Break the Cycle of Inflammatory Rosacea With Or acea ®
The only FDA-approved oral treatment—
Formulated for an effective anti-inflammatory response
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t Results from a clinical study showed: —Almost a 50% reduction in total inflammatory lesion count by week 41 —5x less gastrointestinal upset vs doxycycline 100 mg1
Oracea® is the
#1
ROSACEA BRAND among dermatologists2
Important Safety Information Oracea is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. In clinical trials, the most common adverse events reported were nasopharyngitis/pain, gastrointestinal upsets, hypertension, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines, and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman. Oracea® should not be used 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. All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The efficacy of Oracea® beyond 16 weeks and safety beyond 9 months have not been established. ®
t Anti-inflammatory dose remains below the antimicrobial threshold 2 —No evidence of bacterial resistance in a long-term (9-month) safety study3
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. References: 1. 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. 2. Data on file. Galderma Laboratories, L.P. 3. Preshaw PM, Novak MJ, Mellonig J, et al. Modifiedrelease subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008;79(3):440-452.
Please see brief summary of Prescribing Information on next page. Oracea and Galderma are registered trademarks. ©2011 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 ORA-668 Printed in USA 11/11
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