Avelox I.V. - Moxifloxacin (Intravenous Route)

    Avelox I.V. – Moxifloxacin (Intravenous Route)

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    Description and Brand Names of Avelox I.V. – Moxifloxacin (Intravenous Route)

    US Brand Name

    1. Avelox IV

    Descriptions

    Moxifloxacin injection 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 to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using Avelox I.V. – Moxifloxacin (Intravenous 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 injection 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 injection 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 injection.

    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 receiving 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.

    • Betamethasone
    • Corticotropin
    • Cortisone
    • Cosyntropin
    • Deflazacort
    • Dexamethasone
    • Fludrocortisone
    • Fluocortolone
    • Hydrocortisone
    • Methylprednisolone
    • Paramethasone
    • Prednisolone
    • Prednisone
    • Rifampin
    • Triamcinolone

    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), 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 I.V. – Moxifloxacin (Intravenous Route)

    A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

    Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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

    Precautions

    It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

    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 receive this medicine.

    Moxifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking 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 using the medicine or after you finish using 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 receive 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 receiving 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.

    Side Effects of Avelox I.V. – Moxifloxacin (Intravenous 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 or nurse 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. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
    6. blisters
    7. bloating or swelling of the face, arms, hands, lower legs, or feet
    8. blood in the urine or stools
    9. blurred vision
    10. bone pain
    11. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    12. chest pain
    13. chills
    14. clay-colored stools
    15. cough
    16. crying
    17. dark urine
    18. diarrhea, watery and severe, which may also be bloody
    19. difficult or labored breathing
    20. difficulty with moving
    21. difficulty with swallowing
    22. discouragement
    23. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    24. dry mouth
    25. excessive muscle tone
    26. fainting
    27. fast, irregular, pounding, or racing heartbeat or pulse
    28. feeling of unreality
    29. feeling of warmth or heat
    30. feeling sad or empty
    31. fever
    32. flushed, dry skin
    33. flushing or redness of the skin, especially on the face and neck
    34. fruit-like breath odor
    35. headache
    36. hyperventilation
    37. increased hunger
    38. increased sensitivity of the skin to sunlight
    39. increased thirst
    40. increased urination
    41. irregular heartbeat recurrent
    42. irritability
    43. itching
    44. joint pain, stiffness, or swelling
    45. lack of coordination
    46. loss of appetite
    47. loss of interest or pleasure
    48. lower back, side, or stomach pain
    49. mood or mental changes
    50. muscle aching or cramping
    51. muscle pains or stiffness
    52. muscle tension or tightness
    53. nausea or vomiting
    54. nervousness
    55. noisy breathing
    56. pain
    57. pain in the pelvis
    58. pain, warmth, or burning in the fingers, toes, and legs
    59. painful or difficult urination
    60. painful, swollen joints
    61. pale skin
    62. pinpoint red spots on the skin
    63. pounding in the ears
    64. problems with speech or speaking
    65. problems with vision or hearing
    66. quick to react or overreact emotionally
    67. rapid weight gain
    68. rapidly changing moods
    69. redness or other discoloration of the skin
    70. restlessness
    71. seeing, hearing, or feeling things that are not there
    72. seizures
    73. sensation of the skin burning
    74. sense of detachment from self or body
    75. severe sunburn
    76. shakiness in the legs, arms, hands, or feet
    77. skin rash
    78. sore throat
    79. sores, ulcers, or white spots on the lips or in the mouth
    80. sweating
    81. swelling of the feet or lower legs
    82. swelling or puffiness of the face
    83. swollen glands
    84. tightness in the chest
    85. tingling of the hands or feet
    86. tiredness
    87. trouble concentrating
    88. trouble sleeping
    89. troubled breathing with exertion
    90. unexplained weight loss
    91. unpleasant breath odor
    92. unusual bleeding or bruising
    93. unusual tiredness or weakness
    94. unusual weight gain or loss
    95. vomiting of blood
    96. 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. confusion as to time, place, or person
    5. difficulty in chewing or talking
    6. double vision
    7. drooping eyelids
    8. eye pain
    9. general feeling of tiredness or weakness
    10. hives
    11. hoarseness
    12. irregular or slow heart rate
    13. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    14. light-colored stools
    15. muscle weakness
    16. no blood pressure or pulse
    17. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    18. red, irritated eyes
    19. red skin lesions, often with a purple center
    20. severe headache
    21. severe tiredness
    22. stomach pain, continuing
    23. stopping of heart
    24. unconsciousness
    25. unsteadiness or awkwardness
    26. unusual excitement, nervousness, or restlessness
    27. 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 and/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.