Version May 2024
Burn treatment: Topical:
Note: Refer to institutional policies and procedures; application specifics may vary.
Cream: Apply once or twice daily with a sterile-gloved hand, to a thickness of approximately 1/16 inch, or enough to prevent burn dressing adhesion to the wound (thicker application is not needed). The burned area should be covered with cream at all times. Continue treatment until healing is progressing well or the burn site is ready for grafting (Cancio 2017; ISBI 2016; manufacturer’s labeling).
Powder for solution (2.5% or 5%): Wet a burn dressing (eg, gauze) with mafenide topical solution and cover graft area. Keep dressing damp/moist using an irrigation syringe or irrigation tubing every 4 to 12 hours (or as necessary). Avoid maceration through over-wetting or avoid adhesion to wound (if dressing is directly in contact with burn) through over-drying. Continue treatment until healing is progressing well or the burn site is ready for grafting (Afshari 2017; Cancio 2017; Ibrahim 2014; ISBI 2016; manufacturer’s labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use caution, accumulation of parent drug and metabolite may enhance carbonic anhydrase inhibition.
There are no dosage adjustments provided in the manufacturer's labeling.
Acidosis: When acidosis becomes difficult to control, discontinuing treatment for 24 to 48 hours may aid in restoring acid-base balance
Refer to adult dosing.
(For additional information see "Mafenide: Pediatric drug information")
Burns: Topical:
Cream: Infants, Children, and Adolescents: Apply once or twice daily with a sterile-gloved hand; apply to a thickness of approximately 1/16 inch; the burned area should be covered with cream at all times.
Solution (5%): Infants ≥3 months, Children, and Adolescents: Cover graft area with 1 layer of fine mesh gauze. Wet an 8-ply burn dressing with mafenide solution and cover graft area. Keep dressing wet using syringe or irrigation tubing every 4 hours (or as necessary), or by moistening dressing every 6 to 8 hours (or as necessary). Irrigation dressing should be secured with bolster dressing and wrapped as appropriate. May leave dressings in place for up to 5 days.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use caution, accumulation of parent drug and metabolite may enhance carbonic anhydrase inhibition.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Edema, facial edema
Dermatologic: Erythema, maceration, pruritus, rash, urticaria
Endocrine & metabolic: Hyperchloremia, metabolic acidosis
Gastrointestinal: Diarrhea (following accidental ingestion)
Hematologic: Bleeding, bone marrow suppression, DIC, eosinophilia, hemolytic anemia, porphyria
Local: Blisters, burning sensation, excoriation, pain
Respiratory: Dyspnea, hyperventilation, pCO2 decreased, tachypnea
Miscellaneous: Hypersensitivity
Hypersensitivity to mafenide or any component of the formulation.
Concerns related to adverse effects:
• Acid-base imbalance: Mafenide and its metabolite inhibit carbonic anhydrase; metabolic acidosis may occur. Symptoms may include compensatory hyperventilation; risk is increased in patients with impaired renal function. Some patients experience masked hyperventilation and respiratory alkalosis; etiology is unknown. Monitor acid-base balance, especially in patients with extensive second-degree or partial-thickness burns and in patients with pulmonary or renal dysfunction.
• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• G6PD deficiency: Use caution in patients with G6PD deficiency; hemolytic anemia with DIC (including fatalities) has been reported with use, presumably related to G6PD deficiency.
• Renal impairment: Use with caution in burn patients with acute renal impairment; accumulation of parent drug and metabolite may enhance carbonic anhydrase inhibition and increase risk of metabolic acidosis.
Dosage forms specific issues:
• Sulfites: Some dosage forms contain sulfites which may cause allergic-type reactions (including anaphylaxis) as well as life-threatening or less severe asthmatic episodes in certain individuals; consider discontinuation of therapy if allergic reactions occur.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as acetate [strength expressed as base]:
Sulfamylon: 85 mg/g (56.7 g, 453.6 g) [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylparaben, sodium metabisulfite]
Sulfamylon: 85 mg/g (56.7 g [DSC], 113.4 g [DSC], 453.6 g [DSC]) [contains methylparaben, propylparaben, sodium metabisulfite]
Packet, External, as acetate:
Sulfamylon: 50 g (1 ea, 5 ea [DSC])
Generic: 50 g (1 ea, 5 ea)
May be product dependent
Cream (Sulfamylon External)
85 mg/g (per gram): $1.53
Pack (Mafenide Acetate External)
5% (per each): $160.79
Pack (Sulfamylon External)
5% (per each): $122.50
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: For external use only.
Cream: Keep burn area covered with cream at all times. Dressings usually are not required; however, if necessary, only a thin layer of dressings should be used. Apply to clean debrided area with a sterile gloved hand. If possible, patient should bathe daily to aid debridement (eg, whirlpool bath, shower, or bathed in bed).
Powder for solution (2.5% or 5%): Cover graft area with 1 layer of fine mesh gauze. Wet dressing (eg, gauze) with the mafenide topical solution and cover graft area. Keep dressing damp/moist using an irrigation syringe or irrigation tubing. Irrigation tubing should be placed over burn dressing in contact with the wound; use an additional dressing to cover. Irrigation dressing should be secured with bolster dressing and wrapped as appropriate. Avoid maceration through over-wetting or avoid adhesion to wound (if dressing is directly in contact with burn) through over-drying (Afshari 2017; Ibrahim 2014; ISBI 2016; manufacturer’s labeling).
For topical use only.
Topical:
Cream: Apply to cleansed, debrided, burned area with a sterile-gloved hand. Keep burn area covered with cream at all times.
Solution: Cover affected area with gauze and the dressing wetted with mafenide solution; wound dressing may be left undisturbed for up to 5 days.
Burn treatment: Adjunctive therapy of patients with second- and third-degree burns (cream); adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds (powder for solution)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
The manufacturer does not recommend use of the cream in women of childbearing potential unless the burn area covers >20% of the total body surface.
The manufacturer does not recommend use of the cream unless the benefits of treatment outweigh possible risks to the fetus.
It is not known if mafenide is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Metabolic acidosis; rash; local wound infection; wound healing.
As a sulfonamide, mafenide interferes with bacterial folic acid synthesis through competitive inhibition of para-aminobenzoic acid. Spectrum of activity encompasses both gram positive and negative organisms, including Pseudomonas and some anaerobes.
Absorption: Diffuses through devascularized areas and is rapidly absorbed from burned surface
Metabolism: To para-carboxybenzene sulfonamide; mafenide and metabolite are carbonic anhydrase inhibitors
Time to peak, serum: Cream 11%: 2 to 4 hours
Burn tissue: Cream 11%: 2 hours, Solution 5%: 4 hours
Excretion: Urine (as metabolites)
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