{"id":"sulfamylon-for-5-topical-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Metabolic acidosis"},{"rate":null,"effect":"Hemolytic anemia"},{"rate":null,"effect":"Local pain or burning at application site"},{"rate":null,"effect":"Allergic reactions (rash, pruritus)"},{"rate":null,"effect":"Pulmonary edema"}]},"_chembl":{"chemblId":"CHEMBL2108694","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Mafenide is a sulfonamide that acts as a competitive inhibitor of dihydropteroate synthase, disrupting bacterial folate metabolism and nucleic acid synthesis. It provides broad-spectrum coverage against gram-positive and gram-negative organisms commonly found in burn wounds, including Pseudomonas aeruginosa. The topical formulation allows direct application to burned tissue to prevent and treat wound infections.","oneSentence":"Mafenide acetate inhibits bacterial folic acid synthesis by competing with para-aminobenzoic acid, thereby exerting broad-spectrum antimicrobial activity against burn wound pathogens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:03.973Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Adjunctive topical antimicrobial agent for second and third-degree burns"}]},"trialDetails":[{"nctId":"NCT00634166","phase":"PHASE4","title":"Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group","status":"TERMINATED","sponsor":"Mylan Inc.","startDate":"2007-09","conditions":"Burns","enrollment":220}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["mafenide acetate"],"phase":"marketed","status":"active","brandName":"Sulfamylon® For 5 % Topical Solution","genericName":"Sulfamylon® For 5 % Topical Solution","companyName":"Mylan Inc.","companyId":"mylan-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sulfamylon 5% Topical Solution is a topical antimicrobial/antifungal medication used to treat burns. Its exact mechanism of action is unknown.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2013-02-12T00:00:00.000Z","mah":"PH HEALTH","brand_name_local":"MAFENIDE ACETATE","application_number":"ANDA201511"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-07-31T00:00:00.000Z","mah":"INGENUS PHARMS LLC","brand_name_local":"MAFENIDE ACETATE","application_number":"ANDA206716"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}