Avelox - Moxifloxacin (Oral Route)

    Avelox – Moxifloxacin (Oral Route)

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    Description and Brand Names of Avelox – Moxifloxacin (Oral Route)

    US Brand Name

    1. Avelox

    Descriptions

    Moxifloxacin is used to treat bacterial infections in many different parts of the body.

    Moxifloxacin belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

    This medicine is available only with your doctor’s prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using Avelox – Moxifloxacin (Oral Route)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of moxifloxacin in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of moxifloxacin in the elderly. However, elderly patients are more likely to have age-related heart problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving moxifloxacin.

    Pregnancy

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Amifampridine
    • Cisapride
    • Dronedarone
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Sparfloxacin
    • Thioridazine
    • Ziprasidone

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acarbose
    • Acetohexamide
    • Acetophenazine
    • Alfuzosin
    • Amiodarone
    • Amitriptyline
    • Amoxapine
    • Apomorphine
    • Arsenic Trioxide
    • Artemether
    • Asenapine
    • Astemizole
    • Azithromycin
    • Bedaquiline
    • Benfluorex
    • Bretylium
    • Chloroquine
    • Chlorpromazine
    • Chlorpropamide
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clomipramine
    • Clozapine
    • Crizotinib
    • Cyclobenzaprine
    • Dasatinib
    • Desipramine
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone
    • Dothiepin
    • Doxepin
    • Droperidol
    • Erythromycin
    • Ethopropazine
    • Fingolimod
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Fluphenazine
    • Formoterol
    • Gatifloxacin
    • Gemifloxacin
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Gliquidone
    • Glyburide
    • Granisetron
    • Guar Gum
    • Halofantrine
    • Haloperidol
    • Ibutilide
    • Iloperidone
    • Imipramine
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Glulisine
    • Insulin Lispro, Recombinant
    • Ivabradine
    • Lapatinib
    • Levofloxacin
    • Lofepramine
    • Lopinavir
    • Lumefantrine
    • Mefloquine
    • Metformin
    • Methadone
    • Methotrimeprazine
    • Mifepristone
    • Miglitol
    • Moricizine
    • Nilotinib
    • Norfloxacin
    • Nortriptyline
    • Octreotide
    • Ofloxacin
    • Ondansetron
    • Opipramol
    • Paliperidone
    • Pasireotide
    • Pazopanib
    • Perflutren Lipid Microsphere
    • Perphenazine
    • Pipotiazine
    • Posaconazole
    • Procainamide
    • Prochlorperazine
    • Promazine
    • Promethazine
    • Propafenone
    • Propiomazine
    • Protriptyline
    • Quetiapine
    • Quinidine
    • Quinine
    • Ranolazine
    • Salmeterol
    • Saquinavir
    • Sodium Phosphate
    • Sodium Phosphate, Dibasic
    • Sodium Phosphate, Monobasic
    • Solifenacin
    • Sorafenib
    • Sotalol
    • Sunitinib
    • Telavancin
    • Telithromycin
    • Terfenadine
    • Tetrabenazine
    • Thiethylperazine
    • Tizanidine
    • Tolazamide
    • Tolbutamide
    • Toremifene
    • Trazodone
    • Trifluoperazine
    • Triflupromazine
    • Trimeprazine
    • Trimipramine
    • Troglitazone
    • Vandetanib
    • Vardenafil
    • Vemurafenib
    • Vilanterol
    • Vinflunine
    • Voriconazole
    • Warfarin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Aluminum Carbonate, Basic
    • Aluminum Hydroxide
    • Aluminum Phosphate
    • Betamethasone
    • Corticotropin
    • Cortisone
    • Cosyntropin
    • Deflazacort
    • Dexamethasone
    • Didanosine
    • Dihydroxyaluminum Aminoacetate
    • Dihydroxyaluminum Sodium Carbonate
    • Fludrocortisone
    • Fluocortolone
    • Hydrocortisone
    • Iron
    • Magaldrate
    • Magnesium Carbonate
    • Magnesium Hydroxide
    • Magnesium Oxide
    • Magnesium Trisilicate
    • Methylprednisolone
    • Paramethasone
    • Prednisolone
    • Prednisone
    • Rifampin
    • Sucralfate
    • Triamcinolone
    • Zinc

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bradycardia (slow heartbeat) or
    • Diarrhea or
    • Heart disease or
    • Heart rhythm problems (eg, prolonged QT interval), or family history of or
    • Hypokalemia (low potassium in the blood), or
    • Seizures (epilepsy), or history of – Use with caution. May make these conditions worse.
    • Brain disease (eg, hardening of the arteries) or
    • Kidney disease or
    • Liver disease (including cirrhosis) or
    • Organ transplant (eg, heart, kidney, or lung), history of or
    • Tendon disorder (eg, rheumatoid arthritis), history of – Use with caution. May cause side effects to become worse.
    • Myasthenia gravis (severe muscle weakness), or history of – Should not be used in patients with this condition.

    Proper Use of Avelox – Moxifloxacin (Oral Route)

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

    Swallow the tablet whole with a glass of water. Do not split, crush or chew it. This medicine may be taken with or without food.

    Take this medicine at the same time each day.

    Drink plenty of fluids with this medicine to help prevent some unwanted effects.

    If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 4 hours before or 8 hours after taking moxifloxacin. These medicines may keep moxifloxacin from working properly.

    Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):

      • For infections:

        • Adults – 400 milligrams (mg) once every 24 hours.
        • Children – Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Precautions

    It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

    If you have low potassium levels in the blood, moxifloxacin may increase your risk of having a fast, slow or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

    Moxifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

    Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

    Moxifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

    Moxifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor.

    Some people who take moxifloxacin may become more sensitive to sunlight than normal. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, or skin rash, redness, itching, or discoloration. When you begin using this medicine:

    • Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
    • Wear protective clothing, including a hat and sunglasses.
    • Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
    • Do not use a sunlamp or tanning bed or booth.

    If you have a severe reaction from the sun, check with your doctor.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

    Side Effects of Avelox – Moxifloxacin (Oral Route)

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Rare

    1. Abdominal or stomach cramps
    2. abdominal or stomach tenderness
    3. black, tarry stools
    4. bleeding gums
    5. blisters
    6. bloating or swelling of the face, arms, hands, lower legs, or feet
    7. blood in the urine or stools
    8. blurred vision
    9. bone pain
    10. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    11. chest pain
    12. chills
    13. clay-colored stools
    14. cough
    15. crying
    16. dark urine
    17. diarrhea, watery and severe, which may also be bloody
    18. difficult or labored breathing
    19. difficulty with moving
    20. difficulty with swallowing
    21. discouragement
    22. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    23. dry mouth
    24. excessive muscle tone
    25. fainting
    26. fast, irregular, pounding, or racing heartbeat or pulse
    27. feeling of unreality
    28. feeling of warmth or heat
    29. feeling sad or empty
    30. fever
    31. flushed, dry skin
    32. flushing or redness of the skin, especially on the face and neck
    33. fruit-like breath odor
    34. headache
    35. hyperventilation
    36. increased hunger
    37. increased sensitivity of the skin to sunlight
    38. increased thirst
    39. increased urination
    40. irregular heartbeat recurrent
    41. irritability
    42. itching
    43. joint pain, stiffness, or swelling
    44. lack of coordination
    45. loss of appetite
    46. loss of interest or pleasure
    47. lower back, side, or stomach pain
    48. mood or mental changes
    49. muscle aching or cramping
    50. muscle pains or stiffness
    51. muscle tension or tightness
    52. nausea or vomiting
    53. nervousness
    54. noisy breathing
    55. pain
    56. pain in the pelvis
    57. pain, warmth, or burning in the fingers, toes, and legs
    58. painful or difficult urination
    59. painful, swollen joints
    60. pale skin
    61. pinpoint red spots on the skin
    62. pounding in the ears
    63. problems with speech or speaking
    64. problems with vision or hearing
    65. quick to react or overreact emotionally
    66. rapid weight gain
    67. rapidly changing moods
    68. redness or other discoloration of the skin
    69. restlessness
    70. seeing, hearing, or feeling things that are not there
    71. seizures
    72. sensation of the skin burning
    73. sense of detachment from self or body
    74. severe sunburn
    75. shakiness in the legs, arms, hands, or feet
    76. skin rash
    77. sore throat
    78. sores, ulcers, or white spots on the lips or in the mouth
    79. sweating
    80. swelling of the feet or lower legs
    81. swelling or puffiness of the face
    82. swollen glands
    83. tightness in the chest
    84. tingling of the hands or feet
    85. tiredness
    86. trouble concentrating
    87. trouble sleeping
    88. troubled breathing with exertion
    89. unexplained weight loss
    90. unpleasant breath odor
    91. unusual bleeding or bruising
    92. unusual tiredness or weakness
    93. unusual weight gain or loss
    94. vomiting of blood
    95. yellow eyes or skin

    Incidence not known

    1. Blistering, peeling, or loosening of the skin
    2. burning, numbness, tingling, or painful sensations
    3. change in the ability to see colors, especially blue or yellow
    4. difficulty in chewing or talking
    5. double vision
    6. drooping eyelids
    7. eye pain
    8. general feeling of tiredness or weakness
    9. hives
    10. hoarseness
    11. irregular or slow heart rate
    12. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    13. light-colored stools
    14. muscle weakness
    15. no blood pressure or pulse
    16. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    17. red, irritated eyes
    18. red skin lesions, often with a purple center
    19. severe headache
    20. severe tiredness
    21. stomach pain, continuing
    22. stopping of heart
    23. unconsciousness
    24. unsteadiness or awkwardness
    25. unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness
    26. weakness in the arms, hands, legs, or feet

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare

    1. Acid or sour stomach
    2. bad, unusual, or unpleasant (after) taste
    3. belching
    4. burning feeling in the chest or stomach
    5. change in sense of smell
    6. change in taste
    7. changes in vision
    8. continuing ringing or buzzing or other unexplained noise in the ears
    9. difficulty having a bowel movement (stool)
    10. excess air or gas in the stomach or intestines
    11. fear or nervousness
    12. feeling of constant movement of self or surroundings
    13. full feeling
    14. general feeling of discomfort or illness
    15. hearing loss
    16. heartburn
    17. impaired vision
    18. indigestion
    19. itching of the vagina or genital area
    20. lack or loss of strength
    21. loss of memory
    22. pain during sexual intercourse
    23. passing of gas
    24. problems with memory
    25. redness, swelling, or soreness of the tongue
    26. sensation of spinning
    27. sleepiness or unusual drowsiness
    28. sore mouth or tongue
    29. stomach discomfort, upset, or pain
    30. swelling or inflammation of the mouth
    31. thick, white vaginal discharge with no odor or with a mild odor
    32. vaginal yeast infection
    33. white patches in the mouth or on the tongue

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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