FERRIC SUBSULFATE solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

CooperSurgical, Inc.

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

AstrinGyn® is a styptic 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 for applying ferric subsulfate solution for dermal use 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.2  

leaflet_short:

8 gm single-use glass bottles.

authorization_status:

unapproved drug other

SPC

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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ASTRINGYN
ASTRINGYN®
(FERRIC SUBSULFATE, AQUEOUS)
REF 6065
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.
DESCRIPTION
AstrinGyn® (Ferric Subsulfate, Aqueous).
HOW SUPPLIED
8 gm single-use glass bottles.
ACTIONS & USES
AstrinGyn® is a styptic 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 for applying ferric subsulfate solution for dermal use 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.
WARNINGS
FOR EXTERNAL USE ONLY. Should inadvertent ocular administration 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
3+
ml
1
2
membranes, topical application of AstrinGyn® (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 0.6 mm.
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 a