What is the recommended dosing for Debrox (carbamide peroxide) ear drops in a typical adult patient with earwax impaction?

Debrox Dosing for Earwax Impaction

For adults and children over 12 years, apply 5 to 10 drops of Debrox (carbamide peroxide 6.5%) into the affected ear twice daily for up to 4 days, keeping the head tilted or placing cotton in the ear for several minutes to retain the drops. 1

Specific Dosing Instructions

Adults and children over 12 years:

• Tilt head sideways and place 5 to 10 drops into the ear canal 1
• The applicator tip should not enter the ear canal 1
• Keep drops in the ear for several minutes by maintaining head tilt or placing cotton in the ear 1
• Use twice daily for up to 4 days if needed 1
• After 3-5 days of treatment, any remaining wax may be removed by gently flushing the ear with warm water using a soft rubber bulb ear syringe 1, 2

Children under 12 years:

• Consult a physician before use 1

Treatment Algorithm

Step 1: Initial cerumenolytic treatment

• Apply Debrox drops for 3-5 days as first-line therapy 2, 3, 4
• Carbamide peroxide causes instant degradation of cerumen upon contact, showing grade 1 degradation immediately and grade 3 degradation after 20 minutes at body temperature 5

Step 2: Irrigation if impaction persists

• If wax remains after 3-5 days of drops, proceed to irrigation with body-temperature water (37°C/98.6°F) using a bulb syringe or large syringe 2, 3
• This combined approach (cerumenolytic followed by self-irrigation at home) is the most cost-effective protocol 2, 3

Step 3: Manual removal if needed

• If drops and irrigation fail, manual removal by a healthcare provider is the third-line option 2, 4

Absolute Contraindications to Debrox

Do NOT use Debrox if the patient has: 2, 3, 4

• Perforated tympanic membrane (current or history of perforation)
• History of ear surgery (unless cleared by an otolaryngologist)
• Tympanostomy tubes in place
• Active otitis externa or ear infection
• Ear canal stenosis or exostoses

Modifying Factors Requiring Caution

Before prescribing Debrox, assess for: 6, 2, 3

• Anticoagulant therapy (increased bleeding risk with any ear manipulation)
• Immunocompromised state (higher risk of post-procedure otitis externa)
• Diabetes mellitus (altered cerumen pH facilitates pathogen growth)
• Prior radiation therapy to head and neck

Evidence Supporting Carbamide Peroxide

Comparative effectiveness:

• No specific cerumenolytic agent has been proven superior to plain water or saline in randomized trials 2, 7
• However, carbamide peroxide demonstrates immediate cerumen degradation in laboratory studies, while other agents like phenol glycerin require 20 minutes to show similar effects 5
• Water-based preparations (including carbamide peroxide) have the lowest risk of local skin reactions compared to oil-based products 2, 3

Clinical outcomes:

• Active treatment with cerumenolytics results in 22% complete wax clearance versus 5% with no treatment after 5 days (RR 4.09,95% CI 1.00 to 16.80; NNTB = 8) 7
• Carbamide peroxide followed by irrigation is more cost-effective (£24,433 per QALY) than irrigation alone 8

Expected Adverse Effects

Potential side effects are generally mild: 2

• Transient hearing loss
• Dizziness
• Discomfort or irritation
• Local skin reactions (rare with water-based preparations)

Critical Safety Points

What NOT to do: 2, 3, 4

• Never use cotton-tipped swabs—they push wax deeper and can cause canal laceration, tympanic membrane perforation, or ossicular dislocation
• Avoid ear candling—no evidence of efficacy and can cause burns, ear canal occlusion, and tympanic membrane perforation
• Do not use home oral jet irrigators—lack safety and efficacy research

Irrigation safety:

• Always use body-temperature water to avoid caloric effects causing dizziness 2, 3
• Tympanic membrane perforation occurs in approximately 0.2% of irrigations 2, 4
• Overall complications requiring specialist referral occur in 1 in 1000 cases 2

Follow-Up and Referral

Document treatment outcomes: 2

• Assess patients after treatment to confirm resolution of impaction
• If impaction persists despite proper treatment, use additional interventions
• If symptoms persist despite wax clearance, evaluate for alternative diagnoses (otitis media, otitis externa, sudden sensorineural hearing loss)

Refer to otolaryngology if: 2, 3

• Multiple treatment attempts are unsuccessful
• Specialized equipment or training for manual removal is lacking
• Patient has contraindications requiring specialist evaluation