MOXIFLOXACIN HYDROCHLORIDE - moxifloxacin hydrochloride tablet, film coated
Rising Health, LLC

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FDA-Approved Medication Guide


MEDICATION GUIDE

Moxifloxacin Tablets, USP

(mox'' i flox' a sin)

Rx only


Read the Medication Guide that comes with moxifloxacin tablets before you start taking them and each time you get a refill. 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 tablets?


Moxifloxacin tablets belong to a class of antibiotics called fluoroquinolones. Moxifloxacin tablets 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 taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin tablets.

1. Tendon rupture or swelling of the tendon (tendinitis).

●          Tendon problems can happen in people of all ages who take moxifloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
o   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 take moxifloxacin tablets is higher if you:
o   Are over 60 years of age
o   Are taking steroids (corticosteroids)
o   Have had a kidney, heart or lung transplant


●          Other reasons that can increase your risk of tendon problems can include:
o   Physical activity or exercise
o   Kidney failure
o   Tendon problems in the past, such as in people with rheumatoid arthritis (RA).

●          Stop taking moxifloxacin tablets immediately and call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking moxifloxacin tablets 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 tablets. 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 moxifloxacin tablets. Tendon ruptures can happen within hours or days after taking moxifloxacin tablets and have happened up to several months after patients have finished taking their fluoroquinolone.

●    Stop taking moxifloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
o    Hear or feel a snap or pop in a tendon area
o    Bruising right after an injury in a tendon area
o    Unable to move the affected area or bear weight.

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 tablets. Stop taking moxifloxacin tablets 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:



Moxifloxacin tablets 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 antibacterial medicines, including moxifloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking moxifloxacin tablets. CNS side effects may happen as soon as after taking the first dose of moxifloxacin tablets. Stop taking moxifloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:


4. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like moxifloxacin tablets 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 before you start taking moxifloxacin tablets. 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 tablets?” for more information about side effects.

What are moxifloxacin tablets?


Moxifloxacin tablets are 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:



Moxifloxacin tablets should not be used in patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.


Studies of moxifloxacin tablets for use in the treatment of plague were done in animals only, because plague could not be studied in people.


It is not known if moxifloxacin tablet 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 moxifloxacin tablets, do not kill viruses.


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

Who should not take moxifloxacin tablets?


Do not take moxifloxacin tablets 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 moxifloxacin tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in moxifloxacin tablets at the end of this Medication Guide.

What should I tell my healthcare provider before taking moxifloxacin tablets?


See “What is the most important information I should know about moxifloxacin tablets?”

Tell your healthcare provider about all your medical conditions, including if you:


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


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 moxifloxacin tablets?



What should I avoid while taking moxifloxacin tablets?

What are the possible side effects of moxifloxacin tablets?


Moxifloxacin tablets can cause side effects that may be serious or even cause death. See “What is the most important information I should know about moxifloxacin tablets?”


Other serious side effects of moxifloxacin tablets include:

Serious allergic reactions


Aortic aneurysm and dissection

Skin rash

Serious heart rhythm changes (QT prolongation and torsade de pointes)


Intestine infection (Pseudomembranous colitis)


Changes in blood sugar

Sensitivity to sunlight (photosensitivity)


These are not all the possible side effects of moxifloxacin tablets. 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 moxifloxacin tablets?


Keep moxifloxacin tablets and all medicines out of the reach of children.

General Information about moxifloxacin tablets


What are the ingredients in moxifloxacin tablets?



All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.


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

Dispense with medication guide available at : http://www.risingpharma.com/med-guides.html

Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663


Made in India
Code: TS/DRUGS/22/2009

Revised: 06/2019

Revised: 9/2019
Rising Health, LLC