|
HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.
Initial U.S. Approval: 1999
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. |
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).]
|
|
RECENT MAJOR CHANGES
|
|
Boxed Warning 02/11
Warnings and Precautions (5.2) 02/11
|
|
INDICATIONS AND USAGE
|
|
AVELOX is a fluoroquinolone antibacterial indicated for treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria. (1, 12.4)
-
Acute Bacterial Sinusitis (1.1)
-
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
-
Community Acquired Pneumonia (1.3)
-
Skin and Skin Structure Infections: Uncomplicated (1.4) and Complicated (1.5)
-
Complicated Intra-Abdominal Infections (1.6)
|
|
DOSAGE AND ADMINISTRATION
|
Type of Infection |
Dose Every 24 hours |
Duration
(days) |
|
Acute Bacterial Sinusitis (1.1) |
400 mg |
10 |
|
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2) |
400 mg |
5 |
|
Community Acquired Pneumonia (1.3) |
400 mg |
7-14 |
|
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4) |
400 mg |
7 |
|
Complicated SSSI (1.5) |
400 mg |
7-21 |
|
Complicated Intra-Abdominal Infections (1.6) |
400 mg |
5-14 |
-
No dosage adjustment in patients with renal or hepatic impairment. (8.6, 8.7)
-
AVELOX Tablets: Administer 4 hours before or 8 hours after antacids, 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)
|
|
CONTRAINDICATIONS
|
|
Known hypersensitivity to AVELOX or other quinolones (4, 5.4)
|
|
WARNINGS AND PRECAUTIONS
|
-
Increased risk of tendinitis and tendon rupture. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs. (5.1, 8.5)
-
Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, hypokalemia, 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)
-
Serious and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. Discontinue drug use at first sign of skin rash, jaundice or any other sign of hypersensitivity. (5.4, 5.5)
-
Central nervous system (CNS) events including dizziness, confusion, hallucination, depression, and rarely suicidal thoughts or acts may occur after first dose. Use caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold. (5.6)
-
Clostridium difficile-associated diarrhea: eva luate if diarrhea occurs. (5.7)
-
Peripheral neuropathy: Discontinue if symptoms occur. (5.8)
|
|
ADVERSE REACTIONS
|
|
Most common reactions (≥3%) were nausea, diarrhea, headache, and dizziness (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
|
|
DRUG INTERACTIONS
|
|
Interacting Drug |
Interaction |
|
Antacids, sucralfate, multivitamins, and other products containing multivalent cations |
Moxifloxacin absorption is decreased. Administer AVELOX Tablet at least 4 hours before or 8 hours after these products. (2.2, 7.1, 12.3, 17.2) |
|
Warfarin |
Anticoagulant effect of warfarin may be enhanced. Monitor prothrombin time/INR, watch for bleeding. (6.4, 7.2, 12.3) |
|
Class IA and Class III antiarrhythmics: |
Proarrhythmic effect may be enhanced. Avoid concomitant use. (5.3, 7.4) |
|
|
USE IN SPECIFIC POPULATIONS
|
-
Pregnancy: Based on animal data may cause fetal harm (8.1)
-
Geriatrics: Increased risk for severe tendon disorders further increased by concomitant corticosteroid therapy and increased risk of prolongation of the QT interval. (5.1, 5.3, 8.5)
|
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide |
Revised: 08/2011 |
