Avelox

Vigamox is the brand name of eye drops containing the drug moxifloxacin, which is used to treat bacterial infections in the eyes.

The medicine is often prescribed for the common infection known as conjunctivitis (pink eye).

Vigamox is a fluoroquinolone antibiotic. It works by stopping the production of proteins that bacteria need to survive.

The Food and Drug Administration (FDA) approved Vigamox in 1999. It’s manufactured by Alcon, part of Novartis International.

Vigamox Warnings

Don’t use Vigamox if you have a fungal or viral eye infection. This medicine is used only to treat bacterial infections.

Before taking Vigamox, tell your doctor if you have allergies to any medicines, especially other antibiotics.

Vigamox is intended for use in the eyes. Don’t swallow or inject Vigamox.

Also, tell your healthcare provider if you wear contact lenses before taking Vigamox. You’ll have to take out your lenses before using the medicine, and you may have to leave them out until your eye heals.

Don’t use this medicine for a shorter or longer amount of time than your doctor prescribes.

Taking Vigamox for longer periods of time may cause a secondary infection. Stopping the drug too soon may cause a return of the infection.

Tell your healthcare provider if your condition doesn’t improve after seven days of using Vigamox.

Pregnancy and Vigamox

It’s not known whether Vigamox will harm an unborn baby.

Don’t use this medicine without first talking to your doctor if you’re pregnant or plan to become pregnant.

It’s also not known whether the drug passes into breast milk or could hurt a breastfeeding baby. Talk to your doctor before breastfeeding while taking Vigamox.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using moxifloxacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor, usually once daily. Do not inject into the skin or muscle. Give this medication over at least 60 minutes. Your heartbeat may increase if the medication is given too fast. If you feel dizzy, tell your health care professional right away.The dosage and length of treatment are based on your condition and response to treatment. As soon as you are able to take medications by mouth, your doctor will switch you to an antibiotic that is taken by mouth.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Drink plenty of fluids while using this medication unless your doctor directs you otherwise. If you are unable to take fluids by mouth, you will be given fluids through a vein.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition persists or worsens.

• 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.
  • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendinitis.
  • Worsening of myasthenia gravis (a disease which causes muscle weakness), worsening muscle weakness or breathing problems.
  • Peripheral neuropathy may occur. Tell your healthcare provider right away if you experience pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature. These symptoms can occur early in treatment and may be permanent. It may be necessary to stop Avelox, but do not do so without first talking with your health care professional.
• Do not take Avelox if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone (Cipro, Levaquin), or if you are allergic to any of the ingredients in Avelox. Ask your healthcare provider if you are not sure.
• 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.  You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Avelox there are no specific foods that you must exclude from your diet when receiving Avelox.

Avelox tablets should be taken at least 4 hours before or 8 hours after multivitamins (containing iron or zinc), antacids (containing magnesium or aluminum), and sucralfate.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Do not take moxifloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking moxifloxacin. They could make the medication less effective.

You may be taking certain other medicines that should not be taken at the same time as moxifloxacin. Avoid taking the following medicines within 8 hours before or 4 hours after you take moxifloxacin. These other medicines can make moxifloxacin much less effective when taken at the same time:

• antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);

• didanosine (Videx) powder or chewable tablets; or

• vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.

Moxifloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Moxifloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Not metabolized by CYP isoenzymes and does not inhibit CYP3A4, 2D6, 2C9, 2C19, or 1A2.1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.1

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).1 Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride [commercially available under a limited-access protocol only], erythromycin, antipsychotic agents, tricyclic antidepressants).1 (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Antacids (aluminum- or magnesium-containing)	Decreased absorption of oral moxifloxacin1	Administer oral moxifloxacin at least 4 hours before or 8 hours after such antacids1
Anticoagulants, oral (warfarin)	No clinically important pharmacokinetic interactions;1 may enhance anticoagulant effects of warfarin1	Monitor PT, INR, or other suitable coagulation tests1
Antidiabetic agents (sulfonylureas, insulin)	Alterations in blood glucose concentrations (hypoglycemia and hyperglycemia) reported1 Glyburide: No clinically important effect on glyburide pharmacokinetics1	Closely monitor blood glucose concentrations;1 if hypoglycemic reaction occurs, immediately discontinue moxifloxacin and initiate appropriate therapy1
Antifungal agents, azoles	Itraconazole: No effect on pharmacokinetics of either drug1
Atenolol	No effect on atenolol pharmacokinetics1
Calcium supplements	No effect on moxifloxacin pharmacokinetics1
Corticosteroids	Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age1
Cyclosporine	No clinically important effect on pharmacokinetics of either drug1
Didanosine	Decreased absorption of oral moxifloxacin with buffered didanosine preparations1	Administer oral moxifloxacin at least 4 hours before or 8 hours after buffered didanosine (pediatric oral solution admixed with antacid)1
Digoxin	Transient increase in digoxin concentrations; no clinically important effect on pharmacokinetics of either drug1	Dosage adjustment not needed for either drug1
Estrogens/progestins	No clinically important effect on pharmacokinetics of ethinyl estradiol/levonorgestrel oral contraceptives1
Iron preparations	Decreased oral absorption of moxifloxacin1 82	Administer oral moxifloxacin at least 4 hours before or 8 hours after iron preparations1
Morphine	No clinically important effect on moxifloxacin pharmacokinetics1
Multivitamins and dietary supplements	Decreased oral absorption of moxifloxacin1	Administer oral moxifloxacin at least 4 hours before or 8 hours after multivitamins or dietary supplements containing iron or zinc1
NSAIAs	Possible increased risk of CNS stimulation, seizures;1 animal studies using other fluoroquinolones suggest risk varies depending on the specific NSAIA86
Probenecid	No clinically important effect on moxifloxacin pharmacokinetics1
Ranitidine	No clinically important effect on moxifloxacin pharmacokinetics1
Sucralfate	Decreased oral absorption of moxifloxacin1	Administer oral moxifloxacin at least 4 hours before or 8 hours after sucralfate1
Theophylline	No clinically important effect on pharmacokinetics of either drug1

• Advise patients to read manufacturer’s patient information (medication guide) prior to initiating moxifloxacin therapy and each time prescription refilled.1

• Advise patients that antibacterials (including moxifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

• Importance of completing full course of therapy, even if feeling better after a few days.1

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with moxifloxacin or other antibacterials in the future.1

• May be taken without regard to meals,1 but should be taken with liberal amounts of fluids.1

• Importance of taking moxifloxacin at least 4 hours before or 8 hours after multivitamins or dietary supplements containing iron or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral solution admixed with antacid).1

• Inform patients that systemic fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient.1 140 145 Advise patients to immediately discontinue moxifloxacin and contact a clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug.1 140 145 Advise patients to talk with a clinician if they have any questions or concerns.1 140 145

• Inform patients that systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.1 Symptoms may be irreversible.1 Importance of resting and refraining from exercise at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician.1 (See Tendinitis and Tendon Rupture under Cautions.)

• Inform patients that peripheral neuropathies have been reported with systemic fluoroquinolones, including moxifloxacin, and that symptoms may occur soon after initiation of the drug and may be irreversible.1 Importance of immediately discontinuing moxifloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.1

• Inform patients that systemic fluoroquinolones, including moxifloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure).1 Importance of informing clinician of any history of epilepsy or seizures before initiating therapy with the drug.1 Importance of contacting a clinician if persistent headache with or without blurred vision occurs.1

• Advise patients that moxifloxacin may cause dizziness and lightheadedness;1 caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known.1

• Advise patients that systemic fluoroquinolones, including moxifloxacin, may worsen myasthenia gravis symptoms;1 importance of informing clinician of any history of myasthenia gravis.1 Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur.1

• Inform patients that moxifloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose.1 Importance of immediately discontinuing moxifloxacin and contacting a clinician at first sign of rash, hives or other skin reaction, rapid heartbeat, difficulty swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of lips, tongue, face; throat tightness; hoarseness), jaundice, or any other sign of hypersensitivity.1

• Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones.1 Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., tanning beds, UVA/UVB treatment) and using protective measures (e.g., wearing loose-fitting clothes, sunscreen) if outdoors during moxifloxacin therapy.1 Importance of discontinuing moxifloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.1

• Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) reported in patients receiving moxifloxacin.1 Importance of informing a clinician if any signs or symptoms of liver injury (e.g., loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements, dark colored urine) occur.1

• Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia) and of concurrent therapy with any drugs that may affect QT interval (e.g., class IA [quinidine, procainamide] or class III [e.g., amiodarone, sotalol] antiarrhythmic agents).1 Importance of contacting a clinician if symptoms of prolonged QT interval (e.g., prolonged heart palpitations, loss of consciousness) occur.1

• Advise patients with diabetes mellitus receiving an oral antidiabetic agent or insulin that fluoroquinolones, including moxifloxacin, may cause alterations in blood glucose concentrations (hypoglycemia or hyperglycemia).1 Importance of discontinuing moxifloxacin and contacting a clinician if a hypoglycemic reaction occurs.1

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., drugs that may affect QT interval), as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

Moxifloxacin 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 available only with your doctor's prescription.

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 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 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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

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 taking 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
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• 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
• Alfuzosin
• Alogliptin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Benfluorex
• Buserelin
• Canagliflozin
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Exenatide
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lumefantrine
• Mefloquine
• Metformin
• Methadone
• Metronidazole
• Mifepristone
• Miglitol
• Mizolastine
• Nafarelin
• Nateglinide
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pioglitazone
• Pipamperone
• Pitolisant
• Posaconazole
• Pramlintide
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rasagiline
• Repaglinide
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Rosiglitazone
• Saxagliptin
• Sertindole
• Sevoflurane
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolazamide
• Tolbutamide
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vildagliptin
• Vinflunine
• Voriconazole
• Vorinostat
• Warfarin
• Zuclopenthixol

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.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Aminolevulinic Acid
• Didanosine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Iron
• Lanthanum Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Rifampin
• Sucralfate
• Zinc

Interactions with Food/Tobacco/Alcohol

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
• Diabetes or
• Diarrhea or
• Heart disease or
• Heart rhythm problems (eg, prolonged QT interval), or family history of or
• Hypoglycemia (low blood sugar) or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected or
• Seizures (epilepsy), or 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.

1. Clinical and Laboratory Standards Institute (CLSI), Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Approved Standard – Tenth Edition. CLSI Document M7-A10 [2015], CLSI, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, USA. 2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI document M100-S25 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. . 3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. 4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing for Infrequently Isolated or Fastidious Bacteria: Approved GuidelinesSecond Edition CLSI document M45-A2 [2010], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. 5. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard - Eighth Edition. CLSI document M11-A8 [2012]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.

You should not use Avelox if you are allergic to moxifloxacin or other fluoroquinolones (ciprofloxacin, gemifloxacin, levofloxacin, ofloxacin, norfloxacin, and others).

To make sure Avelox is safe for you, tell your doctor if you have:

• tendon problems, arthritis or other joint problems (especially in children);

• a history of myasthenia gravis or other nerve-muscle disorder;

• a heart rhythm disorder (especially if you take medication to treat it) or history of long QT syndrome;

• trouble swallowing pills;

• liver or kidney disease;

• a history of seizures;

• diabetes (especially if you take oral diabetes medication);

• low levels of potassium in your blood (hypokalemia); or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and have "INR" or prothrombin time tests.

Moxifloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking Avelox. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

Avelox is not approved for use by anyone younger than 18 years old.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Moxifloxacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Take Avelox exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Avelox with water, and drink extra fluids to keep your kidneys working properly.

Avelox may be taken with or without food, but take it at the same time each day.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Avelox will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take Avelox with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking Avelox. They could make the medication less effective.

You may be taking certain other medicines that should not be taken at the same time as Avelox. Avoid taking the following medicines within 8 hours before or 4 hours after you take Avelox. These other medicines can make moxifloxacin much less effective when taken at the same time:

• antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);

• didanosine (Videx) powder or chewable tablets; or

• vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.

Avelox may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Avelox can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• theophylline;

• a diuretic or "water pill";

• heart rhythm medication - amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;

• medicine to treat depression or mental illness - amitriptylline, clomipramine, clozapine, desipramine, duloxetine, iloperidone, imipramine, nortriptyline, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with moxifloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.