Table 5.
FDA approved therapies for management of infection.
Treatment type | Product, company | Indication | Composition | Format | FDA approval |
---|---|---|---|---|---|
INFECTION MANAGEMENT | |||||
Silver sulfadiazine | For the prevention and treatment of wound sepsis in patients with 2nd and 3rd degree burns | 1% micronized silver sulfadiazine | Petrolatum based cream | NDA | |
Bacitracin®, Pharmacia and Upjohn | First aid to help prevent infection in minor cuts, scrapes, and burns | Mixture of related cyclic antibiotic peptides | Petrolatum based cream | NDA | |
Sulfamylon®, Mylan Institutional | Adjunctive antimicrobial therapy of patients with 2nd and 3rd burns | Mafenide acetate | Water miscible cream and as a 5% solution | NDA | |
Bactroban®, GlaxoSmithKline | The treatment of secondary infected traumatic skin lesions due to susceptible isolates of S. aureus and S. pyogenes | Mupirocin calcium | Cream with ~2% mupirocin calcium | NDA | |
Nystatin Cream | For treatment of cutaneous mycotic infections caused by C. albicans and other susceptible Candida species | Nystatin | Oil based cream | ANDA | |
Amphotericin B | Emperical therapy for presumed fungal infections in febrile, neutropenic patients. Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections | Amphotericin B | Lyophilized for injection | ANDA | |
Cancidas®, Merk & Co, Inc. | Emperical therapy for presumed fungal infections in febrile, neutropenic patients. Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies | Caspofungin acetate | Lyophilized and reconstituted for injection | NDA | |
Vfend®, Pfizer, Inc. | For Candida infections in skin | Voriconazole | Oral and IV | NDA | |
ANTIMICROBIAL DRESSINGS | |||||
Petrolatum coated gauze | Xeroform™ Wound Dressing, Covidien; Adaptic™ Non-Adhering Dressing, Acelity | As an initial layer in dressing wounds such as skin graft recipient sites, newly sutured wounds, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where protection from contamination and/or deodorization is desired | Gauze or mesh impregnated with petrolatum (Xeroform includes 3% bismuth tribromophenate) | Available in strips, sheets, or rolls | 510 (k) |
Polyhexamethylene biguanide (PHMB) | Telfa® AMD Non-Adherent Dressing, Covidien; Tielle™ PHMB Dressing, Acelity; Kerlix™ AMD Gauze, Covidien | For use as a primary wound contact dressing or as a secondary dressing to protect against bacterial proliferation | Perforated mylar film with absorbent core, gauze, or foam dressing impregnated with PHMB | Available in strips, sheets, or rolls | 510 (k) |
Silver | Mepilex® Ag, Molnlycke; Silverlon®, Argentum Medical; Acticoat™, Smith & Nephew; Aquacel® Ag, ConvaTec; Allevyn™ Ag, Smith & Nephew | (1) May be used for more serious wounds such as surgical wounds or traumatic wounds left to heal by secondary intent, and partial thickness burns, wounds that are prone to bleeding, and management of painful wounds. (2) For the management of infected wounds | Variety of mesh or foam dressings with ionic silver | Available in strips, sheets, or rolls | 510 (k) |
Honey | MediHoney®, DermaSciences/Integra; Manukamed®, ManukaMed | Topical dressing for 1st and 2nd degree burns, skin grafts and donor sites | 100% Leptospermum (Manuka) honey | Gel, paste, hydrogel sheets, impregnated gauze | 510 (k) |
NDA, New Drug Application; ANDA, Abbreviated New Drug Application.