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Biaxin XL extended-release tablets

Generic Name: clarithromycin (kla-RITH-roe-MYE-sin)
Brand Name: Biaxin XL

Biaxin XL extended-release tablets is used for:

Treating infections caused by certain bacteria.

Biaxin XL 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 extended-release tablets if:

  • you are allergic to any ingredient in Biaxin XL extended-release tablets or to any other macrolide antibiotic (eg, erythromycin)
  • you have had liver problems or yellowing of the skin or eyes caused by previous use of Biaxin XL extended-release tablets
  • you have a very slow heartbeat or certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome, ventricular arrhythmias)
  • you have low blood potassium or magnesium levels
  • you are taking alfuzosin, certain antiarrhythmics (eg, amiodarone, dofetilide, dronedarone, procainamide, propafenone, quinidine, sotalol), asenapine, avanafil, bosutinib, cabazitaxel, cisapride, citalopram, conivaptan, crizotinib, diltiazem, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), everolimus, ivabradine, lovastatin, lurasidone, nilotinib, pimozide, quinupristin/dalfopristin, ranolazine, regorafenib, salmeterol, sildenafil, silodosin, simvastatin, tadalafil, tamsulosin, tetrabenazine, ticagrelor, tolvaptan, vardenafil, or vincristine
  • you have kidney or liver problems and you are also taking colchicine

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

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Before using Biaxin XL extended-release tablets:

Some medical conditions may interact with Biaxin XL 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 the blood disorder porphyria, kidney problems, liver problems, or myasthenia gravis
  • if you have a history of heart problems (eg, fast, slow, or irregular heartbeat) or low blood potassium or magnesium levels
  • if you have an ileostomy or a colostomy, or a condition that shortens the amount of time that it takes for food to move through your stomach or bowel
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Biaxin XL extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for abortion, allergies, anxiety, asthma or other lung or breathing problems, blood thinning, blood vessel problems, cancer, Cushing syndrome, cystic fibrosis, decreased blood clot formation, depression or other mental or mood problems, diabetes, enlarged prostate, erectile dysfunction, gout, hepatitis C infection, high blood pressure, high cholesterol, high prolactin levels, HIV, Huntington chorea, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, migraines, myelofibrosis, narcotic addiction, nausea and vomiting, pain, parathyroid problems, pulmonary arterial hypertension [PAH], overactive bladder, seizures, sleep, stomach or bowel problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements because they may interact with Biaxin XL extended-release tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Biaxin XL extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Biaxin XL 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 extended-release tablets:

Use Biaxin XL extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Biaxin XL extended-release tablets by mouth with food.
  • Swallow Biaxin XL extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you are also taking zidovudine, do not take it within 2 hours before or after Biaxin XL extended-release tablets.
  • Biaxin XL extended-release tablets works best if it is taken at the same time each day.
  • To clear up your infection completely, take Biaxin XL extended-release tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Do not miss any doses. If you miss a dose of Biaxin XL 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 extended-release tablets.

Important safety information:

  • Dizziness or confusion may occur while you take Biaxin XL extended-release tablets. Use Biaxin XL extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Be sure to use Biaxin XL 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 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 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.
  • Mild diarrhea is common with antibiotic use. However, a more serious and sometimes fatal 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.
  • Severe and sometimes fatal liver problems have been reported with Biaxin XL extended-release tablets. This has usually been reversible when the medicine is stopped. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Tell your doctor or dentist that you take Biaxin XL extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Biaxin XL extended-release tablets may rarely affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Tell your doctor if you notice tablets of Biaxin XL extended-release tablets in your stool.
  • There have been reports of tooth discoloration with the use of Biaxin XL extended-release tablets. This has usually been reversible with a dental cleaning.
  • There have been reports of hearing loss with Biaxin XL extended-release tablets, usually in elderly women. This has usually been reversible. Discuss any questions or concerns with your doctor.
  • Use Biaxin XL extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).
  • PREGNANCY and BREAST-FEEDING: Biaxin XL extended-release tablets has been shown to cause harm to the fetus. Biaxin XL 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 extended-release tablets while you are pregnant. Biaxin XL extended-release tablets is found in breast milk. If you are or will be breast-feeding while you use Biaxin XL extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Biaxin XL 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; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or watery stools; confusion; decreased urination; dizziness; fast or irregular heartbeat; hallucinations; loss of taste or sense of smell; mental or mood changes (eg, depression); muscle pain or weakness; nightmares; purple spots on the skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea or stomach cramps; severe stomach pain (with or without nausea or vomiting); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness); tremor; trouble sleeping.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

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

Proper storage of Biaxin XL extended-release tablets:

Store Biaxin XL 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 extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Biaxin XL extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Biaxin XL 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Biaxin XL extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Biaxin XL extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Biaxin XL extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Biaxin XL extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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