Universal reference book for medicines
Product name: LEVOMYCETIN ACTIVAB (LEVOMYCETIN ACTITAB)

Active substance: chloramphenicol

Type: Chloramphenicol Group Antibiotic

Manufacturer: ФП ОБОЛЕНСКОЕ (Russia)
Composition, form of production and packaging
Tablets
1 tab.

chloramphenicol 500 mg

10 pieces.
- packings cellular planimetric (1) - packs cardboard
10 pieces.
- packings cellular planimetric (2) - packs cardboard
10 pieces.
- packings cellular planimetric (3) - packs cardboard
10 pieces.
- packings cellular planimetric (4) - packs cardboard
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
Tablets 1 tab.

chloramphenicol 250 mg

10 pieces.
- packings cellular planimetric (1) - packs cardboard
10 pieces.
- packings cellular planimetric (2) - packs cardboard
10 pieces.
- packings cellular planimetric (3) - packs cardboard
10 pieces.
- packings cellular planimetric (4) - packs cardboard
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

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.

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

It is active against the following microorganisms: Escherichia coli, Shigella dysenteriae, Shigellaf Iexneri, 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.
It acts on acid-fast bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant Staphylococcus strains, Acinetobacter spp., Enterobacter spp., Serratia marcescens, Indol-positive strains of Proteus spp., Pseudomonas aeruginosa, protozoa and fungi.
Stability of microorganisms develops slowly.
PHARMACOKINETICS

After taking the connection with plasma proteins is 50-60%.
T max after taking 1-3 hours. V d - 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. With max in spinal fluid it is determined 4-5 hours after a single dose and can reach 21-50% of C max 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 for 24 hours by kidneys - 90% (by glomerular filtration -5-10% in unchanged form, through tubular secretion in the form of inactive metabolites - 80%), through the intestine - 1-3%.
T 1/2 in adults - 1,5-3,5 h, with kidney failure - 3-11 h. T 1/2 in children - 3,0-6,5 h. It is weakly excreted during hemodialysis.
INDICATIONS

- infections of the urinary and bile ducts caused by sensitive microorganisms.

DOSING MODE

Inside (30 minutes before meals, and with the development of nausea and vomiting - 1 hour after meals), 3-4 times / 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 of more than 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 EFFECT

On the part of the digestive system: dyspepsia, nausea, vomiting (the probability of development decreases when taking 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.
On the part of 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.

CONTRAINDICATIONS

hypersensitivity;

- oppression of bone marrow hematopoiesis;

- acute intermittent porphyria;

- deficiency of glucose-6-phosphate dehydrogenase;

- Hepatic and / or renal insufficiency;

- Skin diseases (psoriasis, eczema, fungal lesions);

- Pregnancy;

- lactation period;

- Children's age up to 3 years and / or body weight less than 20 kg.

Use with caution in patients who received previous treatment with cytostatic drugs or radiation therapy.

PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in liver failure.

APPLICATION FOR CHILDREN

Contraindicated in childhood up to 3 years, as well as children with body weight less than 20 kg.

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).

OVERDOSE

Symptoms: nausea, vomiting.

Treatment: gastric lavage, symptomatic therapy, hemosorption.

DRUG INTERACTION

Inhibits microsomal enzymes of the liver, therefore, while using with phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of the metabolism of these drugs, slowing the excretion and increasing 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 action 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 prescribing with drugs that oppress hemopoiesis (sulfonamides, cytostatics) that affect liver metabolism 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.

TERMS OF RELEASE FROM PHARMACY

On prescription


TERMS AND CONDITIONS OF STORAGE

List B. Keep out of reach of children, dry and protected from light, at a temperature of no higher than 25 ° C.

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