Minoleksin capsules 100mg N20
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Active ingredients
Minocycline
Release form
Capsules
Composition
Minocycline hydrochloride 100 mg; Auxiliary substances: microcrystalline cellulose - 147 mg, low molecular weight povidone - 17.5 mg, potato starch - 14 mg, magnesium stearate - 3.5 mg, lactose monohydrate - up to 350 mg; Composition of hard gelatin capsule: water - 13-16 %, titanium dioxide - 2-2.1118%, gelatin - up to 100%.
Pharmacological effect
Semi-synthetic antibiotic from the tetracycline group. It has a bacteriostatic effect on cells of susceptible strains of microorganisms due to the reversible inhibition of protein synthesis at the level of 30S-subunits of ribosomes. It has a broad spectrum of antibacterial activity.; Microorganism sensitivity: - aerobic gram-positive - some of the microorganisms below have shown resistance to minocycline, therefore, prior to use, it is recommended to conduct a laboratory sensitivity test - Bacillus anthracis, Staphylococcus aureus, Listeria monocytogenes, Streptococcus. Antibiotics of the tetracycline group are not recommended for the treatment of streptococcal and staphylococcal infections, unless the microorganisms are sensitive to minocycline; - aerobic gram-negative - Bartonella bacilliformis, Francisella tularensis, Brucella species, Haemophilus ducrey, Calymmatobacterium granulomati, Vibrio cholerae, Campylobacter fetus, Yersinia pestis; For the microorganisms listed below, it is strongly recommended to conduct studies of sensitivity to minocycline: Acinetobacter species, Klebsiella species, Enterobacter aerogenes, Neisseria gonorrhoeae *, Escherichia coli, Neisseria meningitidis *, Haemophilus influenzae, Shigella species,; Mycoplasma pneumoniae, Chlamydia psittaci, Propionibacterium acnes, Chlamydia trachomatis, Rickettsiae, Clostridium species, Treponema pallidum subspecies pallidum, Entamoeba species, Treponema pallidum subspecies pertenue, Fusobacterium –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––,
Pharmacokinetics
Absorption; Eating does not have a significant effect on the degree of absorption of minocycline. Minocycline has a high degree of lipid solubility and low affinity for Ca2 + binding. Rapidly absorbed from the digestive tract in proportion to the dose. The maximum concentration of minocycline in the blood plasma (Cmax) after oral administration at 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 is not investigated. Vd is 0/7 l / kg. Minocycline penetrates well into organs and tissues: 30–45 min after ingestion is found in therapeutic concentrations in the kidneys, spleen, eye tissues, pleural and ascitic fluids, synovial exudate, maxillary and frontal sinuses exudate, in gingival sulcus fluid. Well penetrates into the cerebrospinal fluid (20-25% of the level determined in the plasma).Penetrates through the placental barrier, excreted in breast milk.; With repeated injections, the drug may accumulate. Accumulates in the reticulo-endothelial system and bone tissue. In bones and teeth forms insoluble complexes with Ca2 +; Elimination; Subjects to enterohepatic recirculation, 30-60% of the dose taken is excreted with intestinal contents; 30% is excreted by the kidneys in 72 hours (of which 20-30% is unchanged), with severe chronic renal failure, only 1-5%. The half-life (T1 / 2) of minocycline is approximately 16 h.
Indications
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), rickettsiosis vesicular and tick-borne fever; - respiratory tract infections; - lymphogranuloma venereal; - ornithosis; - trachoma (infectious keratoconjunctivitis); - conjunctivitis with inclusions (paratrahoma); - non-gonococcal urethritis, infections of the cervical canal and anus in adults; - cyclic 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 amoebiasis, minocycline may be used as an adjunct to amoebicidal preparations. In severe acne, minocycline can be used as an adjunctive therapy. To prevent the occurrence of resistance, the use of minocycline is recommended in accordance with the results of laboratory tests, including serotyping and edelenie susceptibility. For the same reason, minocycline is not recommended for prophylactic purposes in case of a high risk of meningococcal meningitis. Minocycline oral administration is not recommended for the treatment of meningococcal infections. Clinical experience shows the effectiveness of minocycline in the treatment of Mycobacterium marinum infections, but at present this data is not supported by controlled clinical trials.
Contraindications
- 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 development of teeth); - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. With caution should be prescribed the drug for violations of the liver and kidneys, the simultaneous use of hepatotoxic drugs.
Use during pregnancy and lactation
The use of the drug is contraindicated in pregnancy and lactation.
Dosage and administration
The drug is taken orally after meals. It is recommended to take the capsules with enough liquid (milk can be used) to reduce the risk of irritation and ulceration in the esophagus. The initial dose of the drug Minoleksin; 200 mg (2 caps. 100 mg or 4 caps. 50 mg), then take 100 mg (1 caps. 100 mg or 2 caps. 50 mg.) every 12 hours (2 times / day). The maximum daily dose should not exceed 400 mg.; Infections of the urogenital system and anogenital region caused by chlamydia and ureaplasmas: 100 mg (1 capsule. 100 mg or 2 capsules. 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 each or 2 capsules. 50 mg each) every 12 hours, sometimes in combination with cephalosporins.; Primary syphilis in patients with hypersensitivity to penicillins: 100 mg (1 caps. 100 mg or 2 caps. 50 mg) 2 times / day for 10-15 days.; Gonorrhea: 100 mg (1 caps. 100 m or 2 capsules. 50 mg each) 2 times a day for 4-5 days, or once 300 mg. Uncomplicated gonococcal infections (excluding urethritis and anorectal infections) in men: the initial dose is 200 mg (2 capsules 100 mg or 4 capsules. 50 mg each), supporting - 100 mg (1 capsules 100 mg each or 2 capsules 50 mg each) every 12 hours for at least 4 days, followed by microbiological evaluation of recovery 2-3 days after discontinuation drug.; Uncomplicated gonococcal urethritis in men: 100 mg (1 caps. 100 mg or 2 caps. 50 mg) every 12 hours for 5 days.; Acne rash: 50 mg (1 capsule. 50 mg) per day, a long course of 6-12 weeks; Against the background of the drug, due to the anti-anabolic effect inherent in the drugs groups of tetracyclines, there may be an increase in the level of urea in the blood plasma.In patients with normal renal function, this does not require discontinuation of the drug. In patients with severe impaired renal function, azotemia, hyperphosphatemia, and acidosis may occur. 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 (QA less than 80 ml / min) is currently not well understood to conclude that the dose should be adjusted. For liver dysfunctions, to use the drug with caution. For 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.
Side effects
The spectrum of adverse events associated with taking minocycline, no different from other tetracyclines; 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 the anogenital region, hyperbilirubinemia, cholestasis, increased activity of liver enzymes, liver failure, including terminal, hepatitis, including autoimmune. From the urogenital system: vulvovaginal candidiasis, interstitial nephritis, dose-dependent increase in plasma urea, balanitis. From the skin: baldness, erythema nodosum, nail pigmentation, itchy skin, toxic epidermus vasculitis, makulo-papular 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, limited mobility and swelling of the joints, change in bone color, muscle pain (myalgia) .; Allergic reactions: urticaria, angioedema, polyarthralgia, anaphylactic reactions (including shock), anaphylactoid purpura (Schönlein-Genoha purpura) ), pericarditis, exacerbations of systemic lupus erythematosus, infiltration of the lungs, accompanied by eosinophilia.; From the side of the hemopoietic system: agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutrocytopenia, pancytopenia, eosinopenia, eosinophilia.; Oron CNS: cramps, dizziness, numbness (includingextremities), lethargy, vertigo, increased intracranial pressure in adults, headaches. From the sensory organs: tinnitus and hearing impairment. From the metabolism: a single case of a malignant thyroid gland, color change (according to the results of pathological studies ), dysfunction of the thyroid gland.; Other: discoloration of the oral cavity (tongue, gums, palate), discoloration of tooth enamel, fever, coloring of secretions (for example, sweat).
Overdose
Symptoms: dizziness, nausea and vomiting are most often observed; Treatment: the 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. Hemo - and peritoneal dialysis remove minocycline in small quantities.
Interaction with other drugs
Tetracycline drugs reduce plasma prothrombin activity, which may necessitate a reduction in doses of anticoagulants in patients receiving anticoagulant therapy. Due to the fact that bacteriostatic drugs affect the bactericidal effect of penicillins, concurrent administration of penicillin and tetracycline groups should be avoided. violated when taken simultaneously with antacids containing aluminum, calcium, magnesium or iron-containing preparations, which can leading to a reduction in the effectiveness of antibiotic therapy.; There have been cases of terminal renal toxicity while taking methoxyfrurane and drugs of the tetracycline group.; Taking antibiotics of the tetracycline group and oral contraceptives simultaneously can reduce the effectiveness of contraception. Should be taken isotretinoin immediately, immediately after administration minocycline because both drugs are capable of causing a benign increase in intracranial pressure.; One Taking the drugs of the tetracycline group with ergot alkaloids and their derivatives increases the risk of ergotism.
special instructions
With prolonged use of minocycline, you should regularly monitor the cellular composition of peripheral blood, carry out functional liver function tests, determine serum nitrogen and urea concentrations; When using contraceptive drugs with estrogens during minocycline therapy, you should use additional contraceptives or their combination. catecholamines in the urine when they are determined by the fluorescent method.; In the study of thyroid biopsy in patients, but receiving tetracyclines, you should consider the possibility of a dark-brown staining tissue slides;. While taking the drug, and 2-3 weeks after cessation of treatment may develop diarrhea caused by Clostridium dificile (pseudomembranous colitis). In mild cases, it is enough to cancel treatment and use of ion-exchange resins (Kolestiramine, Colestipol), in severe cases, it is shown to compensate for the loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit intestinal peristalsis.; In order to avoid the development of resistance, minocycline should be used only in accordance with the results of a study of the sensitivity of pathogenic microorganisms. If it is not possible to study the sensitivity of microorganisms, the epidemiology and sensitivity profile of microorganisms in a particular region should be taken into account. In case of sexually transmitted diseases, if you suspect concomitant syphilis, before starting treatment, dark field microscopy studies are necessary. Serological diagnosis of blood serum is recommended at least 1 time in 4 months.; Periodic laboratory diagnosis of body functions is necessary, incl. hematopoietic and renal functions, as well as the state of the liver.; Algorithms of action in the event of some side effects: - in case of development of superinfection, the administration of minocycline must be stopped and adequate therapy prescribed; - in case of increase in intracranial pressure, taking minocycline should be stopped; - diarrhea is a common disorder associated with the administration of antibiotics.In the case of diarrhea during treatment with minocycline, an urgent need to consult a doctor; - antibiotics of the tetracycline group cause an increase in sensitivity to direct solar and ultraviolet radiation. In case of erythema, the antibiotic should be stopped.; Influence on the ability to drive vehicles and control mechanisms; Care should be taken when driving and doing other potentially hazardous activities that require increased concentration and psychomotor reactions, due to the fact that minocycline has a side effect such as dizziness.