Doxycycline

Product manufactured by Prasco Laboratories

Application Nr Approved Date Route Status External Links
NDA050805 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Doxycycline, Usp, Capsules 40 Mg Is A Tetracycline-Class Drug Indicated For The Treatment Of Only Inflammatory Lesions (Papules And Pustules) Of Rosacea In Adult Patients. ( 1.1 ) Limitations Of Use This Formulation Of Doxycycline 40 Mg Has Not Been Evaluated In The Treatment Or Prevention Of Infections. ( 1.2 ) Efficacy Of Doxycycline 40 Mg Beyond 16 Weeks And Safety Beyond 9 Months Have Not Been Established. ( 1.2 ) 1.1 Indication Doxycycline 40 Mg Is Indicated For The Treatment Of Only Inflammatory Lesions (Papules And Pustules) Of Rosacea In Adult Patients. No Meaningful Effect Was Demonstrated For Generalized Erythema (Redness) Of Rosacea. 1.2 Limitations Of Use This Formulation Of Doxycycline Has Not Been Evaluated In The Treatment Or Prevention Of Infections. Doxycycline 40 Mg Should Not Be Used For Treating Bacterial Infections, Providing Antibacterial Prophylaxis, Or Reducing The Numbers Or Eliminating Microorganisms Associated With Any Bacterial Disease. To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Doxycycline 40 Mg Should Be Used Only As Indicated. Efficacy Of Doxycycline 40 Mg Beyond 16 Weeks And Safety Beyond 9 Months Have Not Been Established. Doxycycline 40 Mg Has Not Been Evaluated For The Treatment Of The Erythematous, Telangiectatic, Or Ocular Components Of Rosacea.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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