Unidox solutab
Unidox solutab: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Unidox Solutab
ATX code: J01AA02
Active ingredient: doxycycline (Doxycycline)
Producer: ZiO-Zdorov'e, JSC (Russia), Astellas Pharma Europe BV (Netherlands)
Description and photo updated: 2018-29-11
Prices in pharmacies: from 286 rubles.
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Unidox solutab is an antibiotic from the tetracyclines group.
Release form and composition
Dosage form - tablets: round, biconvex, from gray-yellow or light yellow to brown interspersed, with a line on one side and engraving "173" on the other (10 pcs. In blisters, in a cardboard box 1 blister and instructions for the use of Unidox solutab).
Composition of 1 tablet:
- active substance: doxycycline (in the form of monohydrate) - 100 mg;
- auxiliary components: magnesium stearate, hyprolose (low-substituted), microcrystalline cellulose, lactose monohydrate, hypromellose, saccharin, colloidal silicon dioxide (anhydrous).
Pharmacological properties
Pharmacodynamics
The active ingredient of Unidox solutab - doxycycline, is a broad-spectrum antibacterial agent belonging to the tetracyclines group.
It has a bacteriostatic effect. By interacting with the 30S ribosome subunit, it inhibits protein synthesis in the microbial cell.
It is effective in diseases caused by many gram-positive and gram-negative microorganisms, including Actinomyces spp., Brucella spp., Staphylococcus spp., Borrelia recurrentis, Bacillus anthracis, Neisseria gonorrhoeae, Bartonella bacilliformis, Campylobacter spp. (including E. aerogenes), Clostridium spp. (except for Clostridium difficile), Escherichia coli, Chlamydia spp., Calymmatobacterium granulomatis, Francisella tularensis, Haemophilus influenzae, Fusobacterium fusiforme, Mycoplasma spp., Klebsiella spp., Risteria multocidia methium, Risteria spp. spp., Shigella spp., Treponema spp., Typhus exanthematicus, Yersinia spp. (including Yersinia pestis), Ureaplasma urealyticum, Vibrio cholerae, as well as some protozoa,such as Entamoeba spp., Plasmodium falciparum.
Doxycycline is generally inactive against Acinetobacter spp., Enterococcus spp., Serratia spp., Pseudomonas spp., Proteus spp., Providencia spp.
Some pathogens can acquire resistance to doxycycline, which is often cross-linked within the group, i.e. strains resistant to doxycycline will be resistant to all members of the tetracyclines group.
Pharmacokinetics
After oral administration, doxycycline is rapidly and almost completely absorbed. Food intake has little effect on the absorption of the substance.
The maximum plasma concentration is 2.6-3 mcg / ml and is reached within 2 hours after taking a dose of 200 mg. After 24 hours, the plasma doxycycline level is reduced to 1.5 μg / ml.
When Unidox solutab is taken on the first day at a dose of 200 mg and 100 mg each on the following days, the equilibrium plasma concentration of doxycycline is 1.5–3 μg / ml.
The drug reversibly binds to plasma proteins by 80–90%. It penetrates well into tissues and organs, poorly into the cerebrospinal fluid (about 10–20% of the plasma level is found), however, with inflammation of the spinal membrane, the concentration in the cerebrospinal fluid increases.
The volume of distribution is 1.58 l / kg. 30–45 minutes after oral administration of Unidox, doxycycline solutab is found in therapeutic concentrations in the following tissues and fluids: kidneys, liver, spleen, lungs, teeth, bones, eye tissues, prostate gland, bile, gingival sulcus fluid, exudate of maxillary and frontal sinuses, synovial exudate, pleural and ascitic fluids.
In saliva, doxycycline is determined in an amount of 5–27% of the total plasma level.
In patients with normal liver function, the concentration in bile is 5–10 times higher than in plasma.
The drug crosses the placental barrier, in small quantities - into breast milk. It accumulates in bone tissue and dentin.
Doxycycline is metabolized in insignificant amounts.
After a single dose of Unidox solutab inside, the half-life (T ½) is 16-18 hours, with repeated use - 22-23 hours.
About 40% of the dose is excreted by the kidneys, 20–40% through the intestines in the form of inactive forms (chelates).
T ½ in case of impaired renal function does not change, while the excretion of the drug through the intestines increases.
In patients receiving peritoneal dialysis or hemodialysis, the plasma concentration of doxycycline does not change.
Indications for use
Unidox solutab is prescribed for the treatment of infectious and inflammatory diseases caused by sensitive microorganisms from various organs and systems of the body:
- respiratory tract: pharyngitis, tracheitis, acute bronchitis, exacerbation of chronic obstructive pulmonary disease, community-acquired pneumonia, lobar pneumonia, bronchopneumonia, pleural empyema, lung abscess;
- gastrointestinal tract and biliary tract: cholangitis, cholecystitis, traveler's diarrhea, gastroenterocolitis, yersiniosis, cholera, amoebic and bacillary dysentery;
- genitourinary system: pyelonephritis, cystitis, acute orchiepididymitis, urethrocystitis, urethritis, urogenital mycoplasmosis, bacterial prostatitis, salpingo-oophoritis, endocervicitis, endometritis, as well as sexually transmitted infections, such as lymphogranuloma venereum, granulomatous gonorrhea, groin therapy), syphilis in patients with penicillin intolerance;
- skin and soft tissues: severe acne (as part of combination therapy), wound infections after a bite of animals, other infectious diseases;
- others: brucellosis, whooping cough, osteomyelitis, malaria, legionellosis, tularemia, rickettsiosis, actinomycosis, plague, Lyme disease (1st degree - erythema migrans), Rocky Mountain spotted fever, Q fever, yaws, leptocytospirosis, granulocytosis including loose, tick-borne recurrent), psittacosis, bartonellosis, anthrax (including the pulmonary form), trachoma, peritonitis, subacute septic endocarditis, sepsis, eye infections, chlamydia of various localization (including proctitis and prostatitis).
Unidox solutab tablets are also used for the prevention of postoperative purulent complications and malaria caused by Plasmodium falciparum, during short travel (up to 4 months) in the territory where strains resistant to pyrimethamine sulfadoxine and / or chloroquine are common.
Contraindications
Absolute:
- porphyria;
- severe impairment of liver and / or kidney function;
- age up to 8 years;
- lactation period;
- hypersensitivity to drug components or other tetracyclines.
Unidox solutab is contraindicated for pregnant women, except in cases of vital necessity.
Unidox solutab, instructions for use: method and dosage
Unidox solutab should be taken orally. The tablets can be swallowed whole with water, or taken as a suspension after dissolving in a small amount of water (approximately 20 ml). They can be divided into pieces or chewed.
It is advisable to take the drug with meals, sitting or standing to reduce the risk of developing esophagitis and esophageal ulcers. Do not take tablets just before bedtime.
Standard doses of Unidox solutab depending on age and body weight:
- adults and children from 8 years old with body weight> 50 kg: on the first day - 200 mg in 1 or 2 doses, then - 100 mg once a day. In severe infections, the drug is prescribed at 200 mg per day during the entire period of treatment;
- children of 8–12 years old with body weight <50 kg: on the first day - on average 4 mg / kg, then - in a daily dose of 2 mg / kg in 1–2 doses. In severe infections, the drug is prescribed at 4 mg / kg per day during the entire period of treatment.
Dosing features for certain diseases and for preventive purposes:
- acne: 100 mg per day for a course of 6-12 weeks;
- leptospirosis: treatment - 100 mg 2 times a day for 7 days, prevention - 200 mg 1 time a week during the entire period of stay in a disadvantaged area and 200 mg upon return;
- cervicitis, uncomplicated urogenital infections caused by Chlamydia trachomatis, and non-gonococcal urethritis caused by Ureaplasma urealyticum: 100 mg 2 times a day for 7 days;
- uncomplicated gonorrhea in adults (with the exception of anorectal forms in men): 100 mg 2 times a day until complete recovery (on average 7 days) or one day 300 mg 2 times with an interval of 1 hour;
- primary syphilis: 100 mg 2 times a day for a course of 14 days;
- secondary syphilis: 100 mg 2 times a day for 28 days;
- prevention of travelers' diarrhea: on the first day of the trip - 200 mg in 1-2 doses, then - 100 mg once a day during the entire travel period, but not more than 3 weeks;
- prevention of malaria: adults - 100 mg once a day, children from 8 years old - 2 mg / kg once a day. You should start using the drug 1–2 days before the trip, continue taking it during the entire trip and for 4 weeks after returning. The total duration of preventive treatment should not exceed 4 months;
- prevention of infections during medical abortion: 100 mg 1 hour before the intervention and 200 mg after.
The maximum permissible daily doses of Unidox solutab:
- adults: 300 mg; in the case of severe gonococcal infection - 600 mg with a duration of treatment for 5 days;
- children from 8 years old with a body weight> 50 kg: 200 mg;
- children 8–12 years old with body weight <50 kg: 4 mg / kg daily for the entire treatment period.
In patients with hepatic or renal (creatinine clearance 60 ml / min) insufficiency, the dose of Unidox solutab is reduced due to the risk of hepatotoxic action due to the accumulation of doxycycline in the body.
Side effects
- on the part of the cardiovascular system: pericarditis;
- from the gastrointestinal tract: dark staining of the tongue, dysphagia, nausea, esophagitis, diarrhea, vomiting, anorexia, esophageal ulcer, anal itching; with prolonged use of Unidox solutab - deficiency of B vitamins;
- from the side of the kidneys: an increase in the residual nitrogen of urea; in patients with renal failure, aggravation of azotemia; in the case of the use of products containing citric acid, symptoms similar to Fanconi's syndrome, such as hypokalemia, hypophosphatemia, glucosuria, albuminuria, renal tubular acidosis;
- from the liver: cholestasis; with renal / hepatic failure or prolonged use of Unidox solutab - liver damage, sometimes associated with pancreatitis;
- from the thyroid gland: with prolonged use of Unidox solutab - reversible dark brown staining of thyroid tissue (in most cases, it is not accompanied by a functional disorder);
- on the part of the musculoskeletal system: myalgia, arthralgia;
- from the hematopoietic system: eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, decreased prothrombin activity;
- from the nervous system: double vision, scotoma, blurred vision, hallucinations, vestibular disorders (dizziness or instability), benign increase in intracranial pressure (swelling of the optic nerve, tinnitus, headache, tremor, vomiting, anorexia);
- on the part of the teeth and bones: slowing down of osteogenesis, violation of the normal development of teeth in children (irreversible discoloration of tooth enamel, development of enamel hypoplasia);
- on the part of the skin: exfoliative dermatitis, photosensitization, erythematous and maculopapular rash, urticaria, anaphylactic reactions, angioedema, photoonicholysis, Shenlein-Genoch's purpura;
- allergic reactions: a syndrome similar to serum sickness, exacerbation of systemic lupus erythematosus, drug rash with eosinophilia and systemic symptoms (dress syndrome), erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, tachycardia, lowering blood pressure;
- others: the development of superinfection (may manifest itself with symptoms such as stomatitis, glossitis, candidiasis, pseudomembranous colitis, staphylococcal enterocolitis, vaginitis, anogenital candidiasis).
Overdose
In case of overdose, side effects caused by liver damage may increase: vomiting, jaundice, fever, azotemia, increased transaminase levels and prothrombin time.
Immediately after taking an excessive dose of Unidox solutab, it is recommended to induce vomiting, gastric lavage, and drink plenty of fluids. It is necessary to take an adsorbent (for example, activated carbon) and an osmotic laxative. Hemodialysis and peritoneal dialysis are ineffective.
special instructions
To prevent the occurrence of dyspeptic disorders, Unidox solutab is recommended to be taken with meals.
There is a possibility of developing cross-resistance and hypersensitivity with other drugs of the tetracycline series.
With long-term treatment, it is necessary to regularly monitor the functions of the kidneys and liver, laboratory blood parameters.
Prolonged intake of Unidox solutab can lead to dysbiosis and, as a result, hypovitaminosis, especially B vitamins.
Considering the risk of developing photodermatitis, during the entire period of treatment and 4–5 days after its end, insolation should be limited.
Unidox solutab can increase the prothrombin time, so it should be used with extreme caution in patients with coagulopathies.
Due to the anti-anabolic effect, it is possible to increase the level of residual urea nitrogen in the blood. For patients with normal renal function, this phenomenon is usually not clinically relevant. However, in renal failure, this can lead to an increase in azotemia. For this reason, in patients with functional impairment of the kidneys, Unidox solutab should be used under close medical supervision.
Influence on the ability to drive vehicles and complex mechanisms
The effect of doxycycline on human cognitive and psychophysical functions has not been studied. There are cases of dizziness, double vision, blurred vision during treatment. Such patients are advised to refrain from driving and performing potentially hazardous activities while taking Unidox Solutab.
Application during pregnancy and lactation
Doxycycline penetrates the hematoplacental barrier, can negatively affect the development of the fetus (slow down osteogenesis) and the formation of tooth enamel (hypoplasia, irreversible discoloration of the enamel), and also cause liver damage in the mother. In this regard, tetracyclines, including Unidox solutab, are contraindicated during pregnancy, unless absolutely necessary, when the drug is the only possible means by which it is possible to cure or prevent the development of a particularly severe and dangerous infection, for example, Rocky Mountain spotted fever or infection Bacillus anthracis.
Before prescribing Unidox solutab for women of childbearing age, pregnancy should be excluded.
Doxycycline passes into mother's milk and may have adverse effects on a nursing infant. In this regard, tetracyclines are contraindicated during lactation. If treatment is necessary, breastfeeding should be interrupted.
Pediatric use
Unidox solutab tablets are not used to treat children under 8 years of age.
With impaired renal function
The use of the drug is contraindicated in severe functional disorders of the kidneys. Doxycycline dose reduction is required for mild to moderate disorders.
For violations of liver function
The use of Unidox solutab is contraindicated in case of severe functional disorders of the liver. Doxycycline dose reduction is required for mild to moderate disorders.
Drug interactions
Phenytoin, carbamazepine, rifampicin, ethanol, barbiturates and other stimulants of microsomal oxidation accelerate the metabolism of doxycycline and reduce its plasma concentration.
Doxycycline reduces the effectiveness of bactericidal antibiotics that disrupt the synthesis of the cell wall (penicillins, cephalosporins).
With the simultaneous use of retinol, intracranial pressure increases.
Aluminum-containing antacids, magnesium-containing laxatives, sodium bicarbonate, iron preparations, calcium and magnesium reduce the absorption of doxycycline. If necessary, their combined intake should be observed at 3-hour intervals.
When taken with estrogen-containing hormonal contraceptives, doxycycline reduces their effectiveness and increases the frequency of acyclic bleeding.
Doxycycline suppresses the intestinal microflora, as a result of which the prothrombin index decreases, which requires a dose adjustment of indirect anticoagulants.
Analogs
Analogues of Unidox solutab are: Vidoccin, Doxycycline, Xedocin, Minolexin, Tetracycline, Tigacil, etc.
Terms and conditions of storage
Store at a temperature of 15 to 25 ° C out of reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Unidox solutab
In positive reviews of Unidox Solutab, patients note the high antibacterial efficacy of the drug, its good tolerance, and a relatively low cost.
In rare negative messages, there are complaints about the insufficient effect of the drug or the development of side reactions.
Price for Unidox solutab in pharmacies
The approximate price for Unidox solutab for a pack of 10 tablets is 300–363 rubles.
Unidox solutab: prices in online pharmacies
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Drug name Price Pharmacy |
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Unidox Solutab 100 mg dispersible tablets 10 pcs. 286 r Buy |
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Unidox Solutab tablets dispersion 100mg 10 pcs. 342 r Buy |
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Unidox Solutab 100 mg dispersible tablets 20 pcs. 554 r Buy |
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Unidox solutab tablets dispers. 100mg 20 pcs. 579 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
