Biaxin XL Filmtab Extended-Release Tablets

Biaxin XL Filmtab Extended-Release Tablets is used for:

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Treating infections caused by certain bacteria.

Biaxin XL Filmtab Extended-Release Tablets is a macrolide antibiotic. It works by stopping the growth or killing bacteria sensitive to macrolide antibiotics.

Do NOT use Biaxin XL Filmtab Extended-Release Tablets if:

• you are allergic to any ingredient in Biaxin XL Filmtab Extended-Release Tablets or to other macrolide antibiotics (eg, erythromycin)
• you are taking cisapride, cyclosporine, dofetilide, eletriptan, ergot alkaloids (eg, ergotamine, dihydroergotamine), H₁ antagonists (eg, terfenadine, astemizole), pimozide, QT-prolonging agents (eg, quinidine, sotalol, thioridazine), quinolones (eg, ciprofloxacin), or sumatriptan

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

Before using Biaxin XL Filmtab Extended-Release Tablets:

Some medical conditions may interact with Biaxin XL Filmtab Extended-Release Tablets. 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 severe kidney problems, diarrhea, a stomach infection, or a blood disorder (eg, porphyria), or liver problems

Some MEDICINES MAY INTERACT with Biaxin XL Filmtab Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because it may decrease Biaxin XL Filmtab Extended-Release Tablets's effectiveness
• Dofetilide, macrolides and ketolides (eg, erythromycin, azithromycin), pimozide, QT-prolonging agents (eg, quinidine, sotalol, thioridazine), quinolones (eg, ciprofloxacin), or streptogramins (eg, mikamycin) because serious, possibly life-threatening side effects on the heart or irregular heartbeat may occur
• Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), benzodiazepines (eg, alprazolam), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, disopyramide, eletriptan, ergot alkaloids (eg, ergotamine, dihydroergotamine), H₁ antagonists (eg, terfenadine, astemizole), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), macrolides and ketolides (eg, erythromycin, azithromycin), phosphodiesterase type-5 inhibitors (eg, sildenafil), rifampin, sumatriptan, theophyllines, or verapamil because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Biaxin XL Filmtab Extended-Release Tablets 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 Biaxin XL Filmtab Extended-Release Tablets:

Use Biaxin XL Filmtab Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Biaxin XL Filmtab Extended-Release Tablets by mouth with food.
• Swallow Biaxin XL Filmtab Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Biaxin XL Filmtab Extended-Release Tablets works best if it is taken at the same time each day.
• To clear up your infection completely, take/use Biaxin XL Filmtab Extended-Release Tablets for the full course of treatment. Keep taking/using it even if you feel better in a few days.
• Do not miss any doses. If you miss a dose of Biaxin XL Filmtab Extended-Release Tablets, 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 Biaxin XL Filmtab Extended-Release Tablets.

Important safety information:

• 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.
• Be sure to use Biaxin XL Filmtab Extended-Release Tablets 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.
• Biaxin XL Filmtab Extended-Release Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Biaxin XL Filmtab Extended-Release Tablets 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.
• PREGNANCY and BREAST-FEEDING: Biaxin XL Filmtab Extended-Release Tablets has been shown to cause harm to the fetus. Biaxin XL Filmtab Extended-Release Tablets is not recommended for use during pregnancy except when no other antibiotic can be used. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Biaxin XL Filmtab Extended-Release Tablets while you are pregnant. It is not known if Biaxin XL Filmtab Extended-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Biaxin XL Filmtab Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Biaxin XL Filmtab Extended-Release Tablets:

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:

Abnormal taste; diarrhea; headache; indigestion; nausea; stomach discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; emotional or mood changes; hallucinations; nightmares; severe diarrhea; severe stomach pain/cramps; trouble sleeping.

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. 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. Symptoms may include diarrhea; nausea; stomach pain; vomiting.

Store Biaxin XL Filmtab Extended-Release Tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a well-closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from light, heat, and moisture. Do not store in the bathroom. Keep Biaxin XL Filmtab Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Biaxin XL Filmtab Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Biaxin XL Filmtab Extended-Release Tablets 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 Biaxin XL Filmtab Extended-Release Tablets. 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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Skin Infection, Sinusitis, Bronchitis, Common Cold, Pneumonia, Helicobacter Pylori Infection, Middle Ear Infection, Bacterial Endocarditis Prevention, Nongonococcal Urethritis, Pharyngitis, Toxoplasmosis, Mycoplasma Pneumonia, Mycobacterium avium-intracellulare -- Treatment, Legionella Pneumonia, Mycobacterium avium-intracellulare -- Prophylaxis

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