Application Nr Approved Date Route Status External Links
ANDA062396 1984-11-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain Effectiveness Of Doxycycline Hyclate Capsules, Usp And Other Antibacterial Drugs, Doxycycline Hyclate Capsules, 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. Treatment Doxycycline Is Indicated For The Treatment Of The Following Infections: •rocky Mountain Spotted Fever, Typhus Fever And The Typhus Group, Q Fever, Rickettsialpox, And Tick Fevers Caused By Rickettsiae. •respiratory Tract Infections Caused By Mycoplasma Pneumoniae. •lymphogranuloma Venereum Caused By Chlamydia Trachomatis. •psittacosis (ornithosis) Caused By Chlamydophila Psittaci. •trachoma Caused By Chlamydia Trachomatis, Although The Infectious Agent Is Not Always Eliminated, As Judged By Immunofluorescence. •inclusion Conjunctivitis Caused By Chlamydia Trachomatis. •uncomplicated Urethral, Endocervical, Or Rectal Infections In Adults Caused By Chlamydia Trachomatis. •nongonococcal Urethritis Caused By Ureaplasma Urealyticum. •relapsing Fever Due To Borrelia Recurrentis. Doxycycline Is Also Indicated For The Treatment Of Infections Caused By The Following Gram-Negative Microorganisms: •chancroid Caused By Haemophilus Ducreyi. •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. •granuloma Inguinale Caused By Klebsiella Granulomatis. 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 Bacteria, When Bacteriologic Testing Indicates Appropriate Susceptibility To The Drug: • Escherichia Coli. • Enterobacter Aerogenes. • Shigella Species. • Acinetobacter Species. •respiratory Tract Infections Caused By Haemophilus Influenzae. •respiratory Tract And Urinary Tract Infections Caused By Klebsiella Species. Doxycycline Is Indicated For Treatment Of Infections Caused By The Following Gram-Positive Microorganisms When Bacteriologic Testing Indicates Appropriate Susceptibility To The Drug: •upper Respiratory Infections Caused By Streptococcus Pneumoniae. •anthrax Due To Bacillus Anthracis, Including Inhalational Anthrax (post-Exposure): To Reduce The Incidence Or Progression Of Disease Following Exposure To Aerosolized Bacillus Anthracis. When Penicillin Is Contraindicated, Doxycycline Is An Alternative Drug In The Treatment Of The Following Infections: •uncomplicated Gonorrhea Caused By Neisseria Gonorrhoeae. •syphilis Caused By Treponema Pallidum. •yaws Caused By Treponema Pallidum Subspecies Pertenue. •listeriosis Due To Listeria Monocytogenes. •vincent’s Infection Caused By Fusobacterium Fusiforme. •actinomycosis Caused By Actinomyces Israelii. •infections Caused By Clostridium Species. In Acute Intestinal Amebiasis, Doxycycline May Be A Useful Adjunct To Amebicides. In Severe Acne, Doxycycline May Be Useful Adjunctive Therapy. Prophylaxis Doxycycline Is Indicated For The Prophylaxis Of Malaria Due To Plasmodium Falciparum In Short-Term Travelers (<4 Months) To Areas With Chloroquine And/or Pyrimethamine-Sulfadoxine Resistant Strains (see Dosage And Administration Section And Information For Patients Subsection Of The Precautions Section ).

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Doxycycline Hyclate DOXYCYCLINE HYCLATE ZINC16052277