Arestin Microspheres

Preventing or treating certain gum problems that may occur after certain dental procedures to treat inflammatory gum disease (periodontitis). It may also be used as part of a gum care maintenance program in some patients who have periodontitis. It may also be used for other conditions as determined by your doctor.

Arestin Microspheres is a tetracycline antibiotic. It works by slowing the growth of certain bacteria and allowing the body's immune system to kill them.

• you are allergic to any ingredient in Arestin Microspheres or to tetracyclines
• you are taking acitretin, isotretinoin, methoxyflurane, or a penicillin

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

Some medical conditions may interact with Arestin Microspheres. 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 a history of oral fungal infections
• if you have a weakened immune system, an autoimmune disorder (eg, lupus), diabetes, or HIV, or if you are receiving chemotherapy or radiation treatment

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

• Aluminum salts (eg, carbonate) or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Arestin Microspheres's effectiveness
• Acitretin, anticoagulants (eg, warfarin), digoxin, ergot alkaloids and derivatives (eg, ergotamine), insulin, isotretinoin, methotrexate, methoxyflurane, or theophyllines because the risk of their side effects may be increased by Arestin Microspheres
• Live oral typhoid vaccine, oral contraceptives (birth control pills), or penicillins because their effectiveness may be decreased by Arestin Microspheres

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arestin Microspheres 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.

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

• Arestin Microspheres is usually given at your dentist's office or clinic.
• If you miss a dose of Arestin Microspheres, contact your doctor right away. You may need to reschedule your appointment.

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

• Long-term or repeated use of Arestin Microspheres may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Arestin Microspheres may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Arestin Microspheres. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Arestin Microspheres only works against bacteria; it does not treat viral infections (eg, the common cold).
• Proper dental care is important while you are taking Arestin Microspheres. Do not brush your teeth or touch the treated area for at least 12 hours after treatment or as directed by your dentist. Do not use other dental cleaning devices for 10 days after treatment with Arestin Microspheres or as directed by your dentist.
• Avoid chewing hard, crunchy, or sticky food (eg, carrots, taffy, gum) for at least 1 week after treatment.
• Arestin Microspheres may cause mild irritation or increased sensitivity of your gums during the first week after treatment. Tell your doctor right away if pain, swelling, or other problems occur.
• If severe diarrhea or stomach pain or cramping develop during treatment or within several months after treatment with Arestin Microspheres, check with your doctor or pharmacist right away. Do not treat it with nonprescription (over-the-counter) medicines.
• Tell your doctor or dentist that you take Arestin Microspheres before you receive any medical or dental care, emergency care, or surgery.
• Be sure to use Arestin Microspheres for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Arestin Microspheres. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Use Arestin Microspheres with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
• Arestin Microspheres should not be used in CHILDREN younger than 8 years old; safety and effectiveness in these children have not been confirmed. Using Arestin Microspheres in CHILDREN younger than 8 years old or in women during the last half of pregnancy may cause permanent changes in the tooth coloring and tooth enamel problems in the child.
• PREGNANCY and BREAST-FEEDING: Arestin Microspheres has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arestin Microspheres while you are pregnant. Arestin Microspheres is found in breast milk. Do not breast-feed while taking Arestin Microspheres.

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:

Flu-like symptoms; headache; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding or discharge from the gums; fever; joint pain; muscle pain or weakness; painful sores in the mouth; red, swollen, or blistered skin; severe diarrhea; severe or persistent headache; stomach pain or cramps; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately.

Store Arestin Microspheres between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Arestin Microspheres out of the reach of children and away from pets.

• If you have any questions about Arestin Microspheres, please talk with your doctor, pharmacist, or other health care provider.
• Arestin Microspheres 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 Arestin Microspheres. 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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