sulfamylon
Pharmaranks rates Sulfamylon 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sulfamylon (Mafenide Acetate) is a medication used to treat Bacterial Infections, Wound Infection.
Mafenide Acetate · by Mylan Institutional
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Mafenide Acetate
- Form
- Topical
- Strength
- Mafenide Acetate 5%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- bacterial infections, wound infection
- Manufacturer
- Mylan Institutional
- FDA application
- NDA019832
- Availability
- Discontinued (per FDA)
What is Sulfamylon?
From the FDA label:Cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds. SULFAMYLON Cream spreads easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream contains mafenide acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives. Chemically, mafenide acetate is α-Amino-ρ-toluenesulfonamide monoacetate and has the following structural formula: mafenide-struc
How to use
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…
Side effects
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.
Warnings
Important safety information
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.
Who should not take Sulfamylon
SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Sulfamylon treat?
- Sulfamylon (Mafenide Acetate) may be used to treat bacterial infections, wound infection, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Sulfamylon rated?
- pharmaranks gives Sulfamylon a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Sulfamylon?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sulfamylon. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sulfamylon?
- Sulfamylon is marketed by Mylan Institutional. You can see Mylan Institutional's full profile, rating, and other products on pharmaranks.
- Is Sulfamylon a brand-name or generic drug?
- Sulfamylon is a brand-name product with the active ingredient Mafenide Acetate.
- Is Sulfamylon available over the counter?
- No. Sulfamylon is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sulfamylon come in?
- Sulfamylon is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Sulfamylon FDA-registered?
- Sulfamylon is on record with the U.S. FDA under application number NDA019832. You can verify this on its official FDA label.
- Has Sulfamylon been recalled by the FDA?
- Sulfamylon has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Sulfamylon safe?
- There's no single safe-or-not verdict. pharmaranks gives Sulfamylon a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Sulfamylon?
- Sulfamylon's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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sulfamylon
70/100