Application Nr Approved Date Route Status External Links
ANDA065425 2008-02-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Demeclocycline Hcl Tablets, Usp Are 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 Cause By Campylobacter Fetus Brucellosis Due To Brucella Species (in Conjunction With Streptomycin); Bartonellosis Due To Bartonella Bacilliformis Granuloma Inguinale Caused By Calymmatobacterium Granulomatis Demeclocycline Hcl Tablets, Usp Are Indicated For Treatment Of Infections 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 Hcl Tablets, Usp Are 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 Hcl, Usp, 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 Hcl, Usp May Be A Useful Adjunct To Amebicides. In Severe Acne, Demeclocycline Hcl, Usp May Be A Useful Adjunctive Therapy. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Demeclocycline Hcl Tablets, Usp And Other Antibacterial Drugs, Demeclocycline Hcl 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 (9 Total)

Name Structure Kind Function Status
1. Alginic Acid ALGINIC ACID Unresolved GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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