Unidox instructions for use of tablets 100 mg. Unidox Solutab - instructions for use

Detailed instructions for use are published on this page. Unidox Solutaba. The available dosage forms of the drug (100 mg tablets), as well as its analogues, are listed. Information is provided on the side effects that Unidox Solutab can cause and on interactions with other medications. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (bronchitis, otitis media, ureaplasma and other infectious diseases), administration algorithms, possible dosages for adults and children are described in detail, and the possibility of use during pregnancy and breastfeeding is clarified. The abstract for Unidox Solutab is supplemented with reviews from patients and doctors. Interaction of the drug with alcohol.

Instructions for use and dosage regimen

It is preferable to take the drug with food. The tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension. The tablets can also be swallowed whole, split into pieces, or chewed with water. Usually the duration of treatment is 5-10 days.

Adults and children over 8 years of age weighing more than 50 kg on the first day of treatment are prescribed 200 mg per day in 1 or 2 doses, on subsequent days of treatment - 100 mg per day in 1 dose. In case of severe infections, 200 mg per day is prescribed for the entire treatment period.

For children aged 8-12 years with body weight 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 infections, the drug is prescribed at a dose of 4 mg/kg daily throughout treatment.

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

For uncomplicated gonorrhea (except for anorectal infections in men), adults are prescribed 100 mg 2 times a day until complete cure (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).

For primary syphilis, 100 mg is prescribed 2 times a day for 14 days, for secondary syphilis - 100 mg 2 times a day for 28 days.

For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg is prescribed 2 times a day for 7 days.

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

To prevent malaria, 100 mg is prescribed once a 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 per day.

To prevent travelers' diarrhea - 200 mg on the first day of the 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 for 7 days; for the prevention of leptospirosis - 200 mg once a week during your stay in a disadvantaged area and 200 mg at the end of the trip.

To prevent infections during medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention.

Maximum daily doses for adults are up to 300 mg per day or up to 600 mg per day for 5 days for severe gonococcal infections. For children over 8 years old weighing more than 50 kg - up to 200 mg, for children 8-12 years old weighing less than 50 kg - 4 mg/kg daily throughout treatment.

In case of renal (creatinine clearance less than 60 ml/min) and/or liver failure, a reduction in the daily dose of doxycycline is required.

Release forms

Dispersible tablets 100 mg.

Unidox Solutab- long-acting tetracycline (active ingredient - antibiotic doxycycline) with a wide spectrum of action. Acts bacteriostatically, inhibits protein synthesis in the microbial cell.

Active against gram-positive and gram-negative aerobic and anaerobic bacteria.

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

Pharmacokinetics

Absorption is fast and high (100%). Food intake has a slight effect on the absorption of the drug, which has no clinical significance. Doxycycline reversibly binds to plasma proteins (80-90%), penetrates well into tissues, poorly into the cerebrospinal fluid (10-20% of the concentration in the blood plasma), however, the concentration of doxycycline in the cerebrospinal fluid increases with inflammation of the spinal membrane. Doxycycline crosses the placental barrier and is secreted into breast milk in small quantities. Only a small portion of doxycycline is metabolized. Approximately 40% of the dose taken is excreted in a biologically active form by tubular secretion in the kidneys, 20-40% is excreted through the intestines in the form of inactive forms (chelates).

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 the ENT organs (including otitis media, sinusitis, tonsillitis);
  • infections of the genitourinary system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingoophoritis /as part of combination therapy/);
  • sexually transmitted infections (urogenital chlamydia, syphilis in patients with penicillin intolerance, uncomplicated gonorrhea /as an alternative therapy/, granuloma inguinale, lymphogranuloma venereum);
  • infections of the gastrointestinal 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 (yaws, legionellosis, chlamydia of various localizations / including prostatitis and proctitis/, rickettsiosis, Q fever, Rocky Mountain spotted fever, typhus / including typhus, tick-borne relapsing/, Lyme disease / stage 1 - erythema migrans/, tularemia, plague, actinomycosis, malaria, leptospirosis, psittacosis, ornithosis, anthrax /including pulmonary form/, bartonellosis, granulocytic ehrlichiosis, whooping cough, 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-term travel (less than 4 months) to areas where strains resistant to chloroquine and/or pyrimethamine-sulfadoxine are common.

Contraindications

  • severe impairment of liver and/or kidney function;
  • porphyria;
  • pregnancy;
  • lactation period (breastfeeding);
  • children under 8 years of age;
  • hypersensitivity to antibiotics of the tetracycline group.

special instructions

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

Tetracyclines may increase prothrombin time; the use of tetracyclines in patients with coagulopathies should be carefully monitored.

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 significant for patients with normal renal function. However, in patients with renal failure, an increase in azotemia may occur. The use of tetracyclines in patients with impaired renal function requires medical supervision.

With long-term use of the drug, periodic monitoring of laboratory blood parameters, liver and kidney function is required.

Due to the possible development of photodermatitis, it is necessary to limit insolation during treatment and for 4-5 days after it.

Long-term use of the drug Unidox Solutab can cause dysbiosis and, as a result, the development of hypovitaminosis (especially B vitamins).

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

Impact on the ability to drive vehicles and operate machinery

The specific effects on the ability to drive a car and operate machinery have not been studied.

Side effect

  • anorexia;
  • nausea, vomiting;
  • dysphagia;
  • diarrhea;
  • enterocolitis;
  • pseudomembranous colitis;
  • photosensitivity;
  • hives;
  • angioedema;
  • anaphylactic reactions;
  • hemolytic anemia;
  • thrombocytopenia;
  • neutropenia;
  • eosinophilia;
  • candidiasis (glossitis, stomatitis, proctitis, vaginitis) as manifestations of superinfection.

Drug interactions

Due to the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants.

When doxycilline is combined with bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter is reduced, which should be taken into account when treating meningitis and tonsillopharyngitis caused by Streptococcus pyogenes.

Doxycycline reduces the reliability of contraception and increases the frequency of acyclic bleeding when taking estrogen-containing hormonal contraceptives.

Ethanol (alcohol), barbiturates, rifampicin, carbamazepine, phenytoin, accelerating the metabolism of doxycycline, reduce its concentration in the blood plasma.

The simultaneous use of doxycycline and retinol increases intracranial pressure.

Analogues of the drug Unidox Solutab

Structural analogues of the active substance:

  • Bassado;
  • Vibramycin;
  • Vidoccin;
  • Dovitsin;
  • Doxal;
  • Doxibene;
  • Doxilan;
  • Doxycycline;
  • Doxycycline Nycomed;
  • Doxycycline Stad;
  • Doxycycline-AKOS;
  • Doxycycline hydrochloride;
  • Xedocin;
  • Monocline.

Use during pregnancy and breastfeeding

Unidox Solutab is contraindicated for use during pregnancy.

The drug is contraindicated for use during lactation (breastfeeding). Doxycycline is excreted in breast milk.

For infectious diseases, doctors often prescribe the new generation antibiotic Unidox. The instructions recommend using this remedy for inflammatory processes caused by various microorganisms. The drug belongs to the group of tetracyclines and is able to act on a wide range of pathogens. The medicine not only destroys bacteria, but also prevents their further reproduction.

What is included in the tablets?

The active component of the drug "Unidox" is the tetracycline antibiotic doxycycline. Each tablet contains 100 mg of this substance, which is what has an antibacterial effect on the body.

The medicine also contains additional components: magnesium stearate, microcrystalline cellulose, hyprolose, lactose monohydrate, colloidal silicon dioxide. These substances do not have a therapeutic effect, but contribute to better absorption of doxycycline.

The medicine is released only in tablet form. In the pharmacy chain you can find the drugs "Unidox" and "Unidox Solutab". The only difference is that Unidox Solutab tablets can be crushed, dissolved in water and prepared as a suspension. This form is convenient when treating children. In all other respects, these drugs are absolutely identical.

The medicine looks like round tablets, convex on both sides. The number 173 is engraved on them - this is the drug code.

How does an antibiotic work?

The medicine affects microorganisms at the cellular level. Doxycycline affects the RNA of harmful bacteria and inhibits the formation of microbial proteins. It is effective against many gram-positive and gram-negative bacteria: streptococci, staphylococci, treponemas, salmonella, pathogens of many intestinal and genitourinary infections. In addition, it is capable of destroying some protozoan microorganisms - dysentery amoeba and plasmodium (the causative agent of malaria).

However, for some infections there will be no effect from using Unidox. The instructions say that doxycycline does not affect all types of viral and fungal microorganisms, as well as Proteus, enterococci and Pseudomonas aeruginosa.

"Unidox" does not adversely affect the natural microflora of the digestive system and does not reduce immunity.

For what diseases is the drug prescribed?

If a patient is diagnosed with an infectious disease, the causative agent of which is susceptible to the effects of doxycycline, then the doctor may prescribe Unidox tablets. The use of antibiotics is indicated for the following pathologies:

  • otolaryngeal infectious diseases (otitis media, sinusitis, sinusitis, tonsillitis, laryngitis, nasopharyngitis);
  • respiratory pathologies caused by bacteria: bronchitis, pneumonia, tracheitis, lung abscess;
  • gastrointestinal infections: gastroenteritis, cholecystitis, cholangitis, bacterial and yersiniosis;
  • sexually transmitted diseases: syphilis, gonorrhea, chlamydia, inguinal and venereal granuloma;
  • eye damage from chlamydial infection (trachoma);
  • tick-borne;
  • whooping cough;
  • sepsis;
  • osteomyelitis;
  • brucellosis;
  • skin infections, acne;
  • after operations to prevent purulent infection;
  • genitourinary cystitis, urethritis, endometritis, prostatitis, cervicitis, salpingoophoritis.

These are the most common indications for prescribing the Unidox antibiotic. In addition, the drug is effective against particularly dangerous infections and imported tropical diseases, such as:

  • cholera;
  • typhus (abdominal, typhus and relapsing);
  • plague;
  • malaria;
  • legionellosis;
  • Q fever;
  • yaws;
  • leptospirosis;
  • Rocky Mountain spotted fever.

In some cases, it is possible to use Unidox tablets for preventive purposes. The instructions recommend prescribing the drug to people traveling to tropical countries to prevent infection with malaria and leptospirosis.

When is the medicine contraindicated?

However, such an effective antibiotic as Unidox is not suitable for all groups of patients. First of all, it should not be taken by people with hypersensitivity to doxycycline and the auxiliary components of the tablets. It should not be used by patients who have previously been allergic to tetracycline medications.

There are other cases when the drug is strictly contraindicated. Unidox tablets should not be taken by pregnant or nursing mothers. Doxycycline is able to overcome and also pass into breast milk. If a woman needs to undergo treatment during lactation, then breastfeeding should be stopped. This antibiotic is not prescribed to children under 8 years of age. Contraindications are due to the fact that doxycycline can accumulate in the bones and lead to calcium deposits in the skeleton of the fetus and small child. In addition, the drug can negatively affect the formation of teeth in children under 8 years of age.

Medicines containing doxycycline are contraindicated in patients with severe pathologies of the liver and kidneys and in patients diagnosed with porphyria.

Undesirable effects of the drug

The body of some patients may react negatively to taking Unidox. Side effects may occur from the following organs and systems:

  1. Central nervous system. May cause headache, intracranial hypertension, dizziness.
  2. Gastrointestinal tract. Sometimes dyspeptic symptoms appear: nausea, vomiting, intestinal disorders, loss of appetite, and some patients experience symptoms of anorexia.
  3. Skin. Dermatitis, rashes, and hyperemia occur. Photosensitivity of the skin increases.
  4. Hematopoiesis: decrease in platelets and red blood cells, increase in the number of eosinophils.
  5. Other body systems. Oral or genital candidiasis may occur.

If such manifestations occur, you should report them to your doctor. After reducing the dose or stopping the antibiotic, all side effects disappear.

How to take the pills?

The attending physician, depending on the nature of the disease, determines the required dose of antibiotic. Taking Unidox is recommended with meals. Take the tablets with water. If you use the Unidox Solutab dosage form, you can first crush and dissolve the tablets in 20 ml of water.

The following antibiotic treatment regimen is usually used:

  1. For adult patients: on the first day, take 200 mg of medication (2 tablets), divided into 2 doses. In the subsequent days of the course of treatment, take 100 mg (1 tablet) of the drug per day. For severe infectious diseases, 200 mg of antibiotic per day is prescribed throughout the entire therapy.
  2. For children over 8 years old and weighing more than 50 kg, the treatment regimen is the same as for adults.
  3. For children over 8 years old weighing less than 50 kg, the dose is calculated based on body weight. On the first day, take 4 mg of medication per 1 kg of weight. In the subsequent days of treatment, take 2 mg of the drug per 1 kg of body weight (in 2 doses). In severe cases, the dosage of 4 mg/kg is maintained throughout the entire course of treatment.

Treatment with the drug usually lasts from 5 to 10 days. For some diseases, the duration of therapy and dosage of Unidox has its own characteristics:

  1. If infected with pyogenic streptococcus, the course of treatment should last at least 10 days.
  2. For syphilis, 2 tablets (200 mg per day) are prescribed for 14-28 days.
  3. When treating gonorrhea, chlamydia and ureaplasmosis of the genitourinary organs, it is recommended to take 2 tablets per day. The duration of therapy is about 7 days. In case of severe gonococcal infection, the dose can be increased to the maximum allowable - 300-600 mg per day, the course is 5 days.
  4. When treating acne on the skin, the drug is taken for a long time, from 6 to 12 weeks at a dosage of 100 mg per day.
  5. To treat leptospirosis, the antibiotic is taken at a dosage of 200 mg per day for a week. To prevent this disease, the drug is taken at a dose of 200 mg once a week while staying in areas unfavorable for leptospirosis. Then take another 200 mg before leaving.
  6. To prevent malaria, take 100 mg of the medicine 1 day before the trip, and then the same dose daily during the trip. After returning home, antibiotics must be continued at the same dosage for another 4 weeks.
  7. 1 hour before a medical abortion, women take 1 Unidox tablet, and immediately after the intervention take 2 more tablets. This helps prevent infection.

It must be remembered that doxycycline greatly increases the skin's sensitivity to ultraviolet radiation. Therefore, during the course of treatment you should avoid tanning or use creams with a high degree of protection.

Compatibility with other medications and alcohol

Some medications may interfere with the absorption of doxycycline. These include antacids, iron supplements, and laxatives with magnesium. Therefore, you need to maintain an interval of 3 hours between taking Unidox and these medications.

It is not advisable to take vitamin A (retinol) during antibiotic treatment. This can cause headaches due to increased intracranial pressure. You should also not combine Unidox treatment with penicillin and cephalosporin antibiotics. These medications will decrease the effects of doxycycline.

Women taking hormonal contraceptives should remember that doxycycline reduces the contraceptive effect of these drugs and increases the likelihood of non-cyclic uterine bleeding.

Patients should know that Unidox and alcohol are incompatible. Drinking alcohol increases the metabolism of the drug, as a result, the concentration of the antibiotic in the blood plasma drops, and the therapeutic effect is reduced to zero. At the same time, a double load falls on the liver, which manifests itself in nausea, vomiting, abdominal pain, diarrhea, and dizziness.

Barbiturates, Carbamazepine, Phenytoin, and Rifampicin can also reduce the therapeutic effect of the antibiotic.

Conditions for dispensing from pharmacies and storage rules

The drug is available with a doctor's prescription. You cannot self-treat with the Unidox antibiotic.

The instructions recommend storing the tablets at a temperature of +15 to +25 degrees. To avoid poisoning, the medicine should be kept in a place where children cannot find it. If the storage rules are followed, the drug is suitable for use for 5 years. After this period, the tablets cannot be taken.

Price of tablets

The price of Unidox in Moscow pharmacies is from 280 to 370 rubles. Currently, you can find on sale mainly Unidox Solutab tablets, which are a soluble form of the drug.

Analogues of the drug

Patients are often interested in analogues of Unidox. You can choose drugs with the same active ingredient - doxycycline. The following medications fall into this category:

  • "Doxycycline."
  • "Vibramycin".
  • "Doxibene".
  • "Xedocin."
  • "Dovitsin".
  • "Doxilan."
  • "Monocline".
  • "Bassado".

Of these drugs, Doxycycline is the most common analogue of Unidox. Its price is very low - from 12 to 32 rubles.

Can Doxycycline be considered a complete replacement for Unidox Solutab soluble tablets? If we consider the chemical composition of these drugs, they contain different modifications of the same medicinal substance. "Doxycycline" is produced on the basis of hydrochloride, and "Unidox Solutab" is produced on the basis of monohydrate. They have the same therapeutic effect, but there are slight differences:

  1. Soluble tablets (solutab) are better absorbed by the body.
  2. Solutab tablets have fewer side effects, as they dissolve well and are absorbed in the intestines. Doxycycline begins its action in the stomach, which often causes cramps and pain.
  3. "Unidox Solutab" goes through several stages of purification during production and is a safer medicine.

We can conclude that Doxycycline is a cheap analogue of Unidox and is somewhat more difficult to tolerate by the body.

Composition and release form of the drug

Dispersible tablets round, biconvex, from light yellow or gray-yellow to brown with inclusions, with an engraving “173” (tablet code) on one side and a line on the other.

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.

10 pieces. - blisters made of PVC/aluminum foil (1) - cardboard packs.

pharmachologic effect

Semi-synthetic broad-spectrum antibiotic. 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., Mycoplasma spp. and Chlamydia spp.

Pseudomonas aeruginosa, Proteus spp., Serratia spp., and most strains of Bacteroides fragilis are resistant to doxycycline.

Pharmacokinetics

After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the absorption of doxycycline. Widely distributed in tissues and body fluids. Protein binding is 80-95%. T1/2 is 12-22 hours. It is excreted unchanged in the urine (40%), but the main part of the dose is excreted unchanged in the feces due to the secretion of bile.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to doxycycline, incl. infections of the respiratory and ENT organs; 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, rickettsiosis, osteomyelitis, trachoma, chlamydia.

Contraindications

Pregnancy, children under 8 years of age (possibility of formation of insoluble complexes with calcium in the bone skeleton, enamel and dentin of teeth), hypersensitivity to tetracyclines, porphyria, severe liver failure, leukopenia, lactation period, myasthenia gravis (for intravenous administration).

Dosage

Adults are prescribed 200 mg/day orally or intravenously (drip) on the first day of treatment, and 100-200 mg/day on subsequent days. Frequency of administration (or intravenous infusion) is 1-2 times/day. For children over 8 years of age and weighing more than 50 kg, the daily dose for oral administration or intravenous administration (drip) is 4 mg/kg on the first day of treatment. In the following days - 2-4 mg/kg/day, depending on the severity of the clinical course of the disease. Frequency of administration (or intravenous infusion) is 1-2 times/day. The recommended minimum time for IV infusion of 100 mg doxycycline (at an infusion solution concentration of 0.5 mg/ml) is 1 hour.

Maximum doses: for adults for oral administration - 300 mg/day or 600 mg/day (depending on the etiology of the pathogen); for intravenous administration - 300 mg/day.

Side effects

From the digestive system: nausea, vomiting, anorexia, diarrhea, constipation, dysphagia, glossitis, esophagitis, transient increase in blood levels of liver transaminases, alkaline phosphatase, bilirubin.

From the hematopoietic system: neutropenia, thrombocytopenia, hemolytic anemia.

Allergic reactions: skin rash, itching, eosinophilia; rarely - Quincke's edema, photosensitivity.

Other: increase in residual nitrogen, candidiasis, intestinal dysbiosis, discoloration of teeth in children.

Drug interactions

Drugs containing metal ions (drugs containing iron, magnesium, calcium) form inactive chelates with doxycycline, and therefore their simultaneous administration should be avoided.

When used simultaneously with barbiturates and phenytoin, the concentration of doxycycline in the blood plasma decreases due to the induction of microsomal liver enzymes, which may cause 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).

The absorption of doxycycline is reduced by cholestyramine and colestipol (keep an interval of at least 3 hours between doses).

Due to the suppression of intestinal microflora, doxycycline reduces the prothrombin index, which requires dose adjustment of indirect drugs.

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.

special instructions

Use doxycycline with caution in cases of liver dysfunction. In case of impaired renal function, no dose adjustment is required.

To prevent local irritation (esophagitis, gastritis, ulceration of the gastrointestinal tract), it is recommended to take it during the daytime with plenty of liquid, food or milk. Due to the possible development of photosensitivity, it is necessary to limit insolation during treatment and for 4-5 days after it.

Doxycycline solution for intravenous administration should be used no later than 72 hours after its preparation.

Pregnancy and lactation

Doxycycline is contraindicated for use during pregnancy and lactation. Doxycycline crosses the placental barrier. May cause long-term discoloration of teeth, enamel hypoplasia, suppression of fetal skeletal bone growth, and the development of fatty liver.

If necessary, use during lactation should stop breastfeeding.

Use in childhood

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

For impaired renal function

In case of impaired renal function, no dose adjustment is required.

For liver dysfunction

Contraindicated in severe liver failure. Use doxycycline with caution in cases of liver dysfunction.

Release form

Dispersible tablets.

Doxycycline monohydrate, equivalent to 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.

Package

pharmachologic effect

Broad-spectrum antibiotic from the tetracycline group. It acts bacteriostatically, suppresses protein synthesis in the microbial cell by interacting with the 30S ribosomal subunit. 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 granulomatosis, 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-resistance within the group (i.e., strains resistant to doxycycline will simultaneously be resistant to the entire group of tetracyclines).

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 the ENT organs (including otitis media, sinusitis, tonsillitis);

- infections of the genitourinary system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingoophoritis /as part of combination therapy/);

- sexually transmitted infections (urogenital chlamydia, syphilis in patients with penicillin intolerance, uncomplicated gonorrhea /as an alternative therapy/, granuloma inguinale, lymphogranuloma venereum);

- infections of the gastrointestinal 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: yaws, legionellosis, chlamydia of various localizations (including prostatitis and proctitis), rickettsiosis, Q fever, Rocky Mountain spotted fever, typhus (including typhus, tick-borne relapsing), Lyme disease (stage I ) - erythema migrans/, tularemia, plague, actinomycosis, malaria, leptospirosis, psittacosis, psittacosis, anthrax (including pulmonary form), bartonellosis, granulocytic ehrlichiosis, whooping cough, 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-term travel (less than 4 months) to areas where strains resistant to chloroquine and/or pyrimethamine-sulfadoxine are common.

Contraindications

- severe dysfunction of the liver and/or kidneys;

- porphyria;

- pregnancy;

- lactation period (breastfeeding);

- children under 8 years of age;

- hypersensitivity to tetracycline antibiotics.

Use during pregnancy and breastfeeding

Doxycycline penetrates the blood-placental barrier. Tetracyclines have an adverse effect on the fetus (slowing osteogenesis) and on the formation of tooth enamel (irreversible discoloration, hypoplasia). Due to this, as well as the increased risk of liver damage in the mother, tetracyclines are not used during pregnancy, except in cases where the drug is the only remedy for the treatment or prevention of particularly dangerous and severe infections (Rocky Mountain spotted fever, inhalation exposure to Bacillus anthracis and others).

Before prescribing doxycycline to women of childbearing age, pregnancy should first be excluded.

Doxycycline passes into breast milk. Due to its adverse effects on the fetus, doxycycline, like other tetracyclines, should not be used during breastfeeding. If the prescription of tetracyclines is necessary, breastfeeding should be discontinued.

Directions for use and doses

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, split into pieces, or chewed with water.

It is preferable to take the drug with food. Take the 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 of age weighing more than 50 kg are prescribed 200 mg/day in 1 or 2 doses on the first day of treatment, and 100 mg/day in 1 dose on subsequent days of treatment. In case of severe infections, 200 mg/day is prescribed throughout the entire treatment period.

For children aged 8-12 years with 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 treatment.

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

For uncomplicated gonorrhea (except for anorectal infections in men), adults are prescribed 100 mg 2 times a day until complete cure (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).

For primary syphilis, 100 mg 2 times a day is prescribed for 14 days, for secondary syphilis - 100 mg 2 times a day for 28 days.

For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg is prescribed 2 times a day for 7 days.

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

For the prevention of malaria, 100 mg is prescribed 1 time / 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 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 a day for 7 days; for the prevention of leptospirosis - 200 mg 1 time/week during stay in a disadvantaged area and 200 mg at the end of the trip.

To prevent infections during medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention.

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 old weighing more than 50 kg - up to 200 mg, for children 8-12 years old weighing less than 50 kg - 4 mg/kg daily throughout treatment.

In case of renal (creatinine clearance less than 60 ml/min) and/or liver failure, a reduction in the daily dose of doxycycline is required, since it gradually accumulates in the body (risk of hepatotoxicity).

Side effects

From the digestive system: anorexia, nausea, vomiting, dysphagia, diarrhea, enterocolitis, pseudomembranous colitis, esophagitis, esophageal ulcer, dark staining of the tongue, liver damage (during long-term use or in patients with renal or hepatic insufficiency), cholestasis.

Dermatological reactions: photosensitivity, 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.

From the hematopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity.

From the endocrine system: in patients receiving doxycycline for a long time, reversible dark brown discoloration of the thyroid tissue is possible.

From the side of the central nervous system: benign increase in intracranial pressure (anorexia, vomiting, headache, papilledema), vestibular disorders (dizziness or instability), blurred vision, double vision.

From the urinary system: increase in residual urea nitrogen (due to the 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.

special instructions

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

Tetracyclines may increase prothrombin time; the use of tetracyclines in patients with coagulopathies should be carefully monitored.

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 significant for patients with normal renal function. However, in patients with renal failure, an increase in azotemia may occur. The use of tetracyclines in patients with impaired renal function requires medical supervision.

With long-term use of the drug, periodic monitoring of laboratory blood parameters, liver and kidney function is required.

Due to the possible development of photodermatitis, it is necessary to limit insolation during treatment and for 4-5 days after it.

When using the drug, both while taking it and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium dificile may develop. In mild cases, it is sufficient to cancel treatment and use ion exchange resins (cholestyramine, colestipol); in severe cases, replacement of loss of fluid, electrolytes and protein is indicated,

prescribing vancomycin or metronidazole.

Do not use medications that inhibit intestinal motility.

Long-term use of the drug can cause dysbacteriosis and, as a result, the development of hypovitaminosis (especially B vitamins).

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

To avoid the development of esophagitis or esophageal ulcers, it is necessary to take the drug with plenty of water and avoid using the drug immediately before bedtime.

Impact on the ability to drive vehicles and operate machinery

The effect on the ability to drive vehicles, machines and mechanisms is unknown. If you develop dizziness, blurred vision or double vision, driving vehicles or using machinery is not recommended.

Drug interactions

Due to the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants.

When doxycilline is combined with bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter is reduced, which should be taken into account when treating meningitis and tonsillopharyngitis 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 increases intracranial pressure.

Overdose

Symptoms: increased adverse reactions caused by liver damage - vomiting, fever, jaundice, azotemia, increased transaminase levels, increased prothrombin time.

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

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15° to 25°C.

Contents [Show]

In this article you can read the instructions for using an antibacterial drug Unidox Solutab. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Unidox Solutab in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Unidox Solutab in the presence of existing structural analogues. Use for the treatment of bronchitis, otitis, ureaplasma and other infections, as well as acne in adults, children, as well as during pregnancy and lactation.

Unidox Solutab

Pharmacokinetics

Indications

  • osteomyelitis;
  • sepsis;
  • peritonitis.

Release forms

Side effect

  • anorexia;
  • nausea, vomiting;
  • dysphagia;
  • diarrhea;
  • enterocolitis;
  • pseudomembranous colitis;
  • photosensitivity;
  • hives;
  • angioedema;
  • anaphylactic reactions;
  • hemolytic anemia;
  • thrombocytopenia;
  • neutropenia;
  • eosinophilia;

Contraindications

  • porphyria;
  • pregnancy;
  • children under 8 years of age;

special instructions

Drug interactions

  • Bassado;
  • Vibramycin;
  • Vidoccin;
  • Dovitsin;
  • Doxal;
  • Doxibene;
  • Doxilan;
  • Doxycycline;
  • Doxycycline Nycomed;
  • Doxycycline Stad;
  • Doxycycline-AKOS;
  • Doxycycline hydrochloride;
  • Xedocin;
  • Monocline.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps and look at the available analogues for the therapeutic effect.

Detailed instructions for use are published on this page. Unidox Solutaba. The available dosage forms of the drug (100 mg tablets), as well as its analogues, are listed. Information is provided on the side effects that Unidox Solutab can cause and on interactions with other medications. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (bronchitis, otitis media, ureaplasma and other infectious diseases), administration algorithms, possible dosages for adults and children are described in detail, and the possibility of use during pregnancy and breastfeeding is clarified. The abstract for Unidox Solutab is supplemented with reviews from patients and doctors. Interaction of the drug with alcohol.

Instructions for use and dosage regimen

It is preferable to take the drug with food. The tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension. The tablets can also be swallowed whole, split into pieces, or chewed with water. Usually the duration of treatment is 5-10 days.

Adults and children over 8 years of age weighing more than 50 kg are prescribed 200 mg per day in 1 or 2 doses on the first day of treatment, and 100 mg per day in 1 dose on subsequent days of treatment. In case of severe infections, 200 mg per day is prescribed for the entire treatment period.

For children aged 8-12 years with body weight 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 infections, the drug is prescribed at a dose of 4 mg/kg daily throughout treatment.

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

For uncomplicated gonorrhea (with the exception of anorectal infections in men), adults are prescribed 100 mg 2 times a day until complete cure (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).

For primary syphilis, 100 mg is prescribed 2 times a day for 14 days, for secondary syphilis - 100 mg 2 times a day for 28 days.

For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg is prescribed 2 times a day for 7 days.

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

To prevent malaria, 100 mg is prescribed once a 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 per day.

To prevent travelers' diarrhea - 200 mg on the first day of the 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 for 7 days; for the prevention of leptospirosis - 200 mg once a week during your stay in a disadvantaged area and 200 mg at the end of the trip.

To prevent infections during medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention.

Maximum daily doses for adults are up to 300 mg per day or up to 600 mg per day for 5 days for severe gonococcal infections. For children over 8 years old weighing more than 50 kg - up to 200 mg, for children 8-12 years old weighing less than 50 kg - 4 mg/kg daily throughout treatment.

In case of renal (creatinine clearance less than 60 ml/min) and/or liver failure, a reduction in the daily dose of doxycycline is required.

Release forms

Dispersible tablets 100 mg.

Unidox Solutab- long-acting tetracycline (active ingredient - antibiotic doxycycline) with a wide spectrum of action. Acts bacteriostatically, inhibits protein synthesis in the microbial cell.

Active against gram-positive and gram-negative aerobic and anaerobic bacteria.

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

Pharmacokinetics

Absorption is fast and high (100%). Food intake has a slight effect on the absorption of the drug, which has no clinical significance. Doxycycline binds reversibly to plasma proteins (80-90%), penetrates well into tissues, poorly into the cerebrospinal fluid (10-20% of the concentration in the blood plasma), however, the concentration of doxycycline in the cerebrospinal fluid increases with inflammation of the spinal membrane. Doxycycline crosses the placental barrier and is secreted into breast milk in small quantities. Only a small portion of doxycycline is metabolized. Approximately 40% of the dose taken is excreted in a biologically active form by tubular secretion in the kidneys, 20-40% is excreted through the intestines in the form of inactive forms (chelates).

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 the ENT organs (including otitis media, sinusitis, tonsillitis);
  • infections of the genitourinary system (cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingoophoritis /as part of combination therapy/);
  • sexually transmitted infections (urogenital chlamydia, syphilis in patients with penicillin intolerance, uncomplicated gonorrhea /as an alternative therapy/, granuloma inguinale, lymphogranuloma venereum);
  • infections of the gastrointestinal 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 (yaws, legionellosis, chlamydia of various localizations / including prostatitis and proctitis/, rickettsiosis, Q fever, Rocky Mountain spotted fever, typhus / including typhus, tick-borne relapsing/, Lyme disease / stage 1 - erythema migrans/, tularemia, plague, actinomycosis, malaria, leptospirosis, psittacosis, ornithosis, anthrax /including pulmonary form/, bartonellosis, granulocytic ehrlichiosis, whooping cough, 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-term travel (less than 4 months) to areas where strains resistant to chloroquine and/or pyrimethamine-sulfadoxine are common.

Contraindications

  • severe impairment of liver and/or kidney function;
  • porphyria;
  • pregnancy;
  • lactation period (breastfeeding);
  • children under 8 years of age;
  • hypersensitivity to antibiotics of the tetracycline group.

special instructions

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

Tetracyclines may increase prothrombin time; the use of tetracyclines in patients with coagulopathies should be carefully monitored.

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 significant for patients with normal renal function. However, in patients with renal failure, an increase in azotemia may occur. The use of tetracyclines in patients with impaired renal function requires medical supervision.

With long-term use of the drug, periodic monitoring of laboratory blood parameters, liver and kidney function is required.

Due to the possible development of photodermatitis, it is necessary to limit insolation during treatment and for 4-5 days after it.

Long-term use of the drug Unidox Solutab can cause dysbiosis and, as a result, the development of hypovitaminosis (especially B vitamins).

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

Impact on the ability to drive vehicles and operate machinery

The specific effects on the ability to drive a car and operate machinery have not been studied.

Side effect

  • anorexia;
  • nausea, vomiting;
  • dysphagia;
  • diarrhea;
  • enterocolitis;
  • pseudomembranous colitis;
  • photosensitivity;
  • hives;
  • angioedema;
  • anaphylactic reactions;
  • hemolytic anemia;
  • thrombocytopenia;
  • neutropenia;
  • eosinophilia;
  • candidiasis (glossitis, stomatitis, proctitis, vaginitis) as manifestations of superinfection.

Drug interactions

Due to the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants.

When doxycilline is combined with bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins), the effectiveness of the latter is reduced, which should be taken into account when treating meningitis and tonsillopharyngitis caused by Streptococcus pyogenes.

Doxycycline reduces the reliability of contraception and increases the frequency of acyclic bleeding when taking estrogen-containing hormonal contraceptives.

Ethanol (alcohol), barbiturates, rifampicin, carbamazepine, phenytoin, accelerating the metabolism of doxycycline, reduce its concentration in the blood plasma.

The simultaneous use of doxycycline and retinol increases intracranial pressure.

Analogues of the drug Unidox Solutab

Structural analogues of the active substance:

  • Bassado;
  • Vibramycin;
  • Vidoccin;
  • Dovitsin;
  • Doxal;
  • Doxibene;
  • Doxilan;
  • Doxycycline;
  • Doxycycline Nycomed;
  • Doxycycline Stad;
  • Doxycycline-AKOS;
  • Doxycycline hydrochloride;
  • Xedocin;
  • Monocline.

Use during pregnancy and breastfeeding

Unidox Solutab is contraindicated for use during pregnancy.

The drug is contraindicated for use during lactation (breastfeeding). Doxycycline is excreted in breast milk.

Instructions

(information for specialists)

According to the medical use of the drug

UNIDOX SOLUTION

Registration number: P N013102/01

Tradename: Unidox Solutab®

INN: Doxycycline

Dosage form: Dispersible tablets

Compound:
Active substance: doxycycline monohydrate 100.0 mg in terms of doxycycline
Excipients: microcrystalline cellulose, saccharin, hyprolose (low-substituted), hypromellose, colloidal silicon dioxide (anhydrous), magnesium stearate, lactose monohydrate

Description:
Round, biconvex tablets from light yellow to gray-yellow in color with “173” (tablet code) engraved on one side and a scored line on the other.

Pharmacotherapeutic group: Antibiotic - tetracycline

ATX code:

Pharmachologic effect:
Pharmacodynamics
Broad-spectrum antibiotic from the tetracycline group. It acts bacteriostatically, suppresses protein synthesis in the microbial cell by interacting with the 30S ribosomal subunit. 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 granulomatosis, 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-resistance within the group (i.e., strains resistant to doxycycline will simultaneously be resistant to the entire group of tetracyclines).

Pharmacokinetics
Suction
Absorption is fast and high (about 100%). Food intake has little effect on the absorption of the drug.
The maximum level of doxycycline in the blood plasma (2.6-3 mcg/ml) is achieved 2 hours after taking 200 mg; after 24 hours, the concentration of the active substance in the blood plasma decreases to 1.5 mcg/ml.
After taking 200 mg on the first day of treatment and 100 mg per day on subsequent days, the plasma concentration of doxycycline is 1.5-3 mcg/ml.

Distribution
Doxycycline binds reversibly to plasma proteins (80-90%), penetrates well into organs and tissues, poorly into the cerebrospinal fluid (10-20% of the level in the blood plasma), however, the concentration of doxycycline in the cerebrospinal fluid increases with inflammation of the spinal membrane.
Volume of distribution - 1.58 l/kg. 30–45 minutes after oral administration, 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, exudate of the maxillary and frontal sinuses, in gingival sulcus 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 blood plasma is determined.
Doxycycline crosses the placental barrier and is secreted into breast milk in small quantities.
Accumulates in dentin and bone tissue.

Metabolism
A small portion of doxycycline is metabolized.

Removal
The half-life after a single oral dose is 16-18 hours, after repeated doses it is 22-23 hours.
Approximately 40% of the drug 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 situations
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.

Indications for use
Infectious and inflammatory diseases caused by sensitive
to the drug with microorganisms:

  • 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 the ENT organs, including otitis media, sinusitis, tonsillitis;
  • infections of the genitourinary system: cystitis, pyelonephritis, bacterial prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, acute orchiepididymitis; endometritis, endocervicitis and salpingoophioritis as part of a combined therapy; including sexually transmitted infections: urogenital chlamydia, syphilis in patients with penicillin intolerance, uncomplicated gonorrhea (as an alternative therapy), granuloma inguinale, lymphogranuloma venereum;
  • infections of the gastrointestinal tract and biliary tract (cholera, yersiniosis, cholecystitis, cholangitis, gastroenterocolitis, bacillary and amoebic dysentery, traveler's diarrhea);
  • infections of the skin and soft tissues (including wound infections after animal bites), severe acne (as part of combination therapy);
  • other diseases: yaws, legionellosis, chlamydia of various localizations (including prostatitis and proctitis), rickettsiosis, Q fever, Rocky Mountain spotted fever, typhus (including typhus, tick-borne relapsing), Lyme disease (I stage. - 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-term travel (less than 4 months) to areas where strains resistant to chloroquine and/or pyrimethamine-sulfadoxine are common.

Contraindications

  • hypersensitivity to tetracyclines
  • pregnancy
  • lactation
  • age up to 8 years
  • severe liver and/or kidney dysfunction
  • porphyria

Directions for use and doses
Usually the duration of treatment is 5-10 days. The tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension; they can also be swallowed whole, divided into pieces or chewed with water. Preferably taken with food.

Adults and children over 8 years old weighing more than 50 kg Prescribe 200 mg in 1-2 doses on the first day of treatment, then 100 mg daily. In cases of severe infections, Unidox is prescribed at a dose of 200 mg daily throughout treatment.
Children 8-12 years old weighing 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 infections, Unidox is prescribed at a dose of 4 mg/kg daily throughout treatment.

Features of dosing for certain diseases
For infection caused by S.pyogenes, Unidox is taken for at least 10 days.
For uncomplicated gonorrhea (excluding anorectal infections in men):
Adults are prescribed 100 mg twice a day until complete cure (on average within 7 days), or 600 mg is prescribed for one day - 300 mg in 2 doses (the second dose 1 hour after the first).

For primary syphilis, 100 mg is prescribed twice a day for 14 days, for secondary syphilis - 100 mg twice a day for 28 days.

For uncomplicated urogenital infections caused by Chlamydia trachomatis, cervicitis, non-gonococcal urethritis caused by Ureaplasma urealiticum, 100 mg is prescribed 2 times a day for 7 days.

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

Malaria (prevention): 100 mg 1 time per day 1-2 days before the trip, then daily during the trip and for 4 weeks after return; for children over 8 years old, 2 mg/kg 1 time per day.

“Travelers’ diarrhea” (prevention) – 200 mg on the first day of the trip (at one dose or 100 mg 2 times a day), then 100 mg 1 time per day throughout your 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 your stay in a disadvantaged area and 200 mg at the end of the trip.

To prevent infections during medical abortion, 100 mg is prescribed 1 hour before and 200 mg after the intervention.

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 old weighing more than 50 kg - up to 200 mg, for children 8-12 years old weighing less than 50 kg - 4 mg/kg daily throughout treatment.

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 leads to a gradual accumulation of it in the body (risk of hepatotoxicity).

Side effects
From the gastrointestinal tract:
anorexia, nausea, vomiting, dysphagia, diarrhea, enterocolitis, pseudomembranous colitis.

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

From the liver:
liver damage (with long-term use of the drug or in patients with renal or liver failure).

From the kidneys: an increase in residual urea nitrogen due to the anti-anabolic effect of the drug.

From the hematopoietic system:
hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity.

From the nervous system:
benign increase in intracranial pressure (anorexia, vomiting, headache, papilledema), vestibular disorders (dizziness or unsteadiness).

From the thyroid gland:
In patients receiving long-term doxycycline, reversible dark brown discoloration of the thyroid tissue is possible.

For teeth and bones:
doxycycline slows down osteogenesis, disrupts the normal development of teeth in children (the color of teeth irreversibly changes, 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 transaminase levels, increased prothrombin time.

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

Drug interactions
Antacids containing aluminum, magnesium, calcium, iron preparations, sodium bicarbonate, magnesium-containing laxatives reduce the absorption of doxycycline, so their use should be separated by an interval of 3 hours.
Due to the suppression of intestinal microflora by doxycycline, the prothrombin index decreases, which requires dose adjustment of indirect anticoagulants.
When doxycycline is combined with bactericidal antibiotics that interfere with 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, accelerating the metabolism of doxycycline, reduce its concentration in the blood plasma.
The simultaneous use of doxycycline and retinol increases intracranial pressure.

special instructions
There is a possibility of cross-resistance and hypersensitivity with other tetracycline drugs.
Tetracyclines may increase prothrombin time; the use of tetracyclines in patients with coagulopathies should be carefully monitored.
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 significant for patients with normal renal function. However, in patients with renal failure, an increase in azotemia may occur. The use of tetracyclines in patients with impaired renal function requires medical supervision.
With long-term use of the drug, periodic monitoring of laboratory blood parameters, liver and kidney function is required.
Due to the possible development of photodermatitis, it is necessary to limit insolation during treatment and for 4-5 days after it.
Long-term use of the drug can cause dysbacteriosis and, as a result, the development of hypovitaminosis (especially B vitamins).
To prevent dyspeptic symptoms, it is recommended to take the drug with meals.

Features of the influence on the ability to drive a car and operate machinery have not been studied.

Release form
Dispersible tablets 100 mg; 10 tablets in a PVC/aluminum foil blister. 1 blister along with instructions for use in a cardboard box.

Storage conditions
At temperatures from 15 to 25 ºС.
Keep out of the reach of children!

Best before date
5 years.
Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies
On prescription.

Produced:

Elisabethof 19, Leiderdorp

Packaged and/or packaged:
Astellas Pharma Europe B.V., Netherlands
or ZAO ORTAT, Russia

Consumer complaints should be sent to:
Moscow representative office of Astellas Pharma Europe B.V., the Netherlands:
109147 Moscow, Marksistskaya st. 16
"Mosalarco Plaza-1" business center, floor 3

Tradename

Unidox Solutab (Unidox Solutab).

International Nonproprietary Name (INN)

Doxycycline

Pharmacological group

Unidox Solutab belongs to the group

antibiotics tetracycline series.

Compound

One Unidox tablet contains doxycycline monohydrate in an amount equal to 100 mg of pure doxycycline - this is the active substance of Unidox Solutab tablets. Excipients:

  • hyprolose (low-substituted);
  • magnesium stearate;
  • microcrystalline cellulose;
  • hypromellose;
  • saccharin;
  • lactose monohydrate;
  • colloidal silicon dioxide (anhydrous).

The tablets are packaged in plastic blisters of 10 pieces, one in a cardboard box.

Release form

The drug Unidox Solutab is available in the form of dispersible (soluble) biconvex round tablets. The color can be different shades of yellow. A notch is visible on one side of the tablet, and “173” is engraved on the other.

pharmachologic effect

Doxycycline, which is part of Unidox, is a substance that stops the proliferation of bacterial cells, which is associated with a violation of protein formation in the cells of microorganisms.

This drug belongs to the group of broad-spectrum antibiotics, but it should be noted that many microorganisms have currently become insensitive to this antibiotic.

In our time, the most sensitive to Unidox among gram-positive cocci are pneumococcus, most enterococci and some groups of staphylococci, and among gram-negative cocci - moraxella and meningococcus. Most gonococci are insensitive.

Doxycycline is active against leptospira, rickettsia, spirochetes, chlamydia, borrelia, mycoplasma, some protozoa and actinomycetes.

The destructive effect of doxycycline has been established against certain types of gram-positive and gram-negative bacilli: yersinia, listeria, brucella, vibrios (including cholera), pathogens of plague, granuloma inguinale, tularemia, anthrax.

Salmonella, Enterobacter, E. coli, Klebsiella, Shigella are resistant to doxycycline.

Among anaerobic microorganisms, fusobacteria, clostridia, and propionibacteria (P. acnes) are susceptible to the action of doxycycline.

Pharmacokinetics

When taken orally, it is perfectly absorbed, and its absorption and effect in the body does not depend on food intake. In the period from an hour to 3 hours after taking the drug, the maximum concentration of doxycycline is recorded in the blood. This drug also creates a fairly high concentration of doxycycline in the tissues. In the cerebrospinal fluid, the level of the drug is 25% higher than in the blood, in bile – 20%. The drug is able to penetrate the placenta to the fetus and enter the

breast milk

It is eliminated from the body through the gastrointestinal tract. The period during which exactly half the dose of the drug taken is eliminated from the body is 20 hours.

Application

The drug Unidox Solutab has found wide use in the treatment of diseases such as:

  • STIs (sexually transmitted infections) – gonorrhea, syphilis, lymphogranuloma venereum, granuloma inguinale;
  • chlamydial infections - trachoma, urethritis, cervicitis, psittacosis, prostatitis;
  • mycoplasma infections;
  • rosacea (rosacea);
  • acne;
  • borreliosis – relapsing fever, Lyme disease;
  • bacterial zoonotic infections – tularemia, plague, brucellosis, anthrax, leptospirosis;
  • rickettsiosis;
  • lower respiratory tract infections - community-acquired atypical pneumonia, chronic bronchitis in the acute stage;
  • gynecological infectious diseases - salpingoophoritis, adnexitis, endometritis;
  • actinomycosis;
  • acute dacryocystitis;
  • intestinal infectious diseases – yersiniosis, cholera;
  • animal bites complicated by wound infection;
  • cat scratch disease;
  • prevention of tropical malaria.

Contraindications

  • children under 8 years of age;
  • severe liver pathology;
  • pregnancy;
  • lactation period.

Instructions for use Pimples (acne, acne vulgaris, rosacea) In case of intolerance and ineffectiveness of local treatment of acne, in case of severe and moderate course of the disease (including scar formation), systemic antibiotic therapy is prescribed. In this case, the antibiotic Unidox is the drug of choice. Take 100-200 mg of the drug, dividing the dose into 2 doses. The duration of treatment is 12 days.

Ureaplasmosis Treatment of ureaplasmosis is carried out by taking 100 mg of the drug Unidox twice a day with a 12-hour break, for 7 days.

Chlamydia For the treatment of urogenital chlamydia, Unidox is taken 100 mg twice a day for a week.

Prostatitis The duration of treatment of bacterial prostatitis with Unidox at a daily dose of 200 mg is at least 4 weeks. The drug is taken in two doses, 12 hours apart.

Syphilis In case of intolerance to penicillin antibiotics, reserve antibiotics are used in the treatment of syphilis, one of which is Unidox Solutab. For preventive treatment, the drug is prescribed 3 times a day, 100 mg, for 2 weeks. For the treatment of fresh forms, the period of use of the drug at the same dose is increased to 20-25 days.

Gonorrhea Uncomplicated subacute and acute forms of gonorrhea can be treated with Unidox Solutab. Tablets are taken orally at 100 mg (the first dose is 200 mg) every 12 hours, the total dose of treatment is 1000 mg. For other forms of gonorrhea, treatment is carried out according to the same scheme, but the total dose per course is 1500 mg.

Granuloma For the treatment of lymphogranuloma venereum and inguinal granuloma (donovanosis), Unidox tablets are taken for 3 weeks, 100 mg every 12 hours.

Actinomycosis Actinomycosis can be treated with Unidox in a daily dose of 0.2 g, taken for six months to a year.

Eye diseases Eye diseases, such as trachoma and acute dacryocystitis, are treated with Unidox for 21-28 days at a daily dose of 200 mg, in two doses.

Cholera For cholera, 300 mg of Unidox is prescribed once.

Rickettsial disease The treatment regimen for rickettsiosis includes prescribing Unidox 100 mg twice a day for a week (or for 2 days after normalization of body temperature).

Zoonosis The treatment regimen for bacterial zoonoses is similar, the only differences are in the duration of drug administration. Unidox is prescribed 100 mg every 12 hours, for plague - 10 days, for tularemia - 2 weeks, for anthrax - 2 months.

Brucellosis The treatment regimen for brucellosis also includes the administration of Unidox 100 mg twice a day, in combination with other antimicrobial drugs (streptomycin, rifampicin).

Leptospirosis To prevent leptospirosis, take 100 mg of Unidox once a week.

For tick-borne

borreliosis

For a month, take 0.1 g of the drug every 12 hours. For prevention purposes, 200 mg of Unidox is prescribed once.

Malaria When traveling to areas where malaria is endemic, you must take Unidox the day before departure, and take the drug during the entire period of your stay in this country. The total interval for taking Unidox should not exceed 6 months. The daily dose is 100 mg.

Respiratory system infections For lower respiratory tract infections, the duration of Unidox therapy is from 7 to 10 days, for mycoplasma pneumonia - up to 3 weeks. Unidox is taken 200 mg orally once a day.

Other Applications To prevent the development of postoperative infectious complications, after an abortion in the first trimester of pregnancy, in the presence of PID (pelvic inflammatory disease), multiple sexual partners, a history of gonorrhea, take 100 mg of Unidox 1 hour before surgery, and 200 mg of the drug after 1.5 hours after an abortion.

For children For children over 8 years of age, Unidox is prescribed in a daily dose of 5 mg per 1 kg of weight, but not more than 200 mg. The daily dose is divided into 2 doses.

Side effect Adverse reactions from various organs and systems of the body when using the drug Unidox Solutab include the following symptoms:

  • nausea and vomiting, abdominal pain, diarrhea, glossitis with blackening of the tongue and hypertrophy of the papillae, esophagitis, inflammation of the pancreas, erosion of the esophagus, inflammation of the large intestine, disruption of the intestinal and vaginal microflora, fungal infections;
  • pseudotumor cerebri syndrome with long-term use (increased intracranial pressure), dizziness;
  • dysfunction of the liver up to the appearance of liver necrosis;
  • urticaria, Quincke's edema, itchy rash, anaphylactic shock;
  • photosensitivity (under the influence of direct sunlight, dermatitis and rash appear on the skin);
  • the appearance of defects in tooth enamel, discoloration of teeth in a gray-brown or yellow color.

Overdose (symptoms) When taking large doses of the drug, nausea, vomiting, increased body temperature, yellowness of the skin, and bleeding may occur.

If these symptoms are observed, gastric lavage is necessary. You should also take activated charcoal and laxatives. Drinking plenty of fluids is recommended.

Interaction with other drugs

Reduces bioavailability

antacids

- drugs containing

Cholestyramine, magnesium, aluminum, sodium bicarbonate. There should be a break of at least 1 hour between taking Unidox and these drugs.

The absorption of both drugs is impaired when Unidox is prescribed simultaneously with iron supplements.

Barbiturates, phenytoin and carbamazepine increase the breakdown of doxycycline in the liver and reduce its concentration in the blood, which may require dosage adjustment of Unidox.

Unidox may enhance the medicinal effect of indirect coagulants when taken simultaneously; monitoring of prothrombin time is necessary.

The risk of developing pseudotumor cerebri increases when taking vitamin A supplements while using Unidox.

The reduced therapeutic effect of oral estrogen-containing contraceptives should also be taken into account.

special instructions

Unidox Solutab should be taken orally, preferably in a standing position, washed down with a large amount

This will prevent possible damage to the esophagus and irritation of the gastric and intestinal mucosa.

The drug is taken regardless of meals, but at regular intervals, without skipping or doubling the dose.

During treatment, it is necessary to refrain from exposure to the sun (under direct exposure).

Unidox can be used to treat patients with renal failure, as it is eliminated through the gastrointestinal tract.

Unidox Solutab during pregnancy

The drug penetrates the uteroplacental barrier and can contribute to severe disorders of bone tissue development in the fetus. Therefore, the use of Unidox Solutab is CONTRAINDICATED during

pregnancy

Combination with alcohol

When taking Unidox Solutab and alcohol simultaneously, their toxic effect on the liver increases, which can lead to the development of toxic

hepatitis A

The therapeutic effect of the drug is also reduced. Drinking alcohol is possible only a week after completing the course of treatment with Unidox.

Analogs Preparations with a similar active ingredient (doxycycline):

  • Dovicil;
  • Doxycycline Nycomed;
  • Bassada;
  • Vidoccin;
  • Doxibene;
  • Vibramycil;
  • Xedocin;
  • Doxal;
  • Monocline;
  • Apo-doxy;
  • Doxidar 100.

Storage conditions and periods

The drug is stored in a dry place at a temperature of 15 to 25

C, in a place inaccessible to children.

The drug is considered fit for use within 5 years from the date of production.

Dispensing conditions in pharmacies

You can buy Unidox Solutab in the pharmacy chain upon presentation of a doctor's prescription for this drug.

Price Price in Ukraine Unidox Solutab soluble tablets can be bought in Ukraine at an average price of 68 hryvnia per pack.

Price in Russia Dispersible antibiotic tablets Unidox Solutab 100 mg can be bought in Russia at an average price of 300 rubles per pack.