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1 Indications And Usage • Oracea 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 Has Not Been Evaluated In The Treatment Or Prevention Of Infections. ( 1.2 ) • Efficacy Of Oracea Beyond 16 Weeks And Safety Beyond 9 Months Have Not Been Established. ( 1.2 ) 1.1 Indication Oracea 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. Oracea 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, Oracea Should Be Used Only As Indicated. Efficacy Of Oracea Beyond 16 Weeks And Safety Beyond 9 Months Have Not Been Established. Oracea Has Not Been Evaluated For The Treatment Of The Erythematous, Telangiectatic, Or Ocular Components Of Rosacea.
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