Hydrogen peroxide (Eskata): Difference between revisions
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*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. | ||
[[image:h2o2clinicaltrial.png|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
|howSupplied= | |||
*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: | |||
[[image:h2o2howsupplied.png|none|thumb|400px|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). | |||
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|packLabel= | |packLabel= | ||
[[image:eskata1.jpeg|none|thumb|400px|This image is provided by the National Library of Medicine.]] | [[image:eskata1.jpeg|none|thumb|400px|This image is provided by the National Library of Medicine.]] | ||
Revision as of 16:08, 16 July 2018
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sonya Gelfand
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Black Box Warning
|
Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
|
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.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
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
- (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
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Condition 3
- Dosing Information
- (Dosage)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
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
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Condition 3
- Dosing Information
- (Dosage)
Contraindications
CONTRAINDICATIONS
Warnings
|
Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
|
Conidition 1
(Description)
Conidition 2
(Description)
Conidition 3
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Condition 2
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
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
(Description)
Nursing Mothers
(Description)g
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
There is limited information regarding the compatibility of Hydrogen peroxide (Eskata) and IV administrations.
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Hydrogen peroxide (Eskata)
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| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | ? |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
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.
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:
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
{{#ask: Page Name::Hydrogen peroxide (Eskata) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Hydrogen peroxide (Eskata) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.
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.