DRUG TITLE

Sumycin (Tetracycline)

Pharmacological action

It is a broad-spectrum antibiotic. It has a bacteriostatic effect due to inhibition of pathogen protein synthesis due to disruption of formation of the complex between transport RNA and ribosome.

It is active against Gram-positive microorganisms: Staphylococcus spp. (including Staphylococcus aureus, including strains producing penicillinase), 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. (in combination with streptomycin); in case of contraindications to the use of drugs of penicillin group - Clostridium spp., Neisseria gonorrhoeae, Actinomyces spp; also active against Calymmatobacterium granulomatis, Chlamydia trachomatis, Chlamydia psittaci, Mycoplasma pneumoniae, Treponema spp, Entamoeba spp.

Pseudomonas aeruginosa, Proteus spp., Serratia spp., most strains of Bacteroides fragilis, most fungi, viruses, Streptococcus pyogenes, Streptococcus faecalis are resistant to tetracycline.

Pharmacokinetics

Absorption is 75-77% after oral administration; absorption decreases while eating; binding to plasma proteins is 55-65%.

Time to reach Cmax when taken orally - 2-3 hours (it may take 2-3 days to reach therapeutic concentration). During the next 8 hours the concentration gradually decreases. Cmax is 1.5-3.5 mg/l (a concentration of 1 mg/l is sufficient to achieve therapeutic effect). It is unevenly distributed in the body: Cmax is determined in the liver, kidneys, lungs and in organs with well-developed RES - spleen, lymph nodes. The concentration in bile is 5-10 times higher than in blood serum. In thyroid and prostate tissues tetracycline concentration corresponds to that found in plasma; in pleural, ascitic fluid, saliva, breast milk of women - 60-100% concentration in plasma. It accumulates in large amounts in bone tissue, tumor tissues, dentin and enamel of milk teeth. It penetrates poorly through the GEB. In intact cerebral membranes in the cerebrospinal fluid is not detected or detected in small amounts (5-10% of the plasma concentration). In patients with CNS diseases, especially in inflammatory processes in the brain membranes, the concentration in the cerebrospinal fluid is 8-36% of the plasma concentration. It penetrates through the placental barrier and is excreted with breast milk. Vd - 1.3-1.6 l/kg. Slightly metabolized in the liver. T1/2 is 6-11 hours, anuria is 57-108 hours. It is highly concentrated in the urine two hours after injection and is retained for 6-12 hours; during the first 12 hours 10-20% of the dose is excreted by the kidneys. Smaller amounts (5-10% of the total dose) are excreted with bile in the intestine, where there is partial reverse absorption, which promotes prolonged circulation of the active substance in the body (intestine-hepatic circulation). Excretion through the intestine is 20-50%. With hemodialysis it is removed slowly.

Contraindications to use

Hypersensitivity to tetracycline, leukopenia, renal insufficiency (CK <50-10 ml/min), pregnancy, breast-feeding, children under 8 years of age.

Caution

Renal failure (CK>80-50 ml/min).

Administration during pregnancy and lactation

Pregnancy and breast-feeding are contraindicated.

Administration in patients with liver dysfunction

Use with caution in patients with hepatic impairment.

Administration in impaired renal function

This drug is contraindicated for use in patients with impaired renal function.

Administration in children

Contraindicated in children under 8 years of age. Administration of tetracycline in children in the period of dental development may lead to irreversible discoloration of teeth.

Administration in elderly patients

In elderly patients, take into account the state of kidney function.

Indications of active ingredients of Sumycin (Tetracycline)

Infectious-inflammatory diseases caused by microorganisms sensitive to tetracycline: pneumonia and respiratory tract infections caused by Mycoplasma pneumoniae, respiratory tract infections caused by Haemophilus influenzae and Klebsiella spp, Bacterial infections of the urinary and genital system, skin and soft tissue infections, ulcerative-necrotic gingivostomatitis, conjunctivitis, acne, actinomycosis, intestinal amebiasis, anthrax, brucellosis, bartonellosis, chancroid, cholera, chlamydia, uncomplicated gonorrhea, inguinal granuloma, venereal lymphogranuloma, listeriosis, plague, psittacosis, vesicular rickettsiosis, Rocky Mountain spotted fever, typhus, syphilis, trachoma, tularemia, yaws.

Dosing regimen

The optimal dosing regimen is determined by the doctor. You should strictly follow the compliance of the dosage form used for the particular drug indications and the dosing regimen.

When administered orally a single dose for adults can be from 300 mg to 1.5 g depending on the indication, kidney function and the treatment regimen used.

In children over 8 years of age, 20-25 mg/kg every 6 hours.