Hydrogen peroxide (Eskata)

Hydrogen peroxide (Eskata)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sonya Gelfand

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Overview

Hydrogen peroxide (Eskata) is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1

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Condition 2

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

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Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

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Non–Guideline-Supported Use

Condition 1

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Condition 3

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

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Condition 2

• Dosing Information

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

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Condition 2

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Condition 3

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Contraindications

CONTRAINDICATIONS

Warnings

Conidition 1

(Description)

Conidition 2

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Conidition 3

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Adverse Reactions

Clinical Trials Experience

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Postmarketing Experience

(Description)

Drug Interactions

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Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Risk Summary

• Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to the drug.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydrogen peroxide (Eskata) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydrogen peroxide (Eskata) during labor and delivery.

Nursing Mothers

Risk Summary

• Hydrogen peroxide is not absorbed systemically by the mother following topical administration, and breastfeeding is not expected to result in exposure of the child to hydrogen peroxide.

Pediatric Use

• Seborrheic keratosis is not seen in the pediatric population.

Geriatic Use

• Of the 841 subjects treated with ESKATA in the clinical trials, 70% were 65 years of age and older and 26% were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Gender

There is no FDA guidance on the use of Hydrogen peroxide (Eskata) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydrogen peroxide (Eskata) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydrogen peroxide (Eskata) in patients who are immunocompromised.

Administration and Monitoring

Administration

Important Administration Information

• Hydrogen peroxide is to be administered by a health care provider.
• For topical use only. Not for oral, ophthalmic, or intravaginal use.
• Do not apply hydrogen peroxide topical solution to open or infected seborrheic keratoses.
• During a single in-office treatment session, apply hydrogen peroxide to seborrheic keratosis lesions 4 times, approximately 1 minute apart. After one use, discard the unit dose applicator.

Dosage and Administration Instructions

Preparation of lesions

• Prior to application of hydrogen peroxide, clean seborrheic keratoses to be treated using an alcohol wipe. When treating seborrheic keratoses on the face, take appropriate actions to ensure that hydrogen peroxide will not come into contact with the eyes.

Preparation of the hydrogen peroxide applicator

• Wear nitrile or vinyl examination gloves during the activation of the hydrogen peroxide applicator and during the administration of the solution to the lesion(s).
• The method for preparing the hydrogen peroxide applicator for use is illustrated below. While activating the applicator, hold it away from the patient.

This image is provided by the National Library of Medicine.

Application of hydrogen peroxide topical solution

• Following release of the solution from the ampule, remove the cap from the hydrogen peroxide applicator. Gently squeeze the applicator barrel to express a drop of hydrogen peroxide and ensure wetting of the applicator tip. Apply solution directly to the seborrheic keratosis in a circular motion. Apply enough solution to uniformly wet the lesion surface, including the edges without excess running or dripping. During the application, remove any excess solution from the surrounding skin using a clean absorbent wipe (do not use paper towels or tissue). Apply again in the same manner, 3 additional applications 1 minute apart.

If the treated lesions have not completely cleared approximately 3 weeks after treatment, another treatment may be administered following the same procedure.

Monitoring

• Improvement or resolution of seborrheic keratotic lesions may be indicative of efficacy.

IV Compatibility

There is limited information regarding the compatibility of Hydrogen peroxide (Eskata) and IV administrations.

Overdosage

• Topical overdosing of hydrogen peroxide could result in an increased incidence and severity of local skin reactions.

Pharmacology

Hydrogen peroxide (Eskata)
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PubChem	784
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Mechanism of Action

• The mechanism of action for hydrogen peroxide for the treatment of seborrheic keratosis is unknown.

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

• The pharmacodynamics of hydrogen peroxide in the treatment of seborrheic keratosis are unknown.

Pharmacokinetics

• Following application of hydrogen peroxide in patients with seborrheic keratosis lesions, hydrogen peroxide rapidly dissociates into water and reactive oxygen species. Indirect assessment of reactive oxygen species in patients with seborrheic keratosis lesions did not demonstrate any systemic absorption of hydrogen peroxide.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Long-term animal studies have not been performed to evaluate the carcinogenic potential of hydrogen peroxide.
• Hydrogen peroxide has been found to exhibit positive results in in vitro tests for genotoxicity, but has not exhibited positive results in in vivo tests for genotoxicity, presumably due to the rapid metabolism of hydrogen peroxide.
• The effects of hydrogen peroxide on fertility have not been evaluated. Hydrogen peroxide has been associated with effects on sperm function and elevated testicular hydrogen peroxide concentration has been implicated in male infertility, although in vivo, no effect of hydrogen peroxide on sperm function has been demonstrated.

Clinical Studies

• In two double-blind, vehicle-controlled clinical trials, 937 subjects with 4 clinically typical seborrheic keratoses that are raised on the face, trunk, or extremities were randomized to treatment with either ESKATA or vehicle. Subjects ranged from 42 to 91 years of age (mean 68.7 years), 58% percent were female, and 98% were Caucasian. A total of 925 subjects completed the trials. Each lesion was treated with 4 applications, at baseline and again at Day 22, if needed, and subjects were followed through Day 106.
• Efficacy was assessed at Day 106. Success rate was defined as the proportion of subjects achieving “clear” on the Physician’s Lesion Assessment Scale for all 4 treated lesions. Efficacy was also assessed for the proportion of subjects achieving “clear” on the Physician’s Lesion Assessment Scale for at least 3 of 4 lesions. TABLE 2 presents the efficacy results for the two clinical trials.

This image is provided by the National Library of Medicine.

How Supplied

• Hydrogen peroxide topical solution, 40% (w/w) is a clear, colorless solution and is supplied in a unit dose package. The available carton packages are presented below:

This image is provided by the National Library of Medicine.

Storage

• Store hydrogen peroxide at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59° F and 86° F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• Advise the patient to read the FDA-approved patient labeling.

Ophthalmic Adverse Reactions

• Inform patients that severe eye injury can occur with hydrogen peroxide application. Advise patients to inform the healthcare provider immediately if hydrogen peroxide runs into eyes, mouth, or nose during administration.

Local Skin Reactions

• Inform patients that treatment with hydrogen peroxide may lead to local skin reactions.

This image is provided by the National Library of Medicine.

Precautions with Alcohol

Alcohol-Hydrogen peroxide (Eskata) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

• Eskata

Look-Alike Drug Names

There is limited information regarding Hydrogen peroxide (Eskata) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.