carbamide peroxide [Otic]

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Use and Dosing ⬇

Adult Dosing

Impacted cerumen

Instill 5-10 gtt in ear canal bid x 4 days PRN
Max: 4 days
Drops should remain in ear for several minutes

Pediatric Dosing

Impacted cerumen (>12 yrs)

Instill 5-10 gtt in ear canal bid x 4 days PRN
Max: 4 days
Drops should remain in ear for several minutes

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

As an aid to soften, loosen and remove excessive earwax

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Ear drainage or discharge
Irritation or rash in the ear
An injury or perforation (hole) of the eardrum
Recently had ear surgery
Ear pain
Dizziness

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

Only for otic use, do not use in eye
Advise patient to contact their physician if dizziness or otic redness, rash, irritation, tenderness, pain, drainage, or discharge are present or develop, or if an infection is suspected

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: No studies conducted on carbamide (urea) peroxide during breastfeeding. Unlikely to be absorbed into the bloodstream, however if absorbed it would be broken down to urea and hydrogen peroxide, both of which are normally found in human milk. Use of the product is not a reason to discontinue breastfeeding and no special precautions are required if carbamide (urea) peroxide is used by nursing mother. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/ht mlgen?LACT last accessed 22 June 2011).

Adverse Reactions ⬆ ⬇

LOCAL: Irritation, rash

Clinical Pharmacology ⬆ ⬇

Otic preparation; source of hydrogen peroxide and nascent oxygen, by releasing oxygen mechanically removes debris from inaccessible regions
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown