Oracea

Oracea is used for:

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Treating inflammatory lesions caused by rosacea.

Oracea is a tetracycline. Tetracyclines are often used to treat infections; however, Oracea will not treat infection. It works by reducing skin inflammation caused by rosacea.

Do NOT use Oracea if:

• you are allergic to any ingredient in Oracea or to another tetracycline (eg, minocycline)
• you are taking acitretin, isotretinoin, methoxyflurane, or a penicillin antibiotic (eg, amoxicillin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Oracea :

Some medical conditions may interact with Oracea . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems, the blood disease porphyria, or a history of recurring fungal infections in the mouth or vagina
• if you have a history of stomach surgery (eg, gastric bypass surgery for weight loss) or other conditions that may cause a low amount of acid in your stomach
• if you use tanning booths, sunlamps, or spend a lot of time in the sun

Some MEDICINES MAY INTERACT with Oracea . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin, isotretinoin, or methoxyflurane because the risk of increased pressure in the brain and fatal kidney toxicity may be increased
• Anticoagulants (eg, warfarin) or methotrexate because their risk of side effects and toxic effects may be increased by Oracea
• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), iron, proton pump inhibitors (eg, omeprazole), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Oracea 's effectiveness
• Hormonal birth control (eg, birth control pills) or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Oracea

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oracea may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Oracea :

Use Oracea as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Oracea . Talk to your pharmacist if you have questions about this information.
• Take Oracea by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Swallow Oracea whole with a full glass of water (8 oz/240 mL) to help reduce the risk of throat or esophagus irritation. Do not break, crush, or chew Oracea before swallowing. Do not lie down for 30 minutes after taking Oracea .
• Do not take bismuth-containing products, iron, multivitamins with minerals or iron, urinary alkalinizers (eg, sodium bicarbonate), or an antacid that has aluminum, calcium, or magnesium in it within 2 hours before or 2 hours after you take Oracea .
• If you miss a dose of Oracea , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Oracea .

Important safety information:

• Oracea is only used to treat skin problems caused by rosacea. Do not use Oracea to treat or prevent infections.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Oracea . Talk with your doctor before you receive any vaccine.
• Oracea may discolor the skin, scars, teeth, or gums. Check with your doctor if you have questions about these effects.
• Oracea may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Oracea . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Mild diarrhea is common with this type of medicine. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use Oracea or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Oracea . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Oracea should not be use by men or women who are trying to conceive a child. If you are trying to conceive a child, check with your doctor about the risks and benefits of using Oracea .
• Tell your doctor or dentist that you take Oracea before you receive any medical or dental care, emergency care, or surgery.
• Oracea may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Oracea .
• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Oracea . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Oracea should not be used in CHILDREN younger than 8 years old; permanent yellow-gray-brown tooth discoloration may occur.
• PREGNANCY and BREAST-FEEDING: Oracea has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oracea while you are pregnant. Oracea is found in breast milk. Do not breast-feed while taking Oracea .

Possible side effects of Oracea :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nose or throat irritation; sensitivity to sunlight.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Oracea at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oracea out of the reach of children and away from pets.

General information:

• If you have any questions about Oracea , please talk with your doctor, pharmacist, or other health care provider.
• Oracea is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Oracea . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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