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Oracea

(doxycycline, USP) Once-daily 40 mg* Capsules

*30 mg Immediate Release and 10 mg Delayed Release Beads

ORACEA^®is effective

ORACEA^®is an oral therapy that reduces the inflammatory lesions (red bumps, blemishes, and pustules) of rosacea. It will not lessen the facial redness caused by this condition.

Many patients treated with ORACEA^®in clinical trials started to see improvements (reduction in inflammatory lesions) by around 3-4 weeks and these continued through the full 16 week course of the study. In clinical studies, with over 300 patients, 30% were clear of bumps and blemishes by week 16. 50% showed significant improvement over that time.

ORACEA^®is different

Unlike traditional doxycyclines (antibiotics), ORACEA^®does not work by killing bacteria. Instead, it has a lower dosage designed to help reduce the inflammatory lesions of rosacea. That’s important because:

Rosacea is a chronic inflammatory condition — not a bacterial infection
In many cases, rosacea requires long-term management, and in clinical studies, ORACEA^® has not shown to contribute to bacterial resistance

Please be aware that there are no generic equivalent medications for Oracea^®.

How to Use ORACEA^®

Oracea for rosacea taken with water A Simple Routine

1. A once-daily capsule

2. Typically taken in the morning with a full glass of water

3. At least 1 hour before or 2 hours after a meal

But as always, be sure to take ORACEA® exactly as prescribed and discuss any concerns you have with your doctor.

ORACEA^®: Before and After

The proof is in the pictures—ORACEA^® (doxycycline, USP) Capsule delivers visible results.

The patients pictured were actual participants in the rosacea treatment clinical trials for ORACEA^® .

Individual results may vary.

In this clinical trial, many study subjects demonstrated improvements in their rosacea over course of the study, and approximately 14% were clear or almost clear of disease symptoms by the end of the study.

This study was Phase III, parallel-group, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ORACEA^®, in which patients received 40 mg of ORACEA^® or a placebo for 16 weeks.

See more Before and After Images.

ORACEA^® is well tolerated

In clinical trials, the most frequent side effects included soreness in the nose and throat (nasopharyngitis), diarrhea and sinus infection. For the most part, the side effects reported were mild in severity. The safety of ORACEA^® has been studied over nine months, with no increase in side effects seen with longer treatment.

Discuss any concerns you may have with your doctor. Also, be sure to tell your doctor if you:

Have kidney disease
Take blood thinners
Take medicines to treat acne, psoriasis or seizures
Are pregnant or nursing
Have had allergic reactions to tetracyclines in the past

There are no equivalent generic medications for ORACEA^®, and using more than prescribed will not make it work faster and may lead to additional side effects.

Important Safety Information: ORACEA^®

Oracea^® is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. You may experience intestinal upsets, sore throat or sinus infections/sinusitis when taking Oracea^®. Do not take Oracea^® if you are allergic to tetracyclines, and it may cause harm to a developing fetus; so do not take Oracea^® if you are pregnant or breastfeeding.

When taking Oracea^®, stay out of direct or artificial sunlight, and make sure you tell your doctor if you have stomach or GI problems, kidney disease, have a yeast or fungal infection, take blood thinners, take oral contraceptives, or take medicine to treat acne, psoriasis or seizures. Oracea^® does not treat bacterial infections. Use Oracea^®only as prescribed by your doctor.

For more information about Oracea^®, see Full Prescribing Information.

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.

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Oracea© is a registered trademark of Galderma Laboratories.

Image courtesy of Galderma Laboratories.

Last updated August 1, 2012.

All rights reserved. Any redistribution or reproduction of part or all of the contents in any form is prohibited. You may not, except with our express written permission, distribute, reproduce, or commercially exploit the content.

This information is for general educational uses only. It may not apply to you and your personal medical needs. This information should not be used in place of a visit, call, consultation with or the advice of your physician or health care professional.

Communicate promptly with your physician or other health care professional with any health-related questions or concerns.

Be sure to follow specific instructions given to you by your physician or health care professional.

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