which is better: Levomycetin or Albucid?

Albucid belongs to the sulfonamides, which affect a narrower range of bacteria than Levomycetin. However, albucid penetrates perfectly into the fluids and tissues of the eye, so the main area of ​​application of this drug is ophthalmological pathology, acute inflammatory and purulent processes of the eye. The validity of the use of Levomycetin and Albucid for eye diseases is equivalent, and Levomycetin is better as an antibacterial agent for systemic use and a reserve antibiotic.

Which is better: Levomycetin or Tobrex?

Tobrex is a drug from the group of aminoglycosides based on active substance tobramycin. This is a broad-spectrum antibacterial agent, but with interesting features distribution - it accumulates in organ tissues respiratory system, in particular the lungs. This feature is used in the clinic to treat diseases of the respiratory system, pneumonia. Therefore, for systemic use, Levomycetin is better as the one to which microorganisms have lower resistance, but Tobrex is more effective for treating diseases of the lungs and respiratory tract.

Which is better: Levomycetin or Enterofuril?

Enterofuril is an antibacterial agent based on nifuroxazide, which is widely used to treat pathologies of the gastrointestinal tract. It is as effective for treating intestinal infections with a large number of pathogens as Levomycetin, but does not change the composition of the intestinal microflora and does not inhibit it. Thus, Enterofuril can be taken without the development of intestinal dysbiosis, while Levomycetin is a more universal drug, but more harmful to the microbiome.

Which is better: Levomycetin or Sodium Sulfacyl?

Sulfacyl Sodium is also a sulfonamide for use in eye diseases - blepharitis, uveitis, purulent lesions. When treating pathologies of other organs and systems, it is ineffective compared to Levomycetin.

Which is better: Levomycetin or Floxal?

Floxal is developed on the basis of ofloxacin and has a pronounced antibacterial effect. Levomycetin has the same effectiveness, and a fairly large number of side effects, but Floxal in this sense is even more dangerous. It causes damage to tendons, changes in their structure, which leads to ruptures, and also affects mental condition patients. In many countries, the sale of ofloxacin and drugs based on it has been suspended, but Levomycetin is effective and safer.

Which is better: Levomycetin or Furazolidone?

Furazolidone is a nitrofuran that has the same broad spectrum of action as Levomycetin, and is just as ineffective against protozoa, fungi and Pseudomonas aeruginosa. But this effect is compensated by a very weakly expressed inhibition of the microflora - usually the therapeutic effect occurs even before the saprophytic microorganisms die. In addition, Furazolidone has an immunostimulating effect. It is more appropriate for the treatment of food toxic infections and intestinal infections with a specific pathogen than Levomycetin - but is not suitable for systemic therapy.

Which is better: Levomycetin or Vitabact?

This drug is not an antibiotic, it is antiseptic. Vitabakt is suitable for daily sanitation of the eye, followed by moisturizing and washing away dust, particles and bacteria from it. Can be used simultaneously with Levomycetin to achieve better effect, but only Levomycetin is able to truly influence the proliferation of pathogenic microorganisms.

Which is better: Levomycetin or Tsiprolet?

Tsiprolet contains ciprofloxacin, which is a fluoroquinolone. It has a unique mechanism of action and a wide spectrum of activity against bacteria. Tsiprolet is widely used to treat pathologies of the eye and ENT organs, for example, sinusitis (sinusitis), sore throat. Thus, it is the drug of choice in the treatment of these pathologies. If during treatment it is determined that the bacterial strains are resistant and the treatment is ineffective, Levomycetin can be included in the treatment tactics as a reserve drug.

Which is better: Levomycetin or Tetracycline?

The spectrum of activity of these drugs is almost identical, but tetracycline is more often used to treat diseases of the respiratory system. It is also better tolerated and is often a first-line drug. However, tetracycline is not recommended for use before age 8 if it can be avoided. Another characteristic effect is the development of photosensitivity, which can lead to limited exposure to the sun.

Use of Levomycetin for children

Tablet forms of Levomycetin are not recommended for use by children under 3 years of age. From 3 years of age, the drug should be prescribed with extreme caution under the monitoring of liver and kidney function and in the presence of reasonable medical indications. Children aged 3 to 8 years are prescribed 125 mg of Levomycetin 3-4 times a day, and children from 8 years old are prescribed 250 mg of the drug 3-4 times a day during a course of treatment of 7-10 days.

Injection forms of Levomycetin are prescribed to children in the presence of strict indications and in the absence alternative therapy from 1 year at a dosage of 25 mg/kg body weight, and after 1 year - 50 mg/kg body weight under medical supervision.

Levomycetin eye drops are prescribed to children under 4 weeks of age only for health reasons; after 4 years, the medicine can be prescribed if necessary without dangerous consequences at a dose similar to that of an adult.

The solution for external use can be used to lubricate affected areas of the skin in children over 1 year of age.

Levomycetin and alcohol

The active ingredient of the drug Levomycetin undergoes most of the stages of transformation in the liver with the help of cytochromes of the P450 family and some other enzymes, like ethanol. Levomycetin is also a pronounced inhibitor of these biotransformation enzymes, which is observed in experiments with long-term use of the drug or with increasing its dosage.

The simultaneous use of Levomycetin and alcohol produces a toxic effect on the liver, and then on other organs and systems. The development of an antabuse effect is possible, which is caused by stopping the metabolism of alcohol at the stage of the toxic metabolite acetaldehyde. This reaction is manifested by nausea, vomiting, dizziness, tremor, headache, sweating, and fever. In this regard, the simultaneous use of alcohol and chloramphenicol is contraindicated (simultaneous use means the use within the window of complete elimination of one of the components - chloramphenicol or ethanol).

Levomycetin during pregnancy

Pregnancy is a direct contraindication to the use of Levomycetin. This is due to the characteristics of the distribution of the drug and its side effects, which are caused by toxic effects on the organs and systems of the mother and fetus.

Levomycetin easily penetrates the hematoplacental barrier into the fetus, accumulating there. Since the child is in period intrauterine development the liver does not have biotransformation systems, the toxic effect of the drug is many times stronger than in adults. The use of the drug can lead to intrauterine development disorders or fetal death.

According to information obtained during research, Levomycetin also penetrates into breast milk, which can be dangerous for the baby when feeding. Due to such rapid distribution, the drug is not recommended for use during lactation and breastfeeding.

Terms of sale

As a reserve antibiotic, the drug is available in pharmacies with a prescription.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C. It is recommended to store in the original packaging out of direct sunlight.

Best before date

Tablet forms retain medicinal properties and remain safe for internal use for up to 5 years.

Injection forms in powder form (before preparing the solution for injection) are valid for 5 years.

An alcohol solution for external use can be stored for up to 2 years.

Levomycetin eye drops can be stored for up to 2 years before opening the bottle, and up to 15 days after opening.

Manufacturer

JSC "Dalkhimfarm", Khabarovsk, Russia.

PJSC "Kievmedpreparat", Kyiv, Ukraine.

PJSC Pharmaceutical Factory "Viola", Zaporozhye, Ukraine.

Tver Pharmaceutical Factory, Tver, Russia.

JSC Pharmaceutical Factory Lecco.

Bibliography:

1. Anatomical Therapeutic Chemical Classification (ATX);
2. Nosological classification (ICD-10);
3. Official instructions from the manufacturer.