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AVELOX- moxifloxacin hydrochloride injection, solutionAVELOX- moxifloxacin hydrochloride tablet, film coated


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Avelox?
  3. The Risk Of Getting Tendon Problems While You Take Avelox Is Higher If You:
  4. Other Reasons That Can Increase Your Risk Of Tendon Problems Can Include:
  5. Stop Taking Avelox Immediately And Get Medical Help Right Away If You Get Any Of The Following Signs Or Symptoms Of A Tendon Rupture:
  6. 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. These Bacterial Infections Include:
  7. Who Should Not Take Avelox?
  8. Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  9. Certain Medicines May Keep Avelox From Working Correctly. Take Avelox Either 4 Hours Before Or 8 Hours After Taking These Products:
  10. How Should I Take Avelox?
  11. Do Not Skip Any Doses, Or Stop Taking Avelox Even If You Begin To Feel Better, Until You Finish Your Prescribed Treatment, Unless:
  12. What Are The Possible Side Effects Of Avelox?
  13. Other Serious Side Effects Of Avelox Include:
  14. 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:
  15. 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:
  16. How Should I Store Avelox?
  17. Avelox Tablets:
  18. Avelox Injection:
  19. Manufactured For:
  20. Disabling And Potentially Irreversible Serious Adverse Reactions That May Occur Together:
  21. Tendinitis And Tendon Rupture:
  22. Peripheral Neuropathies:
  23. Exacerbation Of Myasthenia Gravis:
  24. Hypersensitivity Reactions:
  25. Hepatotoxicity:
  26. Aortic Aneurysm And Dissection:
  27. Diarrhea:
  28. Prolongation Of The Qt Interval:
  29. Blood Glucose Disturbances:
  30. Photosensitivity/phototoxicity:

Patient Information 

FDA-Approved Medication Guide

MEDICATION GUIDE

AVELOX(AV-eh-locks)
(moxifloxacin hydrochloride)
Tablets

AVELOX(AV-eh-locks)
(moxifloxacin hydrochloride)
Injection Solution for Intravenous use

Read the Medication Guide that comes with AVELOXbefore 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 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 AVELOX and 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 of all ages who take AVELOX.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 Take Avelox 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 take AVELOX.

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

Stop Taking Avelox 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 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 AVELOX. Stop taking AVELOX 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
AVELOX may need to be stopped to prevent permanent nerve damage.
Central Nervous System (CNS) effects.Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including AVELOX. Tell your healthcare provider if you have a history of seizures before you start taking AVELOX. CNS side effects may happen as soon as after taking the first dose of AVELOX. Stop taking AVELOX 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, for more information about side effects.

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. These Bacterial Infections Include: 

Community Acquired Pneumonia
Uncomplicated Skin and Skin Structure Infections
Complicated Skin and Skin Structure Infections
Complicated Intra-Abdominal Infections
Plague
Acute Bacterial Sinusitis
Acute Bacterial Exacerbation of Chronic Bronchitis

AVELOX 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 AVELOX 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 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.

Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 

Have tendon problems; AVELOX should not be used in patients who have a history of tendon problems
Have a disease that causes muscle weakness (myasthenia gravis); AVELOX should not be used in patients who have a history of myasthenia gravis
Have central nervous system problems (such as epilepsy)
Have nerve problems; AVELOX should not be used in patients 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 a history of seizures
Have kidney problems
Have rheumatoid arthritis (RA) or other history of joint problems
Are pregnant or planning to become pregnant. It is not known if AVELOX will harm your unborn child
Are breast-feeding or planning to breast-feed. It is not known if AVELOX passes into breast milk. You and your healthcare provider should decide whether you will take AVELOX or breast-feed.
Have diabetes or problems with low blood sugar (hypoglycemia).

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:

An NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take AVELOX 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)
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.

Certain Medicines May Keep Avelox From Working Correctly. Take Avelox Either 4 Hours Before Or 8 Hours After Taking These Products: 

An antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc
Sucralfate (Carafate)
Didanosine oral suspension or solution

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? 

Take AVELOX once a day exactly as prescribed by your healthcare provider.
Take AVELOX at about the same time each day.
AVELOX Tablets should be swallowed.
AVELOX can be taken with or without food.
Drink plenty of fluids while taking AVELOX.
AVELOX Injection is given to you by intravenous infusion into your vein slowly, over 60 minutes, as prescribed by your healthcare provider.

Do Not Skip Any Doses, Or Stop Taking Avelox Even If You Begin To Feel Better, Until You Finish Your Prescribed Treatment, Unless: 

You have tendon effects ().
You have nerve problems.
You have central nervous system problems.
You have a serious allergic reaction (

AVELOX 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 AVELOX affects you.
Avoid sunlamps, tanning beds, and try to limit your time in the sun. AVELOX 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 taking AVELOX, 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 Avelox? 

AVELOX can cause side effects that may be serious or even cause death.

Other Serious Side Effects Of Avelox Include: 

Serious allergic reactions

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: 

Hives
Trouble breathing or swallowing
Swelling of the lips, tongue, face
Throat tightness, hoarseness
Rapid heartbeat
Faint
Yellowing of the skin or eyes. Stop taking AVELOX and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to AVELOX (a liver problem).

Aortic aneurysm and dissection

Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
Skin rash
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.
Serious heart rhythm changes (QT prolongation and torsade de pointes)

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: 

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)
Intestine infection (Pseudomembranous colitis)
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.
Changes in blood sugar
People who take AVELOX 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 taking AVELOX, stop taking AVELOX and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
Sensitivity to sunlight (photosensitivity)
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? 

AVELOX Tablets
Store AVELOX 59 86 F (15 30 C)
Keep AVELOX away from moisture (humidity)

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 call 1-888-842-2937.

Avelox Tablets: 

Active ingredient: moxifloxacin hydrochloride
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide

Avelox Injection: 

Active ingredient: moxifloxacin hydrochloride
Inactive ingredients: sodium chloride, USP, water for injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment

Manufactured For: 

Bayer HealthCare Pharmaceuticals Inc.
Whippany NJ, 07981

AVELOX Tablets manufactured in Germany
AVELOX Injection manufactured in Germany

AVELOXis a registered trademark of Bayer Aktiengesellschaft

Rx Only

1999 Bayer HealthCare Pharmaceuticals Inc.

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

Revised 5/2019

Disabling And Potentially Irreversible Serious Adverse Reactions That May Occur Together: 

Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of AVELOX and may occur together in the same patient. Inform patients to stop taking AVELOX immediately if they experience an adverse reaction and to call their healthcare provider.

Tendinitis And Tendon Rupture: 

Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue AVELOX treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Peripheral Neuropathies: 

Inform patients that peripheral neuropathies have been associated with AVELOX use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue AVELOX and tell them to contact their physician.
Central nervous system effects(for example, convulsions, dizziness, lightheadedness, increased intracranial pressure):Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including AVELOX. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to AVELOX before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.

Exacerbation Of Myasthenia Gravis: 

Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.

Hypersensitivity Reactions: 

Inform patients that AVELOX can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.

Hepatotoxicity: 

Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking AVELOX. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.

Aortic Aneurysm And Dissection: 

Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain.

Diarrhea: 

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.

Prolongation Of The Qt Interval: 

Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.

Blood Glucose Disturbances: 

Inform the patients that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue AVELOX and consult a physician.

Photosensitivity/phototoxicity: 

Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.

Antibacterial Resistance

Inform patients that antibacterial drugs including AVELOX should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When AVELOX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AVELOX or other antibacterial drugs in the future.

Administration With Food, Fluids, and Drug Products Containing Multivalent Cations

Inform patients that AVELOX tablets may be taken with or without food. Advise patients drink fluids liberally.

Inform patients that AVELOX tablets should be taken at least 4 hours before or 8 hours after multivitamins (containing iron or zinc), antacids (containing magnesium or aluminum), sucralfate, or didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.

Plague Studies

Inform patients given AVELOX for plague that efficacy studies could not be conducted in humans for feasibility reasons. Therefore, approval for plague was based on efficacy studies conducted in animals.



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