Ferric Subsulfate

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Ferric Subsulfate uses


SPL UNCLASSIFIED SECTION

AstrinGyn®


REF 6065

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.

DESCRIPTION

AstrinGyn®.

HOW SUPPLIED

8 gm single-use glass bottles.

SPL UNCLASSIFIED SECTION

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. 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

WARNINGS

For External Use Only. Should inadvertent ocular administration occur, the eye 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 AstrinGyn® (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 0.6 mm. 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 hemosiderin, together with shrinkage and discoloration of collagen bundles. 8, 9 Similarly, previous use of Ferric Subsulfate solution may result in a radiographic artifact.

SPL UNCLASSIFIED SECTION

CAUTION

Federal law prohibits dispensing without a prescription.

STORAGE

Keep tightly closed and protect from light. DO NOT use if seal is broken. Store at room temperature 59°-86°F (15°-30° C).

DISPOSAL

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for later disposal according to local hazardous waste practices. Waste containing AstrinGyn® should not be subjected to any thermal process whether intended for destruction or recycling purposes.

REFERENCES

Armstrong RB, Nichols J. Pachance J. Punch biopsy wounds treated with Monsel’s solution or a collagen matrix. A comparison of healing. Arch. Dermatol 1986;122:546-549.

Baden HP, Rapid hemostasis with Monsel’s solution. Arch Dermatol 1984; 120:708.

Demis DJ, Clinical dermatology, Hagerstown MD: Harper & Row, 1986; pp. 11-4:1-11-4:5.

Camisa C, Roberts W. Monsel solution tattooing (letter). J Am Acad Dermatol 1983;8:753-754.

Amazon K, Robinson MJ, Rywlin AM. Ferrugination caused by Monsel’s solution. Clinical observations and experimentation. Am J Dermatopathol 1980;2:197-205.

Davis JR, Steinbronn KK, Graham AR, Dawson BV. Effects of Monsel’s solution in uterine cervix, AM J Clin Pathol 1984;82:332-335.

Horn MS, Circeo RB, Hassan C. Radiographic artifacts produced by silver nitrate and Monsel’s solution (letter). J Am Acad Dernatol 1983;8:560-562.

Olmstead PM, Lund HZ, Leonard DD. Monsel’s solution: a histologic nuisance. J Am Acad Dermatol 1980;3:492-498.

Wood C, Severin GL. Unusual histiocytic reaction to Monsel’s solution. Am J Dermatopathol 1980;2:261-264.

PRINCIPAL DISPLAY PANEL

AstrinGyn ®

Ferric Subsulfate, Aqueous

Contents

One Dozen (12)

8 gm Vials

NDC 59365-6065-1


AstrinGyn ® Ferric Subsulfate, Aqueous Contents One Dozen (12) 8 gm Vials NDC 59365-6065-1

PRINCIPAL DISPLAY PANEL

8gm NDC 59365-6065-0

AstrinGyn ®

(Ferric Subsulfate)

Aqueous


PRINCIPAL DISPLAY PANEL8gm NDC 59365-6065-0AstrinGyn ®(Ferric Subsulfate)Aqueous

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Ferric Subsulfate pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Ferric Subsulfate available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Ferric Subsulfate destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Ferric Subsulfate Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Ferric Subsulfate pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FERROUS SULFATE ELIXIR [LLC FEDERAL SOLUTIONS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Ferric subsulfate". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ferric Subsulfate?

Depending on the reaction of the Ferric Subsulfate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ferric Subsulfate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Ferric Subsulfate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Ferric Subsulfate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ferric Subsulfate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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