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| Drug Name: | Doxycycline |
| Manufacturer: | Bedford Laboratories |
| Other Info: | Doxycycline is stable for 48 hours in solution when diluted with Sodium Chloride Injection, or 5% Dextrose Injection, to concentrations between 1 mg/mL and 0.1 mg/mL and stored at 25°C. Doxycycline in these solutions is stable under fluorescent light for 48 hours, but must be protected from direct sunlight during storage and infusion. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion if refrigerated and protected from sunlight and artificial light. Infusion must then be completed within 12 hours. Solutions must be used within these time periods or discarded.Doxycycline, when diluted with Ringer's Injection, or Invert Sugar, 10% in Water, or Normosol-M® in D5-W (Abbott), or Normosol-R® in D5-W (Abbott), or Plasma-Lyte® 56 in 5% Dextrose (Travenol), or Plasma-Lyte® 148 in 5% Dextrose (Travenol) to a concentration between 1 mg/mL and 0.1 mg/mL, must be completely infused within 12 hours after reconstitution to ensure adequate stability. During infusion, the solution must be protected from direct sunlight. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion, if refrigerated and protected from sunlight and artificial light. Infusion must then be completed within 12 hours. Solutions must be used within these time periods or discarded.When diluted with Lactated Ringer's Injection, or Dextrose 5% in Lactated Ringer's, infusion of the solution (ca. 1 mg/mL) or lower concentrations (not less than 0.1 mg/mL) must be completed within six hours after reconstitution to ensure adequate stability. During infusion, the solution must be protected from direct sunlight. Solutions must be used within this time period or discarded.Solutions of doxycycline hyclate at a concentration of 10 mg/mL in Sterile Water for Injection, when frozen immediately after reconstitution are stable for 8 weeks when stored at –20°C. If the product is warmed, care should be taken to avoid heating it after the thawing is complete. Once thawed the solution should not be refrozen.Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. |
| Clinical Trials: | |
Doxycycline is indicated in infections caused by the following microorganisms:Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsialpox and tick fevers), Mycoplasma pneumoniae (PPLO, Eaton Agent),Agents of psittacosis and ornithosis, Agents of lymphogranuloma venereum and granuloma inguinale, The spirochetal agent of relapsing fever (Borrelia recurrentis).The following gram-negative microorganisms:Haemophilus ducreyi (chancroid),Pasteurella pestis and Pasteurella tularensis,Bartonella bacilliformis,Bacteroides species,Vibrio comma and Vibrio fetus,Brucella species (in conjunction with streptomycin).Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli,Enterobacter aerogenes (formerly Aerobacter aerogenes),Shigella species,Mima species and Herellea species,Haemophilus influenzae (respiratory infections),Klebsiella species (respiratory and urinary infections).Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Streptococcus species: Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs.
Therefore, tetracyclines should not be used for streptoccal disease unless the organism has been demonstrated to be sensitive.Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.Diplococcus pneumoniae,Staphylococcus aureus, respiratory, skin and soft tissue infections.
Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to:Neisseria gonorrhoeae and N.
meningitis, Treponema pallidum and Treponema pertenue (syphilis and yaws), Listeria monocytogenes, Clostridium species, Fusobacterium fusiforme (Vincent's infection), Actinomyces species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).
TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX, (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses.
ENAMEL HYPOPLASIA HAS ALSO BEEN REPORTED.
Tetracycline drugs, therefore, should not be used in this age group unless other drugs are not likely to be effective or are contraindicated.Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.The antianabolic action of the tetracyclines may cause an increase in BUN.
Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
NIH - Clinical Trials