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Manufacturers: Pfizer MFG. Belgium NV (Belgium)
Active ingredients
- Doxycycline
Disease class
- Other disorders of the eye and its adnexa in diseases classified elsewhere
- Otitis media, unspecified
- Acute sinusitis
- Pneumonia without specifying the pathogen
- Acute bronchitis
- Chronic sinusitis
- Chronic tonsillitis
- Chronic bronchitis, unspecified
- Periodontal disease, unspecified
- Peritonitis, unspecified
- Cholecystitis
- Cholera, unspecified
- Shigellosis, unspecified
- Enteritis caused by Yersinia enterocolitica
- Acute amoebic dysentery
- Diarrhea and gastroenteritis of suspected infectious origin
- Tularemia
- Brucellosis, unspecified
- Leptospirosis icteric-hemorrhagic
- Leptospirosis, unspecified
- Extraintestinal yersiniosis
- Actinomycosis
- Mycoplasma infection, unspecified
- Syphilis, unspecified
- Gonococcal infection
- Gonococcal infection of the lower genitourinary tract without abscessation of the periurethral or accessory glands
- Relapsing fever, unspecified
- Necrotizing ulcerative stomatitis
- Chlamydia psittaci infection
- Trachoma
- Typhus, unspecified
- Spotted fever caused by Rickettsia rickettsii
- KU fever
- Other specified rickettsial diseases
- Malaria caused by Plasmodium falciparum
- Malaria, unspecified
- Post-traumatic wound infection, not elsewhere classified
- Surgical practice
- Acute tonsillitis, unspecified
- Cystitis
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Antibacterial
Pharmacological group
- Tetracyclines
Aerosol Vibramycin
Instructions for medical use of the drug
Description of pharmacological action
Inhibits protein synthesis in microbial cells by disrupting the connection of aminoacyl-tRNA with the 30S subunit of the ribosomal membrane.
Indications for use
Infections caused by sensitive ones, incl. intracellular microorganisms: Q fever, rocky mountain spotted fever, typhus (including typhus, relapsing), brucellosis, yersiniosis, bacillary and amoebic dysentery, tularemia, cholera, Lyme disease (stage I), actinomycosis, malaria; as part of combination therapy - leptospirosis, trachoma, ornithosis, granulocytic ehrlichiosis; diseases of the ENT organs and lower respiratory tract (sinusitis, otitis, tonsillitis, acute bronchitis, exacerbation of chronic bronchitis, pneumonia, pleurisy), infections of the biliary tract and gastrointestinal tract (cholecystitis, cholangitis, gastroenterocolitis, proctitis), periodontitis, peritonitis, urinary tract infections (including cystitis, pyelonephritis, urethritis, urogenital mycoplasmosis), inflammatory diseases of the pelvic organs in the acute stage in women (endometritis), acute prostatitis, epididymitis, gonorrhea, syphilis (with allergies to penicillin), purulent infections of the skin and soft tissues (cellulitis, abscess, furunculosis, felon, infected burns, wounds, acne), infectious eye diseases, incl. ulcerative keratitis. Prevention of postoperative purulent complications after surgical infections, incl. after medical abortion, colon surgery. Prevention of malaria caused by Plasmodium falciparum during short-term stays (less than 4 months) in areas where Plasmodium resistance to chloroquine and/or pyrimethamine-sulfadoxine has been noted.
Release form
capsules 100 mg; blister 10, cardboard box (box) 1; capsules 100 mg; dark glass bottle (bottle) 5, cardboard box (box) 1;
Pharmacokinetics
After oral administration, it is almost completely absorbed (90–100%), food intake has a negligible effect on absorption. It has a high degree of lipid solubility and low affinity for calcium binding. Stable in plasma. After oral administration of 200 mg of doxycycline, the average values of pharmacokinetic parameters were: Cmax - 3.61 μg/ml, Tmax - 2.60 hours; elimination rate constant - 0.049 h-1, T1/2 - 16.33 h. 80–92% bound to plasma proteins. Penetrates into most tissues and body fluids, into bile, paranasal sinus secretions, pleural effusion, synovial and ascitic fluid, and gingival sulcus fluid. Apparent volume of distribution: 52.6–134 L. Accumulates in bones, teeth, liver, spleen, prostate gland, creates therapeutic concentrations in eye tissues. Penetrates the placenta and is found in the fetus. Penetrates poorly into the cerebrospinal fluid (10–20% of plasma levels). 20–60% of the dose is excreted by the intestines, the remaining 35–60% by the kidneys (of which 20–50% is unchanged). With normal renal function (creatinine clearance about 75 ml/min), excretion through the kidneys is 40% in 72 hours. T1/2 does not change with impaired renal function, because in patients with impaired renal function or azotemia, the predominant route of elimination is gastrointestinal secretion. In severe chronic renal failure (creatinine clearance approximately 10 ml/min), renal excretion may be 1–5% in 72 hours. Hemodialysis does not affect the plasma T1/2 of doxycycline. T1/2 after a single dose is 18 hours. With repeated administrations, cumulation is possible. Doxycycline forms insoluble complexes with calcium in bones and teeth.
Use during pregnancy
Contraindicated during pregnancy (possible formation of insoluble complexes with calcium and deposition of doxycycline in the bone skeleton) and breastfeeding. FDA category of effect on the fetus is D.
Contraindications for use
Hypersensitivity, porphyria, severe liver failure, leukopenia, pregnancy (especially the II–III trimester), breastfeeding, children under 8 years of age (due to the possibility of the formation of insoluble complexes with calcium and their deposition in the bone skeleton, enamel and dentin of teeth); for intravenous administration - myasthenia gravis.
Side effects
From the nervous system and sensory organs: benign intracranial hypertension (in adults - anorexia, headache, vomiting, papilledema, changes in vision, in children - protrusion of the fontanelles), toxic effects on the central nervous system (dizziness or instability). From the cardiovascular system and blood (hematopoiesis, hemostasis): hemolytic anemia, thrombocytopenia, eosinophilia, neutropenia, decreased prothrombin activity.
Directions for use and doses
Orally, adults and children weighing more than 50 kg usually - 200 mg on the first day (once or 100 mg every 12 hours) and 100 mg/day on subsequent days (once or 50 mg every 12 hours), during treatment severe infections (especially chronic urinary tract infections) - 200 mg/day throughout the entire period of therapy. Children over 8 years old with a body weight of less than 50 kg - at a dose of 4 mg/kg (once or in 2 doses) on the first day, then - 2 mg/kg, for severe infections - 4 mg/kg throughout the entire period of therapy. For tick-borne relapsing fever and typhus: orally in a dose of 100 or 200 mg, depending on the severity of the infection, once. In order to reduce the risk of persistence or recurrence of tick-borne relapsing fever, it is recommended to use 100 mg every 12 hours for 7 days. Uncomplicated urethral, endocervical and rectal infections in adults caused by Chlamydia trachomatis: orally, 100 mg 2 times a day for 7 days. Acute epididymo-orchitis caused by C. trachomatis or N. gonorrhoeae: ceftriaxone 250 mg IM or another suitable cephalosporin once in combination with doxycycline 100 mg orally 2 times a day for 10 days. Non-gonococcal urethritis caused by Chlamydia trachomatis or Ureaplasma urealyticum: orally, 100 mg 2 times a day for 7 days. Lymphogranulomatosis venereum caused by Chlamydia trachomatis: orally, 100 mg 2 times daily for at least 21 days. Uncomplicated gonococcal infections of the cervix, rectum or urethra caused by sensitive gonococci: orally, 100 mg 2 times a day for 7 days in combination with a cephalosporin or fluoroquinolone, for example: cefixime 400 mg once orally, ceftriaxone 125 mg intramuscularly once, ciprofloxacin 500 mg once orally or ofloxacin 400 mg once orally. Uncomplicated gonococcal infections of the pharynx caused by susceptible gonococci: doxycycline 100 mg orally 2 times a day for 7 days in combination with a cephalosporin or fluoroquinolone, for example: ceftriaxone 125 mg IM once, ciprofloxacin 500 mg once orally or ofloxacin 400 mg once orally. Acute pelvic inflammatory disease: hospitalized patients - doxycycline 100 mg every 12 hours in combination with cefoxitin 2 g IV every 6 hours for at least 4 days and at least 24-48 hours after improvement sick. Then continue treatment with doxycycline 100 mg orally 2 times a day, so that the total duration of the course of its use is 14 days. Outpatients - doxycycline 100 mg orally 2 times a day for 14 days as an addition to ceftriaxone - 250 mg IM once or cefoxitin - 2 g IM in combination with probenecid 1 g orally once or another 3rd generation cephalosporin for parenteral administration (for example, ceftizoxime or cefotaxime). Treatment of malaria caused by chloroquine-resistant Plasmodium falciparum: 200 mg/day for at least 7 days. Given the potential severity of the infection, a fast-acting schizontocidal drug such as quinine should be used concomitantly with doxycycline, the recommended dosage of which varies by region. Treatment and prevention of cholera in adults: 300 mg once. Prevention of Japanese river fever: 200 mg once orally. Treatment of leptospirosis: 100 mg orally 2 times a day for 7 days. It should be remembered that the usual dosage and frequency of use of doxycycline differ from those of most other tetracyclines. Exceeding the recommended dose may increase the incidence of side effects. Therapy should be continued for at least 24–48 hours after symptoms and fever have resolved. For streptococcal infections, treatment must be continued for 10 days to prevent the development of rheumatic fever and glomerulonephritis. Studies have shown that the use of doxycycline at usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with impaired renal function.
Overdose
Not described.
Interactions with other drugs
Absorption is reduced by simultaneous intake of iron preparations, sodium bicarbonate, aluminum, calcium or magnesium antacids, magnesium-containing laxatives, cholestyramine and colestipol. Barbiturates, carbamazepine, phenytoin, rifampicin - reduce plasma concentrations and reduce T1/2 of doxycycline (induction of monooxygenases and acceleration of biotransformation), which can lead to a decrease in the antibacterial effect. When used simultaneously with bactericidal drugs (including penicillins, cephalosporins), the effect is reduced (simultaneous use should be avoided). Doxycycline reduces the reliability of contraception and increases the incidence of breakthrough bleeding during estrogen-containing oral contraceptives. Potentiates the effect of indirect anticoagulants.
Precautions for use
To prevent irritation to the gastrointestinal tract, it is recommended to take the drug during the daytime, with plenty of liquid. To prevent the development of candidiasis, it is recommended to take nystatin simultaneously with doxycycline hydrochloride. If superinfection develops, doxycycline should be discontinued. During treatment with doxycycline and for 4-5 days after its completion, direct exposure to sunlight or UV rays (photosensitization) is contraindicated. With long-term use, you should regularly monitor the cellular composition of peripheral blood, perform liver function tests, and determine the urea content in the serum. If you are using estrogen-containing oral contraceptives, you should use additional contraception or change your method of contraception. A false increase in the level of catecholamines in urine is possible when they are determined by the fluorescent method. When examining a biopsy of the thyroid gland in patients who have been receiving doxycycline for a long time, the possibility of dark brown staining of the tissue in microslides should be taken into account.
Storage conditions
List B.: At a temperature not exceeding 30 °C.
Best before date
60 months
ATX classification:
J Antimicrobials for systemic use
J01 Antimicrobials for systemic use
J01A Tetracyclines
J01AA Tetracyclines
J01AA02 Doxycycline
Vibramycin
IV administration is preferable in severe forms of purulent-septic diseases, when it is necessary to quickly create a high concentration in the blood, and in cases where oral administration is difficult. You should switch to oral administration as soon as possible.
IV drip, in the form of a solution, which is prepared ex tempore. To do this, 0.1 g or 0.2 g is dissolved in 5-10 ml of water for injection, then added to 250 or 500 ml of 0.9% NaCl solution or 5% dextrose solution. The concentration in the solution for infusion should not exceed 1 mg/ml and not less than 0.1 mg/ml. The duration of infusion, depending on the dose (0.1 or 0.2 g), is 1-2 hours at an injection rate of 60-80 drops/min. When infused, solutions should be protected from light (solar and electric). The duration of treatment with intravenous administration is 3-5 days, if well tolerated - 7 days, followed by a transition (if necessary) to oral administration.
For pelvic inflammatory diseases in women in the acute stage - IV, 0.1 g every 12 hours, usually in combination with third generation cephalosporins; then continue therapy orally, 0.1 g 2 times a day for 14 days.
Orally, in adults and children weighing more than 45 kg, the average daily dose is 0.2 g on the first day (divided into 2 doses - 0.1 g 2 times a day), then 0.1 g / day (in 1-2 doses). For chronic infections of the urinary system - 200 mg/day throughout the entire period of therapy.
When treating gonorrhea, one of the following regimens is prescribed: acute uncomplicated urethritis - a course dose of 0.5 g (1 dose - 0.3 g, the next 2 - 0.1 g at an interval of 6 hours) or 0.1 g / day until complete cure (in women) or 0.1 g 2 times a day for 7 days (in men); for complicated forms of gonorrhea, the course dose is 0.8-0.9 g, which is divided into 6-7 doses (0.3 g - 1 dose, then with an interval of 6 hours for 5-6 subsequent doses).
When treating syphilis - 0.3 g/day for at least 10 days (orally or intravenously).
For uncomplicated infections of the urethra, cervix and rectum caused by Chlamydia trachomatis, 0.1 g is prescribed 2 times a day for at least 7 days.
Infections of male genital organs - 0.1 g 2 times a day for 4 weeks.
Treatment of malaria resistant to chloroquine - 0.2 g/day for 7 days (in combination with schizontocidal drugs - quinine); prevention of malaria - 0.1 g 1 time per day 1-2 days before the trip, then daily during the trip and for 4 weeks after return; children over 8 years old - 2 mg/kg 1 time per day.
Traveler's diarrhea (prevention) - 0.2 g on the first day of the trip (at one dose or 0.1 g 2 times a day), then 0.1 g 1 time per day during the entire stay in the region (no more than 3 weeks).
Treatment of leptospirosis - 0.1 g orally 2 times a day for 7 days; prevention of leptospirosis - 0.2 g once a week during stay in a disadvantaged area and 0.2 g at the end of the trip.
Prevention of infections after a medical abortion - 0.1 g 1 hour before the abortion and 0.2 g 30 minutes after.
For acne - 0.1 g/day, course - 6-12 weeks.
Maximum daily doses for adults are up to 0.3 g/day or up to 0.6 g/day for 5 days for severe gonococcal infections.
In children 9-12 years old with body weight up to 45 kg, the average daily dose is 4 mg/kg on the first day, then 2 mg/kg per day (in 1-2 doses). For severe infections, 4 mg/kg is prescribed every 12 hours.
In the presence of severe liver failure, a reduction in the daily dose is required, since this causes a gradual accumulation in the body (risk of hepatotoxicity).
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Vibramycin, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Vibramycin is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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