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News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point Specialty: Multispecialty Allergy & Immunology Anesthesiology Cardiology Critical Care Dermatology Diabetes & Endocrinology Emergency Medicine Family Medicine Gastroenterology General Surgery Hematology - Oncology HIV/AIDS Hospital Medicine Infectious Diseases Internal Medicine Multispecialty Nephrology Neurology Ob/Gyn & Women's Health Oncology Ophthalmology Orthopedics Pathology & Lab Medicine Pediatrics Plastic Surgery Psychiatry Public Health Pulmonary Medicine Radiology Rheumatology Transplantation Urology Today on Medscape Business of Medicine Medical Lifestyle Science & Technology Medical Students Nurses Pharmacists Residents Edition: English Medscape English Deutsch Español Français Português UKNew Univadis Français New Italiano New Log In Sign Up It's Free! English Edition Medscape * English * Deutsch * Español * Français * Português * UKNew Univadis * Français New * Italiano New X Univadis from Medscape Register Log In No Results No Results Sunday, April 2, 2023 News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point close Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit. Log out Cancel News > Medscape Medical News > Approvals FDA SAFETY CHANGES: DEPODUR, NEORAL, LEXIVA Yael Waknine November 04, 2009 0 November 4, 2009 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the need for individualized dosing in patients receiving morphine sulfate extended-release liposome injection, cyclosporine drug interactions with repaglinide, and the potential risks for nephrolithiasis and elevated triglyceride and cholesterol levels in patients receiving treatment with fosamprenavir calcium. On September 24, the FDA approved safety labeling revisions for cyclosporine capsules and oral solution (Neoral; Novartis Pharmaceuticals, Inc) to warn of drug interactions with repaglinide. Cyclosporine may increase the plasma concentrations of repaglinide and thereby increase the risk for hypoglycemia, the FDA warned. Repaglinide appears to be a substrate for the hepatic uptake transporter organic anion-transporting protein (OATP1B1). Drugs that inhibit OATP1B1, such as cyclosporine, may therefore also increase plasma concentrations of repaglinide and the potential for exposure-related adverse events. In a pharmacokinetic study of 12 healthy volunteers, coadministration of two 100-mg cyclosporine doses 12 hours apart increased the maximal exposure and total exposure to a single dose of 0.25 mg of repaglinide by 1.8-fold (range, 0.6 - 3.7-fold) and 2.4-fold (range, 1.2 - 5.3-fold), respectively. Close monitoring of blood glucose levels is advisable for a patient taking cyclosporine and repaglinide concomitantly. Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplant, and has been used in combination with azathioprine and corticosteroids. Cyclosporine may also be used for the treatment of methotrexate-resistant, severe rheumatoid arthritis and severe recalcitrant plaque psoriasis in patients who have failed or cannot tolerate systemic therapy. Repaglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Fosamprenavir (Lexiva) Linked to Reports of Nephrolithiasis and Elevated Cholesterol Levels On September 11, the FDA approved safety labeling revisions for fosamprenavir calcium tablets and oral suspension (Lexiva; GlaxoSmithKline) to warn of the potential risk for nephrolithiasis. Cases of nephrolithiasis have been reported during postmarketing surveillance, the FDA said, noting that estimates of frequency cannot be made because the events were reported voluntarily during clinical practice. Temporary interruption or discontinuation of therapy should be considered for patients in whom signs or symptoms of kidney stones develop. The FDA also warned that treatment with fosamprenavir and ritonavir has been linked to increases in triglyceride and cholesterol levels. Triglyceride and cholesterol levels should therefore be evaluated at baseline and at periodic intervals during therapy, and lipid disorders should be managed as clinically appropriate. Fosamprenavir is a protease inhibitor prodrug indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. DepoDur Prescribing Information Neoral Prescribing Information Lexiva Prescribing Information To continue reading this article ... or Continue reading your article with a Medscape account Join the Top Medical Resource for Physicians Today. Free Membership! * 0 * 12 Next Medscape Medical News © 2009 Medscape, LLC Send press releases and comments to news@medscape.net. Cite this: FDA Safety Changes: DepoDur, Neoral, Lexiva - Medscape - Nov 04, 2009. TOP PICKS FOR YOU AUTHORS AND DISCLOSURES AUTHORS AND DISCLOSURES JOURNALIST YAEL WAKNINE Yael Waknine is a freelance writer for Medscape. Yael Waknine has disclosed no relevant financial relationships. COMMENTS 3090D553-9492-4563-8681-AD288FA52ACE Commenting is limited to medical professionals. To comment please Log-in. Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion. Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion. My Alerts You have already selected for My Alerts * Add Other Topics Click the topic below to receive emails when new articles are available. * Add You've successfully added to your alerts. You will receive email when new content is published. Share Facebook Twitter LinkedIn WhatsApp Email Close Print Add to Email Alerts processing.... What to Read Next on Medscape Special Coverage: COVID-19 * Latest * Perspective * Guidelines * Drugs & Diseases * Global Coverage * Additional Resources Recommended Reading * 2001/viewarticle/711764 News FDA Safety Changes: DepoDur, Neoral, Lexiva b:recommendationscuratedHasData : false EMAIL THIS FEEDBACK Help us make reference on Medscape the best clinical resource possible. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. Your Name: Your Email: Send me a copy Recipient's Email: Subject: Optional Message Comment or Suggestion(Limited to 1500 Characters) Send Send Feedback Pleasedo not use this form to submit personal or patient medical information or to report adverse drug events. You are encouraged to report adverse drug event information to the FDA. Your Name is required. Subject is required. 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