General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Sulfamylon
MAFENIDE ACETATE
INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:SULFAMYLON
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- MAFENIDE ACETATE
- Medicine class
- General Medicine
- Brand names
- SULFAMYLON
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
Medical Review
Medically reviewed- Reviewed by
- MedCentralHub Medical Review Board
- Credentials
- Licensed Pharmacists & Physicians
- Last reviewed
- Next review
Written from primary sources (FDA labeling, NIH/MedlinePlus, peer-reviewed literature) and verified by our review board. Educational information only — not a substitute for professional medical advice. See our medical disclaimer.
What Is Sulfamylon?
INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Sulfamylon (MAFENIDE ACETATE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Sulfamylon. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Sulfamylon with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Sulfamylon is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
DOSAGE AND ADMINISTRATION 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 dura
Available Forms
Available Strengths
Side Effects
Common
- ADVERSE REACTIONS 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 .
Serious
- WARNINGS 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
WARNINGS Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.
How Sulfamylon Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Sulfamylonwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Sulfamylon
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Sources & References
Content on this page is drawn from the following primary sources and reviewed against current labeling.
- FDA DailyMed — Official FDA prescribing information and drug labels
- MedlinePlus (NIH) — Patient-friendly drug information from the National Library of Medicine
- FDA Drug Safety Communications — Current FDA safety alerts, recalls, and label changes
- PubMed — Peer-reviewed clinical literature
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.