HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS-----------------------------­ These highlights do not include all the information needed to use Known hypersensitivity to AVELOX or other quinolones (4, 5.4) AVELOX safely and effectively. See full prescribing information for AVELOX. -----------------------WARNINGS AND PRECAUTIONS-----------------------­ AVELOX (moxifloxacin) hydrochlorideTablet, film-coated Increased risk of tendinitis and tendon rupture. This risk is further increased AVELOX (moxifloxacin) hydrochloride Injection, solution for IV use in older patients usually over 60 years of age, in patients taking Initial U.S. Approval: 1999 corticosteroids, and in patients with kidney, heart or lung transplants. To reduce the development of drug-resistant bacteria and maintain the Discontinue if pain or inflammation in a tendon occurs. (5.1, 8.5) effectiveness of AVELOX and other antibacterial drugs, AVELOX should be Prolongation of the QT interval and isolated cases of torsade de pointes has used only to treat or prevent infections that are proven or strongly suspected to been reported. Avoid use in patients with known prolongation, hypokalemia, be caused by susceptible bacteria. and with drugs that prolong the QT interval. (5.3, 7.4, 8.5). Use caution in patients with proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia. (5.3) WARNING: Serious and sometimes fatal hypersensitivity reactions, including Fluoroquinolones, including AVELOX®, are associated with an anaphylactic reactions, may occur after first or subsequent doses. increased risk of tendinitis and tendon rupture in all ages. This risk is Discontinue drug use at first sign of skin rash, jaundice or any other sign of further increased in older patients usually over 60 years of age, in hypersensitivity. (5.4, 5.5) patients taking corticosteroid drugs, and in patients with kidney, heart Central nervous system (CNS) events including dizziness, confusion, or lung transplants. [see Warnings and Precautions (5.1)] hallucination, depression, and rarely suicidal thoughts or acts may occur after Fluoroquinolones, including AVELOX, may exacerbate muscle first dose. Use caution in patients with known or suspected CNS disorders weakness in persons with myasthenia gravis. Avoid AVELOX in that may predispose to seizures or lower the seizure threshold. (5.6) patients with known history of myasthenia gravis [see Warnings and Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs. (5.7) Precautions (5.2).] Peripheral neuropathy: Discontinue if symptoms occur. (5.8) ----------------------------RECENT MAJOR CHANGES-------------------------­ ------------------------------ADVERSE REACTIONS------------------------------­ Warnings and Precautions (5.2, 5.8) 10/11, 07/12 Most common reactions (≥3%) were nausea, diarrhea, headache, and dizziness (6.2) ----------------------------INDICATIONS AND USAGE--------------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Bayer AVELOX is a fluoroquinolone antibacterial indicated for treating infections in HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800­ adults ≥ 18 years of age caused by designated, susceptible bacteria. (1, 12.4) FDA-1088 or www.fda.gov/medwatch Acute Bacterial Sinusitis (1.1) ------------------------------DRUG INTERACTIONS------------------------------­ Acute Bacterial Exacerbation of Chronic Bronchitis (1.2) Community Acquired Pneumonia (1.3) Interacting Drug Interaction Skin and Skin Structure Infections: Uncomplicated (1.4) and Complicated Antacids, sucralfate, Moxifloxacin absorption is decreased. (1.5) multivitamins, and Administer AVELOX Tablet at least 4 hours Complicated Intra-Abdominal Infections (1.6) other products before or 8 hours after these products. (2.2, 7.1, containing multivalent 12.3, 17.2) ----------------------DOSAGE AND ADMINISTRATION----------------------­ cations Warfarin Anticoagulant effect of warfarin may be Dose Every Duration enhanced. Monitor prothrombin time/INR, watch Type of Infection 24 hours (days) for bleeding. (6.4, 7.2, 12.3) Acute Bacterial Sinusitis (1.1) 400 mg 10 Class IA and Class III Proarrhythmic effect may be enhanced. Avoid Acute Bacterial Exacerbation of Chronic antiarrhythmics: concomitant use. (5.3, 7.4) Bronchitis (1.2) 400 mg 5 Community Acquired Pneumonia (1.3) 400 mg 7-14 -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ Uncomplicated Skin and Skin Structure Pregnancy: Based on animal data may cause fetal harm (8.1) Infections (SSSI) (1.4) 400 mg 7 Geriatrics: Increased risk for severe tendon disorders further increased by Complicated SSSI (1.5) 400 mg 7-21 concomitant corticosteroid therapy and increased risk of prolongation of the QT interval. (5.1, 5.3, 8.5) Complicated Intra-Abdominal Infections (1.6) 400 mg 5-14 No dosage adjustment in patients with renal or hepatic impairment. (8.6, 8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved Medication Guide AVELOX Tablets: Administer 4 hours before or 8 hours after antacids, Revised: August/2012 sucralfate, multivitamins and other products with multivalent cations. (2.2) AVELOX IV: Slow IV infusion over 60 minutes. Avoid rapid or bolus IV. (2.3) Do not mix with other medications in IV bag or in IV line (2.3) ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ AVELOX Tablets 400 mg moxifloxacin hydrochloride AVELOX IV 250 mL flexibag containing 400 mg moxifloxacin hydrochloride in sodium chloride injection (3.2) FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: TENDINOPATHY 2.4 Preparation for Administration of AVELOX IV 1 INDICATIONS AND USAGE 3 DOSAGE FORMS AND STRENGTHS 1.1 Acute Bacterial Sinusitis 3.1 AVELOX Tablets 1.2 Acute Bacterial Exacerbation of Chronic Bronchitis 3.2 AVELOX IV 1.3 Community Acquired Pneumonia 4 CONTRAINDICATIONS 1.4 Uncomplicated Skin and Skin Structure Infections 5 WARNINGS AND PRECAUTIONS 1.5 Complicated Skin and Skin Structure Infections 5.1 Tendinopathy and Tendon Rupture 1.6 Complicated Intra-Abdominal Infections 5.2 Exacerbation of Myasthenia Gravis 2 DOSAGE AND ADMINISTRATION 5.3 QT Prolongation 2.1 Dosage in Adult Patients 5.4 Hypersensitivity Reactions 2.2 Drug Interactions with Multivalent Cations 5.5 Other Serious and Sometimes Fatal Reactions 2.3 Administration Instructions 5.6 Central Nervous System Effects 1 Reference ID: 3180115 5.7 Clostridium Difficile-Associated Diarrhea 12.3 Pharmacokinetics 5.8 Peripheral Neuropathy 12.4 Microbiology 5.9 Arthropathic Effects in Animals 13 NONCLINICAL TOXICOLOGY 5.10 Photosensitivity/Phototoxicity 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.11 Development of Drug Resistant Bacteria 13.2 Animal Toxicology and/or Pharmacology 5.12 MRSA Infections 14 CLINICAL STUDIES 5.13 Laboratory Tests 14.1 Acute Bacterial Exacerbation of Chronic Bronchitis 6 ADVERSE REACTIONS 14.2 Community Acquired Pneumonia 6.1 Serious and Otherwise Important Adverse Reactions 14.3 Community Acquired Pneumonia caused by Multi-Drug Resistant 6.2 Clinical Trial Experience Streptococcus pneumoniae (MDRSP) 6.3 Laboratory Changes 14.4 Acute Bacterial Sinusitis 6.4 Postmarketing Experience 14.5 Uncomplicated Skin and Skin Structure Infections 7 DRUG INTERACTIONS 14.6 Complicated Skin and Skin Structure Infections 7.1 Antacids, Sucralfate, Multivitamins and other products containing 14.7 Complicated Intra-Abdominal Infections Multivalent Cations 15 REFERENCES 7.2 Warfarin 16 HOW SUPPLIED/STORAGE AND HANDLING 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) 16.1 AVELOX Tablets 7.4 Drugs that Prolong QT 16.2 AVELOX Intravenous Solution – Premix Bags 8 USE IN SPECIFIC POPULATIONS 17 PATIENT COUNSELING INFORMATION 8.1 Pregnancy 17.1 Antibacterial Resistance 8.3 Nursing Mothers 17.2 Administration With Food, Fluids, and Drug Products Containing 8.4 Pediatric Use Multivalent Cations 8.5 Geriatric Use 17.3 Serious and Potentially Serious Adverse Reactions 8.6 Renal Impairment MEDICATION GUIDE 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 11.1 AVELOX Tablets 11.2 AVELOX IV 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action *Sections or subsections omitted from the Full Prescribing Information are not listed FULL PRESCRIBING INFORMATION WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [see Warnings and Precautions (5.1)]. Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see Warnings and Precautions (5.2)]. 1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX 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® Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates of the designated microorganisms