|Manufacturer:||PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.|
Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue LEVAQUIN® and consult a physician.Patients should be informed that concurrent administration of warfarin and LEVAQUIN® has been associated with increases of the International Normalized Ratio (INR) or prothrombin time and clinical episodes of bleeding.
Patients should notify their physician if they are taking warfarin, be monitored for evidence of bleeding, and also have their anticoagulation tests closely monitored while taking warfarin concomitantly.Manufactured by:Janssen Ortho LLC, Gurabo, Puerto Rico 00778 (for the Tablets).Janssen Pharmaceutica N.V., Beerse, Belgium (for the Oral Solution and Injection, Single-Use Vials).Hospira, Inc., Lake Forest, IL 60045 (for the Injection Pre-Mixed Solution Single-Use in Flexible Container).Manufactured for:PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, NJ 08869 (for the Tablets and Oral Solution)Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869 (for the Injection, Single-Use Vials and Injection Pre-Mixed Solution Single-Use in Flexible Container)©Ortho-McNeil-Janssen Pharmaceuticals, IncU.S. Patent No.5,053,407.Issued September 2008
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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.LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults (?18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).