Dosing & Uses
Dosage Forms & Strengths
solution, topical
- 40%
Seborrheic Keratosis
Indicated for raised seborrheic keratosis (SK) in adults
During a single in-office treatment session, apply topical solution to seborrheic keratosis lesions 4 times, ~1 minute apart
After one use, discard the unit dose applicator
If treated lesions have not completely cleared ~3 weeks after treatment, another treatment may be administered following the same procedure
See Administration
Seborrheic keratosis is not seen in the pediatric population
Safety and efficacy not established
Adverse Effects
>10%
10 minutes after application
- Erythema (98%)
- Stinging (93%)
- Edema (85%)
- Pruritus (32%)
- Vesiculation (18%)
1 week after application
- Scaling (72%)
- Erythema (66%)
- Crusting (67%)
- Pruritus (18%)
15 weeks after application
- Erythema (21%)
- Hyperpigmentation (18%)
- Scaling (16%)
- Crusting (12%)
1-10%
1 week after application
- Erosion (9%)
- Ulceration (4%)
15 weeks after application
- Hypopigmentation (7%)
<1%
Eyelid edema
Herpes zoster
Postmarketing Reports
Crepitus
Warnings
Contraindications
None
Cautions
Eye disorders
- Avoid eye exposure
- Eye disorders, including corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain, or permanent eye injury, including blindness, can occur after exposure
- If accidental exposure occurs, flush eyes with water for 15-30 minutes and initiate monitoring and further evaluation as appropriate
Local skin reactions
- Severe reactions, including ulcerations and scarring, may occur
- Do not retreat until the skin has recovered from any reaction caused by the previous treatment
Pregnancy
Pregnancy
Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to the drug
Lactation
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Exact mechanism unknown; the 40% topical solution is designed to penetrate into the SK lesion and causing oxidative damage, which can ultimately result in the sloughing of the SK cells
Absorption
Hydrogen peroxide rapidly dissociates into water and reactive oxygen species
Indirect assessment of reactive oxygen species in patients with SK lesions did not demonstrate any systemic absorption of hydrogen peroxide
Administration
Topical Preparation
Prepare lesions
- Clean SKs to be treated using an alcohol wipe
- When treating SKs on the face, take appropriate actions to ensure that solution will not come into contact with the eyes
Prepare applicator
- Wear nitrile or vinyl examination gloves during activation of the applicator and during administration of the solution to the lesion(s)
- While activating the applicator, hold it away from the patient
- See illustrated instructions in prescribing information
Topical Administration
High-concentration solution (40%) designed for in-office topical application by healthcare provider
Provides targeted treatment applied directly to raised SK using a penlike applicator
For topical use only; not for oral, ophthalmic, or intravaginal use
Do not apply to mucous membranes
Do not apply to open or infected SKs
Application
- Following release of the solution from the ampule, remove the cap from applicator
- Gently squeeze applicator barrel to express a drop of solution 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, but 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
Storage
Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (59-86° F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Peroxyl mucous membrane - | 1.5 % solution |  | |
| Peroxide Sore Mouth Cleanser - | 1.5 % solution |  | |
| hydrogen peroxide - | 3 % solution |  | |
| hydrogen peroxide - | 3 % solution |  | |
| hydrogen peroxide - | 3 % solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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