... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Drug Safety Labeling Changes-Resources for You Prandin (repaglinide) tablets June 09 Prescribing Information-- Prandin (repaglinide) tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-June 2009 Summary View CONTRAINDICATIONS Prandin is contraindicated in patients with: Co-administration of gemfibrozil. PRECAUTIONS Drug-Drug Interactions Repaglinide appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1). Drugs that inhibit OATP1B1 (e.g. cyclosporine) may likewise have the potential to increase plasma concentrations of repaglinide. ADVERSE REACTIONS Infrequent Adverse Events (< 1 %of Patients ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Drug Safety Labeling Changes-PrandiMet (repaglinide / metformin HCl fixed-dose combination) tablet Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) â €“ May 2010 Summary View CONTRAINDICATIONS PrandiMet is contraindicated in: Patients receiving gemfibrozil WARNINGS AND PRECAUTIONS Drug Interactions Gemfibrozil significantly increased repaglinide exposure. Therefore, patients should not take PrandiMet with gemfibrozil Drugs that inhibit OATP1B1 (e.g, cyclosporine) may have the potential to increase plasma concentrations of repaglinide-- Links on this page: Page Last Updated: 06 / 15 / 2010 Note: If you need help accessing information in ...

... Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products 2010 Safety Alerts for Human Medical Products 2009 Safety Alerts for Human Medical Products 2008 Safety Alerts for Human Medical Products 2007 Safety Alerts for Human Medical Products 2006 Safety Alerts for Human Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Prandin (repaglinide) Audience: Endocrinologists, pharmacists and other healthcare providers Novo Nordisk and FDA revised the PRECAUTIONS / Drug Interaction section of the prescribing information to inform healthcare professionals of a drug-drug interaction between repaglinide (PRANDIN ), a short-acting insulin secretagogue, and gemfibrozil (Lopid) a lipid-lowering agent used to treat dyslipidemia. A study that evaluated the co-administration of gemfibrozil with PRANDIN in healthy subjects found a significant increase in repaglinide blood levels. Concomitant use may result in enhanced and prolonged blood glucose-lowering effects of repaglinide. For patients already on PRANDIN and gemfibrozil, ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prandin (repaglinide) Tablets Prescribing Information Jul 2008-- Prandin (repaglinide) Tablets July 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-July 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified PRECAUTIONS Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Prandin or ...

... & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Drug Safety Labeling Changes-Resources for You Lopid (gemfibrozil) Prescribing Information July 2009-- Lopid (gemfibrozil) tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-July 2009 Summary View CONTRAINDICATIONS Combination therapy of gemfibrozil with repaglinide (due to the risk for severe hypoglycemia) PRECAUTIONS Drug Interactions Repaglinide: In healthy volunteers, co-administration with gemfibrozil increased the plasma concentration of repaglinide and prolonged its hypoglycemic effects. Coadministration of gemfibrozil and repaglinide increases the risk for severe hypoglycemia and is contraindicated.-- Links on this page: Page Last Updated: 08 / 12 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About FDA Contact Us A to Z Subject Index Site Map Web Site Policies ...

... . DRUG INTERACTIONS Effect of Deferasirox on Drug Metabolizing Enzymes Deferasirox inhibits human CYP3A4, CYP2C8, CYP1A2. Interaction with Agents Metabolized by CYP2C8 In a healthy volunteer study, the concomitant administration of Exjade. Interaction with Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism In a healthy volunteer study, the concomitant administration of Exjade Highlights Section Increase the dose of Exjade and monitor serum ferritin levels and clinical response for further dose modification when it is used concomitantly with potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir). Exjade increases repaglinide exposure. Consider repaglinide dose reduction and carefully monitor blood glucose levels when repaglinide is used concomitantly with Exjade. An interaction between Exjade and other CYP2C8 substrates cannot be excluded. PATIENT COUNSELING INFORMATION Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with potent UGT inducers. Perform careful monitoring of glucose levels when repaglinide is used concomitantly ...

... CYP3A4, and is a substrate of the multidrug efflux transporter P-glycoprotein. Various agents are known to either increase or decrease plasma or whole blood of cyclosporine levels usually by inhibition or induction of CYP3A4 or P-glycoprotein transporter or both. Drugs That Increase Cyclosporine Concentrations voriconazole nefazodone Drugs / Dietary Supplements That Decrease Cyclosporine Concentrations oxcarbazepine bosentan Other Drug Interactions Cyclosporine is an inhibitor of CYP3A4 and of the multidrug efflux transporter Pglycoprotein and may increase plasma concentrations of comedications that are substrates of CYP3A4 or P-glycoprotein or both. Cyclosporine may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycemia. In 12 healthy male subjects who received two doses of 100mg cyclosporine capsule orally 12 hours apart with a single dose of 0.25mg repaglinide tablet (one half of a 0.5mg tablet) orally 13 hours after the cyclosporine initial dose, the repaglinide mean Cmax and AUC were increased 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 level is advisable for a patient taking cyclosporine and repaglinide concomitantly. ADVERSE REACTIONS Renal ...

... at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov / medwatch INDICATIONS AND USAGE-DRUG INTERACTIONS-· Based on Exjade's mechanism of action, do not take Exjade with Exjade is an iron chelating agent indicated for the treatment of chronic iron aluminum-containing antacid preparations. (7) overload due to blood transfusions in patients 2 years of age and older. (1) · Use caution when Exjade is administered with drugs metabolized by CYP3A4. (7.1, 7.2) Individualize the decision to initiate Exjade therapy based on consideration of · Exjade increases repaglinide exposure. Consider repaglinide dose the anticipated clinical benefit and risks of the therapy, taking into reduction and carefully monitor blood glucose levels when repaglinide is consideration factors such as the life expectancy and comorbidities of the used concomitantly with Exjade. An interaction between Exjade and other patient. (1) CYP2C8 substrates cannot be excluded. (7.3) The safety and efficacy of Exjade when administered with other iron chelation USE IN SPECIFIC POPULATIONS-therapy have not been established. (1) · Pregnancy: Based on animal studies, may cause fetal ...

... acetate) for Injection (Intravenous Use Only) X X Capastat Sulfate (capreomycin for injection, USP) for Intramuscular and Intravenous Infusion Only X X Colazal (balsalazide disodium) Capsules X X Coreg (carvedilol) Tablets X Duac Topical Gel (clindamycin, 1 %- benzoyl peroxide, 5 %) X X Flovent HFA (fluticasone propionate) Inhalation Aerosol for Oral Inhalation Only X PPI Fortamet (metformin hydrochloride) Extended-Release Tablets X Levoxyl (levothyroxine sodium) Tablets X Natacyn (natamycin ophthalmic suspension) 5 %X X Prandin (repaglinide) Tablets X Starlix (nateglinide) Tablets X Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for Oral Inhalation Only X MG Synthroid (levothyroxine sodium tablets, USP) X (Click on drug name to go to detailed view) BW C W P AR PPI / MG Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound] X Imuran (azathioprine) 50 mg Tablets and 100 mg (as the sodium salt) for Intravenous Injection X Simcor (simvastatin / niacin extended-release) Tablet, Film Coated ...

... multidrug efflux transporter P-glycoprotein. Various agents are known to either increase or decrease plasma and whole blood cyclosporine concentrations usually by inhibition or induction of CYP3A4 or P-glycoprotein transporter or both. Drug Interactions / Drugs That Increase Cyclosporine Concentrations nefazodone Other Drug Interactions Cyclosporine is an inhibitor of CYP3A4 and of the multidrug efflux transporter Pglycoprotein and may increase plasma concentrations of comedications that are substrates of CYP3A4 or P-glycoprotein transporter or both. Cyclosporine may reduce the clearance of .etoposide. Literature and postmarketing cases .including muscle pain. Cyclosporine may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycemia. ADVERSE REACTIONS Kidney, Liver, Heart and Heart Transplantation Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine-containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). Both generalized and localized infections can occur. Pre-existing infections may also be aggravated. Fatal outcomes have been reported.-- Links on this page: Page Last Updated: 10 / 19 / 2009 Note: If you need help accessing information in different file formats, see Instructions for ...