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Doxycycline (Doxycycline Hyclate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Note: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result.

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF INTRAVENOUS DOXYCYCLINE (100 TO 200 MG/DAY) DIFFERS FROM THAT OF THE OTHER TETRACYCLINES (1 TO 2 G/DAY). EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Studies to date have indicated that doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.

Adults

The usual dosage of intravenous doxycycline is 200 mg on the first day of treatment administered in one or two infusions. Subsequent daily dosage is 100 to 200 mg depending upon the severity of infection, with 200 mg administered in one or two infusions.

In the treatment of primary and secondary syphilis, the recommended dosage is 300 mg daily for at least 10 days.

In the treatment of inhalational anthrax (post-exposure) the recommended dose is 100 mg of doxycycline, twice a day. Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. Oral therapy should be instituted as soon as possible. Therapy must continue for a total of 60 days.

For Children Above Eight Years of Age

The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight on the first day of treatment, administered in one or two infusions. Subsequent daily dosage is 1 to 2 mg/lb of body weight given as one or two infusions, depending on the severity of the infection. For children over 100 pounds the usual adult dose should be used. (See WARNINGS: Pediatric Use).

In the treatment of inhalational anthrax (post-exposure) the recommended dose is 1 mg/lb (2.2 mg/kg) of body weight, twice a day in the children weighing less than 100 lb (45 kg). Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. Oral therapy should be instituted as soon as possible. Therapy must continue for a total of 60 days.

General

The duration of infusion may vary with the dose (100 to 200 mg per day), but is usually one to four hours. A recommended minimum infusion time for 100 mg of a 0.5 mg/mL solution is one hour. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. Intravenous solutions should not be injected intramuscularly or subcutaneously. Caution should be taken to avoid the inadvertent introduction of the intravenous solution into the adjacent soft tissue.

Preparation of Solution

To prepare a solution containing 10 mg/mL, the contents of the vial should be reconstituted with 10 mL of Sterile Water for Injection, or any of the ten intravenous infusion solutions listed below. Each 100 mg of doxycycline (i.e., withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below:

  1. 0.9% Sodium Chloride Injection
  2. 5% Dextrose Injection
  3. Ringer's Injection
  4. Invert Sugar, 10% in Water
  5. Lactated Ringer's Injection
  6. Dextrose 5% in Lactated Ringer's
  7. Normosol-M® in D5-W (Abbott)
  8. Normosol-R® in D5-W (Abbott)
  9. Plasma-Lyte® 56 in 5% Dextrose (Travenol)
  10. Plasma-Lyte® 148 in 5% Dextrose (Travenol)

This will result in desired concentrations of 0.1 to 1 mg/mL. Concentrations lower than 0.1 mg/mL or higher than 1 mg/mL are not recommended.

Stability

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.

HOW SUPPLIED

Doxycycline for Injection USP is supplied as a sterile lyophilized powder in a single-use vial. Retain in carton until time of use.

NDC 55390-110-10 Each vial contains doxycycline hyclate equivalent to 100 mg doxycycline and 480 mg ascorbic acid. 10 vials per carton.

Store lyophilized product at or below 25°C (77°F), and protect from light.

Manufactured by:                                                            Manufactured for:

Ben Venue Laboratories, Inc.                                         Bedford Laboratories™

Bedford, OH 44146                                                        Bedford, OH 44146

September 2004                                                              Div-DCY-P03

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