Avelox

Avelox is used for:

Treating infections caused by certain bacteria.

Avelox is a fluoroquinolone that kills sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Avelox if:

• you are allergic to any ingredient in Avelox or to any other quinolone antibiotic (eg, levofloxacin)
• you have certain types of irregular heartbeat (eg, QT prolongation) or low blood potassium levels
• you are taking cisapride, a class IA or III antiarrhythmic (eg, quinidine, procainamide, amiodarone, sotalol), a phenothiazine (eg, thioridazine), astemizole, terfenadine, or a tricyclic antidepressant (eg, amitriptyline)

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

Before using Avelox:

Some medical conditions may interact with Avelox. 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 Alzheimer disease, a central nervous system disease, hardening of the arteries in your brain, diarrhea, a stomach infection, recent low blood potassium levels, increased pressure in your head, liver problems or disease, seizures, or a personal or family history of heart problems (eg, fast, slow, or irregular heartbeat)
• if you are taking a corticosteroid (eg, prednisone)

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

• Aluminum salts or zinc salts because they may decrease Avelox's effectiveness
• Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased
• Arsenic, astemizole, cisapride, class IA antiarrhythmics (eg, procainamide, quinidine), class IC antiarrhythmics (eg, flecainide, propafenone), class III antiarrhythmics (eg, amiodarone), dofetilide, droperidol, foscarnet, imidazoles (eg, ketoconazole), macrolides and ketolides (eg, erythromycin, azithromycin), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenothiazines (eg, thioridazine), pimozide, procainamide, serotonin receptor antagonist antiemetics (eg, ondansetron), sotalol, terfenadine, tramadol, tricyclic antidepressants (eg, amitriptyline), warfarin, or ziprasidone because the actions and side effects of either medicine may be increased, possibly leading to abnormal heart rhythms
• Risperidone because heart problems may occur
• Live oral typhoid vaccine because it may decrease Avelox's effectiveness

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

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

• An extra patient leaflet is available with Avelox. Talk to your pharmacist if you have questions about this information.
• Take Avelox by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Drink plenty of liquids while taking Avelox.
• Do not take any medicine that has magnesium or aluminum in it within 4 hours before or 8 hours after taking Avelox.
• Take Avelox on a regular schedule to get the most benefit from it.
• To clear up your infection completely, take Avelox for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Avelox, use 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 use 2 doses at once.

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

Important safety information:

• Avelox may cause dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Avelox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Be sure to use Avelox 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.
• Avelox may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Avelox. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic 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.
• Avelox only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Avelox 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.
• Avelox has infrequently caused tendon problems, including tendon rupture. If you experience any unusual pain or swelling in your joints (eg, shoulder, elbow, hand, hip, knee, ankle, foot), contact your doctor immediately. Rest and avoid exercise or other physically stressful activity until your doctor tells you otherwise.
• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Avelox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Avelox with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).
• Avelox should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Avelox can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Avelox while you are pregnant. It is not known if Avelox is found in breast milk. Do not breast-feed while taking Avelox.

Possible side effects of Avelox:

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; dizziness; headache; nausea; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; convulsions; dark urine; decreased urination; depression; fainting; fever, chills, or unusual cough; hallucinations; irregular heartbeat; joint or muscle pain; mental or mood changes; moderate to severe sunburn; nerve pain; numbness or tingling of the skin; pounding in the chest; red, swollen, or blistered skin; seizures; severe diarrhea; shortness of breath; stomach pain/cramps; suicidal thoughts; tendon pain or swelling; tremor; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

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 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), or emergency room immediately. Symptoms may include dizziness; drowsiness; facial swelling or numbness; hot and cold flushes; mild to moderate disorientation; nausea; slurring of speech.

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

General information:

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