MOXIFLOXACIN - moxifloxacin hydrochloride injection, solution 
Fresenius Kabi USA, LLC

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

Revised:10/2022

Medication Guide
MOXIFLOXACIN
(mox i FLOX a sin) (in jek shun)
injection, for intravenous use
Read the Medication Guide that comes with moxifloxacin injection before you start receiving it and each time you receive it. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about moxifloxacin injection?
Moxifloxacin injection is in a class of antibiotics called fluoroquinolones. Moxifloxacin injection can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop receiving moxifloxacin injection and get medical help right away. Talk with your healthcare provider about whether you should continue to receive moxifloxacin injection.
1. Tendon rupture or swelling of the tendon (tendinitis).

  • Tendon problems can happen in people of all ages who receive moxifloxacin injection. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
    • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
  • The risk of getting tendon problems while you receive moxifloxacin injection is higher if you:
    • Are over 60 years of age.
    • Are taking steroids (corticosteroids).
    • Have had a kidney, heart or lung transplant.
    Tendon problems can happen in people who do not have the above risk factors when they receive moxifloxacin injection.
  • Other reasons that can increase your risk of tendon problems can include:
    • Physical activity or exercise.
    • Kidney failure.
    • Tendon problems in the past, such as in people with rheumatoid arthritis (RA).
  • Stop receiving moxifloxacin injection immediately and call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop receiving moxifloxacin injection 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 moxifloxacin injection. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are receiving or after you have finished receiving moxifloxacin injection. Tendon ruptures can happen within hours or days after taking moxifloxacin and have happened up to several months after people have finished receiving their fluoroquinolone.
  • Stop receiving moxifloxacin injection immediately and 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 put weight on the area.
2. Changes in sensation and possible nerve damage (peripheral neuropathy).
Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including moxifloxacin. Stop receiving moxifloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • pain
  • burning
  • tingling
  • numbness
  • weakness
     Moxifloxacin may need to be stopped to prevent permanent nerve damage.
3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibiotic medicines, including moxifloxacin. Tell your healthcare provider if you have a history of seizures before you start taking moxifloxacin. CNS side effects may happen as soon as after taking the first dose of moxifloxacin. Stop taking moxifloxacin immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • trouble sleeping
  • nightmares
  • feel lightheaded or dizzy
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
  • headaches that will not go away, with or without blurred vision
4. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like moxifloxacin injection may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis. Moxifloxacin should not be used in people who have a history of myasthenia gravis. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
See the section “What are the possible side effects of moxifloxacin injection?” for more information about side effects.
What is moxifloxacin injection?
  • Moxifloxacin injection is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. These bacterial infections include:
    • Community Acquired Pneumonia
    • Uncomplicated Skin and Skin Structure Infections
    • Complicated Skin and Skin Structure Infections
    • Complicated Intra-Abdominal Infections
    • Acute Bacterial Sinusitis
    • Acute Bacterial Exacerbation of Chronic Bronchitis
  • It is not known if moxifloxacin injection 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.
  • Moxifloxacin should not be used in people with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.
  • 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 moxifloxacin injection, do not kill viruses.
Call your healthcare provider if you think your condition is not getting better while you are receiving moxifloxacin injection.
Who should not receive moxifloxacin injection?
Do not receive moxifloxacin injection if you have ever had an allergic reaction to moxifloxacin, other fluoroquinolone antibiotics, or any of the ingredients in moxifloxacin injection. Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in moxifloxacin injection.
What should I tell my healthcare provider before receiving moxifloxacin injection?
  • See “What is the most important information I should know about moxifloxacin injection?” Tell your healthcare provider about all your medical conditions, including if you:
  • Have tendon problems. Moxifloxacin should not be used in people who have a history of tendon problems.
  • Have a disease that causes muscle weakness (myasthenia gravis). Moxifloxacin should not be used in people who have a history of myasthenia gravis.
  • Have central nervous system problems (such as epilepsy).
  • Have nerve problems. Moxifloxacin should not be used in people who have a history of a nerve problem called peripheral neuropathy.
  • 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 congestive heart failure.
  • Have a history of seizures.
  • Have kidney problems.
  • Have rheumatoid arthritis (RA) or other history of joint problems.
  • Are on a salt-restricted diet. People on a salt-restricted diet should not receive moxifloxacin injection.
  • Have diabetes or problems with low blood sugar (hypoglycemia).
  • Are pregnant or plan to become pregnant. It is not known if moxifloxacin injection will harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if moxifloxacin injection passes into breast milk. You and your healthcare provider should decide whether you will receive moxifloxacin injection or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal and dietary supplements. Moxifloxacin injection and other medicines can affect each other causing side effects.
Especially tell your healthcare provider if you take:
  • A Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you receive moxifloxacin injection 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). See “What are the possible side effects of moxifloxacin injection?
  • An anti-psychotic medicine.
  • A tricyclic antidepressant.
  • An oral anti-diabetes medicine or insulin.
  • Erythromycin.
  • A water pill (diuretic).
  • A steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. See “What is the most important information I should know about moxifloxacin injection?
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 receive moxifloxacin injection?

What should I avoid while receiving moxifloxacin injection?

  • Moxifloxacin injection 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 moxifloxacin injection affects you. Avoid sunlamps, tanning beds, and try to limit your time in the sun. Moxifloxacin injection 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 receiving moxifloxacin injection, 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 moxifloxacin injection?
Moxifloxacin injection can cause side effects that may be serious or even cause death.

  • See “What is the most important information I should know about moxifloxacin injection?
  • Serious heart rhythm changes (QT prolongation and torsades de pointes). Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint. Moxifloxacin injection may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
    • Who are elderly
    • With a family history of prolonged QT interval
    • With low blood potassium (hypokalemia)
    • Who take certain medicines to control heart rhythm (antiarrhythmics)
  • Serious allergic reactions. Allergic reactions can happen in people taking fluoroquinolones, including moxifloxacin injection, even after only 1 dose. Stop receiving moxifloxacin injection and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • Hives
  • Trouble breathing or swallowing
  • Swelling of the lips, tongue, face
  • Throat tightness, hoarseness
  • Fast heartbeat
  • Faint
  • Yellowing of the skin or eyes. Stop receiving moxifloxacin injection and tell your healthcare provider right away if you get yellowing of your skin or of the white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to moxifloxacin injection (a liver problem).
  • Skin rash. Skin rash may happen in people receiving moxifloxacin injection even after only 1 dose. Stop receiving moxifloxacin injection at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to moxifloxacin injection.
  • Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have a swelling of the large artery that carries blood from the heart to the body (aortic aneurysm). Get emergency medical help right away if you have sudden chest, stomach, or back pain.
  • Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including moxifloxacin injection. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have stopped receiving moxifloxacin injection.
  • Changes in blood sodium. Increased blood sodium can happen in people who receive moxifloxacin injection. Tell your healthcare provider if you are on a salt-restricted diet or have congestive heart failure. You should not receive moxifloxacin injection if you are on a salt-restricted diet.
  • Changes in blood sugar. People who receive moxifloxacin injection and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while receiving moxifloxacin injection, stop receiving moxifloxacin injection and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
  • Sensitivity to sunlight (photosensitivity). See “What should I avoid while receiving moxifloxacin injection?
The most common side effects of moxifloxacin injection include:
  • nausea
  • diarrhea
  • headache
  • dizziness
These are not all the possible side effects of moxifloxacin injection. 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.
General Information about the safe and effective use of moxifloxacin injection.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about moxifloxacin injection. If you would like more information about moxifloxacin injection, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about moxifloxacin injection that is written for health professionals

What are the ingredients in moxifloxacin injection?
Active ingredient:
moxifloxacin
Inactive ingredients: sodium acetate-trihydrate, disodium sulfate, sulfuric acid (for pH adjustment), and water for injection
Manufactured for:

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Lake Zurich, IL 60047
www.fresenius-kabi.com/us

For more information, call 1-800-551-7176.
451327G

Revised: 1/2023
Fresenius Kabi USA, LLC