Unidox solutab dispersible tablets 100mg, No. 20

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BIDL3177888
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Expiration Date: 05/2027

Russian Pharmacy name:

Юнидокс солютаб таблетки диспергируемые 100мг, №20

Unidox solutab dispersible tablets 100mg, No. 20

  • Infectious and inflammatory diseases caused by microorganisms sensitive to doxycycline, incl. respiratory and upper respiratory tract infections; gastrointestinal infections;

  • purulent infections of the skin and soft tissues (including acne);

  • infections of the genitourinary system (including gonorrhea, primary and secondary syphilis);

  • typhus, brucellosis, rickettsioses, osteomyelitis, trachoma, chlamydia.

The tablets are dispersed (dissolved) in a small amount of water (about 20 ml) to obtain a suspension. The tablets can also be swallowed whole, divided into pieces, or chewed with water. The drug is preferably taken with meals.

Taking tablets while sitting or standing, which reduces the likelihood of developing 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 on the first day of treatment are prescribed 200 mg / day in 1 or 2 doses, on 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 of 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 during the entire treatment.

For Streptococcus pyogenes infection, the duration of treatment is at least 10 days.

In uncomplicated gonorrhea (with the exception of anorectal infections in men), adults are prescribed 100 mg 2 times / day until complete recovery (on average, within 7 days), or 600 mg is prescribed for one day - 300 mg in 2 doses (second dose 1 hour after the first).

In primary syphilis, 100 mg is prescribed 2 times / day for 14 days, 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, appoint 100 mg 2 times / day for 7 days.

For acne, 100 mg / day is prescribed, the course of treatment is 6-12 weeks.

For the prevention of malaria, appoint 100 mg 1 time / day 1-2 days before the trip, then every day during the trip and for 4 weeks after returning; children over 8 years old - 2 mg / kg 1 time / day. The duration of prophylaxis should not exceed 4 months. For the prevention of travelers' diarrhea - 200 mg on the first day of the trip in 1 or 2 doses, then - 100 mg 1 time / 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 1 time / week during a stay in a disadvantaged area and 200 mg at the end of the trip. In order to prevent infections during 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 in severe gonococcal infections. For children over 8 years old with a body weight of more than 50 kg - up to 200 mg, for children 8-12 years old with a body weight of less than 50 kg - 4 mg / kg daily during the entire treatment. With renal (CC less than 60 ml / min) and / or hepatic insufficiency, a decrease in the daily dose of doxycycline is required, since it gradually accumulates in the body (risk of hepatotoxic action).since at the same time there is a gradual accumulation of it in the body (the risk of hepatotoxic action).since at the same time there is a gradual accumulation of it in the body (the risk of hepatotoxic action).

Dispersible tablets are round, biconvex, from light yellow or gray-yellow to brown interspersed, engraved with '173' (tablet code) on one side and a line on the other.

1 tab. doxycycline monohydrate, in terms of doxycycline 100 mg

Excipients: microcrystalline cellulose - 45 mg, saccharin - 10 mg, hyprolose (low substituted) - 18.75 mg, hypromellose - 3.75 mg, colloidal silicon dioxide (anhydrous) - 0.625 mg, magnesium stearate - 2 mg, lactose monohydrate - up to 250 mg.

- hypersensitivity to antibiotics of the tetracyclines group.

- severe impairment of liver and / or kidney function;

- porphyria;

- children under 8 years old;

pharmachologic effect

Semi-synthetic antibiotic of the tetracyclines group of broad spectrum of action. It has a bacteriostatic effect by suppressing the protein synthesis of pathogens. Active against aerobic gram-positive bacteria: Staphylococcus spp. (including strains producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae), Bacillus anthracis, Listeria monocytogenes; anaerobic bacteria: Clostridium spp. Doxycycline is also active against aerobic gram-negative bacteria: Neisseria gonorrhoeae, Escherichia coli, Shigella spp., Salmonella spp., Enterobacter spp., Klebsiella spp., Bordetella pertussis, as well as against Rickettsia spp., Treponema spp., Treponema spp. and Chlamydia spp. Pseudomonas aeruginosa, Proteus spp., Serratia spp., Most strains of Bacteroides fragilis are resistant to doxycycline.

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake does not significantly affect the absorption of doxycycline. It is widely distributed in tissues and body fluids. Plasma protein binding is 80-95%. T1 / 2 is 12-22 hours. It is excreted in the urine unchanged (40%), but the main part of the dose is excreted unchanged in the feces due to the secretion of bile.

Side effect

From the digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea, constipation, dysphagia, glossitis, esophagitis, a transient increase in the blood levels of hepatic transaminases, alkaline phosphatase, bilirubin. From the hematopoietic system: neutropenia, thrombocytopenia, hemolytic anemia. Allergic reactions: skin rash, itching, eosinophilia; rarely - Quincke's edema, photosensitivity. Others: an increase in residual nitrogen, candidiasis, intestinal dysbiosis, discoloration of teeth in children.

Application during pregnancy and lactation

Doxycycline is contraindicated during pregnancy and lactation. Doxycycline crosses the placental barrier. May cause long-term discoloration of teeth, enamel hypoplasia, suppression of the growth of fetal skeletal bones, as well as the development of fatty liver infiltration. If necessary, use during lactation should stop breastfeeding.

Application for violations of liver function

Contraindicated in severe hepatic impairment. Doxycycline is used with caution in case of liver dysfunction.

Application for impaired renal function

In case of impaired renal function, dose adjustment is not required.

Application in children

Doxycycline is not used in children under 8 years of age, because tetracyclines (including doxycycline) cause long-term discoloration of teeth, enamel hypoplasia and slowing of the longitudinal growth of skeletal bones in this category of patients.

special instructions

Doxycycline is used with caution in case of liver dysfunction. In case of impaired renal function, dose adjustment is not required. To prevent local irritating effects (esophagitis, gastritis, ulceration of the gastrointestinal tract), it is recommended to take it during the daytime with a large amount of liquid, food or milk. In connection with the possible development of photosensitization, it is necessary to limit insolation during treatment and for 4-5 days after it. Doxycycline is not used in children under 8 years of age, because tetracyclines (including doxycycline) cause long-term discoloration of teeth, enamel hypoplasia and slowing of the longitudinal growth of skeletal bones in this category of patients. Doxycycline solution for intravenous administration should be used no later than 72 hours after its preparation.

Drug interactions

Preparations containing metal ions (antacids, preparations containing iron, magnesium, calcium) form inactive chelates with doxycycline, and therefore it is necessary to avoid their simultaneous administration. With simultaneous use with barbiturates, carbamazepine, phenytoin, the concentration of doxycycline in the blood plasma decreases due to the induction of microsomal liver enzymes, which may be the reason for a decrease in its antibacterial effect. It is necessary to avoid combination with penicillins, cephalosporins, which have a bactericidal effect and are antagonists of bacteriostatic antibiotics (including doxycycline). Doxycycline absorption is reduced by cholestyramine and colestipol (observe the interval between doses of at least 3 hours). Due to the suppression of the intestinal microflora, doxycycline reduces the prothrombin index,which requires dose adjustment of indirect anticoagulants. Taking doxycycline reduces the reliability of contraception and increases the incidence of breakthrough bleeding while taking estrogen-containing oral contraceptives. The simultaneous use of retinol increases intracranial pressure.

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