Pharmacodynamics. doxycycline has a bacteriostatic effect. its antimicrobial effect is realized by inhibiting protein synthesis. the preparation is active against a wide range of gram-positive and gram-negative bacteria, as well as other microorganisms.
Pharmacokinetics. Tetracyclines are well absorbed and bind to blood plasma proteins. They are accumulated by the liver in the bile and excreted in a biologically active form in high concentrations in the urine and feces.
Doxycycline is almost completely absorbed after oral administration. Studies show that the absorption of doxycycline is different from other tetracyclines and is not affected by concurrent consumption of food (including milk).
After taking a dose of 200 mg, the Cmax of doxycycline in the blood plasma of healthy adult volunteers averaged 2.6 μg / ml after 2 hours and decreased to 1.45 μg / ml after 24 hours.
Doxycycline is a highly lipophilic substance and has a low affinity for calcium. It is highly stable in blood plasma. Doxycycline is not metabolized into the epi-anhydro form.
Unidox solutab is used to treat infections caused by sensitive strains of gram-positive and gram-negative microorganisms, namely:
respiratory tract infections: pneumonia and other diseases of the lower respiratory tract caused by Streptococcus pneumoniae, Haemophilus influenza, Klebsiella pneumoniae. Pneumonia due to Mycoplasma pneumoniae. Treatment of chronic bronchitis, sinusitis;
urinary tract infections: infections caused by susceptible strains of the species Klebsiella, Enterobacter, as well as bacteria Escherichia coli, Streptococcus faecalis, etc.;
sexually transmitted diseases: infections caused by Chlamydia trachomatis, including uncomplicated urethral and endocervical infections and rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum (T-mycoplasma). Chancre, inguinal granuloma, venereal granuloma. Unidox Solutab is an alternative preparation for the treatment of gonorrhea and syphilis;
skin infections: acne when antibiotic therapy is needed.
Since Unidox Solutab belongs to the group of tetracycline antibiotics, it can be used for infections caused by microorganisms sensitive to tetracyclines, namely:
ophthalmic infections: infections caused by the susceptible bacteria Gonococci, Staphylococci, and Haemophilus influenza. The infection that causes trachoma is not always eliminated, which is confirmed by immunofluorescence analysis. For the treatment of paratrachoma, Unidox Solutab can be used as monotherapy or in combination with other preparations.
Rickettsial infections: Rocky Mountain spotted fever, typhus group, Q fever, Coxiella endocarditis, tick fever.
Other infections: psittacosis, brucellosis (when used in combination with streptomycin), cholera, bubonic plague, epidemic relapsing fever, tick-borne recurrent fever, tularemia; melioidosis; tropical malaria resistant to chloroquine and acute intestinal amebiasis (when used in combination with an amoebicide).
Unidox Solutab is an alternative preparation for the treatment of leptospirosis, gas gangrene and tetanus.
The preparation is indicated for the prevention of the following conditions: Japanese river fever, traveler's diarrhea (caused by enterotoxigenic Esherihia coli), leptospirosis, malaria. Malaria prophylaxis should be carried out in accordance with current practice because of the potential for resistance to develop.
Unidox Solutab is intended for oral use only.
The preparation is used in the form of a suspension, which is obtained by adding at least 20 ml of water to the tablet. The suspension should be drunk while sitting or standing, well before bedtime to reduce the risk of irritation or ulceration of the esophagus. If irritation of the esophagus occurs, the preparation should be used with food (including milk). Studies show that the simultaneous consumption of food (including milk) does not affect the absorption of the preparation.
Adults. The usual dose of the preparation Unidox Solutab for adults for the treatment of acute infections is 200 mg on the first day of treatment (1 dose or 100 mg every 12 hours) and 100 mg / day on the following days. In the treatment of severe infections, the preparation should be used at a dose of 200 mg / day during the entire period of treatment.
Exceeding the recommended dose may lead to an increase in the incidence of adverse reactions. Therapy should be continued for 24–48 hours after the symptoms of illness and fever disappear.
In case of streptococcal infectious diseases, the use of the preparation should be continued for 10 days to prevent the development of rheumatic fever or glomerulonephritis.
Children. For children over the age of 12 with a body weight of up to 45 kg, the recommended dose is 4.4 mg / kg of body weight (on the first day of treatment, the recommended dose is taken in 1 or 2 doses), on the following days the dose is 2.2 mg / kg of body weight body (for 1 or 2 doses); for more severe infectious diseases, up to 4.4 mg / kg of body weight can be prescribed.
Children weighing 45 kg are prescribed the usual adult dose.
The use of the preparation for the treatment of selected infections
Acne: The recommended dose is 50 mg / day with food (including liquid) for 6-12 weeks.
Sexually transmitted diseases: for the treatment of diseases such as uncomplicated gonococcal infection (except for anorectal infections in men), uncomplicated urethral and endocervical infections, rectal infections caused by Chlamydia trachomatis, non-gonococcal urethritis caused by Ureaplasma, the recommended dose is 100 mg 2 times a day for 7 days.
For the treatment of acute epididymo-orchitis caused by Chlamydia trachomatis or Neisseria gonorrhea, the preparation should be used 100 mg 2 times a day for 10 days.
For the treatment of primary and secondary syphilis, the recommended dose for patients without confirmed pregnancy and with an allergy to penicillins is 200 mg orally 2 times a day for 2 weeks (as an alternative to penicillin therapy).
Epidemic relapsing fever, tick-borne relapsing fever: the recommended dose is 100-200 mg once, depending on the severity of the disease.
Chloroquine-resistant tropical malaria: The recommended dose is 200 mg / day for at least 7 days due to the possible severe course of the infectious disease.
Always, as an additional therapy to the preparation Unidox Solutab, a fast-acting schizonticide (for example, quinine) should be used, the dose of which depends on each specific case, due to the potential severe course of an infectious disease.
Prevention of malaria: The recommended dose for adults is 100 mg / day. For children over the age of 12, the recommended dose is 2 mg / kg / day with a total dose of 100 mg / day. Prophylaxis can be started 1–2 days before traveling to an area with malaria. Prophylactic use of the preparation should be continued every day while in an area with malaria and for 4 weeks after it has been left. You should also take into account the current standards for the treatment of malaria.
Prevention of Japanese river fever: The recommended dose is 200 mg once.
Prevention of traveler's diarrhea in adults: the recommended dose is 200 mg on the first day of travel (200 mg or 100 mg once every 12 hours) and 100 mg / day during the next days of travel. There is no information on the use of the preparation for more than 21 days for the purpose of prophylaxis.
Prevention of leptospirosis: the recommended dose is 200 mg once a week during the entire stay in the region with leptospirosis and 200 mg at the end of the trip. There is no information on the use of the preparation for more than 21 days for the purpose of prophylaxis.
Use of the preparation in elderly patients: the preparation can be used in normal doses without special reservations. There is no need for dose adjustment in case of impaired renal function. Unidox Solutab may be the preparation of choice for elderly patients, since its use is less associated with the development of irritation and ulcers of the esophagus.
Use of the preparation in patients with impaired liver function - see SPECIAL INSTRUCTIONS.
Use of the preparation in patients with impaired renal function: studies have shown that the use of the preparation in the recommended doses does not lead to the accumulation of the antibiotic in this category of patients (see SPECIAL INSTRUCTIONS).
Hypersensitivity to doxycycline and tetracyclines or any component of the preparation. any conditions that include severe renal or hepatic impairment. During pregnancy and breastfeeding. age 12 years.
In patients using tetracyclines, including doxycycline, the following adverse reactions were noted.
From the nervous system. Tides.
General violations. Hypersensitivity reactions, including anaphylactic shock, anaphylaxis, anaphylactoid reactions, anaphylactoid purpura, angioedema; hypotension; pericarditis; exacerbation of the course of systemic lupus erythematosus; dyspnea; serum sickness; peripheral edema; tachycardia; hives.
From the central and peripheral nervous system.
Headache. Bulging fontanelles in neonates and benign intracranial hypertension in adolescents and adults have been reported with full therapeutic doses of tetracyclines. In older children and adults, a benign increase in intracranial pressure was also noted. Symptoms of benign intracranial hypertension may include headache, nausea, tinnitus, dizziness, blurred vision, hallucinations, cattle, and preparation withdrawal. Abdominal pain, anorexia, loss of appetite, nausea, vomiting, diarrhea, dyspepsia, stomatitis, blackening of the tongue, rarely dysphagia. Suppression of the growth of bacteria synthesizing vitamin B. The development of esophagitis and esophageal ulcers has been reported.
On the part of the organ of hearing and vestibular apparatus. Tinnitus, vertigo.
From the side of hematopoiesis. With the use of tetracyclines, adverse reactions have been reported such as hemolytic anemia, thrombocytopenia, neutropenia, decreased prothrombin levels, porphyria, and eosinophilia.
From the hepatobiliary system. Rarely reported hepatotoxicity with a temporary increase in liver function values, hepatitis, jaundice, liver failure and pancreatitis.
On the part of the musculoskeletal system. Arthralgia, myalgia. The development of bones and teeth may be impaired (bones become brittle, and teeth irreversibly change color).
On the part of the skin and subcutaneous tissues. Rash, including maculopapular and erythematous rash, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin photosensitivity, photoonycholysis.
Development of superinfection. As with the use of all antibiotics, when using the preparation Unidox Solutab, the number of insensitive microorganisms may increase, which can lead to the development of candidiasis, glossitis, enterocolitis, staphylococcal enterocolitis, pseudomembranous colitis (with an overgrowth of Clostridium difficile) and inflammatory damage (with an overgrowth of bacteria of the genus Candida) of the anal-genital area, itching in the anal area. There have also been reports of the development of stomatitis and vaginitis.
From the urinary system. Increased blood urea levels. Increased azotemia in patients with renal insufficiency. Tetracyclines used after the expiration date have been associated with the development of a syndrome like Fanconi: albuminuria, glucosuria, aminoaciduria, hypophosphatemia, hypokalemia, and tubular acidosis.
Other violations. With the use of tetracyclines for a long time, brown-black microscopic staining of the thyroid tissue was noted. At the same time, no pathology of the thyroid gland was revealed. Tetracyclines can cause discoloration of teeth and enamel hypoplasia, which is more common with prolonged use.
Cross-resistance and cross-sensitivity to other tetracycline antibiotics may occur.
Patients with impaired liver function. Tetracyclines can be hepatotoxic, especially when taken in high doses or when taken with other hepatotoxic preparations or with pre-existing hepatic and renal impairment. Unidox Solutab should be used with caution in patients with impaired liver function (see CONTRAINDICATIONS), as well as in those who are simultaneously taking potentially hepatotoxic preparations. Abnormal liver function tests that have occurred during both oral and parenteral administration of tetracyclines, including doxycycline, have been reported rarely.
Patients with impaired renal function. In patients with normal renal function, excretion of doxycycline by the kidneys is about 40% in 72 hours. This indicator can decrease to 1–5% in 72 hours in patients with severe renal insufficiency (creatinine clearance - 10 ml / min). Studies have shown that there is no significant difference in plasma T½ of doxycycline in patients with normal renal function and in severe renal failure. Hemodialysis does not affect the T½ of doxycycline from blood plasma.
The anti-anabolic effect of tetracyclines can increase blood urea levels. Studies have shown that this anti-anabolic effect does not occur when used in patients with renal impairment. However, azotemia may worsen in patients with impaired renal function. Tetracyclines should be used with caution in patients with moderate to moderate renal insufficiency, always under medical supervision.
Photosensitivity. This effect manifests itself as an increased response to sun exposure and has been noted in some patients who have taken tetracycline, including doxycycline. Patients who should be in the open sun or under the influence of ultraviolet radiation should be informed about the possibility of developing this reaction and that treatment should be discontinued at the first manifestations of erythema.
Increased growth of microorganisms. The use of antibiotics for ioccal enteritis in patients with diarrhea, which is a consequence of antibiotic therapy. Depending on the diagnosis, vancomycin and teicoplanin should be used to treat pseudomembranous colitis and cloxacillin to treat staphylococcal enteritis.
With the use of antibacterial preparations, including doxycycline, the development of diarrhea associated with Clostridium difficile (CDAD), with a severity from mild to fatal colitis, has been reported. The use of antibacterial preparations affects the normal intestinal flora and leads to an increased growth of C. difficile.
C. difficile produces toxins A and B, which in turn contributes to the development of CDAD.
C. difficile strains that produce toxins can increase morbidity and mortality because such infections are resistant to antibiotic therapy and may require colectomy. It is important to consider the possibility of this diagnosis in patients with diarrhea that is a consequence of antibiotic therapy. A careful analysis of the history is required, since the development of CDAD was reported 2 months after the completion of antibiotic therapy.
Esophagitis. It has been reported about the development of esophagitis and ulcers of the esophagus with the use of tetracyclines, including doxycycline, in the form of tablets and capsules. Most patients with such complaints used the preparation immediately before bedtime or with insufficient fluid.
Bulging fontanelles in neonates and benign intracranial hypertension in juveniles and adults have been reported with full therapeutic doses of tetracyclines. These conditions quickly disappear when the preparation is discontinued.
Porphyria. The development of porphyria in patients receiving tetracycline has been rarely reported.
Venereal diseases. During the treatment of sexually transmitted diseases, if concomitant syphilis is suspected, appropriate diagnostics should be carried out, including microscopic examination in a dark field. In such cases, serological tests should be performed monthly for at least 4 months.
Infections caused by β-hemolytic streptococcus. For infections caused by group A β-hemolytic streptococci, treatment should be carried out for at least 10 days.
Myasthenia gravis. Due to the possibility of a weak neuromuscular blockade, the preparation should be used with caution in patients with myasthenia gravis.
Systemic lupus erythematosus. The use of tetracyclines can lead to an exacerbation of the course of systemic lupus erythematosus.
Methoxyflurane. Caution should be exercised when using methoxyflurane with tetracyclines.
The use of tetracyclines can affect blood coagulation (prolongation of prothrombin time). Therefore, patients with blood clotting disorders should use tetracycline with extreme caution (see INTERACTIONS).
During long-term treatment, it is necessary to periodically carry out laboratory monitoring of the functioning of organs and systems, including a study of the hematopoietic system, kidney and liver function. In case of revealing deviations in the indicators, therapy should be discontinued.
During treatment with tetracyclines, increased excretion of ascorbic and folic acids was noted, but, as a rule, this is not of clinical significance.
The preparation contains lactose, therefore, patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not use this preparation.
Use during pregnancy and lactation. The use of tetracyclines during the development of the fetal teeth (during pregnancy) can cause a permanent discoloration of the teeth (yellow-brown-gray). Such an adverse reaction occurs more often with prolonged use, but can also be detected with repeated short courses of treatment. There have also been reports of enamel hypoplasia. In connection with the above, the preparation is contraindicated for use during pregnancy.
Tetracyclines penetrate into breast milk, therefore, the use of the preparation is contraindicated during breastfeeding (see information on the use of the preparation during dental development above).
Children. The preparation Unidox Solutab is contraindicated in children under 12 years of age. Like other tetracyclines, Unidox Solutab forms stable calcium complexes in any bone-forming tissue. A decrease in the level of growth of the fibula was observed in premature infants who received oral tetracycline at a dose of 25 mg / kg every 6 hours. This adverse reaction is reversible when the preparation is discontinued. The use of tetracyclines during dental development (in children under 12 years of age) can cause permanent discoloration of the teeth (yellow-brown-gray). Such an adverse reaction occurs more often with prolonged use, but can also occur with repeated short courses of treatment. There have also been reports of enamel hypoplasia.
The ability to influence the reaction rate when driving or working with other mechanisms. The effect of doxycycline on ability has not been studied. If you experience such undesirable reactions as arterial hypotension, ringing in the ears, blurred vision, scotoma, diplopia or long-term loss of vision, you should refrain from driving or working with other mechanisms.
Interactions
The absorption of doxycycline can be reduced with the simultaneous use of antacids containing aluminum, calcium, magnesium, or other preparations containing these cations, with oral administration of zinc, preparations of iron salts or bismuth. the use of doxycycline simultaneously with such preparations should be divided as much as possible in time.
Bacteriostatic preparations can affect the bactericidal effect of penicillin, therefore it is recommended to avoid the simultaneous use of doxycycline with penicillin.
Prolongation of prothrombin time has been reported in patients taking warfarin and doxycycline. Tetracyclines reduce the activity of plasma prothrombin, therefore, a decrease in the dose of anticoagulants may be required.
With the simultaneous use of barbiturates, carbamazepine and phenytoin, T½ of doxycycline decreases. Therefore, the possibility of increasing the daily dose of the preparation Unidox Solutab should be considered.
Alcohol can decrease the T½ of doxycycline.
Several cases of pregnancy and breakthrough bleeding have been reported with the simultaneous use of doxycycline and oral contraceptives.
Doxycycline may increase plasma concentrations of cyclosporine. The simultaneous use of these preparations should be accompanied by close supervision.
Fatal kidney toxicity has been reported with concomitant use of tetracyclines and methoxyflurane (see SPECIAL INSTRUCTIONS).
Laboratory indicators. A false increase in urine catecholamine levels may occur due to interaction with a fluorescence test. Tetracycline inhibit the reaction with glucose in the urine.
Acute antibiotic overdose is rare. symptoms of intoxication may include liver damage, accompanied by symptoms such as vomiting, fever attacks, jaundice, hematoma, melena, azotemia, increased transaminase levels, and increased prothrombin time.
Intoxication treatment. Drinking a lot of fluids. Artificial induction of vomiting. In case of taking a large amount of the preparation: gastric lavage, then prescribe activated charcoal and an osmotic laxative (sodium sulfate).
Hemodialysis and peritoneal dialysis should not be performed as they do not affect plasma T½ and are ineffective in overdose.
At a temperature not higher than 25 ° C.
ALL / 2017/0003 / UA / Dec / 2017 / Morion / 15000
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