Tetracycline (Tetracycline)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTetracyclineTetracycline
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    • Dosage form: & nbspcoated tablets
    Composition:

    Composition per 1 tablet: active substance: tetracycline (in terms of active substance) - 100 mg; Excipients: sucrose 1.4 mg, talc 1.4 mg, calcium stearate 1.4 mg, corn starch, to prepare a tablet weighing 140 mg (excluding shell); composition of the shell: sucrose-110.455 mg, dextrin-2.8185 mg, gelatin-0.875 mg, magnesium hydroxycarbonate-2.92 mg, talc 2.92 mg, azorubin E-122 dye 0.0105 mg, quinoline yellow color E-104 0.001 mg.

    Description:coated tablets, from light pink to dark pink, round in shape with a biconvex surface. Three layers are visible on the cross-section.
    Pharmacotherapeutic group:Antibiotic-tetracycline.
    ATX: & nbsp

    J.01.A.A.07   Tetracycline

    Pharmacodynamics:Bacteriostatic antibiotic from the group of tetracyclines. It disrupts the formation of a complex between the transport RNA and the ribosome, which leads to suppression of protein synthesis. Active in against gram-positive microorganisms: Staphylococcus spp. (incl. Staphylococcus aureus, including penicillinase-producing strains), Streptococcus spp. (incl. Streptococcus pneumoniae), Mycoplasma pneumoniae;, Listeria spp., Bacillus anthracis, Clostridium spp., Actinomyces israelii; Gram-negative microorganisms: Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, the majority of enterobacteria: Escherichia coli, Enterobacter spp., including Enterobacter aerogenes, Klebsiella spp;, Salmonella spp;, Shigella spp., Yersinia pestis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia spp., Francisella tularensis, Borrelia burgdorferi, Brucella spp. (in combination with streptomycin), Chlamydia spp. (incl. Chlamydia trachomatis); with contraindications to the appointment of penicillins - Clostridium spp., Neisseria gonorrhoeae, Actinomyces spp.; is also active against the causative agents of the venereal and inguinal lymphogranuloma, Treponema spp/ To tetracycline, microorganisms are stable: Pseudomonas aeruginosa, Proteus spp., Serratia spp., most 'strains Bacteroides spp. and fungi, viruses, beta-hemolytic streptococci. Groups A (including 44 % strains Streptococcus pyogenes and 74% of strains Streptococcus faecalis).
    Pharmacokinetics:

    Absorption - 75-77%, with food intake decreases, communication with plasma proteins - 55-65%. Time to reach the maximum concentration in the blood serum 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 in the blood is 1.5-3.5 mg / l (enough concentration of 1 mg / l is sufficient to achieve the therapeutic effect). In the body is distributed unevenly: maximumThe concentration is determined in the liver, kidneys, lungs and in organs with a well developed reticuloendothelial system of 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. When intact cerebral membranes are in the cerebrospinal fluid, it is not detected or detected in an insignificant 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 % concentration in plasma. Penetrates through the placental barrier 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 stored for 6-12 hours; for the first 12 hours the kidneys are excreted up to 10-20% of the dose. In smaller amounts (5-10% of the total, the 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 urino-genital organs, skin and soft tissue infections, ulcerative necrotic gingivostomatitis,conjunctivitis, acne, actinomycosis, intestinal amoebiasis, anthrax, whooping cough, brucellosis, bartonella, chancroid, cholera, chlamydia, uncomplicated gonorrhea, inguinal granuloma, venereal lymphogranuloma, listeriosis, plague, psittacosis, vesicle rickettsiosis, spotted fever of the Rocky Mountains, typhus, recurrent typhus, syphilis, trachoma, tularemia, yaws.

    Contraindications:

    Hypersensitivity to tetracycline, drug components, pregnancy, lactation period, children's age (up to 8 years), leukopenia, sugar deficiency / isomaltase, fructose intolerance, glucose-galactose malabsorption.

    Carefully:Renal failure.
    Pregnancy and lactation:Contraindicated use during pregnancy and lactation.
    Dosing and Administration:

    Inside, squeezed large amounts of fluid, adults - 300-500 mg 4 times a day or 500-1000 mg every 12 hours. The maximum daily dose is 4000 mg.

    With acne: 500-2000 mg / day in divided doses. If the condition improves (usually after 3 weeks), the dose is gradually reduced to a maintenance dose of 100-1000 mg. Adequate remission of acne can be achieved by using the drug every other day or intermittent therapy.

    Brucellosis: 500 mg every 6 hours for 3 weeks, simultaneously with intramuscular injectionStreptomycin in a dose of 1000 mg every 12 hours for 1 week and once a day for 2 weeks.

    Uncomplicated gonorrhea: the initial single dose of 1500 mg, then 500 mg every 6 hours for 4 days (total dose of 9000 mg).

    Syphilis - 500 mg every 6 hours for 15 days (early syphilis) or 30 days (late syphilis).

    Uncomplicated urethral endocervical and rectal infections caused by Chlamydia trachomatis: 500 mg 4 times a day for at least 7 days.

    Persons with impaired renal function correction of the dosing regimen is required. When creatinine clearance is more than 50 ml / min, 200-400 mg 2-3 times a day, with a creatinine clearance of 10-50 ml / min, 200-400 mg 1-2 times a day, with a creatinine clearance of less than 10 ml / min 200 -400 mg once a day (under the control of kidney function).

    Children aged 8-12 years - 100-200 mg 3-4 times a day.
    Side effects:

    From 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 hematopoiesis: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia.

    From the urinary system: azotemia, hypercreatininaemia.

    Allergic and immunopathological reactions: maculopapular rash, congestion tovein, angioedema, anaphylactoid reactions, drug systemic lupus erythematosus, photosensitivity.

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

    Overdose:

    Symptoms: increased severity of dose-dependent side effects; hepatotoxicity, accompanied by fatty liver dystrophy, pancreatitis.

    Treatment: cancellation, drug, symptomatic therapy (there is no specific antidote), maintenance of vital functions.

    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) .It 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 Al3+, Mg2+ and Ca2+, drugs Fe and colestramine. Chymotrypsin increases 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 Ca2+ in any bone-forming tissue. In connection with this reception in the period of development of thebov can cause long-term staining of 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:Persons experiencing side effects from the nervous system (headache, and dizziness) should refrain from driving or other potentially dangerous mechanisms.
    Form release / dosage:

    Tablets, coated with a coating, 100 mg. 10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. Two contour packs with instructions for use are placed in a pack of cardboard.

    Packaging for hospitals: 350 contour mesh packages with an equal number of instructions for use are placed in a cardboard box.

    Packaging:(10) - packings, cellular, outline (2) - packs, cardboard
    (10) - packings, cellular planimetric (350) - cardboard boxes
    Storage conditions:

    In a dry, protected from light 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 expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000868
    Date of registration:10.08.2010
    The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus
    Manufacturer: & nbsp
    BELMEDPREPARATY, RUP Republic of Belarus
    Information update date: & nbsp26.09.2015
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