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

Tablet core aids: potato starch - 0.0191 g, microcrystalline cellulose 0.0017 g, sodium starch glycolate (carboxymethylstarch sodium) 0.0013 g, povidoy 0.0030 g, talc 0.0010 g, calcium stearate 0.0009 g

Auxiliary substances of the film shell: hypromellose - 0.00181 g, polysorbate 80 - 0.00028 g, titanium dioxide - 0.00028 g, dye azorubin (acid red 2C) - 0.000064 g, tropeolin colorant O - 0.000043 g, silicone emulsion of CE 10-16 - 0.000523 g.

Description:

tablets are round, biconcave, covered with a film shell of red color. The color of the core is yellow. Two layers are visible on the cross-section.

Pharmacotherapeutic group:antibiotic-tetracycline

ATX: & nbsp

J.01.A.A.07 Tetracycline

Pharmacodynamics:

It is active against gram-positive microorganisms: Staphylococcus spp. (incl. Staphylococcus aureus, including penicillinase-producing strains), Streptococcus pneumoniae, Listeria spp., Bacillus anthracis, Clostridium spp., Actinomyces israelii; Gram-negative microorganisms: Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, Escherichia coli, Enterobacter spp. (including Enterobacter aerogenes), Acinetobacter spp., Klebsiella spp., Salmonella spp., Shigella spp., Yersinia pestis, Francisella tularensis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia spp., Borrelia burgdorferi, Brucella spp. (in combination with streptomycin); with contraindications to the use of penicillins - Clostridium spp., Neisseria gonorrhoeae, Actinomyces spp .; is also active in relation to Calymmatobacterium gra- nulomatis, Chlamydia trachomatis, Chlamydia psittaci, Mycoplasma pneumoniae, Treponema spp. To tetracycline are stable: Pseudomonas aeruginosa, Proteus spp., Serratia spp., most strains Bacteroides spp. and fungi, viruses, Streptococcus pyogenes, Streptococcus faecalis.

Pharmacokinetics:

Absorption - 75-77%, when food intake decreases, the connection with plasma proteins is 55-65%. The time to reach the maximum concentration of the drug in plasma (Topach) with oral intake - 2-3 hours (to achieve a therapeutic concentration may take 2-3 days). During the next 8 hours the concentration gradually decreases.The maximum concentration of the drug in the plasma is 1.5-3.5 mg / l (enough concentration of 1 mg / l is sufficient to achieve the therapeutic effect).

The body is distributed unevenly: the maximum concentration of the drug is determined in the liver, kidneys, lungs and in organs with a well developed reticulo-endothelial system - the spleen, lymph nodes. Concentration in bile is 5-10 times higher than in serum. In the tissues of the thyroid and prostate gland, the concentration of tetracycline corresponds to that found in plasma; in the pleural, ascitic fluid, saliva, milk lactating women - 60-100% concentration in the plasma. In large quantities, it accumulates in bone tissue, tumor tissues, in dentin and enamel of baby teeth. Poorly penetrates the blood-brain barrier. In intact cerebral membranes in cerebrospinal fluid it 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 in inflammatory processes in the brain envelopes, the concentration in the cerebrospinal fluid is 8-36% of the concentration in the plasma. Penetrates through the 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 of the drug (T1/2) - 6-11 h, with anuria - 57-108 h. In urine it is detected in high concentration 2 h after administration and stored for 6-12 h; for the first 12 hours the kidneys are excreted up to 10-20% of the dose. In smaller amounts (5-10% of the total dose) is excreted with bile into the intestine, where partial reverse absorption occurs, 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 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 urogenital organs, skin and soft tissue infections, ulcerative necrotic gingivitis, conjunctivitis, acne, actinomycosis, intestinal amoebiasis, anthrax, brucellosis, bartonella, chancroid, cholera, chlamydia, uncomplicated gonorrhea, inguinal granuloma, venereal lymphogranuloma, listeria, plague, psittacosis, vesicle rickettsiosis, spotted fever of the Rocky Mountains, typhus, typhus, syphilis, trachoma, tularemia, yaws.

Contraindications:

Hypersensitivity to tetracycline, drug components, sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, renal insufficiency, leukopenia, pregnancy, lactation, children under 8 years (children under 8 years tetracycline can cause a long-term discoloration of the teeth, hypoplasia of the enamel, slowing of the longitudinal growth of the bones of the skeleton).

Carefully:The drug should be administered with caution to patients with an indication of allergic reactions in the anamnesis.

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 large amounts of fluid, adults - to 0.5 g 4 times a day or 0.5-1 g every 12 hours.The maximum daily dose is 4 g.

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 0.5-1 g. Adequate remission of acne may be achieved with the use of 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 of 1.5 g, then 0.5 g every

6 h for 4 days (total dose 9 g).

Syphilis - 0.5 g every 6 hours for 15 days (early syphilis) or 30 days (late syphilis).

Uncomplicated urethral, endocervical and rectal infections caused by Chlamydia trachomatis, - 0.5 g 4 times a day for at least 7 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.

Side effects:

On the part of the digestive system: decreased appetite, vomiting, diarrhea, nausea, glossitis, esophagitis, gastritis, ulceration of the stomach and duodenum, hypertrophy of the papillae of the tongue, dysphagia, hepatotoxic effect, increased activity of "liver" transaminases, pancreatitis, intestinal dysbiosis, enterocolitis .

From the nervous system: increased intracranial pressure, dizziness or instability, headache.

From the hemopoiesis: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia.

From the side of the urinary system: azotemia, hypercreatininaemia. Allergic and immunopathological reactions: maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug systemic lupus erythematosus, photosensitivity.

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

Overdose:

It is possible to increase dose-dependent side effects.

Treatment: symptomatic therapy.

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 ions, magnesium and calcium ions, 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, and therefore, with the possibility of a mixed infection, you need a monthly serological analysis for 4 months.

All tetracyclines form stable complexes with calcium ions in any bone-forming tissue. In this regard, 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, brewer's yeast.

Effect on the ability to drive transp. cf. and fur:There is no data on the effect on the reaction rate when driving vehicles or working with machinery.

Form release / dosage:

Tablets, film-coated 100 mg.

For 10 tablets in a contour mesh box made of PVC film and aluminum foil printed lacquered.

By 2, 4 contour mesh packages with instructions for use are placed in a pack of cardboard.

Packaging:(10) - packings, cellular, outline (2) - packs, cardboard
(10) - packings, cellular, outline (4) - packs, cardboard

Storage conditions:

At a temperature of ns above 25 ° C. Keep out of the reach of children's place.

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-001413

Date of registration:23.01.2012

The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Information update date: & nbsp26.09.2015

Illustrated instructions

Instructions

Tetracycline (Tetracycline)