Avelox

Name: Avelox

How should this medicine be used?

Moxifloxacin comes as tablet to take by mouth. It is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take moxifloxacin. Take moxifloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take moxifloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with moxifloxacin. If your symptoms do not improve or if they get worse, call your doctor.

Take moxifloxacin until you finish the prescription, even if you feel better. Do not stop taking moxifloxacin without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING and SIDE EFFECTS sections. If you stop taking moxifloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Vigamox Side Effects

Common Side Effects of Vigamox

Common side effects of Vigamox in the eyes include:

  • Burning
  • Stinging
  • Itching
  • Dryness
  • Redness
  • Irritation
  • Tearing
  • Blurred vision

Serious Side Effects of Vigamox

Tell your doctor right away if you experience any signs of an allergic reaction while using Vigamox. These may include:

  • Severe itching or rash
  • Swelling of the face, tongue, or throat
  • Dizziness
  • Trouble breathing

Avelox Drug Class

Avelox is part of the drug class:

  • Fluoroquinolones

Side Effects of Avelox

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

Seizures have been reported in people who take fluoroquinolone antibiotics including Avelox.

Serious allergic reactions allergic reactions can happen in people taking Avelox. Symptoms of a severe allergic reaction:

  • hives
  • trouble breathing or swallowing
  • wwelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • rash

Serious heart rhythm changes (QT prolongation and torsade de pointes) may occur with Avelox use.

  • Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat) like if your heart is racing or if you feel faint.
  • 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)

The most common side effects of Avelox include nausea, diarrhea, and dizziness.

    Avelox and Lactation

    Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Avelox passes into breast milk or if it will harm your baby.

    Other Requirements

    • Store Avelox at room temperature.
    • Keep Avelox away from moisture (humidity).
    • Keep Avelox and all medicines out of the reach of children.

    Actions and Spectrum

    • Usually bactericidal.1

    • Like other fluoroquinolones, moxifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1

    • Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative aerobic bacteria, some anaerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium).1 23 24 28

    • More active in vitro than some other fluoroquinolones (e.g., ciprofloxacin, levofloxacin, ofloxacin) against S. pneumoniae7 8 9 while generally retaining the in vitro activity of these drugs against gram-negative bacteria and etiologic agents of atypical pneumonia (e.g., C. pneumoniae, M. pneumoniae, Legionella).3 7 8

    • Gram-positive aerobes: Active in vitro and in clinical infections against Enterococcus faecalis, Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only),1 24 S. pneumoniae (including multidrug-resistant strains),1 56 S. anginosus,1 S. constellatus,1 24 27 and S. pyogenes (group A β-hemolytic streptococci).1 24 Also active in vitro against S. epidermidis (oxacillin-susceptible strains only),1 24 S. agalactiae (group B streptococci),1 24 and viridans streptococci.1

    • Gram-negative aerobes: Active in vitro and in clinical infections against Enterobacter cloacae,1 Escherichia coli,1 24 H. influenzae,1 24 H. parainfluenzae,1 K. pneumoniae,1 M. catarrhalis,1 and Proteus mirabilis.1 Active against Y. pestis in vitro and in a primate infection model.1 Also active in vitro against Citrobacter freundii,1 24 K. oxytoca,1 and Legionella pneumophila.1

    • Anaerobes and other organisms: Active in vitro and in clinical infections against Bacteroides fragilis, B. thetaiotaomicron, Clostridium perfringens, C. pneumoniae, Peptostreptococcus,1 24 41 and M. pneumoniae.1 Also active in vitro against M. tuberculosis,23 24 28 M. avium complex (MAC), 23 M. kansasii,23 M. fortuitum,23 29 Fusobacterium,1 and Prevotella.1 24

    • Active against some strains of M. tuberculosis resistant to isoniazid, rifampin, or streptomycin,24 28 but moxifloxacin-resistant M. tuberculosis have been reported and some multidrug-resistant strains (i.e., strains resistant to rifampin and isoniazid) also are resistant to moxifloxacin or other fluoroquinolones.64 66 67 68 69 71 72

    • Some cross-resistance occurs between moxifloxacin and other fluoroquinolones.1

    Proper Use of Avelox

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

    Swallow the tablet whole with a glass of water. Do not split, crush or chew it. This medicine may be taken with or without food.

    Take this medicine at the same time each day.

    Drink plenty of fluids with this medicine to help prevent some unwanted effects.

    If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 4 hours before or 8 hours after taking moxifloxacin. These medicines may keep moxifloxacin from working properly.

    Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For infections:
        • Adults—400 milligrams (mg) once every 24 hours.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Drug Interactions

    Antacids, Sucralfate, Multivitamins and other Products Containing Multivalent Cations

    Fluoroquinolones, including Avelox, form chelates with alkaline earth and transition metal cations. Oral administration of Avelox with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of Avelox, resulting in systemic concentrations considerably lower than desired. Therefore, Avelox should be taken at least 4 hours before or 8 hours after these agents [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

    Warfarin

    Fluoroquinolones, including Avelox, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Avelox is administered concomitantly with warfarin or its derivatives [see Adverse Reactions (6.2) and Clinical Pharmacology (12.3)].

    Antidiabetic Agents

    Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones, including Avelox, and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered. If a hypoglycemic reaction occurs, Avelox should be discontinued and appropriate therapy should be initiated immediately [see Warnings and Precautions (5.11) and Adverse Reactions (6.1)].

    Nonsteroidal Anti-Inflammatory Drugs

    The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolone, including Avelox, may increase the risks of CNS stimulation and convulsions [see Warnings and Precautions (5.4)].

    Drugs that Prolong QT

    There is limited information available on the potential for a pharmacodynamic interaction in humans between Avelox and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous Avelox in dogs. Therefore, Avelox should be avoided with Class IA and Class III antiarrhythmics [see Warnings and Precautions, (5.6) and Nonclinical Toxicology (13.2)].

    Avelox Description

    Avelox (moxifloxacin) hydrochloride is a synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows:

    Avelox Tablets

    • Avelox Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin). • The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide.

    Avelox Injection

    • Avelox Injection for intravenous use is available in ready-to-use 250 mL flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The flexibag is not made with natural rubber latex. • The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability. • The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. • Avelox Injection contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.

    Nonclinical Toxicology

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed.

    Moxifloxacin was not mutagenic in 4 bacterial strains (TA 98, TA 100, TA 1535, TA 1537) used in the Ames Salmonella reversion assay. As with other fluoroquinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.

    Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 12 times the maximum recommended human dose based on body surface area) or at intravenous doses as high as 45 mg/kg/day, approximately equal to the maximum recommended human dose based on body surface area). At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

    Animal Toxicology and/or Pharmacology

    Fluoroquinolones have been shown to cause arthropathy in immature animals. In studies in juvenile dogs oral doses of moxifloxacin 30 mg/kg/day or more (approximately 1.5 times the maximum recommended human dose based upon systemic exposure) for 28 days resulted in arthropathy. There was no evidence of arthropathy in mature monkeys and rats at oral doses up to 135 and 500 mg/kg/day, respectively.

    Moxifloxacin at an oral dose of 300 mg/kg did not show an increase in acute toxicity or potential for CNS toxicity (for example, seizures) in mice when used in combination with NSAIDs such as diclofenac, ibuprofen, or fenbufen. Some fluoroquinolones have been reported to have proconvulsant activity that is exacerbated with concomitant use of NSAIDs.

    A QT-prolonging effect of moxifloxacin was found in dog studies, at plasma concentrations about five times the human therapeutic level. The combined infusion of sotalol, a Class III antiarrhythmic agent, with moxifloxacin induced a higher degree of QTc prolongation in dogs than that induced by the same dose (30 mg/kg) of moxifloxacin alone. Electrophysiological in vitro studies suggested an inhibition of the rapid activating component of the delayed rectifier potassium current (IKr) as an underlying mechanism.

    No signs of local intolerability were observed in dogs when moxifloxacin was administered intravenously. After intra-arterial injection, inflammatory changes involving the peri-arterial soft tissue were observed suggesting that intra-arterial administration of Avelox should be avoided.

    Medication Guide

      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 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 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: o Are over 60 years of age o Are taking steroids (corticosteroids) o 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: o Physical activity or exercise o Kidney failure o 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: 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 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. 3. 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, 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 Avelox 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 Avelox. 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. 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. 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:

    • 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. See “What are the possible side effects of Avelox?” • A blood thinner (warfarin, Coumadin, Jantoven). • A medicine to control your heart rate or rhythm (antiarrhythmic) See “What are the possible side effects of Avelox?” • 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 Avelox?” • Certain medicines may keep Avelox from working correctly. Take Avelox either 4 hours before or 8 hours after taking these products: o An antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc o Sucralfate (Carafate®) o 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: o You have tendon effects (see “What is the most important information I should know about Avelox?”). o You have nerve problems. See “What is the most important information I should know about Avelox?” o You have central nervous system problems. See “What is the most important information I should know about Avelox?” o You have a serious allergic reaction (see “What are the possible side effects of Avelox?”), or your healthcare provider tells you to stop. • This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to Avelox. If this happens, Avelox and other antibiotic medicines may not work in the future. • If you miss a dose of Avelox, take it as soon as you remember. Do not take more than 1 dose of Avelox in one day. • If you take too much, call your healthcare provider or get medical help immediately.

    What should I avoid while taking Avelox?

    • 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. See “What is the most important information I should know about Avelox?”

    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). • 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: o Who are elderly o With a family history of prolonged QT interval o With low blood potassium (hypokalemia) o 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)   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?

    • Avelox Tablets o Store Avelox 59–86°F (15–30°C) o 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.

    What are the ingredients in Avelox?

    • Avelox Tablets: o Active ingredient: moxifloxacin hydrochloride o Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide • Avelox Injection: o Active ingredient: moxifloxacin hydrochloride o 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
    or
    Avelox Injection manufactured in Norway by
    Fresenius Kabi Norge AS
    NO-1753 Halden, Norway

    Distributed by:

    Merck Sharp & Dohme Corp., a a subsidiary of Merck & Co.,Inc.

    Whitehouse Station, NJ 08889, USA

    Rx Only

    ©1999 Bayer HealthCare Pharmaceuticals Inc.

    Revised 7/2016

    What is Avelox?

    Avelox is used to treat different types of bacterial infections of the skin, sinuses, lungs, or stomach. It is also used to treat and prevent plague.

    Fluoroquinolone antibiotics can cause serious or disabling side effects. Avelox should be used only for infections that cannot be treated with a safer antibiotic.

    For the Consumer

    Applies to moxifloxacin: oral tablet

    Other dosage forms:

    • intravenous solution

    Along with its needed effects, moxifloxacin (the active ingredient contained in Avelox) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur while taking moxifloxacin:

    Rare
    • Abdominal or stomach cramps
    • abdominal or stomach tenderness
    • black, tarry stools
    • bleeding gums
    • blisters
    • bloating or swelling of the face, arms, hands, lower legs, or feet
    • blood in the urine or stools
    • blurred vision
    • bone pain
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • chest pain
    • chills
    • clay-colored stools
    • cough
    • crying
    • dark urine
    • diarrhea, watery and severe, which may also be bloody
    • difficult or labored breathing
    • difficulty with moving
    • difficulty with swallowing
    • discouragement
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • dry mouth
    • excessive muscle tone
    • fainting
    • fast, irregular, pounding, or racing heartbeat or pulse
    • feeling of unreality
    • feeling of warmth or heat
    • feeling sad or empty
    • fever
    • flushed, dry skin
    • flushing or redness of the skin, especially on the face and neck
    • fruit-like breath odor
    • headache
    • hyperventilation
    • increased hunger
    • increased sensitivity of the skin to sunlight
    • increased thirst
    • increased urination
    • irregular heartbeat recurrent
    • irritability
    • joint pain, stiffness, or swelling
    • lack of coordination
    • loss of appetite
    • loss of interest or pleasure
    • lower back, side, or stomach pain
    • mood or mental changes
    • muscle aching or cramping
    • muscle pains or stiffness
    • muscle tension or tightness
    • nausea or vomiting
    • nervousness
    • noisy breathing
    • pain
    • pain in the pelvis
    • pain, warmth, or burning in the fingers, toes, and legs
    • painful or difficult urination
    • painful, swollen joints
    • pale skin
    • pinpoint red spots on the skin
    • pounding in the ears
    • problems with speech or speaking
    • problems with vision or hearing
    • quick to react or overreact emotionally
    • rapid weight gain
    • rapidly changing moods
    • redness or other discoloration of the skin
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • seizures
    • sensation of the skin burning
    • sense of detachment from self or body
    • severe sunburn
    • shakiness in the legs, arms, hands, or feet
    • skin rash or itching
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • sweating
    • swelling of the feet or lower legs
    • swelling or puffiness of the face
    • swollen glands
    • tightness in the chest
    • tingling of the hands or feet
    • tiredness
    • trouble concentrating
    • trouble sleeping
    • troubled breathing with exertion
    • unexplained weight loss
    • unpleasant breath odor
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • unusual weight gain or loss
    • vomiting of blood
    • yellow eyes or skin
    Incidence not known
    • Blistering, peeling, or loosening of the skin
    • burning, numbness, tingling, or painful sensations
    • change in the ability to see colors, especially blue or yellow
    • difficulty with chewing or talking
    • double vision
    • drooping eyelids
    • eye pain
    • general feeling of tiredness or weakness
    • hives
    • hoarseness
    • irregular or slow heart rate
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • muscle weakness
    • no blood pressure or pulse
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red, irritated eyes
    • red skin lesions, often with a purple center
    • severe headache
    • severe tiredness
    • stomach pain, continuing
    • stopping of heart
    • unconsciousness
    • unsteadiness or awkwardness
    • unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness
    • weakness in the arms, hands, legs, or feet

    Some side effects of moxifloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare
    • Acid or sour stomach
    • bad, unusual, or unpleasant (after) taste
    • belching
    • burning feeling in the chest or stomach
    • change in sense of smell
    • change in taste
    • changes in vision
    • continuing ringing or buzzing or other unexplained noise in the ears
    • difficulty having a bowel movement (stool)
    • excess air or gas in the stomach or intestines
    • fear or nervousness
    • feeling of constant movement of self or surroundings
    • full feeling
    • general feeling of discomfort or illness
    • hearing loss
    • heartburn
    • impaired vision
    • indigestion
    • itching of the vagina or genital area
    • lack or loss of strength
    • loss of memory
    • pain during sexual intercourse
    • passing of gas
    • problems with memory
    • redness, swelling, or soreness of the tongue
    • sensation of spinning
    • sleepiness or unusual drowsiness
    • sore mouth or tongue
    • stomach discomfort, upset, or pain
    • thick, white vaginal discharge with no odor or with a mild odor
    • white patches in the mouth or on the tongue

    Moxifloxacin Pregnancy Warnings

    Animal studies have revealed evidence of fetotoxicity; no evidence of teratogenicity in rats (oral and IV doses) or cynomolgus monkeys (oral doses). In rats, reduced fetal weights, slightly delayed fetal skeletal development, maternal toxicity, and minor effects on placental weight and appearance were observed with oral doses (0.24 times the maximum recommended human dose [MRHD] based on AUC) or IV doses (about 2 times MRHD based on body surface area). In a pre- and postnatal development study in rats, slight increases in pregnancy duration and prenatal loss, reduced pup birth weight and neonatal survival, and therapy-related maternal mortality during gestation were observed with oral doses. In rabbits, reduced fetal weights, increased incidence (fetal and litter) of rib and vertebral malformations, delayed fetal skeletal ossification, increased incidence (fetal) of prominent liver lobulation, and maternal toxicity (including mortality, abortions, markedly reduced food consumption, reduced water intake, weight loss, hypoactivity) were observed with IV doses (about equal to oral MRHD based on AUC). In cynomolgus monkeys, increased incidence of smaller fetal size was observed with oral doses (2.5 times MRHD based on AUC). Animal studies suggest placental drug transfer. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects with other quinolones; however, cartilage damage and arthropathies are reported in immature animals exposed to quinolones, giving rise to concern over effects on fetal bone formation. Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

    AU: Use is not recommended. UK: Use is contraindicated. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Based on animal data, this drug may cause fetal harm.

    Moxifloxacin Breastfeeding Warnings

    Cartilage erosion and arthropathy have been reported in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.

    LactMed: Short-term use is considered acceptable; however, use of an alternate drug is preferred. -AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. -GB: Use is contraindicated. Excreted into human milk: Yes (small amounts) Comments: The effects in the nursing infant are unknown.

    (web3)