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AVELOX- moxifloxacin hydrochloride tablet, film coated


  1. What Is The Most Important Information I Should Know About Avelox?
  2. Pain, Swelling, Tears And Inflammation Of Tendons Including The Back Of The Ankle (achilles), Shoulder, Hand, Or Other Tendon Sites Can Happen In People Of All Ages Who Take Fluoroquinolone Antibiotics, Including Avelox. The Risk Of Getting Tendon Problems Is Higher If You:
  3. What Is Avelox?
  4. Who Should Not Take Avelox?
  5. Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  6. Certain Medicines May Keep Avelox From Working Correctly. Take Avelox Either 4 Hours Before Or 8 Hours After Taking These Products:
  7. How Should I Take Avelox?
  8. Do Not Skip Any Doses, Or Stop Taking Avelox Even If You Begin To Feel Better, Until You Finish Your Prescribed Treatment, Unless:
  9. What Are The Possible Side Effects Of Avelox?
  10. Other Serious Side Effects Of Avelox Include:
  11. Central Nervous System (cns) Side Effects May Happen As Soon As After Taking The First Dose Of Avelox. Talk To Your Healthcare Provider Right Away If You Have Any Of These Side Effects, Or Other Changes In Mood Or Behavior:
  12. How Should I Store Avelox?
  13. Avelox Tablets:
  14. Avelox Iv:
  15. Revised: 8/2011document Id:
  16. Patient Information
  17. Tendon Disorders:
  18. Prolongation Of The Qt Interval:
  19. Hypersensitivity Reactions:
  20. Convulsions:
  21. Neurologic Adverse Effects (for Example, Dizziness, Lightheadedness):
  22. Peripheral Neuropathies:
  23. Photosensitivity/phototoxicity:
  24. Diarrhea:

What Is The Most Important Information I Should Know About Avelox? 

AVELOX belongs to a class of antibiotics called fluoroquinolones. AVELOX can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take AVELOX.

  • Tendon rupture or swelling of the tendon (tendinitis)
    • Tendons are tough cords of tissue that connect muscles to bones.

Pain, Swelling, Tears And Inflammation Of Tendons Including The Back Of The Ankle (achilles), Shoulder, Hand, Or Other Tendon Sites Can Happen In People Of All Ages Who Take Fluoroquinolone Antibiotics, Including Avelox. The Risk Of Getting Tendon Problems Is Higher If You: 

  • Are over 60 years of age
  • Are taking steroids (corticosteroids)
  • Have had a kidney, heart or lung transplant
  • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
  • Other reasons for tendon ruptures can include:
    • Physical activity or exercise
    • Kidney failure
    • Tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking AVELOX until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is in the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of AVELOX. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking AVELOX. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    • Hear or feel a snap or pop in a tendon area
    • Bruising right after an injury in a tendon area
    • Unable to move the affected area or bear weight
  • Worsening of myasthenia gravis (a disease which causes muscle weakness).Fluoroquinolones like AVELOX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
  • for more information about side effects.

    What Is Avelox? 

    AVELOX is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. It is not known if AVELOX is safe and works in people under 18 years of age. Children have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibiotic medicines.

    Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including AVELOX, do not kill viruses.

    Call your healthcare provider if you think your condition is not getting better while you are taking AVELOX.

    Who Should Not Take Avelox? 

    Do not take AVELOX if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in AVELOX. Ask your healthcare provider if you are not sure.

    Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 

    • Have tendon problems
    • Have a disease that causes muscle weakness (myasthenia gravis)
    • Have central nervous system problems (such as epilepsy)
    • Have nerve problems
    • Have or anyone in your family has an irregular heartbeat, especially a condition called QT prolongation
    • Have low blood potassium (hypokalemia)
    • Have a slow heartbeat (bradycardia)
    • Have a history of seizures
    • Have kidney problems
    • Have rheumatoid arthritis (RA) or other history of joint problems
    • Are pregnant or planning to become pregnant. It is not known if AVELOX will harm your unborn child.
    • Are breast-feeding or planning to breast-feed. It is not known if AVELOX passes into breast milk. You and your healthcare provider should decide whether you will take AVELOX or breast-feed.

    Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. AVELOX and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

    • An NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take AVELOX or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
    • A blood thinner (warfarin, Coumadin, Jantoven)
    • A medicine to control your heart rate or rhythm (antiarrhythmic)
    • An anti-psychotic medicine
    • A tricyclic antidepressant
    • Erythromycin
    • A water pill (diuretic)
    • A steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury.

    Certain Medicines May Keep Avelox From Working Correctly. Take Avelox Either 4 Hours Before Or 8 Hours After Taking These Products: 

  • An antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc
  • Sucralfate (Carafate)
  • Didanosine (Videx, Videx EC)
  • Ask your healthcare provider if you are not sure if any of your medicines are listed above.

    Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

    How Should I Take Avelox? 

    • Take AVELOX once a day exactly as prescribed by your healthcare provider.
    • Take AVELOX at about the same time each day.
    • AVELOX Tablets should be swallowed.
    • AVELOX can be taken with or without food.
    • Drink plenty of fluids while taking AVELOX.
    • AVELOX IV is given to you by intravenous (IV) infusion into your vein slowly, over 60 minutes, as prescribed by your healthcare provider.

    Do Not Skip Any Doses, Or Stop Taking Avelox Even If You Begin To Feel Better, Until You Finish Your Prescribed Treatment, Unless: 

    • You have tendon effects (

      • AVELOX can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how AVELOX affects you.
      • Avoid sunlamps, tanning beds, and try to limit your time in the sun. AVELOX can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking AVELOX, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

    What Are The Possible Side Effects Of Avelox? 

    AVELOX can cause side effects that may be serious or even cause death.

    Other Serious Side Effects Of Avelox Include: 

    • Central Nervous System effects

    Seizures have been reported in people who take fluoroquinolone antibiotics including AVELOX. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking AVELOX will change your risk of having a seizure.

    Central Nervous System (cns) Side Effects May Happen As Soon As After Taking The First Dose Of Avelox. Talk To Your Healthcare Provider Right Away If You Have Any Of These Side Effects, Or Other Changes In Mood Or Behavior: 

    • Feeling dizzy
    • Seizures
    • Hear voices,

      The most common side effects of AVELOX include nausea and diarrhea.

      These are not all the possible side effects of AVELOX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

      Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How Should I Store Avelox? 

    AVELOX Tablets

    • Store AVELOX 59 86 F (15 30 C)
    • Keep AVELOX away from moisture (humidity)

    Keep AVELOX and all medicines out of the reach of children.

    General Information about AVELOX

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVELOX for a condition for which it is not prescribed. Do not give AVELOX to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about AVELOX. If you would like more information about AVELOX, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about AVELOX that is written for healthcare professionals. For more information go to www.AVELOX.com or call 1-800-526-4099.

    Avelox Tablets: 

    • Active ingredient: moxifloxacin hydrochloride
    • Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide

    Avelox Iv: 

    • Active ingredient: moxifloxacin hydrochloride
    • Inactive ingredients: sodium chloride, USP, water for injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment

    Revised February 2011

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by:
    Bayer HealthCare Pharmaceuticals Inc.
    Wayne, NJ 07470

    Avelox Tablets made in Germany
    Avelox IV made in Germany
    or
    Avelox IV made in Norway by
    Fresenius Kabi Norge AS
    NO-1753 Halden, Norway

    Distributed by: Schering Corporation, a subsidiary of

    MERCK& CO., INC.

    Whitehouse Station, NJ 08889, USA

    AVELOX is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation.

    Rx Only

    81532312, R.5 02/11 15830

    2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A.

    copy of labelcopy of label
    AVELOX
    moxifloxacin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67296-0154(NDC:0085-1733)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MOXIFLOXACIN HYDROCHLORIDE(UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)MOXIFLOXACIN HYDROCHLORIDE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
    LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
    CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
    MAGNESIUM STEARATE(UNII: 70097M6I30)
    HYPROMELLOSES(UNII: 3NXW29V3WO)
    TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
    POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
    FERRIC OXIDE RED(UNII: 1K09F3G675)
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (capsule-shaped)Size17mm
    FlavorImprint CodeBAYER;M400
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67296-0154-110 in 1 BOTTLE
    2NDC:67296-0154-27 in 1 BOTTLE
    3NDC:67296-0154-35 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02108502/25/2011
    Labeler -RedPharm Drug Inc. (008039641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer Schering Pharma AG341081414MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresenius Kabi Norge AS731170932MANUFACTURE

    Revised: 8/2011document Id: 

    4c8fe3c9-0537-4fda-aef5-918f0a961a8bSet id: fe9226f8-64f4-4eff-8339-ed3fce0896f2Version: 2Effective Time: 20110808RedPharm Drug Inc.

    Patient Information 

    See FDA-Approved Medication Guide

    17.1 Antibacterial Resistance

    Antibacterial drugs including AVELOX should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When AVELOX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AVELOX or other antibacterial drugs in the future.

    17.2 Administration With Food, Fluids, and Drug Products Containing Multivalent Cations

    Patients should be informed that AVELOX tablets may be taken with or without food. Patients should be advised to drink fluids liberally.

    AVELOX tablets should be taken at least 4 hours before or 8 hours after multivitamins (containing iron or zinc), antacids (containing magnesium or aluminum), sucralfate, or VIDEX(didanosine) chewable/buffered tablets or the pediatric powder for oral solution.

    17.3 Serious and Potentially Serious Adverse Reactions

    Tendon Disorders: 

    Patients should contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue AVELOX treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • Exacerbation of Myasthenia Gravis: fluoroquinolones like AVELOX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
  • Prolongation Of The Qt Interval: 

    AVELOX may produce changes in the electrocardiogram (QTc interval prolongation). AVELOX should be avoided in patients receiving Class IA (for example quinidine, procainamide) or Class III (for example amiodarone, sotalol) antiarrhythmic agents. AVELOX may add to the QTc prolonging effects of other drugs such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants. The patients should inform their physician of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, and acute myocardial ischemia. Patients should contact their physician if they experience palpitations or fainting spells while taking AVELOX.

    Hypersensitivity Reactions: 

    Patients should be advised that AVELOX may be associated with hypersensitivity reactions, including anaphylactic reactions, even following a single dose. Patients should discontinue AVELOX at the first sign of a skin rash or other signs of an allergic reaction.

    Convulsions: 

    Convulsions have been reported in patients receiving quinolones, and they should notify their physician before taking AVELOX if there is a history of this condition. Patients should also inform their physician if they are taking NSAIDs concurrently with AVELOX.

    Neurologic Adverse Effects (for Example, Dizziness, Lightheadedness): 

    AVELOX may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.

    Peripheral Neuropathies: 

    If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, patients should discontinue AVELOX and contact their physician.

    Photosensitivity/phototoxicity: 

    Patients should be informed that photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.

    Diarrhea: 

    Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.



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