*Oracea is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Oracea exerts anti-inflammatory activity and no antimicrobial effect, and should not be used to treat infections. To avoid risk of antimicrobial-related effects, including increased risk of resistance and/or side effects, do not substitute other tetracyclines for Oracea. Oracea has no bioequivalent.
Safety Considerations
Oracea is a 40 mg capsule of doxycycline, containing 30 mg immediate release and 10 mg delayed release beads. The dosage of Oracea differs from that of doxycycline used to treat infections. To reduce the development of resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Oracea should be used only as indicated. Traditional tetracycline contraindications, warnings, and precautions must be considered prior to the use of Oracea. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines. Doxycycline, like other tetracycline drugs, can cause fetal harm when administered to a pregnant woman. In addition, these drugs are excreted in breast milk and should not be administered to a woman who is nursing. Tetracycline drugs should not be used during tooth development (last half of pregnancy up to age of 8 years) as they may cause permanent discoloration of the teeth. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with Oracea, patients should minimize or avoid exposure to natural or artificial sunlight. Safety of Oracea beyond 9 months has not been established.
Please see the full prescribing information.