Indication: ORACEA® is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA® does not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA® were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA® should not be used to treat or prevent infections. ORACEA® should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA® should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA® patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA® treatment beyond 16 weeks and safety beyond 9 months have not been established.
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Del Rosso JQ, Webster, GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791-802.
Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576.
Baldwin HE. A community-based study of the effectiveness of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) on quality of life and satisfaction with treatment in participants with rosacea. Cutis. 2010;86(suppl 5[i]):26-36.
Webster GF. An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads). Cutis. 2010;86(suppl 5[i]):7-15.
Del Rosso JQ. The ORCA (Oracea® for rosacea: a community-based assessment) Trial: a large-scale, phase 4 trial in papulopustular rosacea. Cutis.2010;86(5 Suppl):4–6.
Del Rosso JQ. Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing regimens for the treatment of papulopustular rosacea: results from a community-based trial. Cutis. 2010;86(suppl 5[i]):16-25.
ORACEA® [prescribing information]. Fort Worth, Tex: Galderma Laboratories, L.P.; 2008.