AVELOX - moxifloxacin hydrochloride tablet, film coated
Physicians Total Care, Inc.
AVELOX® IV (AV-eh-locks)
Injection Solution for IV use
Read the Medication Guide that comes with AVELOX® before you start taking it 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 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.
1. Tendon rupture or swelling of the tendon (tendinitis).
Tendon problems can happen in people who do not have the above risk factors when they take AVELOX.
2. 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.
See the section “What are the possible side effects of AVELOX?” 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. See the list of ingredients in AVELOX at the end of this Medication Guide.
What should I tell my healthcare provider before taking AVELOX?
See “What is the most important information I should know about AVELOX?”
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 and herbal and dietary supplements. AVELOX 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 AVELOX?
What should I avoid while taking AVELOX?
What are the possible side effects of AVELOX?
AVELOX can cause side effects that may be serious or even cause death. See “What is the most important information I should know about AVELOX?”
Other serious side effects of AVELOX include:
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:
Allergic reactions can happen in people taking fluoroquinolones, including AVELOX, even after only one dose. Stop taking AVELOX and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
Skin rash may happen in people taking AVELOX even after only one dose. Stop taking AVELOX 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 AVELOX.
Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. AVELOX 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:
Pseudomembranous colitis can happen with most antibiotics, including AVELOX. 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 finished your antibiotic.
Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including AVELOX. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
AVELOX may need to be stopped to prevent permanent nerve damage.
See “What should I avoid while taking AVELOX?”
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?
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.
What are the ingredients in AVELOX?
Revised October 2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
AVELOX Tablets made in Germany
AVELOX IV made in Germany
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, a subsidiary of Merck & Co., Inc.
©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A.