pharmacopeia
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/api/v1/drug/mafenide

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Para-Aminobenzoic Acid Inhibitors; Unknown Cellular or Molecular Interaction.

Para-Aminobenzoic Acid

Indications

Sourced from openFDA
  • SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.

Contraindications

Sourced from openFDA
  • SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.contraindicated

Dosage & administration

Sourced from openFDA

Prompt institution of appropriate measures for controlling shock and pain is of prime importance. The burn wounds are then cleansed and debrided, and SULFAMYLON Cream is applied with a sterile gloved hand. Satisfactory results can be achieved with application of the cream once or twice daily, to a thickness of approximately 1/16 inch; thicker application is not recommended. The burned areas should be covered with SULFAMYLON Cream at all times. Therefore, whenever necessary, the cream should be reapplied to any areas from which it has been removed (e.g., by patient activity). The routine of administration can be accomplished in minimal time, since dressings usually are not required, if individual patient demands make them necessary, however, only a thin layer of dressings should be used. When feasible, the patient should be bathed daily to aid in debridement. A whirlpool bath is particularly helpful, but the patient may be bathed in bed or in a shower. The duration of therapy with SULFAMYLON Cream depends on each patient’s requirements. Treatment is usually continued until healing is progressing well or until the burn site is ready for grafting. SULFAMYLON Cream should not be withdrawn from the therapeutic regimen while there is the possibility of infection. However, if allergic manifestations occur during treatment with SULFAMYLON Cream, discontinuation of treatment should be considered.

Warnings & precautions

Sourced from openFDA

Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse reactions

Sourced from openFDA

It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn. A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream. Dermatologic: The most frequently reported reaction was pain on application or a burning sensation. Rare occurrences are excoriation of new skin and bleeding of skin. Allergic: Rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia. Respiratory: Tachypnea or hyperventilation, decrease in arterial pCO 2 . Metabolic: Acidosis, increase in serum chloride. Accidental ingestion of SULFAMYLON Cream has been reported to cause diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Approval history

Sourced from openFDA
  • Jan 24, 1969NDANDA016763Rising

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
31 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective413%
  2. 2Pyrexia413%
  3. 3Sepsis413%
  4. 4Wound Infection39.7%
  5. 5Agitation26.5%
  6. 6Anxiety26.5%
  7. 7Clostridium Difficile Colitis26.5%
  8. 8Dry Skin26.5%
  9. 9Erythema26.5%
  10. 10Fatigue26.5%
  11. 11Gait Disturbance26.5%
  12. 12Hypotension26.5%
  13. 13Medication Error26.5%
  14. 14Multiple Organ Dysfunction Syndrome26.5%
  15. 15Nausea26.5%

Literature

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Recent PubMed references pinned to Mafenide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Mafenide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Mafenide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CFDA label: Informative PGx
    G6PD

Frequently asked questions

How does Mafenide work?
Mechanism-of-action classes: Para-Aminobenzoic Acid Inhibitors; Unknown Cellular or Molecular Interaction.
What is Mafenide used for?
According to FDA labeling, Mafenide carries indications including: SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Mafenide?
Mafenide is classified as Sulfonamides, Methylated Sulfonamide Antibacterial, Para-Aminobenzoic Acid Inhibitors, Unknown Cellular or Molecular Interaction, Cellular Synthetic Activity Alteration.
What are the brand names for Mafenide?
Mafenide is marketed under brand names including Sulfamylon.
What are the contraindications for Mafenide?
Mafenide labeling lists contraindications including: SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.. Always consult the full prescribing information and a clinician.
Note. Data for mafenide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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