Application Nr Approved Date Route Status External Links
NDA050278 2007-04-03 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 The Effectiveness Of Tetracycline Hydrochloride And Other Antibacterial Drugs, Tetracycline Hydrochloride Should Be Used Only To Treat 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. Tetracycline Is Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Organisms In The Conditions Listed Below: Upper Respiratory Tract Infections Caused By Streptococcus Pyogenes, Streptococcus Pneumoniae And Hemophilus Influenzae. Note: Tetracycline Should Not Be Used For Streptococcal Disease Unless The Organism Has Been Demonstrated To Be Susceptible. Lower Respiratory Tract Infections Caused By Streptococcus Pyogenes, Streptococcus Pneumoniae, Mycoplasma Pneumoniae (eaton Agent, And Klebsiella Sp.) Skin And Soft Tissue Infections Caused By Streptococcus Pyogenes, Staphylococcus Aureaus. (tetracyclines Are Not The Drugs Of Choice In The Treatment Of Any Type Of Staphylococcalinfections.) Infections Caused By Rickettsia Including Rocky Mountain Spotted Fever, Typhus Group Infections, Q Fever, Rickettsialpox. Psittacosis Caused By Chlamydophila Psittaci. Infections Caused By Chlamydia Trachomatis Such As Uncomplicated Urethral, Endocervical Or Rectal Infections, Inclusion Conjunctivitis, Trachoma, And Lymphogranuloma Venereum. Granuloma Inquinale Caused By Klebsiella Granulomatis. Relapsing Fever Caused By Borrelia Sp. Bartonellosis Caused By Bartonella Bacilliformis. Chancroid Caused By Hemophilus Ducreyi. Tularemia Caused By Francisella Tularensis. Plaque Caused By Yersinia Pestis. Cholera Caused By Vibrio Cholerae. Brucellosis Caused By Brucella Species (tetracycline May Be Used In Conjunction With An Aminoglycoside). Infections Due To Campylobacter Fetus. As Adjunctive Therapy In Intestinal Amebiasis Caused By Entamoeba Histolytica. Urinary Tract Infections Caused By Susceptible Strains Of Escherichia Coli, Klebsiella, Etc. Other Infections Caused By Susceptible Gram-Negative Organisms Such As E. Coli, Enterobacter Aerogenes, Shigella Sp., Acinetobacter Sp., Klebsiella Sp., And Bacteroides Sp. In Severe Acne, Adjunctive Therapy With Tetracycline May Be Useful. When Penicillin Is Contraindicated, Tetracyclines Are Alternative Drugs In The Treatment Of The Following Infections: Syphilis And Yaws Caused By Treponema Pallidum And Pertenue, Respectively, Vincent’s Infection Caused By Fusobacterium Fusiforme, Infections Caused By Neisseria Gonorrhoeae, Anthrax Caused By Bacillus Anthracis, Infections Due To Listeria Monocytogenes, Actinomycosis Caused By Actinomyces Species, Infections Due To Clostridium Species.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
2. Light Mineral Oil LIGHT MINERAL OIL Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tetracycline Hydrochloride TETRACYCLINE HYDROCHLORIDE ZINC84441937

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