Minolexin capsules 50mg, No. 20

Minocycline hydrochloride is used to treat the following diseases, subject to the sensitivity of pathogenic microorganisms:

• acne;

• skin infections;

• spotted fever, typhoid fever, typhoid fever, Q fever (coxiellosis), vesicular rickettsiosis and tick fever; respiratory tract infections;

• lymphogranuloma venereal;

• psittacosis;

• trachoma (infectious keratoconjunctivitis);

• conjunctivitis with inclusions (paratrachoma);

• non-gonococcal urethritis, infections of the cervical canal and anus in adults;

• cyclical fever;

• chancroid;

• plague;

• tularemia;

• cholera;

• brucellosis;

• bartonellosis;

• inguinal granuloma;

• syphilis;

• gonorrhea;

• yaws (tropical granuloma, non-venereal syphilis);

• listeriosis;

• anthrax;

• angina Vincent;

• actinomycosis.

  In the case of acute intestinal amebiasis, minocycline may be used as an adjunct to amoebicidal drugs.

  For severe acne, minocycline can be used as adjunctive therapy.

  The use of minocycline is indicated in asymptomatic carriers of Neisseria meningitidis for the eradication of meningococci from the nasopharynx.

  To prevent the emergence of resistance, the use of minocycline is recommended in accordance with the results of laboratory tests, including serotyping and determination of the sensitivity of pathogens. For the same reason, the prophylactic use of minocycline is not recommended in case of a high risk of meningococcal meningitis. Clinical experience has shown the efficacy of minocycline in the treatment of Mycobacterium marinum infections, however, these data are currently not supported by the results of controlled clinical trials.

The drug is taken orally, after meals.

It is recommended to drink the capsules with a sufficient amount of liquid (milk can be used) to reduce the risk of irritation and ulceration in the esophagus. The initial dose of MinolexinЃ is 200 mg (2 capsules 100 mg each or 4 capsules 50 mg each), then take 100 mg (1 capsule 100 mg each or 2 capsules 50 mg each) every 12 hours (2 times / day). The maximum daily dose should not exceed 400 mg.

Infections of the genitourinary system and anogenital area caused by chlamydia and ureaplasma: 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours for 7-10 days.

Inflammatory diseases of the pelvic organs in women in the acute stage: 100 mg (1 capsule 100 mg or 2 capsules 50 mg) every 12 hours, sometimes in combination with cephalosporins.

Primary syphilis in patients with hypersensitivity to penicillins: 100 mg (1 capsule 100 mg or 2 capsules 50 mg) 2 times / day for 10-15 days. Gonorrhea: 100 mg (1 capsule 100 mg or 2 capsules 50 mg) 2 times / day for 4-5 days, or 300 mg once.

Uncomplicated gonococcal infections (excluding urethritis and anorectal infections) in men: initial dose - 200 mg (2 capsules 100 mg each or 4 capsules 50 mg each), maintenance dose - 100 mg (1 capsule 100 mg each or 2 capsules each 50 mg) every 12 hours for at least 4 days, followed by a microbiological assessment of recovery 2-3 days after stopping the drug.

Uncomplicated gonococcal urethritis in men: 100 mg (1 capsule 100 mg or 2 capsules 50 mg) every 12 hours for 5 days.

Acne: 50 mg (1 capsule, 50 mg each) per day, for a long course of 6-12 weeks. While taking the drug, due to the anti-anabolic effect inherent in the drugs of the tetracyclines group, an increase in the level of urea in the blood plasma may be observed. In patients with normal renal function, this does not require discontinuation of the drug. Patients with severe renal impairment may develop azotemia, hyperphosphatemia, and acidosis. In this situation, it is necessary to control the level of urea and creatinine in the blood plasma; the maximum daily dose of minocycline should not exceed 200 mg. The pharmacokinetics of minocycline in patients with renal insufficiency (CC less than 80 ml / min) is currently insufficiently studied to conclude that dose adjustment is necessary. In case of impaired liver function, the drug should be used with caution.Children over 8 years old with infections caused by pathogens sensitive to minocycline: the initial dose is 4 mg / kg, then 2 mg / kg every 12 hours.

Hard gelatin capsules, No. 2, with a yellow body and lid; the contents of the capsules are yellow powder.

1 caps.

minocycline hydrochloride 50 mg

Excipients: microcrystalline cellulose - 73.5 mg, low molecular weight povidone - 8.75 mg, potato starch - 7 mg, magnesium stearate - 1.75 mg, lactose monohydrate - up to 175 mg.

• Hypersensitivity to minocycline, tetracyclines and other components of the drug;

• porphyria;

• severe liver failure;

• severe renal failure;

• leukopenia;

• systemic lupus erythematosus;

• simultaneous reception with isotretinoin;

• pregnancy;

• lactation period (breastfeeding);

• children's age up to 8 years (the period of tooth development);

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

• With caution, the drug should be prescribed for violations of liver and kidney function, the simultaneous use of hepatotoxic drugs.

pharmachologic effect

Semi-synthetic antibiotic from the tetracyclines group. It has a bacteriostatic effect on cells of sensitive strains of microorganisms due to reversible inhibition of protein synthesis at the level of 30S ribosome subunits. Possesses a wide spectrum of antibacterial activity. Microorganism sensitivity: aerobic gram-positive - some of the microorganisms below have shown resistance to minocycline, therefore, it is recommended to conduct a laboratory sensitivity test before use - Bacillus anthracis, Listeria monocytogenes, Staphylococcus aureus, Streptococcus pneumoniae. Antibiotics of the tetracycline group are not recommended for the treatment of streptococcal and staphylococcal infections, unless the sensitivity of microorganisms to minocycline is shown; aerobic gram-negative - Bartonella bacilliformis, Brucella species,Calymmatobacterium granulomatis, Campylobacter fetus, Francisella tularensis, Haemophilus ducrey, Vibrio cholerae, Yersinia pestis. Minocycline susceptibility testing is strongly recommended for the following microorganisms: Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species. In addition: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium pallasum acnes, Rickettsia subspeciesFrancisella tularensis, Haemophilus ducrey, Vibrio cholerae, Yersinia pestis. Minocycline susceptibility testing is strongly recommended for the following microorganisms: Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species. In addition: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium pallasum acnes, Rickettsia subspeciesFrancisella tularensis, Haemophilus ducrey, Vibrio cholerae, Yersinia pestis. Minocycline susceptibility testing is strongly recommended for the following microorganisms: Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species. In addition: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium pallasum acnes, Rickettsia subspeciesMinocycline susceptibility testing is strongly recommended for the following microorganisms: Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species. Additionally: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium subspecies acnes, RickettsiaMinocycline susceptibility testing is strongly recommended for the following microorganisms: Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species. In addition: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium pallasum acnes, Rickettsia subspeciesNeisseria gonorrhoeae, Neisseria meningitidis, Shigella species. Additionally: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium subspecies acnes, RickettsiaNeisseria gonorrhoeae, Neisseria meningitidis, Shigella species. In addition: Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium pallasum acnes, Rickettsia subspeciesUreaplasma urealyticum.Ureaplasma urealyticum.

Pharmacokinetics

Suction

Food intake does not significantly affect the degree of absorption of minocycline. Minocycline has a high lipid solubility and low Ca2 + binding affinity. It is rapidly absorbed from the digestive tract in proportion to the dose taken. The maximum concentration of minocycline in blood plasma (Cmax) after oral administration in a dose of 200 mg is 3.5 mg / l and is reached (Tmax) after 2-4 hours.

Distribution

Binding to blood proteins is 75%, the effect of various diseases on this parameter has not been studied. Vd is 0.7 l / kg. Minocycline penetrates well into organs and tissues: 30-45 minutes after ingestion, it is found in therapeutic concentrations in the kidneys, spleen, eye tissues, pleural and ascitic fluids, synovial exudate, exudate of the maxillary and frontal sinuses, in the fluid of the gingival grooves. It penetrates well into the cerebrospinal fluid (20-25% of the level determined in plasma). Penetrates through the placental barrier, excreted in breast milk. With repeated administrations, the drug may accumulate. It accumulates in the reticuloendothelial system and bone tissue. Forms insoluble complexes with Ca2 + in bones and teeth.

Withdrawal

Undergoes intestinal-hepatic recirculation, 30-60% of the dose taken is excreted with intestinal contents; 30% is excreted by the kidneys within 72 hours (of which 20-30% - unchanged), with severe chronic renal failure - only 1-5%. The half-life (T1 / 2) of minocycline is approximately 16 hours.

Side effect

The spectrum of adverse events associated with taking minocycline does not differ from other tetracyclines.

On the part of the digestive system: anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, hypoplasia of tooth enamel, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (including fungal) in the oral cavity and anerbilogenital area, , cholestasis, increased activity of liver enzymes, liver failure, incl. terminal, hepatitis, including autoimmune.

From the genitourinary system: vulvovaginal candidiasis, interstitial nephritis, dose-dependent increase in plasma urea, balanitis.

On the part of the skin: alopecia, erythema nodosum, nail pigmentation, pruritus, toxic epidermal necrosis, vasculitis, maculopapular and erythematous rash, Stevens-Johnson syndrome, exfoliative dermatitis.

From the respiratory system: shortness of breath, bronchospasm, exacerbation of asthma, pneumonia.

From the musculoskeletal system: arthralgia, arthritis, limitation of mobility and joint swelling, discoloration of bone tissue, muscle pain (myalgia).

Allergic reactions: urticaria, angioedema, polyarthralgia, anaphylactic reactions (including shock), anaphylactoid purpura (Schonlein-Genoch purpura), pericarditis, exacerbations of systemic lupus, pulmonary infiltration, accompanied by eosinophilia.

From the hematopoietic system: agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutrocytopenia, pancytopenia, eosinopenia, eosinophilia.

From the side of the central nervous system: convulsions, dizziness, numbness (including limbs), lethargy, vertigo, increased intracranial pressure in adults, headaches.

From the senses: tinnitus and hearing impairment.

From the side of metabolism: a single case of a malignant neoplasm of the thyroid gland, discoloration (according to the results of pathomorphological studies), dysfunction of the thyroid gland.

Others: discoloration of the oral cavity (tongue, gums, palate), discoloration of tooth enamel, fever, staining of secretions (eg, sweat).

Application during pregnancy and lactation

During pregnancy, minocycline is recommended to be prescribed only in cases where the expected benefit from its use to the mother outweighs the potential risk to the fetus. During treatment with minocycline, breastfeeding is suspended.

Application for violations of liver function

The drug should be prescribed with caution in case of liver dysfunction. The use of the drug is contraindicated in severe hepatic insufficiency.

Application for impaired renal function

The drug should be prescribed with caution in case of impaired renal function. The use of the drug is contraindicated in severe renal failure.

special instructions

With prolonged use of minocycline, the cellular composition of peripheral blood should be regularly monitored, functional liver function tests should be performed, and the concentration of nitrogen and urea in serum should be determined. When using contraceptives with estrogens during therapy with minocycline, additional contraceptives or their combinations should be used. There may be a false increase in the level of catecholamines in the urine when they are determined by the fluorescent method. When examining a biopsy of the thyroid gland in patients who have been receiving tetracyclines for a long time, one should take into account the possibility of dark brown staining of tissue in micropreparations. While taking the drug and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium dificile (pseudomembranous colitis) may develop.In mild cases, it is enough to discontinue treatment and use ion-exchange resins (cholestyramine, colestipol), in severe cases, it is shown to replace the loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit intestinal motility. To avoid the development of resistance, minocycline should be used only in accordance with the results of the study of the sensitivity of pathogenic microorganisms. If susceptibility testing of microorganisms is not possible, the epidemiology and susceptibility profile of the microorganisms in the specific region should be taken into account. In the case of sexually transmitted diseases, if there is a suspicion of concomitant syphilis, before starting treatment, it is necessary to carry out studies by microscopy in a dark field.Serological diagnosis of blood serum is recommended at least once every 4 months. Periodic laboratory diagnostics of body functions is required, incl. hematopoietic and renal functions, as well as liver conditions. Algorithms of action in the event of some side effects: in case of development of superinfection, taking minocycline should be discontinued and adequate therapy prescribed; in case of an increase in intracranial pressure, the administration of minocycline must be discontinued; diarrhea is a common antibiotic disorder. If diarrhea occurs during treatment with minocycline, an urgent need to consult a doctor; antibiotics of the tetracycline group cause an increase in sensitivity to direct sunlight and ultraviolet radiation. If erythema occurs, the antibiotic should be discontinued.

Influence on the ability to drive vehicles and use mechanisms

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, due to the fact that minocycline has such a side effect as dizziness.

Overdose

Symptoms: Dizziness, nausea and vomiting are most common. Treatment: A selective antidote for minocycline is currently unknown. In case of overdose, it is necessary to stop taking the drug, provide symptomatic treatment and supportive therapy. Minocycline is excreted in small amounts by hemo- and peritoneal dialysis.

Drug interactions

Preparations of the tetracycline group reduce the prothrombin activity of blood plasma, which may necessitate a decrease in the doses of anticoagulants in patients receiving anticoagulant therapy. Due to the fact that bacteriostatic drugs affect the bactericidal effect of penicillins, simultaneous administration of drugs of the penicillin and tetracycline groups should be avoided. The absorption of tetracyclines is impaired when taken simultaneously with antacids containing aluminum, calcium, magnesium or iron-containing drugs, which can lead to a decrease in the effectiveness of antibiotic therapy. There have been cases of end-stage renal toxicity with the simultaneous administration of methoxyfruran and drugs of the tetracycline group. The simultaneous use of antibiotics of the tetracycline group and oral contraceptives can lead to a decrease in the effectiveness of contraception.You should avoid taking isotretinoin immediately before, simultaneously and immediately after taking minocycline, since both drugs can cause a benign increase in intracranial pressure. The simultaneous administration of drugs of the tetracycline group with ergot alkaloids and their derivatives increases the risk of developing ergotism.