To reduce the development of drug-resistant bacteria and maintain the effectiveness of Avelox (Moxifloxacin hydrochloride) and other antibacterial drugs, Avelox (Moxifloxacin hydrochloride) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Avelox (Moxifloxacin hydrochloride) Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin . Therapy with Avelox (Moxifloxacin hydrochloride) may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

The dose of Avelox (Moxifloxacin hydrochloride) is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in .

 Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Avelox (Moxifloxacin hydrochloride) IV may be switched to Avelox (Moxifloxacin hydrochloride) Tablets when clinically indicated at the discretion of the physician.

To prepare Avelox (Moxifloxacin hydrochloride) IV injection premix in flexible containers:

NOTE:

Avelox (Moxifloxacin hydrochloride) is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.

Avelox (Moxifloxacin hydrochloride) has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of Avelox (Moxifloxacin hydrochloride) the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 10 msec (±22) on Day 1 (n=667) and 7 msec (± 24) on Day 3 (n = 667).

The drug should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.

Pharmacokinetic studies between Avelox (Moxifloxacin hydrochloride) and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of Avelox (Moxifloxacin hydrochloride) and these drugs cannot be excluded; therefore caution should be exercised when Avelox (Moxifloxacin hydrochloride) is given concurrently with these drugs. In premarketing clinical trials, the rate of cardiovascular adverse events was similar in 798 Avelox (Moxifloxacin hydrochloride) and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval.

Avelox (Moxifloxacin hydrochloride) should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsade de pointes. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Avelox (Moxifloxacin hydrochloride) treatment in over 15,500 patients in controlled clinical studies, including 759 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 Avelox (Moxifloxacin hydrochloride) tablet treated patients in a postmarketing observational study in which ECGs were not performed. Elderly patients using IV Avelox (Moxifloxacin hydrochloride) may be more susceptible to drug-associated QT prolongation In addition, Avelox (Moxifloxacin hydrochloride) should be used with caution in patients with mild, moderate, or severe liver cirrhosis

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Avelox (Moxifloxacin hydrochloride) . These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted

Fluoroquinolones, including Avelox (Moxifloxacin hydrochloride) , may cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia
Convulsions and increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones. Fluoroquinolones may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Avelox (Moxifloxacin hydrochloride) , the drug should be discontinued and appropriate measures instituted. As with all fluoroquinolones, Avelox (Moxifloxacin hydrochloride) should be used with caution in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Avelox (Moxifloxacin hydrochloride) in 14981 patients in 71 active controlled Phase II- IV clinical trials in different indications . The population studied had a mean age of 50 years (approximately 73% of the population was
Discontinuation of Avelox (Moxifloxacin hydrochloride) due to adverse events occurred in 5.0% of patients overall, 4.1% of patients treated with 400 mg PO, 3.9% with 400 mg IV and 8.2% with sequential therapy 400 mg PO/IV. The most common adverse events leading to discontinuation with the 400 mg PO doses were nausea (0.8%), diarrhea (0.5%), dizziness (0.5%), and vomiting (0.4%). The most common adverse event leading to discontinuation with the 400 mg IV dose was rash (0.5%). The most common adverse events leading to discontinuation with the 400 mg IV/PO sequential dose were diarrhea (0.5%), pyrexia (0.4%).

Adverse reactions occurring in ≥1% of Avelox (Moxifloxacin hydrochloride) -treated patients and less common adverse reactions, occurring in 0.1 to
 

Table 4
 

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Avelox (Moxifloxacin hydrochloride) . This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Avelox (Moxifloxacin hydrochloride) to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Avelox (Moxifloxacin hydrochloride) and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.

In controlled multiple-dose clinical trials, 23% of patients receiving oral Avelox (Moxifloxacin hydrochloride) were greater than or equal to 65 years of age and 9% were greater than or equal to 75 years of age. The clinical trial data demonstrate that there is no difference in the safety and efficacy of oral Avelox (Moxifloxacin hydrochloride) in patients aged 65 or older compared to younger adults.

In trials of intravenous use, 42% of Avelox (Moxifloxacin hydrochloride) patients were greater than or equal to 65 years of age, and 23% were greater than or equal to 75 years of age. The clinical trial data demonstrate that the safety of intravenous Avelox (Moxifloxacin hydrochloride) in patients aged 65 or older was similar to that of comparator-treated patients. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Therefore, Avelox (Moxifloxacin hydrochloride) should be avoided in patients taking drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia).

Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. ECG monitoring is recommended due to the possibility of QT interval prolongation. The patient should be carefully observed and given supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.

Single oral Avelox (Moxifloxacin hydrochloride) doses of 2000, 500, and 1500 mg/kg were lethal to rats, mice, and cynomolgus monkeys, respectively. The minimum lethal intravenous dose in mice and rats was 100 mg/kg. Adverse clinical signs included CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting and diarrhea.

Avelox (Moxifloxacin hydrochloride) is a synthetic broad spectrum 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 CHFNO*HCl and its chemical structure is as follows:

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 reversion assay. As with other quinolones, 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 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 (mg/m), or at intravenous doses as high as 45 mg/kg/day, approximately equal to the maximum recommended human dose based on body surface area (mg/m). 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.

Quinolones have been shown to cause arthropathy in immature animals. In studies in juvenile dogs oral doses of moxifloxacin ≥ 30 mg/kg/day (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 quinolones have been reported to have proconvulsant activity that is exacerbated with concomitant use of non-steroidal anti-inflammatory drugs (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 studies suggested an inhibition of the rapid activating component of the delayed rectifier potassium current (I) 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 (Moxifloxacin hydrochloride) should be avoided.

Avelox (Moxifloxacin hydrochloride) Tablets (400 mg once daily for five days) were evaluated for the treatment of acute bacterial exacerbation of chronic bronchitis in a randomized, double-blind, controlled clinical trial conducted in the US. This study compared Avelox (Moxifloxacin hydrochloride) with clarithromycin (500 mg twice daily for 10 days) and enrolled 629 patients. Clinical success was assessed at 7-17 days post-therapy. The clinical success for Avelox (Moxifloxacin hydrochloride) was 89% (222/250) compared to 89% (224/251) for clarithromycin.

 The microbiological eradication rates (eradication plus presumed eradication) in Avelox (Moxifloxacin hydrochloride) treated patients were 100%, 89%, 100%, 85%, 94%, and 85%.

A randomized, double-blind, controlled clinical trial was conducted in the US to compare the efficacy of Avelox (Moxifloxacin hydrochloride) Tablets (400 mg once daily) to that of high-dose clarithromycin (500 mg twice daily) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 474 patients (382 of whom were valid for the efficacy analysis conducted at the 14 - 35 day follow-up visit). Clinical success for clinically evaluable patients was 95% (184/194) for Avelox (Moxifloxacin hydrochloride) and 95% (178/188) for high dose clarithromycin.

A randomized, double-blind, controlled trial was conducted in the US and Canada to compare the efficacy of sequential IV/PO Avelox (Moxifloxacin hydrochloride) 400 mg QD for 7-14 days to an IV/PO fluoroquinolone control (trovafloxacin or levofloxacin) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 516 patients, 362 of whom were valid for the efficacy analysis conducted at the 7-30 day post-therapy visit. The clinical success rate was 86% (157/182) for Avelox (Moxifloxacin hydrochloride) therapy and 89% (161/180) for the fluoroquinolone comparators.

An open-label ex-US study that enrolled 628 patients compared Avelox (Moxifloxacin hydrochloride) to sequential IV/PO amoxicillin/clavulanate (1.2 g IV q8h/625 mg PO q8h) with or without high-dose IV/PO clarithromycin (500 mg BID). The intravenous formulations of the comparators are not FDA approved. The clinical success rate at Day 5-7 for Avelox (Moxifloxacin hydrochloride) therapy was 93% (241/258) and demonstrated superiority to amoxicillin/clavulanate ± clarithromycin (85%, 239/280) [95% C.I. of difference in success rates between moxifloxacin and comparator (2.9%, 13.2%)]. The clinical success rate at the 21-28 days post-therapy visit for Avelox (Moxifloxacin hydrochloride) was 84% (216/258), which also demonstrated superiority to the comparators (74%, 208/280) [95% C.I. of difference in success rates between moxifloxacin and comparator (2.6%, 16.3%)].

The clinical success rates by pathogen across four CAP studies are presented in .

Table 9: Clinical Success Rates By Pathogen (Pooled CAP Studies)
 

Avelox (Moxifloxacin hydrochloride) was effective in the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant MDRSP* isolates. Of 37 microbiologically evaluable patients with MDRSP isolates, 35 patients (95%) achieved clinical and bacteriological success post-therapy. The clinical and bacteriological success rates based on the number of patients treated are shown in .

* MDRSP, Multi-drug resistant includes isolates previously known as PRSP (Penicillin-resistant ), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 mcg/mL), 2 generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

 Not all isolates were resistant to all antimicrobial classes tested. Success and eradication rates are summarized in .

In a controlled double-blind study conducted in the US, Avelox (Moxifloxacin hydrochloride) Tablets (400 mg once daily for ten days) were compared with cefuroxime axetil (250 mg twice daily for ten days) for the treatment of acute bacterial sinusitis. The trial included 457 patients valid for the efficacy analysis. Clinical success (cure plus improvement) at the 7 to 21 day post-therapy test of cure visit was 90% for Avelox (Moxifloxacin hydrochloride) and 89% for cefuroxime.

An additional non-comparative study was conducted to gather bacteriological data and to evaluate microbiological eradication in adult patients treated with Avelox (Moxifloxacin hydrochloride) 400 mg once daily for seven days. All patients (n = 336) underwent antral puncture in this study. Clinical success rates and eradication/presumed eradication rates at the 21 to 37 day follow-up visit were 97% (29 out of 30) for , 83% (15 out of 18) for , and 80% (24 out of 30) for .

Two randomized, active controlled trials of cSSSI were performed. A double-blind trial was conducted primarily in North America to compare the efficacy of sequential IV/PO Avelox (Moxifloxacin hydrochloride) 400 mg QD for 7-14 days to an IV/PO beta-lactam/beta-lactamase inhibitor control in the treatment of patients with cSSSI. This study enrolled 617 patients, 335 of which were valid for the efficacy analysis. A second open-label International study compared Avelox (Moxifloxacin hydrochloride) 400 mg QD for 7-21 days to sequential IV/PO beta-lactam/beta-lactamase inhibitor control in the treatment of patients with cSSSI. This study enrolled 804 patients, 632 of which were valid for the efficacy analysis. Surgical incision and drainage or debridement was performed on 55% of the Avelox (Moxifloxacin hydrochloride) treated and 53% of the comparator treated patients in these studies and formed an integral part of therapy for this indication. Success rates varied with the type of diagnosis ranging from 61% in patients with infected ulcers to 90% in patients with complicated erysipelas. These rates were similar to those seen with comparator drugs. The overall success rates in the evaluable patients and the clinical success by pathogen are shown in .

 

Two randomized, active controlled trials of cIAI were performed. A double-blind trial was conducted primarily in North America to compare the efficacy of sequential IV/PO Avelox (Moxifloxacin hydrochloride) 400 mg QD for 5-14 days to IV/ piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of patients with cIAI, including peritonitis, abscesses, appendicitis with perforation, and bowel perforation. This study enrolled 681 patients, 379 of which were considered clinically evaluable. A second open-label international study compared Avelox (Moxifloxacin hydrochloride) 400 mg QD for 5-14 days to IV ceftriaxone plus IV metronidazole followed by PO amoxicillin/clavulanic acid in the treatment of patients with cIAI. This study enrolled 595 patients, 511 of which were considered clinically evaluable. The clinically evaluable population consisted of subjects with a surgically confirmed complicated infection, at least 5 days of treatment and a 25-50 day follow-up assessment for patients at the Test of Cure visit. The overall clinical success rates in the clinically evaluable patients are shown in .

 

Avelox (Moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.

The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side.

 

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) . Avoid high humidity.

Avelox (Moxifloxacin hydrochloride) IV (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.

 

Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.

Because the premix flexible containers are for single-use only, any unused portion should be discarded.

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) .

DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.

See FDA-Approved Medication Guide

Patients should be informed that Avelox (Moxifloxacin hydrochloride) tablets may be taken with or without food. Patients should be advised to drink fluids liberally.

Avelox (Moxifloxacin hydrochloride) 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 VIDEX (didanosine) chewable/buffered tablets or the pediatric powder for oral solution.

Read the Medication Guide that comes with Avelox (Moxifloxacin hydrochloride) 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.

Avelox (Moxifloxacin hydrochloride) belongs to a class of antibiotics called fluoroquinolones. Avelox (Moxifloxacin hydrochloride) can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Avelox (Moxifloxacin hydrochloride) .

See the section “” for more information about side effects.

Avelox (Moxifloxacin hydrochloride) is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. It is not known if Avelox (Moxifloxacin hydrochloride) 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 (Moxifloxacin hydrochloride) , do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking Avelox (Moxifloxacin hydrochloride) .

Do not take Avelox (Moxifloxacin hydrochloride) 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 (Moxifloxacin hydrochloride) . Ask your healthcare provider if you are not sure. See the list of ingredients in Avelox (Moxifloxacin hydrochloride) at the end of this Medication Guide.

See

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.

Avelox (Moxifloxacin hydrochloride) can cause side effects that may be serious or even cause death. See “”

Other serious side effects of Avelox (Moxifloxacin hydrochloride) include:

Seizures have been reported in people who take fluoroquinolone antibiotics including Avelox (Moxifloxacin hydrochloride) . Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Avelox (Moxifloxacin hydrochloride) will change your risk of having a seizure.

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of Avelox (Moxifloxacin hydrochloride) . Talk to your healthcare provider right away if you have any of these side effects, or other changes in mood or behavior:

Allergic reactions can happen in people taking fluoroquinolones, including Avelox (Moxifloxacin hydrochloride) , even after only one dose. Stop taking Avelox (Moxifloxacin hydrochloride) and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

Skin rash may happen in people taking Avelox (Moxifloxacin hydrochloride) even after only one dose. Stop taking Avelox (Moxifloxacin hydrochloride) 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 (Moxifloxacin hydrochloride) .

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 (Moxifloxacin hydrochloride) may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:

Pseudomembranous colitis can happen with most antibiotics, including Avelox (Moxifloxacin hydrochloride) . Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Avelox (Moxifloxacin hydrochloride) . Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

Avelox (Moxifloxacin hydrochloride) may need to be stopped to prevent permanent nerve damage.

See “ ”

The most common side effects of Avelox (Moxifloxacin hydrochloride) include nausea and diarrhea.

These are not all the possible side effects of Avelox (Moxifloxacin hydrochloride) . 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.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Avelox (Moxifloxacin hydrochloride) for a condition for which it is not prescribed. Do not give Avelox (Moxifloxacin hydrochloride) 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 (Moxifloxacin hydrochloride) . If you would like more information about Avelox (Moxifloxacin hydrochloride) , talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Avelox (Moxifloxacin hydrochloride) that is written for healthcare professionals. For more information go to www.Avelox (Moxifloxacin hydrochloride) .com or call 1-800-526-4099.

Revised October 2011

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

Manufactured for:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470

Avelox (Moxifloxacin hydrochloride) Tablets made in GermanyAvelox (Moxifloxacin hydrochloride) IV made in Germany or Avelox (Moxifloxacin hydrochloride) IV made in Norway byFresenius Kabi Norge ASNO-1753 Halden, Norway

Distributed by: Schering Corporation, a subsidiary of

Whitehouse Station, NJ 08889, USA

Avelox (Moxifloxacin hydrochloride) is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation, a subsidiary of Merck & Co., Inc.

©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A.

83680831, R.1