Unidox Solutab, 100 mg 20 pcs

Pharmacological action – antibacterial, bacteriostatic.

Inhibits protein synthesis in the microbial cell by disrupting the communication of transport RNA of ribosomal membrane.

Pharmacodynamics

A broad-spectrum antibiotic of tetracycline group. It is bacteriostatic, inhibits protein synthesis in microbial cell by interaction with 30S ribosome subunit. It is 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, Escherichia coli, Shigella spp, Campylobacter fetus, Vibrio cholerae, 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 granulomatis, Propionibacterium acnes, some protozoa (Entamoeba spp., Plasmodium falciparum).

As a rule, it has no effect on Acinetobacter spp., Proteus spp., Pseudomonas spp., Serratia spp., Providencia spp., Enterococcus spp.

The possibility of acquired resistance to doxycycline in a number of pathogens should be taken into account, which is often cross-over within the group (i.e., strains resistant to doxycycline will simultaneously be resistant to the entire group of tetracyclines).

Pharmacokinetics

Absorption

Absorption is rapid and high (about 100%). Food intake has little effect on absorption of the drug.

The Cmax of doxycycline in blood plasma (2.6-3 mcg/ml) is reached 2 hours after 200 mg administration, after 24 hours the concentration of active substance in blood plasma decreases to 1.5 mcg/ml.

After administration of 200 mg on the first day of treatment and 100 mg/day on subsequent days, the plasma concentration of doxycycline is 1.5-3 mcg/ml.

Distribution

Doxycycline reversibly binds to plasma proteins (80-90%), penetrates well into organs and tissues, poorly – into the cerebrospinal fluid (10-20% of plasma levels), but doxycycline concentration in the cerebrospinal fluid increases with inflammation of the spinal cord.

The volume of distribution is 1.58 l/kg. Within 30-45 minutes after oral administration doxycycline is found in therapeutic concentrations in the liver, kidneys, lungs, spleen, bones, teeth, prostate, eye tissues, pleural and ascitic fluid, bile, synovial exudate, exudate of maxillary and frontal sinuses and gingival sinus fluid.

In normal hepatic function, the drug level in bile is 5-10 times higher than in plasma.

In saliva, 5-27% of the value of doxycycline concentration in blood plasma is determined.

Doxycycline penetrates the placental barrier, in small amounts is secreted into breast milk.

Accumulates in dentin and bone tissue.

Metabolism

A small portion of doxycycline is metabolized.

Elevation

The T1/2 after a single oral dose is 16-18 hours, after repeated doses is 22-23 hours.

About 40% of the drug taken is excreted by the kidneys and 20-40% is excreted through the intestines as 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 intestine increases.

Hemodialysis and peritoneal dialysis have no effect on plasma concentration of doxycycline.

Indications

– respiratory tract infections, including pharyngitis, acute bronchitis, exacerbation of COPD, tracheitis, bronchopneumonia, lobar pneumonia, community-acquired pneumonia, lung abscess, pleural empyema;

– ENT infections, including.

– infections of the urogenital system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingoophoritis 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);

– gastrointestinal and biliary tract infections (cholera, yersiniosis, cholecystitis, cholangitis, gastroenterocolitis, bacillary and amoebic dysentery, traveler’s diarrhea);

– skin and soft tissue infections (including wound infections after an animal bite), severe acne (as part of combination therapy);

– other diseases (yaws, legionellosis, chlamydia of various localizations (including prostatitis, proctitis and proctitis).Prostatitis and proctitis), rickettsiosis, Q fever, Rocky Mountain spotted fever, typhoid fever (including rash, tick-borne return fever), Lyme disease (Stage I. – Lyme disease (Stage I), tularemia, plague, actinomycosis, malaria; eye infections (including trachoma in combination therapy); leptospirosis, psittacosis, ornithiasis, anthrax (including (including pulmonary form), bartonellosis, granulocytic ehrlichiosis; whooping cough, brucellosis, osteomyelitis; sepsis, subacute septic endocarditis, peritonitis);

– prevention of postoperative purulent complications;

– prevention of malaria caused by Plasmodium falciparum, when traveling for short periods (less than 4 months) in areas where chloroquine and/or pyrimethamine-sulfadoxine-resistant strains are common.

Active ingredient

Composition

How to take, the dosage

On the inside, with meals, the tablet can be swallowed whole, broken into pieces or chewed up with a glass of water, or diluted in a small amount of water (about 20 ml).

The treatment usually lasts for 5-10 days.

Adults and children over 8 years of age with body weight over 50 kg – 200 mg in 1-2 doses on the first day of treatment, then 100 mg daily. In cases of severe infections – in a dose of 200 mg daily during the entire treatment.

In children 8-12 years old with body weight less than 50 kg the average daily dose is 4 mg/kg on the first day and further 2 mg/kg daily (in 1-2 doses). In cases of severe infections – in a dose of 4 mg/kg daily during the whole treatment.

Peculiarities of dosing in some diseases

In case of infection caused by S.pyogenes, Unidox Solutab® is taken for at least 10 days.

In uncomplicated gonorrhea (except for anorectal infections in men): in adults, 100 mg twice daily until cure (average of 7 days), or in one day, 600 mg – 300 mg in 2 doses (second dose 1 hour after the first) is prescribed.

In primary syphilis, 100 mg 2 times a day for 14 days; in secondary syphilis, 100 mg 2 times a day for 28 days.

In uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, nongonococcal urethritis caused by Ureaplasma urealyticum – 100 mg 2 times a day for 7 days.

In case of acne it is 100 mg daily; the course of treatment is 6-12 weeks.

Malaria (prophylaxis) – 100 mg once daily 1 to 2 days before travel, then daily during travel and for 4 weeks after return; children over 8 years of age – 2 mg/kg once daily.

Traveler’s diarrhea (prophylaxis) – 200 mg on the first day of the trip in 1 or 2 doses, then 100 mg once a day for the entire stay in the region (not more than 3 weeks).

The treatment of leptospirosis – 100 mg orally 2 times a day for 7 days; prevention of leptospirosis – 200 mg once a week during the stay in the disadvantaged area and 200 mg at the end of the trip.

To prevent infections during medical abortion, 100 mg 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 for severe gonococcal infections. For children over 8 years of age with a body weight over 50 kg – up to 200 mg, for children 8-12 years of age with a body weight less than 50 kg – 4 mg/kg daily for the duration of treatment.

In the presence of renal (Cl creatinine <60 ml/min) and/or hepatic insufficiency it is required to reduce the daily dose of doxycycline, because in this case there is a gradual accumulation in the body (risk of hepatotoxic effects).

Interaction

Antacids containing aluminum, magnesium, calcium, iron preparations, sodium bicarbonate, magnesium-containing laxatives reduce absorption of doxycycline, so their use should be separated by an interval of 3 hours.

In connection with the suppression of intestinal microflora by doxycycline, prothrombin index decreases, which requires adjustment of the dose of indirect anticoagulants.

When doxycycline is combined with bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter is reduced.

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 stimulants of microsomal oxidation, by accelerating the metabolism of doxycycline, reduce its concentration in plasma.

The concomitant use of doxycycline and retinol contributes to increased intracranial pressure.

Special Instructions

There is a possibility of cross-resistance and hypersensitivity to other tetracycline drugs.

Tetracyclines can increase PV, the prescription of tetracyclines in patients with coagulopathies should be carefully monitored.

The anti-anabolic effect of tetracyclines may result in increased levels of residual urea nitrogen in the blood. This is generally not significant in patients with normal renal function. However, in patients with renal insufficiency, an increase in azotemia may be observed. The use of tetracyclines in patients with impaired renal function requires medical monitoring.

In case of long-term use of the drug it is necessary to periodically control laboratory blood parameters, liver and kidney function.

Perhaps due to the development of photodermatitis it is necessary to limit sun exposure during treatment and for 4-5 days afterwards.

Long use of the drug may cause disbacteriosis and, as a consequence, the development of hypovitaminosis (especially of B vitamins).

To prevent dyspeptic complaints, it is recommended to take the drug with meals.

Particular effects on driving and operating machinery have not been studied.

Contraindications

hypersensitivity to tetracyclines;

age less than 8 years;

breastfeeding;

pregnancy;

porphyria;

severe hepatic and/or renal dysfunction.

Side effects

Gastrointestinal tract disorders: anorexia, nausea, vomiting, dysphagia, diarrhea; enterocolitis, pseudomembranous colitis.

Dermatological and allergic reactions: urticaria, photosensitization, angioedema, anaphylactic reactions, exacerbation of systemic lupus erythematosus, maculopapular and erythematous rash, pericarditis, exfoliative dermatitis.

Liver disorders: liver damage during long-term use or in patients with renal or hepatic insufficiency.

Kidney side: increase in residual urea nitrogen (due to anti-anabolic effect).

Hematopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity.

Nervous system disorders: benign increase of intracranial pressure (anorexia, vomiting, headache, optic edema), vestibular disorders (dizziness or unsteadiness).

The thyroid side: in patients who have received doxycycline for a long time, reversible dark brown staining of thyroid tissue is possible.

Tooth and bone: doxycycline slows osteogenesis, disrupts normal dental development in children (irreversibly changes the color of teeth, enamel hypoplasia develops).

Other: candidiasis (stomatitis, glossitis, proctitis, vaginitis) as a manifestation of superinfection.

Overdose

Symptoms: increased adverse reactions caused by liver damage (vomiting, fever, jaundice, azotemia, increased transaminases, increased PV).

Treatment: immediately after taking large doses, gastric lavage, plenty of drinking, inducing vomiting if necessary are recommended. Administer activated carbon and osmotic laxatives. Hemodialysis and peritoneal dialysis are not recommended due to low effectiveness.

Pregnancy use

Similarities