Unidox Solutab 100mg soluble pills N10
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Active ingredients
Doxycycline
Composition
Doxycycline monohydrate, in terms of doxycycline 100 mg. Excipients: microcrystalline cellulose - 45 mg, saccharin - 10 mg, hyprolosis (low-substituted) - 18.75 mg, hypromellose - 3.75 mg, silicon dioxide colloidal (anhydrous) - 0.625 mg, magnesium stearate - 2 mg, lactose monohydrate - up to 250 mg.
Pharmacological effect
An antibiotic is a long-acting broad-spectrum tetracycline. It acts bacteriostatic, inhibits protein synthesis in a microbial cell by interacting with the 30S subunit of ribosomes. Active against gram-positive and gram-negative aerobic and anaerobic bacteria: Streptococcus spp., Staphylococcus spp., Klebsiella spp., Enterobacter spp. (including Enterobacter aerugenes), Neisseria gonorrhoeae, Neisseria meningitidis, meetians, mexico, mexico, mexico spp., oasis, listeria 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, Treponema spp., Typhus exanthematicus; Some protozoa: Entamoeba spp., Plasmodium falciparum. As a rule, not active against Acinetobacter spp., Proteus spp., Pseudomonas spp., Serratia spp., Providencia spp., Enterococcus spp. The possibility of acquired resistance to doxycycline in a number of pathogens, which is often cross-cutting within a group (ie, strains resistant to doxycycline, will simultaneously be resistant to the entire group of tetracyclines) should be taken into account.
Pharmacokinetics
Absorption Absorption - fast and high (100%). Food intake slightly affects the absorption of the drug, which has no clinical significance. Doxycycline Cmax in plasma (2.6–3 mcg / ml) is reached 2 hours after taking 200 mg, and after 24 hours, the concentration of the active substance in blood plasma is reduced to 1.5 mcg / ml. After receiving 200 mg on the first day of treatment and 100 mg / day on the following days, the concentration of doxycycline in the blood plasma is 1.5-3 μg / ml. Distribution Doxycycline binds reversibly to plasma proteins (80–90%), penetrates well into tissues, and poorly into cerebrospinal fluid (10–20% of plasma concentration), however, the concentration of doxycycline in the cerebrospinal fluid increases with inflammation of the spinal cord. Vd - 1.58 L / kg. After 30-45 minutes after ingestion, doxycycline is found in therapeutic concentrations in the liver, kidneys, lungs, spleen, bones, teeth, prostate gland, eye tissue, pleural and ascitic fluids, bile, synovial exudate, maxillary and frontal sinuses exudate, gum furrow fluids.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 plasma is determined. Doxycycline penetrates the placental barrier, is secreted in small quantities into breast milk. Accumulates in the dentin and bone tissue. Metabolism Only a small fraction of doxycycline is metabolized. Removal of T1 / 2 after a single intake is 16-18 hours, after receiving repeated doses - 22-23 hours. Approximately 40% of the dose taken is biologically active by tubular secretion in the kidneys, 20-40% is excreted through the intestine as inactive forms (chelates). The pharmacokinetics in special clinical cases of T1 / 2 doxycycline in patients with impaired renal function does not change, since its excretion through the intestines increases. Hemodialysis and peritoneal dialysis do not affect the plasma concentration of doxycycline.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - 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 upper respiratory tract (including otitis, sinusitis, tonsillitis); - infections of the genitourinary system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingo-oophoritis / as part of a combination therapy /); - sexually transmitted infections (urogenital chlamydia, syphilis in patients with penicillin intolerance, uncomplicated gonorrhea / as an alternative therapy /, inguinal granuloma, sexually transmitted lymphogranuloma); - infections of the digestive tract and biliary tract (cholera, yersiniosis, cholecystitis, cholangitis, gastroenterocolitis, bacillary and amoebic dysentery, travelers' diarrhea); - infections of the skin and soft tissues (including wound infections after animal bites), severe acne (as part of combination therapy); - other diseases: frambesia, legionellosis, chlamydia of various localization (including prostatitis and proctitis), rickettsiosis, Q fever, spotty fever of the Rocky Mountains, typhoid fever (includingsypnya, tick-borne recurrent), Lyme disease (stage I) - erythema migrans /, tularemia, plague, actinomycosis, malaria, leptospirosis, psittacosis, ornithosis, anthrax (including pulmonary form), bartonellosis, granulocytic erythiosis, musculosis, cocoon brucellosis; - Infectious eye diseases (as part of combination therapy) - trachoma; - osteomyelitis; - sepsis; - Subacute septic endocarditis; - peritonitis. Prevention of postoperative purulent complications and malaria caused by Plasmodium falciparum during short trips (less than 4 months) in an area where chloroquine and / or pyrimethamine sulfadoxine resistant strains are common.
Contraindications
- severe violations of the liver and / or kidneys; - porphyria; - pregnancy; - lactation period (breastfeeding); - children's age up to 8 years; - hypersensitivity to antibiotics of the tetracycline group.
Use during pregnancy and lactation
Doxycycline penetrates the hemato-placental barrier. Tetracyclines have an adverse effect on the fetus (slowing down of osteogenesis) and on the formation of tooth enamel (irreversible discoloration, hypoplasia). Because of this, as well as an increased risk of liver damage to the mother, tetracyclines are not used during pregnancy unless the drug is the only way to treat or prevent particularly dangerous and serious infections (rocky mountain fever, inhalation effects of Bacillus anthracis, and others). Before the appointment of doxycycline in women of childbearing age, pregnancy should be ruled out. Doxycycline penetrates into breast milk. Due to adverse effects on the fetus, doxycycline, like other tetracyclines, is not used during breastfeeding. If the prescription of tetracyclines is necessary, breastfeeding should be discontinued.
Dosage and administration
The pills are dispersed (dissolved) in a small amount of water (about 20 ml) to form a suspension. Tablets can also be swallowed whole, divided into parts or chewed, drinking water. The drug is preferably taken with meals. Take the pill while sitting or standing, which reduces the likelihood of esophagitis and esophageal ulcers. The drug should not be taken immediately before bedtime. Usually the duration of treatment is 5-10 days.Adults and children over 8 years old with a body weight of more than 50 kg are prescribed 200 mg / day in 1 or 2 doses on the first day of treatment, and in the following days of treatment - 100 mg / day in 1 dose. In the case of severe infections, 200 mg / day is prescribed for the entire period of treatment. For children aged 8-12 years with a body weight less than 50 kg, the average daily dose is 4 mg / kg on the first day, then 2 mg / kg / day (in 1-2 doses). In cases of severe infections, the drug is prescribed at a dose of 4 mg / kg daily throughout the treatment. For infections caused by Streptococcus pyogenes, the duration of treatment is at least 10 days. With uncomplicated gonorrhea (with the exception of anorectal infections in men), adults are prescribed 100 mg 2 times / day until they are completely cured (an average of 7 days), or 600 mg are prescribed in one day, 300 mg in 2 divided doses 1 h after the first). In primary syphilis, 100 mg is prescribed 2 times / day for 14 days, and in secondary syphilis, 100 mg 2 times / day for 28 days. For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg 2 times / day are prescribed for 7 days. For acne, 100 mg / day is prescribed, the course of treatment is 6-12 weeks. For malaria prophylaxis, 100 mg is prescribed 1 time per day 1-2 days before the trip, then daily during the trip and for 4 weeks after returning; children over 8 years old - 2 mg / kg 1 time / day. The duration of prevention should not exceed 4 months. For the prevention of travelers' diarrhea, 200 mg on the first day of a trip in 1 or 2 doses, then 100 mg 1 time per day during the entire stay in the region (no more than 3 weeks). For the treatment of leptospirosis - 100 mg orally 2 times / day for 7 days; for the prevention of leptospirosis, 200 mg once a week during a stay in a deprived area and 200 mg at the end of the trip. In order to prevent infections in a medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention. The maximum daily doses for adults are up to 300 mg / day or up to 600 mg / day for 5 days with severe gonococcal infections. For children over 8 years old weighing more than 50 kg - up to 200 mg, for children 8-12 years old with a body weight less than 50 kg - 4 mg / kg daily during the entire treatment. In case of renal (QC less than 60 ml / min) and / or hepatic insufficiency, a decrease in the daily dose of doxycycline is required, as this results in its gradual accumulation in the body (risk of a hepatotoxic action).
Side effects
On the part of the digestive system: anorexia, nausea, vomiting, dysphagia, diarrhea, enterocolitis, pseudomembranous colitis, esophagitis, esophagus ulcer, dark staining of the tongue, liver damage (during long-term use or in patients with renal or hepatic insufficiency), cholestasis. Dermatological reactions: photosensitization, maculopapular and erythematous rash, exfoliative dermatitis. Allergic reactions: urticaria, angioedema, anaphylactic reactions, exacerbation of systemic lupus erythematosus, pericarditis, a syndrome similar to serum sickness, erythema multiforme. On the part of the hematopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity. On the part of the endocrine system: in patients who received doxycycline for a long time, there is a possible reversible dark brown staining of the thyroid tissue. On the part of the central nervous system: a benign increase in intracranial pressure (anorexia, vomiting, headache, swelling of the optic nerve), vestibular disorders (dizziness or instability), blurred vision, double vision. From the urinary system: an increase in residual urea nitrogen (due to anti-anabolic effect). From the musculoskeletal system: doxycycline slows down osteogenesis, disrupts the normal development of teeth in children (irreversibly changes the color of teeth, enamel hypoplasia develops). Other: candidiasis (glossitis, stomatitis, proctitis, vaginitis) as manifestations of superinfection.
Overdose
Symptoms: increased adverse reactions caused by damage to the liver - vomiting, fever, jaundice, azotemia, increased levels of transaminases, an increase in prothrombin time. Treatment: immediately after taking large doses, gastric lavage is recommended, abundant drinking, if necessary, induction of vomiting. Take activated carbon and osmotic laxatives. Hemodialysis and peritoneal dialysis are not recommended due to low effectiveness.
Interaction with other drugs
Antacids containing aluminum, magnesium, calcium, iron preparations, sodium bicarbonate, magnesium-containing laxatives reduce the absorption of doxycycline, so their use should be separated by a 3-hour interval.In connection with the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants. When doxycilin is combined with bactericidal antibiotics that violate cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter decreases, which should be considered when treating meningitis and tonsillofaringitis caused by Streptococcus pyogenes. Doxycycline reduces the reliability of contraception and increases the frequency of acyclic bleeding when taking estrogen-containing hormonal contraceptives. Ethanol, barbiturates, rifampicin, carbamazepine, phenytoin, accelerating the metabolism of doxycycline, reduce its concentration in the blood plasma. The simultaneous use of doxycycline and retinol contributes to the increase in intracranial pressure.
special instructions
There is a possibility of cross-resistance and hypersensitivity with other drugs of the tetracycline series. Tetracyclines can increase prothrombin time, the prescription of tetracyclines in patients with coagulopathy should be carefully controlled. The anti-anabolic effect of tetracyclines can lead to an increase in the level of residual urea nitrogen in the blood. As a rule, this is not essential for patients with normal renal function. However, patients with renal insufficiency may experience an increase in azotemia. The use of tetracyclines in patients with impaired renal function requires medical supervision. With prolonged use of the drug requires periodic monitoring of laboratory parameters of blood, liver and kidney function. Due to the possible development of photodermatitis, it is necessary to limit insolation during treatment and for 4-5 days after it. With the use of the drug, both in reception and 2-3 weeks after discontinuation of treatment, it is possible that diarrhea caused by Clostridium dificile may develop. In mild cases, it is enough to cancel the 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 or metronidazole. Do not use drugs that inhibit intestinal peristalsis. Prolonged use of the drug can cause dysbacteriosis and, consequently, the development of hypovitaminosis (especially vitamins of group B).To prevent dyspeptic symptoms, it is recommended to take the drug with meals. In order to avoid the development of esophagitis or ulcers of the esophagus, you must take the drug with plenty of water and avoid using the drug just before bedtime. Impact on the ability to drive motor vehicles and control mechanisms On the impact on the ability to drive vehicles, vehicles and mechanisms is unknown. In the case of the development of dizziness, blurred vision or doubling in the eyes, the management of vehicles or mechanisms is not recommended.