FERRIC SUBSULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611)

Available from:

CooperSurgical, Inc.

INN (International Name):

FERRIC SUBSULFATE

Composition:

FERRIC CATION 259 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.1 One method of applying ferric subsulfate solution 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 ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds. 2

Authorization status:

unapproved drug other

Summary of Product characteristics

FERRIC SUBSULFATE- FERRIC SUBSULFATE SOLUTION
COOPERSURGICAL, INC.
_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._
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FERRIC SUBSULFATE AQUEOUS
DESCRIPTION
Ferric Subsulfate, Aqueous; 8gm single-use glass vials.
CONTENTS
Ferric subsulfate 259mg/g [0.0638gm Fe
/
]. Preserved with benzalkonium chloride
0.005%. Povidone USP 23.2%. Glycerin USP 13.3%. Purified Water USP.
INDICATIONS AND USAGE
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. ONE METHOD OF APPLYING FERRIC SUBSULFATE SOLUTION 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
FERRIC
SUBSULFATE SOLUTION APPLIED, AND THE TENSION MAINTAINED FOR
APPROXIMATELY 15
SECONDS.
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”).
Microscopically, this hyperpigmentation
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 necrosis to a maximum depth of 0.6mm.
In an in vitro study, ferric
subsulfate solution produced a radiopacity with a density intermediate
between that of
water/tissue and calcium.
Should a re-biopsy of the same lesion be required, pathologists and
other physicians
3+
ml
1
2
3,4
5
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7
involved in