Levomitsetin Aktitab - instructions for use, dose, side effects, contraindications

excipients for the shell: Opadrai II 85F30695 blue [polyvinyl alcohol, macrogol, talc, titanium dioxide, aluminum lacquer based on indigo carmine dye, iron oxide dye yellow].

Description:

The tablets covered with a film membrane of light blue color, biconvex, oblong with rounded ends, with a risk. On the cross-section the nucleus is white or white with a yellowish tint of color.

Pharmacotherapeutic group:Antibiotic

ATX: & nbsp

D.06.A.X.02 Chloramphenicol

S.01.A.A.01 Chloramphenicol

J.01.B.A.01 Chloramphenicol

Pharmacodynamics:

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

It is effective against strains of bacteria that are resistant to penicillin, tetracycline, sulfonamides.

It is active against the following microorganisms: Escherichia soli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, 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, Klebsiella pneumoniae, Haemophilus influenzae.

He acts on acid-fast bacteria (incl. Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratia marcescens, and idolpositive strains Proteus spp., Pseudomonas aeruginosa, protozoa and fungi. Stability of microorganisms develops slowly.

Pharmacokinetics:

After taking the connection with plasma proteins is - 50-60%. Time to reach the maximum concentration (TCmax) after taking 1-3 hours. The volume of distribution is 0.6-1.0 l / kg. The therapeutic concentration in the blood is maintained for 4-5 hours after administration. It penetrates well into body fluids and tissues. Its greatest concentrations are created in the liver and kidneys. In bile, up to 30% of the administered dose is detected. The maximum concentration (Сmах) in spinal fluid is determined in 4-5 hours after a single dose and can reach 21-50% of Cmax in plasma and 45-89% in the presence of inflammation of the meninges in the absence of inflammation of the meninges.Passes through the placental barrier, the concentration in the fetal blood serum can be 30-80% of that in the mother's blood. Penetrates into breast milk. The majority (90%) is metabolized in the liver. In the intestines, under the influence of intestinal bacteria, it hydrolyses with the formation of inactive metabolites.

It is excreted within 24 hours by kidneys - 90% (by glomerular filtration - 5-10% in unchanged form, by tubular secretion in the form of inactive metabolites - 80 %), through the intestine - 1-3%. The half-life period (T1 / 2) in adults is 1.5-3.5 hours, with kidney failure 3-11 hours. T1 / 2 in children is 3.0-6.5 hours. It is poorly excreted during hemodialysis.

Indications:

Urinary and biliary tract infections caused by sensitive microorganisms.

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

Carefully:

Patients who received previous treatment with cytostatic drugs or radiation therapy.

Pregnancy and lactation:

During pregnancy and during breastfeeding, the use of the drug is contraindicated.

Dosing and Administration:

Inside (30 minutes before meals, and with the development of nausea and vomiting - 1 hour after eating), 3-4 times a day. A single dose for adults is 0,25-0,5 g, daily - 2 g. In severe forms of infections (in a hospital), it is possible to increase the dose to 3-4 g / day (under the control of blood, kidney and liver function). Children over 3 years of age and / or body weight over 20 kg are prescribed 12.5 mg / kg every 6 hours or 25 mg every 12 hours, with severe infections up to 75-100 mg / kg / day (under control concentration of the drug in the blood serum). The average duration of treatment is 8-10 days.

Side effects:

From the digestive system: dyspepsia, nausea, vomiting (the probability of development decreases with admission after 1 hour after eating), diarrhea, irritation of the mucous membrane of the mouth and throat, dermatitis, dysbiosis (suppression of normal microflora).

On the part of the organs of hematopoiesis: 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 acuity and hearing, headache.

Allergic reactions: skin rash, angioedema.

Other: secondary fungal infection.

Overdose:

Symptoms: nausea, vomiting.

Treatment: gastric lavage, symptomatic therapy, hemosorption.

Interaction:

Inhibits microsomal enzymes of the liver, so when used with phenobarbital, phenytoin, indirect anticoagulants, weaken the metabolism of these drugs, slow the excretion and increase their concentration in the plasma.

Reduces the antibacterial effect of penicillins and cephalosporins. With simultaneous use with erythromycin, clindamycin, lincomycin, there is a mutual weakening of the effect 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 appointment with drugs that depress hemopoiesis (sulfonamides, cytostatics),influencing metabolism in the liver, with radiation therapy increases the risk of side effects. When administered with oral hypoglycemic drugs, their effect is noted (by suppressing metabolism in the liver and increasing their concentration in the plasma).

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

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

With the simultaneous administration of ethanol, a disulfiram-like reaction may develop (facial hyperemia, abdominal and stomach cramps, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).

Effect on the ability to drive transp. cf. and fur:

In the period of drug treatment when driving vehicles, mechanisms and other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, care must be taken.

Form release / dosage:Film coated tablets shell, 250 mg and 500 mg.

Packaging:

For 10, 12 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 1,2, 3, 4, 5, 6 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002927 / 01

Date of registration:03.12.2009 / 02.10.2017

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levomycetin Aktitab (Levomycetin-Actitab)