Ferric subsulfate, Monsel's Solution is a topically applied solution containing roughly 20-26% iron. The solution is produced by the oxidation of ferrous sulfate along with sulfuric and nitric acid. It is used primarily as a topical hemostatic agent in minor surgical procedures (particularly dermatologic and gynecologic procedures). The solution is moderately caustic and should be used with proper protection (e.g., gloves, eye mask if necessary) and in an area with adequate ventilation to avoid irritation to the skin, eyes, or respiratory tract. Monsel's solution has been in use medically for decades and was found in the early publications of the National Formulary of the United States.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-For external topical application only. Do not ingest internally.
-Application should take place in a room that provides proper ventilation to avoid respiratory irritation. Protective barriers, like gloves, are recommended to avoid skin irritation. Goggles may also be recommended for use to protect eyes during administration.
-The time to local hemostasis depends on the depth of tissue exposure. For example, in punch biopsies of the full dermis the time to achieve hemostasis is typically less than 20 seconds.
-One method for dermal application consists of the physician placing fingers at the opposite edges of the wound and stretching the skin. The wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.
As with all iron solutions applied to mucous membranes or to dermal surfaces denuded of epithelium, topical application of ferric subsulfate may result in mucous membrane or skin discoloration ("tattooing"). Microscopically, this discoloration may be observed as ferrugination of collagen fibers and fibrin. In one study of uterine cervical tissue, ferric subsulfate solution penetrated denuded mucosa and produced coagulation tissue necrosis to a maximum depth of 0.6 mm. In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium. Previous use of ferric subsulfate solution may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosiderin, together with shrinkage and discoloration of collagen bundles. Similarly, previous use of ferric subsulfate solution may result in a radiographic artifact.
Ferric subsulfate solutions are moderately caustic and can cause respiratory tract and skin irritation during the application process. Healthcare personnel should ensure proper application technique, including wearing protection (e.g., gloves) and only using in area with proper ventilation.
Ferric subsulfate solutions are for external use only, and should not be given by oral or parenteral administration. Oral ingestion may cause direct harm to mucosal tissue on contact, and could also result in iron poisoning. The solutions are moderately caustic and can cause skin and respiratory tract irritation during the application process. Healthcare personnel should ensure proper application technique, including wearing proper protection (e.g., gloves) and only using in area with proper ventilation. Ferric subsulfate should not be used in vesicular, bullous, or exudative skin disease or conditions, because it may then cause permanent pigmentation on the skin.
Ferric subsulfate solutions are for external use only, and should not be given by ophthalmic administration as eye irritation would result. Should inadvertent ocular exposure or administration occur, immediately wash the eye(s) with large amounts of water or normal saline, occasionally lifting the upper and lower lids until no evidence of solution remains (approximately 15-20 minutes).
As with all iron solutions applied to dermal surfaces denuded of epithelium or to mucous membranes, topical application of ferric subsulfate may result in skin discoloration ("tattooing"). Microscopically, this discoloration may be observed as ferrugination of collagen fibers and fibrin. Should a repeat organ biopsy of the same lesion be required, pathologists and other physicians involved in the care of the patient should be aware of the previous use of ferric subsulfate solution. Previous use may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosiderin, together with shrinkage and discoloration of collagen bundles. Similarly, previous use may result in a radiographic artifact.
Use ferric subsulfate only if clearly needing during pregnancy; reproductive studies have not been conducted.
It is unlikely that ferric subsulfate is excreted in human milk. Use caution when ferric subsulfate is applied to a woman who is breast-feeding.
For use as a hemostatic for minor surgical bleeding occurring during minor dermatologic or gynecologic procedures:
Topical dosage:
Adults: Apply topically to the site as needed, using a cotton swab or other appropriate application device.
Maximum Dosage Limits:
-Adults
Maximum dosage information is not available.
-Geriatric
Maximum dosage information is not available.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are required.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are required.
*non-FDA-approved indication
There are no drug interactions associated with Ferric Subsulfate, Monsel's Solution products.
Application of ferric subsulfate solution (containing roughly 20-26% iron) coagulates tissue and blood proteins at the site of bleeding, which closes off the blood vessels. Local hemostasis of a full dermis punch biopsy occurs within 20 seconds of application.
Ferric subsulfate solution is administered topically. Pharmacokinetic data are unknown.