Indicated for the treatment of the following bacterial infections caused by susceptible strains:

Community Acquired Pneumonia:

• In adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.

MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

Uncomplicated Skin and Skin Structure Infections:

• In adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin susceptible Staphylococcus aureus or Streptococcus pyogenes.

Complicated Skin and Skin Structure Infections:

• In adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

Complicated Intra-Abdominal Infections:

• In adult patients for the treatment of Complicated Intra-Abdominal Infections (cIAI) including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.

Plague:

• In adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.

Acute Bacterial Sinusitis:

• In adult patients for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including AVELOX, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve AVELOX for treatment of ABS in patients who have no alternative treatment options.

Acute Bacterial Exacerbation of Chronic Bronchitis:

• In adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.

Because fluoroquinolones, including AVELOX, have been associated with serious and for some patients ABECB is self-limiting, reserve AVELOX for treatment of ABECB in patients who have no alternative treatment options.

Because only limited data are available on the compatibility of AVELOX intravenous injection with other intravenous substances, additives or other medications should not be added to AVELOX Injection or infused simultaneously through the same intravenous line.

Fluoroquinolones, including AVELOX, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting moxifloxacin or as long as several months after completion of therapy. Tendinitis and tendon rupture can occur bilaterally. 

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Fluoroquinolones, including AVELOX, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including AVELOX. Symptoms may occur soon after initiation of AVELOX and may be irreversible in some patients.

Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis. 

Fluoroquinolones, including AVELOX, have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis, Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and, suicidal thoughts or acts. These adverse reactions may occur following the first dose.

Fluoroquinolones, including AVELOX, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).These reactions can occur within hours to weeks after starting AVELOX. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AVELOX, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with AVELOX. In AVELOX treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, sulfonylurea) or with insulin. Severe cases of hypoglycemia resulting in coma or death have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones, including AVELOX, after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided.

Avoid AVELOX in patients with the following risk factors due to the lack of clinical experience with the drug in these patient populations:

• Known prolongation of the QT interval

• Ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions

• Ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia

• Uncorrected hypokalemia or hypomagnesemia

• Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents

• Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants

Administer AVELOX Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.

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.

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones, including AVELOX, and an antidiabetic agent.

The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolone, including AVELOX, may increase the risks of CNS stimulation and convulsions.

AVELOX should be avoided with Class IA and Class III antiarrhythmics.

There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, Avelox may cause fetal harm.

It is not known if moxifloxacin is present in human milk. Based on animal studies in rats, moxifloxacin may be excreted in human milk.

GoToSource

• Use in patients under the age of 18. GoToSource

• MRSA. GoToSource

• Anthrax exposure. GoToSource

• Odontogenic infections. GoToSource

• Dosage greater than 400 mg per day. GoToSource

• Multidrug-resistant tuberculosis. GoToSource

• Endophthalmitis prophylaxis. GoToSource

• Corneal ulcers. GoToSource

• Diabetic foot infections and polymicrobial bone and joint infections. GoToSource

• Prophylactic therapy for chronic obstructive pulmonary disease. GoToSource

• Nocardia farcinica. GoToSource

• Prophylactic therapy for reduction of chemotherapy-induced febrile neutropenia. GoToSource

Tendonitis and tendon ruptures. GoToSource

Peripheral neuropathy (nerve damage). GoToSource

Liver failure. GoToSource 

Drug hypersensitivity syndrome and toxic epidermal necrolysis (severe skin reaction). GoToSource

Arrhythmia. GoToSource

Pseudomembranous colitis. GoToSource

Hypoglycemia. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Orofacial dyskinesia (involuntary repetitive movements of the mouth and face). GoToSource

Syndrome of inappropriate antidiuretic hormone (body produces excessive amount of antidiuretic hormone). GoToSource

Exacerbations of myasthenia gravis (abnormal muscle weakness). GoToSource

Acute interstitial nephritis (kidney disorder). GoToSource

Seizures. GoToSource

Confusion, encephalopathy (brain injury) myoclonus (involuntary muscle jerk). GoToSource

Hallucinations. GoToSource

QTc prolongation and torsade de pointes. GoToSource

Psychosis, anxiety, depression and suicidal thoughts. GoToSource

Clostridium difficile-associated diarrhea. GoToSource 

Increased risk of aortic dissection and aortic aneurysm. GoToSource

Lawsuits filed for tendon ruptures, liver failure and stevens-johnson syndrome.