Finished product reference
Mafenide Acetate
Cream · Topical · 112 mg/1g · 30 g
- List code
- 795
Indications
INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Dosage and administration (summary)
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).
Contraindications
CONTRAINDICATIONS SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.
Warnings and precautions
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.
Storage and supply
HOW SUPPLIED 16 oz. Plastic Jar (453.6 g) - NDC 16571-723-48 4 oz. Tube (113.4 g) - NDC 16571-723-12 2 oz. Tube (56.7 g) - NDC 16571-723-60 Avoid exposure to excessive heat (temperature above 104° F or 40° C). For External Use Only. Keep this and all medications out of the reach of children. Rx only Manufactured for: Rising Pharma Holdings, Inc.
Source: Mafenide Acetate (Sulfamylon) — US FDA prescribing information, 2023-07-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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