Safety

Avelox (Moxifloxacin Hydrochloride) Tablet and Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

November 2014

Summary View

WARNINGS AND PRECAUTIONS

Blood Glucose Disturbances
  • 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. In diabetic patients, careful monitoring of blood glucose is recommended [see Adverse Reactions (6.2)]. If a hypoglycemic reaction occurs, AVELOX should be discontinued and appropriate therapy should be initiated immediately and the addition of cyclosporine to the list of drugs that do not affect moxifloxacin concentration 

 

August 2012

Summary View 

WARNINGS AND PRECAUTIONS

Peripheral Neuropathy
  • Rare 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 quinolones including Avelox. Avelox should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.

Page Last Updated: 12/11/2014
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