Ferric Subsulfate Aqueous

Dosage form: topical solution
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ferric Subsulfate Aqueous Description

Ferric Subsulfate, Aqueous; 8gm single-use glass vials.

CONTENTS

Ferric subsulfate 259mg/g [0.0638gm Fe 3+/ml]. Preserved with benzalkonium chloride 0.005%. Povidone USP 23.2%. Glycerin USP 13.3%. Purified Water USP.

Indications and Usage for Ferric Subsulfate Aqueous

Ferric Subsulfate, Aqueous, is a stypic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1One method of applying ferricsubsulfatesolution for dermal use consists of the physician placing fingers at the opposite edge of the wound and stretching the skin. The wound is then wiped with gauze, the ferricsubsulfatesolution applied, and the tension maintained for approximately 15 seconds.2

Warnings

For External Use Only. Should inadvertent eye contact occur, the eye(s) should be washed immediately 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).

Precautions

As with all iron solutions applied to dermal surfaces denuded of epithelium or to mucous membranes topical application of Ferric Subsulfate Aqueous (ferric subsulfate) may result in hyperpigmentation (“tattooing”).3,4 Microscopically, this hyperpigmentation may be observed as ferrugination of collagen fibers and fibrin.5 In one study of uterine cervical tissue, ferric subsulfate solution penetrated denuded mucosa and produced coagulation necrosis to a maximum depth of 0.6mm.6 In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium.7

Should a re-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 of ferric subsulfate solution may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosider...