Levomycetin Aktitab

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Levomycetin Aktitab: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews
18. Price in pharmacies

Latin name: Levomycetin-Actitab

ATX code: J01BA01

Active ingredient: chloramphenicol (chloramphenicol)

Producer: FP Obolenskoe, JSC (Russia)

Description and photo update: 2018-25-10

Prices in pharmacies: from 79 rubles.

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Film-coated tablets, Levomycetin Aktitab

Levomycetin Aktitab is an antimicrobial drug of the chloramphenicol group.

Release form and composition

Levomycetin Aktitab is produced in the form of film-coated tablets: oblong with rounded ends, biconvex, on one side there is a dividing risk; the film sheath is light blue, the inner layer on the cross section (core) is white with a yellowish tinge or pure white (10, 12 or 15 pcs. in blisters, 1–6 packs in a cardboard box).

1 tablet contains:

active ingredient: chloramphenicol - 250 or 500 mg;
auxiliary ingredients: microcrystalline cellulose, povidone, crospovidone, kollidone VA-64 (copovidone), aerosil (colloidal silicon dioxide), calcium stearate;
film casing: Opadray II 85F30695 blue (polyvinyl alcohol, macrogol, titanium dioxide, talc, aluminum varnish based on indigo carmine dye, yellow iron oxide).

Pharmacological properties

Pharmacodynamics

The active component of Levomycetin Aktitab - chloramphenicol - is a broad-spectrum antibiotic with bacteriostatic efficacy that disrupts protein synthesis in microbial cells at the stage of its transfer by transport ribonucleic acid (tRNA) to ribosomes.

Chloramphenicol is active against the following microorganisms (including bacterial strains that are resistant to tetracyclines, penicillins, sulfonamides): Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Escherichia coli, Salmonella spp. (including Salmonella typhi and Salmonella paratyphi), Streptococcus spp. (including Streptococcus pneumoniae), Staphylococcus spp., Neisseria gonorrhoeae (a number of Proteus spp. strains), Neisseria meningitidis, Burkholderia pseudomallei, Treponema spp., Rickettsia spp., Leptospira spp. (including Chlamydia trachomatis), Klebsiella pneumoniae, Coxiella burnetii, Ehrlichia canis, Haemophilus influenzae.

Levomycetin Aktitab is ineffective against acid-fast bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Serratia marcescens, Enterobacter spp. and indole-positive strains of Proteus spp., Pseudomonas aeruginosa, protozoa and fungi. Resistance of microorganisms against chloramphenicol develops slowly.

Pharmacokinetics

The main pharmacokinetic characteristics of chloramphenicol:

absorption: after taking TS, _max (time to reach maximum concentration) is 1-3 hours; from 50 to 60% of the substance binds to plasma proteins;
distribution: chloramphenicol penetrates well into tissues and body fluids, V _d (volume of distribution) - 0.6-1 l / kg, at a therapeutic concentration the substance remains in the blood for 4-5 hours from the moment of administration, accumulating most of all in the kidneys and liver, up to 30% of the dose received is found in bile. C _max (maximum concentration) in the cerebrospinal fluid is achieved after 4-5 h after single administration in the absence of inflammation of the meninges may be 21-50% of the figure C _max plasma, and the presence of such inflammation - 45-89%. Chloramphenicol passes into breast milk and through the placental barrier, its serum concentrations in the blood of the fetus can reach 30–80% of the substance in the mother's blood;
metabolism: up to 90% of the antibiotic is metabolized in the liver; under the influence of intestinal bacteria in the intestine, chloramphenicol is hydrolyzed to the formation of inactive metabolites;
excretion: within a day, up to 90% of the substance is excreted by the kidneys (unchanged - 5-10%, by glomerular filtration; in the form of inactive metabolites - 80%, by tubular secretion), 1-3% are excreted with feces. In adult patients, T _1/2 (half-life) is from 1.5 to 3.5 hours, in children - from 3 to 6.5 hours, in patients with impaired renal function - 3–11 hours. Chloramphenicol is poorly excreted during hemodialysis.

Indications for use

Levomycetin Aktitab is recommended for the treatment of urinary and bile duct infections caused by microorganisms sensitive to chloramphenicol.

Contraindications

Absolute:

inhibition of hematopoiesis;
acute intermittent hepatic porphyria;
G6PD (deficiency of glucose-6-phosphate dehydrogenase);
hepatic / renal failure;
skin diseases (eczema, psoriasis, fungal infections);
During pregnancy and breastfeeding;
children under 3 years old;
the child's body weight is less than 20 kg;
individual hypersensitivity to the components of Levomycetin Aktitab.

The drug is prescribed with caution to patients who have previously undergone treatment with cytostatic drugs or radiation therapy.

Instructions for the use of Levomycetin Aktitab: method and dosage

Levomycetin Aktitab tablets are taken orally, half an hour before meals. If nausea / vomiting develops, it is recommended to take the drug 1 hour after a meal.

Recommended dosage:

adult patients: single dose - 0.25–0.5 g, daily dose - 2 g. For the treatment of severe forms of infection, it is possible to increase the daily dose (only in a hospital setting) up to 3-4 g; treatment in this case is carried out under the control of kidney and liver function and blood condition. Frequency rate of admission - 3-4 times a day;
children (over 3 years old with body weight> 20 kg): every 6 hours at 12.5 mg / kg or every 12 hours at 25 mg. For the treatment of severe forms of infection - up to 75-100 mg / kg / day, the treatment is carried out under the control of the serum concentration of the drug in the blood.

The average duration of a therapeutic course is 8-10 days.

Side effects

digestive system: nausea / vomiting (the likelihood of development decreases when taken 1 hour after eating), dyspepsia, diarrhea, dermatitis, irritation of the mucous membrane of the pharynx and oral cavity, dysbiosis due to suppression of normal microflora;
hematopoietic organs: leukopenia, thrombocytopenia, reticulocytopenia, granulocytopenia, erythrocytopenia; in rare cases - agranulocytosis, aplastic anemia;
nervous system: headache, depression, psychomotor disorders, confusion, optic neuritis, decreased visual acuity and hearing, peripheral neuritis, visual and auditory hallucinations;
hypersensitivity reactions: skin rash, angioedema;
other reactions: secondary fungal infection.

Overdose

Symptoms of a chloramphenicol overdose are nausea and / or vomiting.

For the treatment of the condition, it is required to flush the stomach, after which, as necessary, carry out hemosorption and symptomatic treatment.

special instructions

The development of severe complications from the hematopoietic system is possible, as a rule, associated with prolonged use of the drug in high doses.

With the simultaneous administration of chloramphenicol with ethanol, a disulfiram-like reaction may develop with nausea, vomiting, facial flushing, cramps in the abdomen and stomach area, headache, lowering blood pressure, tachycardia, shortness of breath.

Influence on the ability to drive vehicles and complex mechanisms

In the process of therapy with Levomycetin Aktitab, you should be careful to engage in potentially hazardous activities that require a high speed of psychomotor reactions and increased concentration of attention.

Application during pregnancy and lactation

The use of Levomycetin Aktitab is contraindicated in pregnant and lactating women.

Pediatric use

In pediatrics, the drug is contraindicated in children under 3 years of age and / or weighing up to 20 kg.

With impaired renal function

Levomycetin Aktitab is contraindicated for use in patients with renal failure.

For violations of liver function

According to the instructions, Levomycetin Actitab is contraindicated for use in patients with hepatic insufficiency.

Drug interactions

phenobarbital, phenytoin, indirect anticoagulants: since chloramphenicol is an inhibitor of microsomal liver enzymes, there is a weakening of their metabolism, a slowdown in excretion and an increase in their level in plasma;
penicillins and cephalosporins: their antibacterial effect decreases;
erythromycin, clindamycin, lincomycin: a mutual weakening of the action is recorded due to their displacement by chloramphenicol from the bound state, or preventing their binding to the 50S ribosome subunit of bacteria;
sulfonamides, cytostatics, other drugs that inhibit hematopoiesis and affect the hepatic metabolism of substances: against the background of radiotherapy, the risk of adverse reactions is increased;
oral hypoglycemic drugs: due to inhibition of hepatic metabolism and an increase in their plasma concentration, an increase in effectiveness is noted;
myelotoxic drugs: potentiate the hematotoxicity of chloramphenicol.

Analogs

The analogues of Levomycetin Aktitab are Levomycetin, Levomycetin sodium succinate, Fluimucil.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Levomycetin Aktitab

Most of the reviews about Levomycetin Aktitab are positive. Patients believe that the drug belongs to a group of drugs that are mandatory for every home medicine cabinet. It is indispensable in the treatment of diarrhea, good for cystitis, effective, fast acting, easy to take, not too bitter and inexpensive.

The price of Levomycetin Aktitab in pharmacies

The approximate price for Levomycetin Aktitab (tablets in a dosage of 500 mg, 10 pcs. In a package) is 118 rubles.