Minolexin - instructions for use, dose, side effects, contraindications

Active substanceMinocyclineMinocycline

Similar drugsTo uncover

capsules inwards

Dosage form: & nbspCapsules.

Composition:Active substance: minocycline hydrochloride dihydrate (in terms of, minocycline) 50 mg or 100 mg.
Excipients: cellulose microcrystalline (73.5 mg / 147.0 mg), povidone low molecular weight (8.75 mg / 17.5 mg), potato starch (7.0 mg / 14.0 mg), magnesium stearate (1.75 mg / 3.5 mg), lactose monohydrate (up to 175.0 mg / 350.0 mg).
Hard gelatine capsules:
for 50 mg: water (13-16%), dye quinoline yellow (0.5833% - 0.75%), dye sunset yellow (E110) (0.0025% 0.0059%), titanium dioxide (0.9740% 2.0%), gelatin (up to 100%).
for 100 mg: water (13 - 16%), titanium dioxide (2.0% - 2.11118%), gelatin (up to 100%).

Description:Hard gelatin capsules №2 with a case and a lid of yellow color (for a dosage of 50 mg), №0 with a case and a lid of white color (for a dosage of 100 mg). The contents of the capsules are a yellow powder.

Pharmacotherapeutic group:Antibiotic-tetracycline.

ATX: & nbsp

J.01.A.A.08 Minocycline

Pharmacodynamics:Semisynthetic antibiotic from the group of tetracyclines. It has a bacteriostatic effect on cells of sensitive strains of microorganisms due to reversible inhibition of protein synthesis at the level of 30S subunits of ribosomes. Has a wide range of antibacterial activity.
Sensitivity of microorganisms:
Aerobic Gram positive:
Some of the microorganisms listed below showed resistance to minocycline, so a laboratory sensitivity test is recommended before use. 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.
- Bacillus anthracis
- Listeria monocytogenes
- Staphylococcus aureus
- Streptococcus pneumoniae
Aerobic literate:
- Bartonella bacilliformis
- Brucella species
- Calymmatobacterium granulomatis
- Campylobacter fetus
- Francisella tularensis
- Haemophilus ducreyi
- Vibrio cholerae
- Yersinia pestis
For the following microorganisms, it is strongly recommended that studies of sensitivity to minocycline:
- 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 acnes
- Rickettsiae
- Treponema pallidum subspecies pallidum
- Treponema pallidum subspecies pertenue
- Ureaplasma urealyticum

Pharmacokinetics:The intake of food does not significantly affect the degree of absorption of minocycline. Minocycline has a high degree of lipid solubility and low affinity for the binding of Ca²⁺. Quickly absorbed from the digestive tract in proportion to the dose taken. The maximum concentration of minocycline in the blood plasma (C_max) after ingestion of 200 mg is 3.5 mg / l and is achieved (t_max) in 2-4 hours. Binding to blood proteins is 75%, the effect of various diseases on this parameter has not been investigated.
The volume of distribution is 0.7 l / kg. Minocycline well penetrates into organs and tissues: 30 - 45 minutes after ingestion is found in therapeutic concentrations in the kidneys, spleen, eye tissues, pleural and ascitic fluids, synovial exudate, exudate, maxillary and frontal sinuses, in the fluid of the gingival sulci. It penetrates well into the cerebrospinal fluid (20 - 25% of the level determined in the plasma). Passes through the placenta, penetrates into the mother's milk.
With repeated administration, the drug can accumulate. It accumulates in the reticulo-endothelial system and bone tissue. In bones and teeth forms insoluble complexes with Ca²⁺. It is subject to enterohepatic recirculation, 30-60% of the accepted dose is excreted with intestinal contents; 30% is excreted by the kidneys for 72 hours (of which 20-30% is unchanged), with severe chronic renal failure - only 1-5%. Half-life (T_1/2) minocycline is approximately 16 hours.

Indications:Minocycline hydrochloride is used to treat the following diseases, subject to the sensitivity of pathogenic microorganisms:
- Acne disease
- Skin Infections
- Spotted fever, typhoid fever, typhoid fever, fever Ku (koksiellosis), rickettsiosis vesiculosis and tick fever
- Respiratory tract infections
- Lymphogranuloma venereal
- Ornithosis
- Trachoma (infectious keratoconjunctivitis)
- Conjunctivitis with inclusions (paratrahoma)
- Non-gonococcal urethritis, infection of the cervical canal and anus in adults
- Cyclical fever
- Shankroyd
- 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 is acceptable as an adjunct to amoebicidal drugs.
In severe form of acne minocycline can be used as an adjunctive therapy.
Oral administration of minocycline is indicated in the asymptomatic carriage 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 sensitivity determination of pathogens. For the same reason, the use of minocycline is not recommended for prophylactic purposes in the case of a high risk of meningococcal meningitis.
Oral administration of minocycline is not recommended for the treatment of meningococcal infections.
The clinical experience shows the effectiveness of minocycline in the treatment of infections of Mycobacterium marinum, however, these data are not currently supported by the results of controlled clinical trials.

Contraindications:- Hypersensitivity to minocycline, tetracyclines and other components of the drug
- Porphyry
- Severe hepatic and renal insufficiency
- Leukopenia
- Pregnancy
- Breast-feeding
- Systemic lupus erythematosus
- Children under 8 years (period of development of teeth)
- Simultaneous reception with isotretinoin
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption

Carefully:Dysfunction of the liver and kidneys, simultaneous use with hepatotoxic drugs.

Dosing and Administration:Inside, after eating. It is recommended to drink plenty of liquid (you can milk) to reduce the risk of irritation and ulceration in the esophagus.
The initial dose of the drug Minolexin® is 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg), then 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours (twice a day) .
The maximum daily dose should not exceed 400 mg.
Infections of the genitourinary system and anogenital area caused by chlamydia and ureaplasmas: 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 acute stages: 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours, sometimes in combination with cephalosporins.
Primary syphilis in patients with hypersensitivity to penicillin: 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) twice a day for 10-15 days.
Gonorrhea: 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) twice a day for 4-5 days, or once 300 mg.
Uncomplicated gonococcal infections (excluding urethritis and anorectal infections) in men: the initial dose of 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg), supporting - 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours for a minimum of 4 days followed by a microbiological evaluation of recovery within 2-3 days after discontinuation of the drug. Uncomplicated gonococcal urethritis in men: 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours for 5 days.
Acne: 50 mg (1 capsule of 50 mg) per day, a long course of 6-12 weeks.
Against the background of taking the drug, because of the anti-anabolic effect inherent in the drugs of the tetracycline group, an increase in the level of urea in the blood plasma can be observed. In patients with normal renal function, this does not require withdrawal of the drug. In patients with severe renal dysfunction, development of azotemia, hyperphosphataemia, and acidosis may occur. In this situation, control of the level of urea and creatinine in the blood plasma is necessary, and the maximum daily dose of minocycline should not exceed 200 mg.
The pharmacokinetics of minocycline in patients with renal insufficiency (creatinine clearance less than 80 ml / min) is currently insufficiently studied,to draw a conclusion about the need to correct a dose.
For violations of liver function, use with caution.
Children older than 8 years with infections caused by minocycline-sensitive pathogens: the initial dose is 4 mg / kg, then 2 mg / kg every 12 hours.

Initial

dose

Supportive

dose

Children weighing more than 25 kg

100 mg (1 capsule of 100 mg or 2 capsules of 50 mg each)

50 mg (1 capsule of 50 mg) every 12 hours

Side effects:The spectrum of adverse events associated with taking minocycline does not differ from other tetracyclines.
From the digestive system: anorexia,. nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, dental enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (including fungal) in the oral cavity and anogenital area, hyperbilirubinemia, cholestasis, increased content of "hepatic "Enzymes, liver failure, including terminal, hepatitis, including autoimmune.
From the genitourinary system: candidiasis vulvovaginitis, interstitial nephritis, dose-dependent increase in urea in the blood plasma.
From the skin: alopecia, erythema nodosum, nail pigmentation, pruritus, toxic epidermal necrosis, vasculitis, maculopapular and erythematous rash, Stevens-Johnson syndrome, exfoliative dermatitis, balanitis.
From the respiratory tract: shortness of breath, bronchospasm, exacerbations 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, angioneurotic edema, polyarthralgia, anaphylactic reactions (including shock), anaphylactoid purpura (Purple Shenlaine-Genocha), pericarditis, exacerbations of systemic lupus, lung infiltration accompanied by eosinophilia.
From the hematopoiesis: agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutrocytopenia, pancytopenia, eosinopenia, eosinophilia.
From the central nervous system: convulsions, dizziness, numbness (including limbs), inhibition, vertigo, increased intracranial pressure in adults, headaches.
From the sense organs: noise in the ears and hearing loss.
From the side of metabolism: Thyroid gland: a single case of malignant neoplasm, color change (according to the results of patho-morphological studies), impaired function.
Other:
Discolouration of the oral cavity (tongue, gums, palate), discoloration of tooth enamel, fever, color precipitates (e.g., sweat).

Overdose:Symptoms: most often there is dizziness, nausea and vomiting.
Treatment: The selective antidote for minocycline is currently unknown.
In case of an overdose, it is necessary to stop taking the drug, provide symptomatic treatment and supportive therapy. Haemo- and peritoneal dialysis is excreted minocycline in small quantities.

Interaction:tetracycline drugs reduce prothrombin activity of the blood plasma, which may cause a need to reduce the dose of anticoagulants in patients undergoing anticoagulation therapy.
Due to the fact that the bacteriostatic effect on the bactericidal action of penicillin, it is necessary to avoid simultaneous prescribing penicillin and tetracycline.
The absorption of tetracyclines is impaired when taken concomitantly with antacids containing aluminum, calcium, magnesium or iron containing preparations, which may lead to a decrease in the effectiveness of antibiotic therapy.
There have been cases of terminal renal toxicity with simultaneous administration of methoxyfuran and preparations of the tetracycline group.
The simultaneous administration of antibiotics of the tetracycline group and oral contraceptives can lead to a decrease in the effectiveness of contraception.
Avoiding isotretinoin immediately before, at the same time and immediately after taking minocycline, because both drugs can cause a benign increase in intracranial pressure.
Simultaneous administration of tetracyclines with ergot alkaloids and their derivatives increases the risk of ergotism.

Special instructions:With prolonged use of minocycline, the cellular composition of peripheral blood should be monitored regularly, functional liver tests performed, the concentration of nitrogen and urea in the serum determined.
When using contraceptive medications with estrogen during the therapy with minocycline, additional contraceptive methods or their combination should be used.
There may be a false increase in the level of catecholamines in urine when determined by the fluorescent method.
In the study of the thyroid biopsy in patients who have received tetracyclines for a long time, the possibility of dark brown staining of the tissue in micropreparations should be taken into account.
Against the background of taking the drug and 2-3 weeks after stopping treatment, it is possible to develop diarrhea caused by Clostridium dificile (pseudomembranous colitis). In mild cases, it is sufficient to discontinue treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit the intestinal motility.
To avoid the development of resistance, apply minocycline should only be in accordance with the results of a study of the sensitivity of pathogenic microorganisms. If the study of the sensitivity of microorganisms is not possible, epidemiology and sensitivity profile of microorganisms in a particular region should be taken into account.
In the case of sexually transmitted diseases, with suspected concomitant syphilis, before the start of treatment it is necessary to conduct a study using the method of microscopy in a dark field. Serological diagnosis of serum is recommended at least once every four months.
Periodic laboratory diagnostics of body functions, including hematopoietic and renal functions, as well as liver conditions are necessary. "
Algorithms of action in the event of some side effects:
In the case of superinfection, minocycline should be discontinued and adequate therapy prescribed.
In the case of increased intracranial pressure, minocycline should be discontinued.
Diarrhea is a common disorder associated with taking antibiotics. In case of diarrhea during treatment with minocycline, it is necessary to urgently consult a doctor.
Antibiotics of the tetracycline group cause an increase in sensitivity to direct sunlight and ultraviolet radiation. In case of erythema, stop taking the antibiotic.

Effect on the ability to drive transp. cf. and fur: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 ,. in connection with the fact that minocycline has a side effect such as dizziness (see section "Side effect").

Form release / dosage:Capsules 50 mg and 100 mg.

Packaging:10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil.
For 2 or 3 contour squares, together with the instructions for use, are placed in a pack of cardboard.

Storage conditions:In a place protected from moisture and light, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001666

Date of registration:20.04.2012

Expiration Date:20.04.2017

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp2016-12-11

Illustrated instructions

Instructions

Minolexin® (Minolexin)