Tetracycline, pills 100mg, 20pcs – Biosintez

Composition

Active ingredient:

tetracycline hydrochloride-0.1 g

Excipients:

sucrose (refined sugar) – 7.1 mg,

calcium stearate monohydrate-1.26 mg,

magnesium hydrosilicate (talc) – 1.26 mg,

gelatin-0.54 mg,

potato starch-15.84 mg

Pharmacological action

Tetracycline is active against gram-positive microorganisms: Staphylococcus spp. (including 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. ; also active against Calymmatobacterium granulomatis, Chlamydia trachomatis, Chlamydia psittaci, Mycoplasma pneumoniae, Treponema spp. Tetracycline resistant: Pseudomonas aeruginosa, Proteus spp., Serratia spp., most strains of Bacteroides spp. and fungi, viruses, Streptococcus pyogenes, Streptococcus faecalis.

Pharmacokinetics

Absorption – 75-77%, decreases with food intake, plasma protein binding-55-65%. The time to reach the maximum concentration of the drug in plasma (TCmax) with oral use is 2-3 hours (it may take 2-3 days to reach the therapeutic concentration). Over the next 8 hours, the concentration gradually decreases. The maximum concentration of the drug in plasma is 1.5-3.5 mg/l (to achieve a therapeutic effect, a concentration of 1 mg/l is sufficient).

It is distributed unevenly in the body: 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. The concentration in bile is 5-10 times higher than in the blood serum. In thyroid and prostate tissues, the concentration of tetracycline corresponds to that found in plasma; in pleural, ascitic fluid, saliva, milk of nursing women-60-100% of the plasma concentration. It accumulates in large amounts in bone tissue, tumor tissues, dentin and enamel of baby teeth.

Poorly penetrates the blood-brain barrier. In intact meninges, the cerebrospinal fluid is not detected or detected in a small amount (5-10% of the plasma concentration). In patients with diseases of the central nervous system, especially with inflammatory processes in the meninges, the concentration in the cerebrospinal fluid is 8-36% of the plasma concentration. 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) is 6-11 hours, with anuria-57-108 hours. In the urine, it is detected in high concentrations 2 hours after use and persists for 6-12 hours; in the first 12 hours, up to 10-20% of the dose is excreted by the kidneys. In smaller amounts (5-10% of the total dose) is excreted with bile in the intestines, where partial reabsorption occurs, which contributes to long-term circulation of the Active ingredient in the body (intestinal-hepatic circulation). Intestinal excretion is 20-50%. During hemodialysis, it is removed slowly.

Indications

• Infection caused by tetracycline-sensitive organisms: pneumonia and respiratory tract infections caused by Mycoplasma pneumoniae, respiratory tract infections caused by Haemophilus influenzae and Klebsiella spp.
• bacterial infections of the urinary organs,
• infections of skin and soft tissues,
• ulcerative-necrotic gingivostomatit,
• conjunctivitis,
• acne,
• actinomycosis,
• intestinal amebiasis,
• anthrax,
• brucellosis,
• bartonellosis,
• chancroid,
• cholera,
• chlamydia infections,
• uncomplicated gonorrhea,
• granuloma inguinal,
• lymphogranuloma venereum,
• listeriosis,
• plague,
• psittacosis,
• vesicular rickettsiosis,
• Rocky mountain spotted fever,
• typhus,
• relapsing fever,
• syphilis,
• trachoma,
• tularemia,
• yaws.

Contraindications

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

With caution

The drug should be used with caution in patients with a history of allergic reactions.

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, pancreatitis, intestinal dysbiosis, enterocolitis, increased activity of “liver” transaminases, antibiotic-associated diarrhea.

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

Hematopoietic disorders: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia.

From the urinary system: azotemia, hypercreatininemia, nephrotoxic effect.

Allergic and immunopathological reactions: maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug-induced systemic lupus erythematosus, photosensitization.

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

Overdose

With an overdose of the drug, the side effects described above may increase.

Treatment is symptomatic.

Interaction

Due to the suppression of intestinal microflora, it reduces the prothrombin index (requires a reduction in the dose of indirect anticoagulants).

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

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

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

Chymotrypsin increases the concentration and duration of circulation.

How to take, course of use and dosage

Inside, with plenty of liquid.

Adults – 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 – 6.25-12.5 mg / kg every 6 hours or 12.5-25 mg / kg every 12 hours.

For 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 use of streptomycin at a dose of 1 g every 12 hours for 1 week and 1 time a day for 2 weeks.

Uncomplicated gonorrhea – an initial single dose of 1.5 g, then 0.5 g every 6 hours for 4 days (a total dose of 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 every 6 hours for at least 7 days.

Lyme disease (early stage only) – 1.0 – 1.5 g per day for 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 to 4 weeks.

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

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

Tularemia – 1.5-2 g per day. After the temperature normalizes, treatment is continued for another 5-7 days.

Yawning – 0.5 g every 6 hours for 14 days.

Plague – up to 6 g per day. If the condition improves, the dose is reduced to 2 g per day until the temperature normalizes, but for at least 3 days. Contact persons should take a course of 0.3 g every 6 hours.

Overdose

Possible increase in dose-dependent side effects.

Treatment: symptomatic therapy.

Special instructions

Due to the possible development of photosensitization, it is necessary to limit insolation.

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

It can mask the manifestations of syphilis, and therefore, if a mixed infection is possible, it is necessary to conduct 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 period of tooth development can cause long-term staining of teeth in yellow-gray-brown color, as well as enamel hypoplasia.

For the prevention of hypovitaminosis, vitamins of group B and K, brewer’s yeast should be prescribed.

Impact on the ability to drive vehicles or potentially dangerous mechanisms

There is no data on the effect on the reaction rate when driving vehicles or working with mechanisms.

Form of production

Tablets

Storage conditions

In a dry place at a temperature not exceeding 25 °C. Keep out of reach of children

Shelf life

3 years

Active ingredient

Tetracycline

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Pregnant women in the first trimester as prescribed by a doctor, Children as prescribed by a doctor, Children over 8 years of age, Adults as prescribed by a doctor

Indications

Pneumonia, Cholecystitis, Sore Throat, Acne, Boils, Tonsillitis, Intestinal Infections, Prostatitis, Tracheitis, Skin Infections, Stomatitis, Bronchitis, Infectious Diseases