1 INDICATIONS AND USAGE
Doxycycline hyclate tablets are tetracycline class drugs 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 for 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 tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1.10)
1.1 Rickettsial Infections
Doxycycline hyclate tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by
Rickettsiae.
1.2 Sexually Transmitted Infections
Doxycycline hyclate tablets are indicated for treatment of the following 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
Doxycycline hyclate tablets are indicated for treatment of the following 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
Doxycycline hyclate tablets are indicated for treatment of the following 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
Brucellaspecies (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 hyclate tablets are 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
Shigellaspecies
Acinetobacterspecies
Urinary tract infections caused by
Klebsiellaspecies.
1.5 Ophthalmic Infections
Doxycycline hyclate tablets are indicated for treatment of the following 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)
Doxycycline hyclate tablets are indicated for the treatment of 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
Doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated:
Syphilis caused by
Treponema pallidum.
Yaws caused by
Treponema pallidumsubspecies
pertenue.
Listeriosis due to
Listeria monocytogenes.
Vincent's infection caused by
Fusobacterium fusiforme.
Actinomycosis caused by
Actinomyces israelii.
Infections caused by
Clostridiumspecies.
1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne
In acute intestinal amebiasis, doxycycline hyclate tablets may be a useful adjunct to amebicides.
In severe acne, doxycycline hyclate tablets may be useful adjunctive therapy.
1.9 Prophylaxis of Malaria
Doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to
Plasmodium falciparumin short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethaminesulfadoxine resistant strains
[see
Dosage and Administration (2.4)and
Patient Counseling Information (17)]
.
1.10 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate 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.