Instructions for Unidox Solutab
Composition:
Active ingredient: doxycycline monohydrate in terms of doxycycline - 100.0 mg;
Excipients: microcrystalline cellulose - 45.0 mg,
saccharin - 10.0 mg,
hyprolose (low substituted) - 18.75 mg,
hypromellose - 3.75 mg,
colloidal silicon dioxide (anhydrous) - 0.625 mg,
magnesium stearate - 2, 0 mg,
lactose monohydrate - up to 250.0 mg.
Pharmacodynamics Unidox Solutab:
A broad-spectrum from the tetracycline group. It acts bacteriostatically, inhibits protein synthesis in a microbial cell by interacting with the 30S subunit of ribosomes. Active against many gram-positive and gram-negative microorganisms: Streptococcus spp., Treponema spp., Staphylococcus spp., Klebsiella spp., Enterobacter spp. (including E. aerugenes), Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Chlamydia spp., Mycoplasma spp., Ureaplasma urealyticum, Listeria monocytogenes, Rickettsia spp.,
Typhus exanthematicus, Shigeribella coli campiella colifida colibella Yersinia spp. (including Yersinia pestis), Brucella spp., Francisella tularensis, Bacillus anthracis, Bartonella bacilliformis, Pasteurella multocida, Borrelia recurrentis, Clostridium spp. (except Clostridium difficile), Actinomyces spp., Fusobacterium fusiforme, Calymmatobacterium granulomatosis, Propionibacterium acnes, some protozoa (Entamoeba spp., Plasmodium falciparum). As a rule, it does not affect Acinetobacter spp., Proteus spp., Pseudomonas spp., Serratia spp., Providencia spp., Enterococcus spp. It is necessary to take into account the possibility of acquired resistance to doxycycline in a number of pathogens, which is often cross-within the group (i.e., doxycycline resistant strains will simultaneously be resistant to the entire tetracycline group).
Pharmacokinetics Unidox Solutab:
Suction Absorption - fast and high (about 100%). Eating slightly affects the absorption of the drug Unidox Solutab. The maximum level of doxycycline in blood plasma (2.6-3 μg / ml) is achieved 2 hours after taking 200 mg, after 24 hours the concentration of the active substance in blood plasma decreases to 1.5 μg / ml. After taking 200 mg on the first day of treatment and 100 mg per day on subsequent days, the concentration level of doxycycline in the blood plasma is 1.5-3 μg / ml. Distribution Doxycycline/Unidox Solutab binds reversibly to plasma proteins (80-90%), penetrates well into organs and tissues, poorly into cerebrospinal fluid (10-20% of the level in blood plasma), however, the concentration of doxycycline in cerebrospinal fluid increases with inflammation of the spinal membrane.
Distribution volume - 1,58 l / kg. 30-45 minutes after oral administration, doxycycline/Unidox Solutab is found in therapeutic concentrations in the liver, kidneys, lungs, spleen, bones, teeth, prostate gland, eye tissues, pleural and ascitic fluids, bile, synovial exudate, maxillary and frontal sinus exudate, in fluid gingival fissures. With normal liver function, the level of the drug in bile is 5-10 times higher than in plasma. In saliva, 5-27% of the concentration of doxycycline in the blood plasma is determined. Doxycycline crosses the placental barrier and is secreted in breast milk in small amounts. Accumulates in dentin and bone tissue. Metabolism An insignificant part of doxycycline is metabolized. Withdrawal The half-life after a single oral administration is 16-18 hours, after taking repeated doses - 22-23 hours. About 40% of the drug Unidox Solutab taken is excreted by the kidneys and 20-40% is excreted through the intestines in the form of inactive forms (chelates).
Pharmacokinetics in special clinical cases, the half-life of the drug in patients with impaired renal function does not change, because its excretion through the intestines increases. Hemodialysis and peritoneal dialysis do not affect the concentration of doxycycline in blood plasma.
Side effects Unidox Solutab:
From the gastrointestinal tract: anorexia, nausea, vomiting, dysphagia, diarrhea, anal itching, esophagitis, esophageal ulcer, dark staining of the tongue. With prolonged therapy, a deficiency of B vitamins may be observed due to the suppression of the growth of vitamin B-producing bacteria in the normal intestinal microflora. Allergic reactions: exacerbation of systemic lupus erythematosus, a syndrome similar to serum sickness, erythema multiforme, decreased blood pressure, tachycardia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome).
From the skin: urticaria, photosensitivity, angioedema, anaphylactic reactions, maculopapular and erythematous rashes, exfoliative dermatitis, Schonlein-Genoch purpura, photo-nicholysis. From the cardiovascular system: pericarditis. From the liver: liver damage, sometimes associated with pancreatitis (with prolonged use of the drug or in patients with renal or hepatic insufficiency), cholestasis.
On the part of the kidneys: an increase in residual urea nitrogen due to the anti-anabolic effect of the drug Unidox Solutab, aggravation of azotemia in patients with renal failure.
The use of products containing citric acid while taking doxycycline can cause symptoms similar to Fanconi's syndrome: albuminuria, glucosuria, hypophosphatemia, hypokalemia and renal tubular acidosis. From the hemopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, a decrease in prothrombin activity. From the side of the nervous system: benign increase in intracranial pressure (anorexia, vomiting, headache, tinnitus, tremors, swelling of the optic nerve), vestibular disorders (dizziness or instability), hallucinations, blurred vision, scotoma, double vision.
From the thyroid gland: in patients who have been receiving from the tetracycline group for a long time, a reversible dark brown staining of the thyroid gland tissue is possible, in most cases not accompanied by a violation of its function. From the side of teeth and bones: doxycycline slows down osteogenesis, disrupts the normal development of teeth in children (the color of teeth changes irreversibly, enamel hypoplasia develops). From the musculoskeletal system: arthralgia, myalgia. Other: Superinfection: candidiasis, glossitis, staphylococcal enterocolitis, pseudomembranous colitis, anogenital candidiasis, stomatitis, and vaginitis.
Special conditions:
There is the possibility of cross-resistance and hypersensitivity with other tetracycline drugs Unidox Solutab. Tetracyclines can increase prothrombin time; the administration of tetracyclines in patients with coagulopathies should be closely monitored. The anti-anabolic effect of tetracyclines can lead to an increase in the concentration of residual urea nitrogen in the blood. As a rule, this is not significant for patients with normal renal function. However, in patients with renal failure, an increase in azotemia may be observed.
The use of tetracyclines in patients with impaired renal function requires medical supervision. With prolonged use of the drug Unidox Solutab, periodic monitoring of laboratory blood parameters, liver and kidney function is required. In connection with the possible development of photodermatitis, it is necessary to limit insolation during treatment and within 4-5 days after it. When using the drug Unidox Solutab, both on the background of taking it, and 2-3 weeks after stopping treatment, it is possible to develop diarrhea caused by Clostridium dificile. In mild cases, discontinuation of treatment and the use of ion-exchange resins (colestyramine, colestipol) is sufficient, in severe cases, compensation for the loss of fluid, electrolytes and protein, the appointment of vancomycin or metronidazole are indicated. Do not use drugs Unidox Solutab that inhibit intestinal motility. Prolonged use of the drug can cause intestinal dysbiosis and, as a result, the development of hypovitaminosis (B vitamins).
To prevent dyspeptic phenomena, it is recommended to take the drug with food. In order to avoid the development of esophagitis or ulcers of the esophagus, it is necessary to take the drug with plenty of water and to avoid the use of the drug Unidox Solutab immediately before bedtime. Influence on the ability to drive vehicles and work with mechanisms The effect on the ability to drive vehicles, machines and mechanisms is unknown. In the case of dizziness, blurred vision or double vision, driving vehicles or machinery is not recommended. See Side effects - From the side of the nervous system.
Indications Unidox Solutab:
- Infectious and inflammatory diseases caused by microorganisms sensitive to the drug Unidox Solutab:
- respiratory tract infections,
- including pharyngitis,
- acute bronchitis,
- exacerbation of chronic obstructive pulmonary disease,
- tracheitis,
- bronchopneumonia,
- lobar pneumonia,
- community-acquired pneumonia,
- lung abscess,
- pleural empyema;
- infections of ENT organs,
- including otitis media,
- sinusitis, tonsillitis;
- urogenital system infections:
- cystitis, pyelonephritis,
- bacterial prostatitis,
- urethritis,
- urethrocystitis,
- urogenital mycoplasmosis,
- acute orchiepididymitis;
- endometritis,
- endocervicitis and salpingo-oophoritis in combination therapy;
- including sexually transmitted infections:
- urogenital chlamydia,
- syphilis in patients with penicillin intolerance,
- uncomplicated gonorrhea (as an alternative therapy),
- inguinal granuloma,
- venereal lymphogranuloma;
- infections of the gastrointestinal tract and biliary tract (cholera, yersiniosis, cholecystitis, cholangitis, gastroenterocolitis, bacillary and amoebic dysentery, diarrhea of "travelers"); - infections of the skin and soft tissues (including wound infections after an animal bite), severe acne (as part of combination therapy);
- other diseases:
- phrambesia,
- legionellosis,
- chlamydia of various localization (including prostatitis and proctitis), rickettsiosis,
- Q fever,
- Rocky Mountain spotted fever,
- typhus (including rash, tick-borne relapsing),
- Lyme disease (I Art. -erythema migrans),
- tularemia, plague, actinomycosis,
- malaria;
- infectious eye diseases, as part of combination therapy
- trachoma;
- leptospirosis,
- psittacosis,
- ornithosis,
- anthrax (including pulmonary form), bartonellosis, granulocytic ehrlichiosis;
- whooping cough,
- brucellosis,
- osteomyelitis;
- sepsis,
- subacute septic
- endocarditis,
- peritonitis;
- Prevention of postoperative purulent complications; malaria caused by Plasmodium falciparum during short trips (less than 4 months) in the territory where strains resistant to chloroquine and / or pyrimethamine sulfadoxine are common.
Contraindications Unidox Solutab:
- Hypersensitivity to doxycycline, other tetracyclines or other components of the drug Unidox Solutab
- pregnancy
- period of breastfeeding
- children under 8 years of age - severe hepatic and / or renal impairment
- porphyria - lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Use during pregnancy and during breastfeeding Doxycycline crosses the blood-placental barrier. Tetracyclines have an adverse effect on the fetus (slowing down osteogenesis) and on the formation of tooth enamel (irreversible discoloration, hypoplasia). In view of this, as well as an increased risk of maternal liver damage, tetracyclines are not used during pregnancy, unless the drug Unidox Solutab is the only way to treat or prevent especially dangerous and severe infections (spotty rocky fever, inhaled exposure to Bacillus anthracis, etc.).
- Before prescribing doxycycline to women of childbearing age, pregnancy should be excluded beforehand. Doxycycline passes into breast milk. Due to the adverse effects on the fetus, doxycycline, like other tetracyclines, is not used during breastfeeding. If the appointment of tetracyclines is necessary, breastfeeding ceases.
Drug Interactions Unidox Solutab:
Antacids containing aluminum, magnesium, calcium, iron preparations, sodium bicarbonate, magnesium-containing laxatives reduce the absorption of doxycycline, so their use should be divided by an interval of 3 hours. Due to the suppression of doxycycline intestinal microflora, the prothrombin index decreases, which requires an indirect dose adjustment anticoagulants. With the combination of doxycycline with bactericidal that disrupt the synthesis of the cell wall (penicillins, cephalosporins), the effectiveness of the latter decreases.
Doxycycline reduces the reliability of contraception and increases the frequency of acyclic bleeding when taking estrogen-containing hormonal contraceptives. Ethanol, barbiturates, rifampicin, carbamazepine, phenytoin and other stimulators of microsomal oxidation, accelerating the metabolism of doxycycline, reduce its concentration in blood plasma. The simultaneous use of doxycycline and retinol increases intracranial pressure.
Dosage Unidox Solutab:
Inside. Typically, the duration of treatment is 5-10 days. Immediately before use, the tablet should be dissolved in a small amount of water (at least 50 ml) and mixed thoroughly until a suspension is obtained. The resulting suspension must be taken immediately after preparation. It is preferable to take with food. Take the suspension while sitting or standing, long before bedtime, which reduces the likelihood of developing esophagitis and esophageal ulcers. Adults and children over 8 years old with a body weight of more than 50 kg are prescribed 200 mg in 1-2 doses on the first day of treatment, then 100 mg daily. In cases of severe infections, the drug Unidox Solutab® is prescribed at a dose of 200 mg daily during the entire treatment. For children of 8-12 years old with a body weight of less than 50 kg, the average daily dose is 4 mg / kg on the first day, then 2 mg / kg per day (in 1-2 doses). In cases of severe infection, the drug Unidox Solutab is prescribed at a dose of 4 mg / kg daily during the entire treatment. Features of dosing for certain diseases In case of infection caused by S.pyogenes, the drug Unidox Solutab is taken for at least 10 days. For uncomplicated gonorrhea (with the exception of anorectal infections in men): adults are prescribed 100 mg twice a day until they are completely cured (on average for 7 days), or within one day, 600 mg is prescribed - 300 mg in 2 divided doses (second reception 1 hour after the first). With primary syphilis, 100 mg is prescribed twice a day for 14 days, with secondary syphilis - 100 mg twice a day for 28 days. In uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg 2 times a day are prescribed for 7 days. With acne, 100 mg / day is prescribed, the course of treatment is 6-12 weeks. Malaria (prevention): 100 mg once a day 1-2 days before the trip, then daily during the trip and for 4 weeks after return; children over 8 years old at 2 mg / kg 1 time per day. The duration of prevention should not exceed 4 months. Diarrhea of "travelers" (prevention) - 200 mg on the first day of the trip (for 1 dose or 100 mg 2 times a day), then 100 mg 1 time per day for the entire stay in the region (no more than 3 weeks). Treatment of leptospirosis - 100 mg orally 2 times a day for 7 days; prevention of leptospirosis - 200 mg once a week during a stay in a disadvantaged area and 200 mg at the end of the trip. In order to prevent infections in medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention. The maximum daily dose for adults is up to 300 mg / day or 600 mg / day for 5 days with severe gonococcal infection. For children over 8 years old with a body weight of more than 50 kg - up to 200 mg, for children of 8-12 years old with a body weight of less than 50 kg - 4 mg / kg daily for the entire treatment period. In the presence of renal (creatinine clearance less than 60 ml / min) and / or liver failure, a reduction in the daily dose of doxycycline is required, since this gradually accumulates in the body (risk of hepatotoxicity).
Overdose Unidox Solutab:
Symptoms: Strengthening of adverse reactions caused by liver damage - vomiting, fever, jaundice, azotemia, increased transaminases, increased prothrombin time. Treatment: Immediately after taking large doses, gastric lavage, heavy drinking are recommended, and if necessary, inducing vomiting. Take activated charcoal and osmotic laxatives. Hemodialysis and peritoneal dialysis are not recommended due to low efficacy.
