1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets 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.
Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or diseases:
Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for:
Rickettsial infections (
1.1)
Sexually transmitted infections (
1.2)
Respiratory tract infections (
1.3)
Specific bacterial infections (
1.4)
Ophthalmic infections (
1.5)
Anthrax, including inhalational anthrax (post-exposure) (
1.6)
Alternative treatment for selected infections when penicillin is contraindicated (
1.7)
Adjunctive therapy in acute intestinal amebiasis and severe acne (
1.8)
Prophylaxis of malaria (
1.9)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1)
1.1 Rickettsial infections
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by
Rickettsiae.
1.2 Sexually transmitted infections
Uncomplicated urethral, endocervical or rectal infections caused by
Chlamydia trachomatis.
Nongonococcal urethritis caused by
Ureaplasma urealyticum.
Lymphogranuloma venereum caused by
Chlamydia trachomatis.
Granuloma inguinale caused by
Klebsiella granulomatis.
Uncomplicated gonorrhea caused by
Neisseria gonorrhoeae.
Chancroid caused by
Haemophilus ducreyi.
1.3 Respiratory tract infections
Respiratory tract infections caused by
Mycoplasma pneumoniae.
Psittacosis (ornithosis) caused by
Chlamydophila psittaci.
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Respiratory tract infections caused by
Haemophilus influenzae.
Respiratory tract infections caused by
Klebsiella species.
Upper respiratory infections caused by
Streptococcus pneumoniae.
1.4 Specific bacterial infections
Relapsing fever due to
Borrelia recurrentis.
Plague due to
Yersinia pestis.
Tularemia due to
Francisella tularensis.
Cholera caused by
Vibrio cholerae.
Campylobacter fetus infections caused by
Campylobacter fetus.
Brucellosis due to
Brucella species (in conjunction with streptomycin).
Bartonellosis due to
Bartonella bacilliformis.
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Escherichia coli
Enterobacter aerogenes
Shigella species
Acinetobacter species
Urinary tract infections caused by
Klebsiella species.
1.5 Ophthalmic infections
Trachoma caused by
Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caused by
Chlamydia trachomatis.
1.6 Anthrax, including inhalational anthrax (post-exposure)
Anthrax due
to
Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized
Bacillus anthracis.
1.7 Alternative treatment for selected infections when penicillin is contraindicated
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
Syphilis caused by
Treponema pallidum.
Yaws caused by
Treponema pallidum subspecies pertenue.
Vincents infection caused by
Fusobacterium fusiforme.
Actinomycosis caused by
Actinomyces israelii.
Infections caused by
Clostridium species.
1.8 Adjunctive therapy for acute intestinal amebiasis and severe acne
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
In severe acne, doxycycline may be useful adjunctive therapy.
1.9 Prophylaxis of malaria
Doxycycline is indicated for the prophylaxis of malaria due to
Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains [
see Dosage and Administration (
2.2) and Patient Counseling Information (
17)
].