Pharmacological properties of the drug Unidox solutab
Broad-spectrum antibiotic of the tetracycline group. Acts bacteriostatically. Active against gram-positive and gram-negative microorganisms: Streptococcus haemolyticus, S. pneumoniae, S. viridans, S. faecalis, Staphylococcus aureus, Listeria spp. (including L. monocytogenes), Neisseria gonorrhoeae, N. meningitidis, Haemophilus influencae, Brucella, Mycoplasma spp., Clostridium spp., Escherichia coli, Shigella spp., Salmonella spp., Pasteurella, Spirocheta, Entamoeba hystolitica, Yersinia spp. , Vibrio spp., Francisella tularensis, Enterobacter spp., Klebsiella spp., Bacteroides spp., Chlamydiae spp., Rickettsiae spp. Less active against Proteus spp. and Pseudomonas spp. Doxycycline is almost completely absorbed when taken orally. Consumption of food or milk has little effect on the absorption of the drug. 2 hours after taking 200 mg on the first day of treatment, 100 mg per day on subsequent days, the level of doxycycline in the blood serum ranges on average from 1.5 to 3 mg/ml, after 24 hours it is 1.5 mg/ml. The maximum concentration in blood plasma (2.6–3 mg/ml) is achieved 2 hours after oral administration at a dose of 200 mg. Doxycycline binds reversibly to plasma proteins (80–90%), penetrates well into tissues, poorly into the CSF (10–20% of plasma levels). The drug accumulates in the reticuloendothelial system and bone tissue. A small part of the drug is metabolized. 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 secreted by the renal tubules in the form of biologically active forms, 20–40% is excreted in the feces in the form of inactive forms (chelates) . The half-life of the drug in patients with impaired renal function does not change, as its excretion in feces increases. Hemodialysis and peritoneal dialysis do not affect plasma doxycycline levels. The drug penetrates the placental barrier and is detected in small quantities in breast milk. 5–27% of the serum level of the drug is determined in saliva, and 50% in prostate tissue.
When is it prescribed?
Unidox Solutab, the instructions indicate this, is prescribed for the treatment of various infectious and inflammatory diseases that are provoked by drug-sensitive pathogenic microorganisms.
A wide range of applications makes it possible to successfully treat diseases of the respiratory system and ENT organs. Indications for prescribing the medicine are infectious diseases of the genitourinary system and gastrointestinal tract. The effectiveness of Unidox Solutab 100 has been proven in the treatment of skin pathologies and in the prevention of purulent complications after operations.
A detailed explanation of the indications for the tetracycline antibiotic is contained in the instructions for use. It is the basis for prescribing the drug.
Use of the drug Unidox Solutab
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 - 100 mg per day in 1 dose daily. Thanks to the dosage form, Solutab tablets can be swallowed without chewing, divided into pieces or chewed with a glass of water, and can also be diluted in water to obtain a syrup (20 ml) or suspension (100 ml). In case of severe infections, 200 mg is prescribed daily for the entire treatment period. Children over 8 years old with a body weight of less than 50 kg on the first day of treatment are prescribed a daily dose of 4 mg/kg in 1 dose, on subsequent days of treatment - 2 mg/kg 1 time per day daily. For severe infections, a daily dose of 4 mg/kg is prescribed throughout the entire course of treatment. The duration of the course of treatment is determined individually. Gonorrhea: women are prescribed 200 mg daily until complete cure (on average within 5 days); for men - 200-300 mg in 1 dose daily for 2-4 days or for 1 day 300 mg 2 times a day (the second dose 1 hour after the first). Primary and secondary syphilis: prescribed 300 mg daily, the minimum duration of treatment is 10 days. Typhus: 100–200 mg is prescribed once (depending on the severity of the disease).
What are the contraindications?
The main contraindication is hypersensitivity to tetracyclines and other components of the drug. It is prohibited to carry out drug therapy during the entire period of pregnancy. The greatest risks of developing pathologies in the fetus occur in the 1st trimester, when the placenta has not yet formed. The active substance can accumulate in bone tissue, which will disrupt mineralization processes and lead to unpredictable consequences.
For the treatment of children under 8 years of age, Unidox Solutab tablets, the instructions for use confirm this, are not prescribed. They should be abandoned if there are serious problems with the liver and kidneys. They are not prescribed for the diagnosis of porphyria. This pathology is hereditary, it is characterized by disorders of pigment metabolism and other pathological symptoms.
Side effects of the drug Unidox Solutab
Anorexia, nausea, vomiting, dysphagia, glossitis, possible diarrhea and enterocolitis caused by the growth of resistant strains of staphylococci, candidiasis due to the proliferation of Candida albicans (clinically manifested by diarrhea, glossitis, stomatitis, proctitis, vaginitis), maculopapular and erythematous rash, rarely exfoliative dermatitis, photosensitivity; urticaria, angioedema, anaphylactic reactions, pericarditis, exacerbation of systemic lupus erythematosus, hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia.
Possible body reactions
While taking Solutab tablets, the instructions for use indicate this, health-threatening symptoms may occur. The most common problems occur in the digestive system. When taking the medicine the following is noted:
- Nausea.
- Vomit.
- Diarrhea.
- Dysbacteriosis.
The drug may cause:
- Anorexia, characterized by refusal to eat due to a neuropsychiatric disorder.
- Dysphagia, which is associated with disorders of the swallowing process.
- Enterocolitis, against the background of which inflammatory processes occur in the intestines.
- Pseudomembranous colitis, which provokes acute inflammation in the large intestine.
After taking Unidox Solutab tablets, allergies or dermatological problems of varying severity may occur. Very often there is urticaria and rash in various manifestations and places. If the patient suffers from autoimmune diseases, for example, lupus erythematosus, then the risks of developing exacerbations increase significantly. Sometimes treatment with the drug leads to the development of pericarditis and exfoliative dermatitis.
When therapy is carried out for a long time, the risks of malfunctions in the liver and kidneys increase. The drug poses an increased danger to patients with renal or liver failure.
Also, the instructions for the drug focus on other side effects. Malfunctions may occur:
- Hematopoietic systems.
- Nervous system.
- ·Endocrine system.
Special instructions for the use of Unidox Solutab
Unidox Solutab is prescribed to patients with severe impairment of liver and kidney function only if treatment with other drugs is impossible, and the dose of the drug is reduced. Strains resistant to other tetracycline drugs may be resistant to doxycycline. Long-term use of the drug can cause hypovitaminosis due to the development of dysbacteriosis. The drug is contraindicated for use in the second and third trimester of pregnancy. Doxycycline slows down osteogenesis, increases bone fragility in the fetus, disrupts the normal process of tooth development (teeth color irreversibly changes, enamel hypoplasia occurs). Doxycycline is detected in breast milk in amounts that are 30–40% of its serum level. To prevent dyspepsia, it is recommended to take the drug with meals.
Form of the medicinal product
The antimicrobial agent Unidox Solutab contains the active substance - doxycycline monohydrate. The release form of the drug is tablets. Various substances are additionally used for their production. Their list is given in the instructions for use of the drug.
Biconvex tablets have certain external signs that can be used to exclude counterfeit. They have a grayish-yellow or brownish tint. Blotches are visible on their surface. In addition, there is an engraving “173” and a risk on different sides. Tablets are packaged in blisters of 10 pieces.
Unidox Solutab 100 mg 10 pcs. dispersible tablets
pharmachologic effect
Antibiotic, tetracycline.
Composition and release form Unidox Solutab 100 mg 10 pcs. dispersible tablets
Tablets - 1 tablet:
- Active substance: doxycycline monohydrate 100.0 mg in terms of doxycycline;
- Excipients: microcrystalline cellulose - 45.0 mg, saccharin - 10.0 mg, hyprolose (low-substituted) - 18.75 mg, hypromellose - 3.75 mg, colloidal silicon dioxide (anhydrous) -0.625 mg, magnesium stearate - 2, 0 mg, lactose monohydrate - up to 250.0 mg.
Dispersible tablets 100 mg.
10 tablets in a PVC/aluminum foil blister. 1 blister along with instructions for use in a cardboard box.
Description of the dosage form
Round, biconvex tablets, light yellow or grey-yellow to speckled brown, engraved “173” (tablet code) on one side and scored on the other.
Characteristic
Broad-spectrum antibiotic from the tetracycline group.
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.
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.
Adults and children over 8 years of age weighing more than 50 kg are prescribed 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.
For 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 infection, 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 for one day they are prescribed 600 mg - 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.
The duration of prophylaxis should not exceed 4 months. Traveler's diarrhea (prevention) - 200 mg on the first day of the trip (in 1 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 600 mg/day for 5 days for severe gonococcal infection. For children over 8 years old with a body weight of more than 50 kg - up to 200 mg, for children 8 - 12 years old with a body weight less than 50 kg - 4 mg/kg daily during the entire treatment period.
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).
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, Neis seria 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 difficilé), 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, which is often cross-linked within a group, should be taken into account (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 Unidox Solutab 100 mg 10 pcs. dispersible tablets
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 salpingoophioritis as part of combination 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 impairment of liver and/or kidney function;
- porphyria.
Application of Unidox Solutab 100 mg 10 pcs. dispersible tablets 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, etc.). 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 is discontinued.
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.
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. See Side effects - Nervous system disorders.
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.
Side effects of Unidox Solutab 100 mg 10 pcs. dispersible tablets
From the gastrointestinal tract: anorexia, nausea, vomiting, dysphagia, diarrhea, anal itching, esophagitis, esophageal ulcer, dark coloration of the tongue. With long-term therapy, a deficiency of B vitamins may occur due to the suppression of the growth of vitamin B-producing bacteria in the normal intestinal microflora.
Allergic reactions: exacerbation of systemic lupus erythematosus, a syndrome similar to serum sickness, erythema multiforme, decreased blood pressure, tachycardia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome).
From the skin: urticaria, photosensitivity, angioedema, anaphylactic reactions, maculopapular and erythematous rash, exfoliative dermatitis, Henoch-Schönlein purpura, photoonycholysis.
From the cardiovascular system: pericarditis.
From the liver: liver damage, sometimes associated with pancreatitis (with long-term use of the drug or in patients with renal or hepatic insufficiency), cholestasis.
From the kidneys: an increase in residual urea nitrogen, due to the anti-anabolic effect of the drug, worsening azotemia in patients with renal failure. Consumption of products containing citric acid while taking doxycycline may cause symptoms similar to Fanconi syndrome: albuminuria, glycosuria, hypophosphatemia, hypokalemia, and renal tubular acidosis.
From the hematopoietic system: hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased prothrombin activity.
From the nervous system: benign increase in intracranial pressure (anorexia, vomiting, headache, tinnitus, tremor, papilledema), vestibular disorders (dizziness or instability), hallucinations, blurred vision, scotoma, double vision.
From the thyroid gland: in patients who have been receiving tetracycline antibiotics for a long time, reversible dark brown staining of the thyroid tissue is possible, in most cases not accompanied by a violation of its function.
From the side of teeth and bones: doxycycline slows down osteogenesis, disrupts the normal development of teeth in children (the color of teeth irreversibly changes, enamel hypoplasia develops).
From the musculoskeletal system: arthralgia, myalgia.
Other:
Superinfection: candidiasis, glossitis, staphylococcal enterocolitis, pseudomembranous colitis, anogenital candidiasis, stomatitis, and vaginitis.
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 doxycilline 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.
