1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets, USP and other antibacterial drugs, doxycycline hyclate delayed-release tablets, USP 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, USP 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, USP 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.
Vincent's 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)].