Tetracycline - instructions for use, dose, side effects, contraindications

Excipients: sucrose (refined sugar) 7.1 mg, calcium stearate mono-hydrate 1.26 mg, magnesium hydrosilicate (talc) 1.26 mg, gelatin 0.54 mg, potato starch 15.84 mg.

Film Sheath: hypromellose (hydroxypropylmethylcellulose) -1.332 mg, paraffin, liquid (Vaseline oil) 0.25 mg, polysorbate 80 (tween 80) 0.388 mg, dye to azo bin (acidic red 2 C) -0.03 mg.

Description:

tablets, covered with a film-shell, red, round, biconvex. On the cross-section, two layers are visible: the outer layer is red, inner - yellow.

Pharmacotherapeutic group:antibiotic, tetracycline.

ATX: & nbsp

J.01.A.A.07 Tetracycline

Pharmacodynamics:

Bacteriostatic antibiotic from the group of tetracyclines. Violates the formation of a complex between the transport of RNA and the ribosome, which leads to suppression of protein synthesis.

Active against gram-positive microorganisms - Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-producing strains), Streptococcus spp. (some strains, 'in, including Streptococcus pneumoniae), Listeria monocytogenes, Bacillus anthracis, Clostridium spp., Actinomyces spp., Propionibacterium acnes, Bacillus fusifonnis;

- Gram-negative microorganisms - Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, Escherichia coli, Enterobacter spp. (including Enterobacter aerogenes), Klebsiella spp., Neisseria gonorrhoeae, Shigella spp., Yersinia pestis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia prawazekii, -Rickettsia reckettsn, Rickettsia akari, Borrelia Vinceni, Borrelia "recurrentis, Borrelia burgdorferi, Brucella spp. (at combinations with streptomycin); Calymmatobacterium granulomatis, 'Francisella tularensis, Treponema pallidum, Treponema pertenue;

- at contraindications to purpose of penicillins - Clostridiumspp., Neisseria gonorrhoeae, Actinomyces spp .;

- active at respect Chlamydia trachomatis; Chlamydia psittaci, Entamoeba histolytica;

- to tetracycline are stable microorganisms: Pseudomonas aeruginosa, Proteus spp.,

Serratia spp., most strains Bacteroides. spp. and fungi, viruses, beta-hemolyticthe; Streptococci group A (including 44 % strains Streptococcus pyogenes and 74% strains Streptococcus faecalis).

Pharmacokinetics:

Absorption - 75-77%, with intake decreases, communication with plasma proteins - 55-65 %.

Time to reach the maximum concentration with oral intake - 2-3 hours (for achieving therapeutic concentration may take 2-3 days). During theThe next 8 hours the concentration gradually decreases. The maximum concentration is 1.5 d. 3.5 mg / l (to achieve the therapeutic effect, enough concentration of 1 mg / l).

The body is distributed unevenly: the maximum concentration is contained in the liver, kidneys, lungs and in organs with a well developed reticuloendothelial systemmy - to the spleen, lymph nodes. Concentration in the bile is 5-10 times higher than in the bilethe collar blood. In the tissues of the thyroid and prostate, the content of tetracycline the same as in plasma; in pleural, ascitic fluid, saliva, lactating milk women - 60-100% concentration in the plasma. In large quantities, accumulates intissue, tumors, dentin and enamel of the baby teeth. Poorly penetrates the blood-brain barrier. In intact cerebral membranes in the cerebrospinal fluid fluid is not detected or detected in a small amount (5-10% of the concentration in the plasma).In patients with diseases of the central nervous system, especially when inflammatory processes in the brain envelopes, the concentration in the cerebrospinal fluid of the liquid is 8-36 % concentration "in the plasma. Penetrates through placental barrier and into breast milk. The volume of distribution is -1.3-1.6 l / kg.

It is slightly metabolized in the liver. The half-life period is 6-11 hours, with anuria - 57-108 hours. In urine it is found in high concentration 2 hours after administration and withstored for 6-12 hours; for the first 12 hours the kidneys are excreted up to 10-20% of the dose. In the smaller(5-10% of the total dose) is excreted with bile into the intestine, where the partial reverse absorption, which contributes to a prolonged circulation of the active substance in the body (intestinal-hepatic circulation).

Excretion through the intestine 20-50 %. When hemodialysis is removed slowly.

Indications:

Infectious-inflammatory diseases caused by tetracycline-sensitive microorganisms: pneumonia and respiratory tract infections caused by Mycoplasma pneumoniae, respiratory tract infections caused by Haemophilus influenzae and Klebsiella spp., bacterial infections of the urino-genital organs, skin and soft tissue infections, ulcerous necrotic gingivostomatitis, conjunctivitis, acne, actinomycosis, intestinal amoebiasis, anthrax, brucellosis, bartonellosis,chancroid, cholera, chlamydia, uncomplicated gonorrhea, inguinal granuloma, gynecologic lymphogranuloma, listeriosis, plague, psittacosis, vesicular ricciosis, spotted fever of the Rocky Mountains,foul typhus, recurrent typhus, syphilis, trachoma, tularemia, yaws, botulism, tetanus, gasesgangrene, food poisoning, pertussis, dysentery, vibriosis, Lyme disease.

Contraindications:

Hypersensitivity to tetracycline and components of the drug, pregnancy, the period of breastfeeding, children's age (up to 8 years), leukopenia, deficiency, sugarul / isomaltase, intolerance to fructose, glucosogalactose malabsorption, renal failure, impaired liver function.

Pregnancy and lactation:

Contraindicated in pregnancy (tetracyclines pass through the placenta, accumulate in the bones and dentition of the fetus, disrupting their mineralization, can cause severe damage to the development of bone tissue).

Action category for the fetus by FDA - D.

For the duration of treatment it is necessary to stop breastfeeding (tetracyclines penetrate into breast milk and can adversely affect the development of the baby's bones and teeth, and also cause photosensitivity reactions,candidiasis of the oral cavity and vagina in infants).

Dosing and Administration:

Inside, squeezed a lot of liquid.

Adult- 0.3-0.5 g every 6 hours (4 times a day) or 0.5-1 g every 12 hours (2 times a day). The maximum daily dose is 4 g. The course of treatment is 5-10 days .

Children older than 8 years - at 6.25-12.5 mg / kg every 6 hours or 12.5-25 mg / kg every 12 hours.

With acne: 0.5-2 g / day in divided doses. If the condition improves (usually after 3 weeks), the dose is gradually reduced to a maintenance dose of 0.1-1 g. Adequate remission of acne can be achieved by using the drug every other day or intermittent therapy.

Brucellosis: 0.5 g every 6 hours for 3 weeks, simultaneously with intramuscular injection of streptomycin in a dose of 1 g every 12 hours for 1 week and 1 time per day for 2 weeks.

Uncomplicated gonorrhea - the initial single dose - 1.5 g, then 0.5 g every 6 hours for 4 days (total dose of 9 g).

Syphilis: 0.5 g every 6 hours, during L5 'days (early syphilis) or 30 days (late syphilis).

Uncomplicated urethral, endocervical and rectal infections caused by Chlamydia trachomatis, - 0.5 g every 6 hours for at least 7 days.

Lyme disease (only the early stage) - 1.0-1.5 g per day 10-14 days.

Listeriosis - 0.2-0.3 g every 6 hours for 7-10 days.

Actinomycosis - 3 g per day for the first 10 days, then 0.5 g every 6 hours for the last 18 days.

Chlamydia - 1,5-2 g per day for 10 days ("fresh" forms) and 15-20 days (chronic, complicated forms).

Inguinal granuloma, venereal lymphogranuloma - 0.5 g every 6 hours for 3-4 weeks.

Psittacosis: 0.5 g every 6 hours (weakening and disappearance of symptoms of the disease occurs in 24-48 hours). Treatment is continued for 7-14 days after the normalization of body temperature to prevent relapse.

Vesicle rickettsiosis - 0.8-1.2 g per day for 8-10 days.

Tularemia - 1,5-2 g per day. After normalizing the temperature, treatment is continued for another 5-7 days.

Yaws-0.5 g every 6 hours for 14 days.

Plague - up to 6 g per day. When the condition is improved, the dose is reduced to 2 g per day, before the temperature normalizes, but for at least 3 days. Contact persons should conduct a course on 0, 3r every 6 hours.

Side effects:

From the digestive system: decreased appetite, vomiting, diarrhea, nausea, glossitis, esophagitis, gastritis, ulceration of the stomach and duodenum, hypertrophyphial papillae of the tongue, dysphagia, hepatotoxic action, pancreatitis, intestinal dysbiosis,enterocolitis, increased activity of "hepatic" transaminases, antibiotic-associated diarrhea.

From the central nervous system: increased intracranial pressure, headache, toxic effects on the central nervous system (dizziness or instability).

On the part of the organs of hematopoiesis: hemolytic anemia, thrombocytopenia, neutronsinging, eosinophilia.

On the part of the urinary system, azotemia, hypercreatininemia, nephrotoxicumPhysical action.

Allergic and immunopathologic reactions: maculopapular rash; hyperemia of the skin, angioedema, anaphylactoid reactions, drug systemic lupus erythematosus, photosensitivity.

Other: superinfection, candidiasis, hypovitaminosis of B vitamins, hyperbilirubinemia, discoloration of tooth enamel in children, stomatitis.

Overdose:When an overdose of the drug may increase the above side effects. Treatment symptomatic.

Interaction:In connection with the suppression of the intestinal microflora, reduces the prothrombin index (requires a reduction in the dose of indirect anticoagulants).

Reduces the effectiveness of bactericidal antibiotics that disrupt the synthesis of the cell wall (penicillins, cephalosporins).

Reduces the effectiveness of estrogen-containing oral contraceptives and increases the risk of bleeding "breakthrough"; retinol - risk of developing increased intracranial pressure.

Absorption is reduced by antacids containing aluminum; magnesium and calcium, iron preparations and colestramine.

Chymotrypsin increases the concentration and duration of circulation.

Special instructions:

In connection with the possible development of photosensitization, it is necessary to limit the insolation.

With prolonged use, periodic monitoring of the function of the kidneys, liver, and hematopoiesis is necessary.

May mask the manifestations of syphilis, in connection with which, if possible mixed monthly serological analysis is needed for 4 months.

All tetracyclines form stable complexes with calcium in any bone-forming tissue. In this regard, the reception during the development of teeth can cause long-term staining of the teeth in yellow-gray-brown color, as well as hypoplasia of the enamel.

To prevent hypovitaminosis should appoint vitamins B and K, beer YEAST.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is necessary to refrain from driving and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 100 mg.

For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 2 contour cell packs in eachWith instructions for use put in a cardboard box.

For 20 tablets in polymer cans. Each bank along with the instruction for use is placed in a cardboard box.

By 2.0 kg in bags of polyethylene food film. Packages with tablets and 3 -5 instructions for use are placed in a cardboard box.

Packaging:(10) - packing of the cell contour [al.foil / PVC] (2) / 2 packs, the contour of the outline together with the instruction for use are placed in a pack of cardboard.
(10) - packaging of the cellular contour [paper with poly. pvc / pvc] (2) / 2 packs, the cell outline along with the instructions for use are placed in a pack of cardboard. / - A pack of cardboard
(2) - double bags of polyethylene film (1) / It is allowed to pack tablets of 2.0 kg per package in double bags of polyethylene film. Between the packages, a label of paper is inserted. Each packet with tablets is placed in a box of cardboard. Each box is filled with 3-5 instructions for use. / - carton box
(20) - polymer can (1) / The bank, together with the instruction for use, is placed in a pack of cardboard. / - A pack of cardboard

Storage conditions:

In a dry place 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001800

Date of registration:11.07.2011

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp26.09.2015

Illustrated instructions

Instructions

Tetracycline (Tetracycline)