Application Nr Approved Date Route Status External Links
ANDA065447 2015-08-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Demeclocycline Hydrochloride Tablets Usp Is Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Below: 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 Due To Chlamydia Trachomatis; Psittacosis (ornithosis) Due To Chlamydia Psittaci; Trachoma Due To Chlamydia Trachomatis, Although The Infectious Agent Is Not Always Eliminated, As Judged By Immunofluorescence; Inclusion Conjunctivitis Caused By Chlamydia Trachomatis; Nongonococcal Urethritis In Adults Caused By Ureaplasma Urealyticum Or Chlamydia Trachomatis; Relapsing Fever Due To Borrelia Recurrentis; 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 Calymmatobacterium Granulomatis; Demeclocycline Hydrochloride Tablets Usp Is Indicated For Treatment Of Infections Caused By The Following Gram-Negative Microorganisms, 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. Demeclocycline Hydrochloride Tablets Usp 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; Skin And Skin Structure Infections Caused By Staphylococcus Aureus. (note: Tetracyclines, Including Demeclocycline, Are Not The Drugs Of Choice In The Treatment Of Any Type Of Staphylococcal Infection.) When Penicillin Is Contraindicated, Tetracyclines, Including Demeclocycline Hydrochloride, Are Alternative Drugs In The Treatment Of The Following Infections: Uncomplicated Urethritis In Men Due To Neisseria Gonorrhoeae, And For The Treatment Of Other Uncomplicated Gonococcal Infections; Infections In Women Caused By Neisseria Gonorrhoeae; Syphilis Caused By Treponema Pallidum Subspecies Pallidum; Yaws Caused By Treponema Pallidum Subspecies Pertenue; Listeriosis Due To Listeria Monocytogenes; Anthrax Due To Bacillus Anthracis; Vincent’s Infection Caused By Fusobacterium Fusiforme; Actinomycosis Caused By Actinomyces Israelii; Clostridial Diseases Caused By Clostridium Species. In Acute Intestinal Amebiasis, Demeclocycline Hydrochloride Tablets Usp May Be A Useful Adjunct To Amebicides. In Severe Acne, Demeclocycline Hydrochloride Tablets Usp May Be A Useful Adjunctive Therapy. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Demeclocycline Hydrochloride Tablets Usp And Other Antibacterial Drugs, Demeclocycline Hydrochloride 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.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Demeclocycline Hydrochloride DEMECLOCYCLINE HYDROCHLORIDE ZINC100036924

Comments