Carbamide peroxide, also known as urea hydrogen peroxide, is an otic and topical (oral) preparation. The otic formulations are used to remove ear wax (cerumen) impaction. Mineral oil, olive oil, and dilute hydrogen peroxide solutions are inexpensive agents used to soften ear wax. One in-vitro study demonstrated that liquid docusate sodium had better efficacy than carbamide peroxide in dissolving ear wax. Oral carbamide peroxide solutions are antiseptics used in the treatment of canker sores (apthous ulcers), gingivitis, and in minor irritations. Topical carbamide peroxide can also be used as an adjunct to oral hygiene after regular brushing or when normal oral hygiene is not possible. Safety and efficacy data for oral use of carbamide peroxide is lacking. Many cosmetic dental whitening systems contain carbamide peroxide 10-20% as the active ingredient.
General Administration Information
For storage information, see specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-For topical application to the mouth only. Do not swallow solution.
Otic Administration
-The solution may be warmed by holding the bottle in the hand for 1-2 minutes.
-The patient should lie with the affected ear upward during installation of the drops. The tip of the applicator should not enter the ear canal. After the drops are instilled, the patient should remain lying with the affected ear upward for 5 minutes to facilitate penetration of the drops into the ear canal. A cotton pledget may be gently inserted at the ear opening for no longer than 5-10 minutes to ensure retention. Repeat, if necessary, for the opposite ear.
-Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Do not irrigate the ear if the tympanic membrane is perforated.
-Avoid soap, shampoo or alcohol in ear. To help prevent ear wax recurrence, olive oil or baby oil may be placed in the ear prior to shampooing.
-Care should be taken to avoid contamination. Do not touch the tip of the dropper to the ear, fingertips, or other surface.
-Do not rinse the dropper after use; keep container tightly closed.
-Do not share with other patients.
Controversy exists over the long-term safety of carbamide peroxide. Carbamide peroxide releases hydrogen radicals and oxygen, and prolonged use may lead to mutagenicity, carcinogenicity, or delayed wound healing. No long term human studies have been completed to address these concerns. Superinfection with opportunistic fungal organisms may also be a risk with long-term use. Long-term safety concerns have been generated primarily due to use of high concentration carbamide peroxide for cosmetic tooth whitening. One animal study evaluated hydrogen peroxide applied twice a week for 22 weeks with or without 9, 10-dimethyl-1,2-benzanthracene (DMBA), a known carcinogen associated with tobacco smoking. The results indicated that hydrogen peroxide could, by itself, induce pathologic changes frequently associated with preneoplastic lesions; it may also augment carcinogenesis associated with DMBA.
No adverse reactions are regularly associated with the use of carbamide peroxide. Transient stinging may occur upon local application to oral mucous membranes. Discontinue treatment if signs and symptoms of a local allergic reaction occur, such as burning, pruritus, pain, erythema, discharge, or rash (unspecified).
With prolonged use of oral carbamide peroxide, there is a potential for overgrowth of opportunistic organisms leading to black hairy tongue, damage to periodontal tissues, transient tooth sensitivity due to decalcification of enamel and delayed wound healing. Self medication with oral topical carbamide peroxide should not occur for longer than 7 days, and patients should contact their health care provider if symptoms (i.e., irritation or inflammation of the mouth or throat) worsen or persist past 7 days. If at any time a rash develops during use of these products, discontinue use and contact a health care provider.
Carbamide peroxide preparations should not be used in the eye. If accidental ocular exposure occurs, flush eyes with water and consult a health care professional.
Self-medication with otic carbamide peroxide should not occur past 4 days, and patients should contact their health care provider if symptoms (i.e., dizziness, drainage, pain, fever, hearing impairment) worsen during treatment or persist past 4 days. Carbamide peroxide will cause cerumen to expand during treatment which may worsen hearing during treatment. Any otic bleeding should be immediately reported to a health care professional.
The otic preparations of carbamide peroxide are not for use in patients with a tympanic membrane perforation, following otic surgery or in patients with ear discharge, ear pain, ear rash, ear irritation, otitis media, tinnitus or dizziness. Additionally, warm water irrigation of the ear canal using a soft bulb irrigator should only be performed if the tympanic membrane is known to be intact. The use of dental jet irrigators (e.g., WaterPik) should not be used for ear wax removal as the force of the water may result in tympanic membrane perforations. Cotton-tipped applicators and other instruments should be avoided to prevent further impaction of cerumen. Otic carbamide peroxide should be avoided for 6 weeks following ear surgery, or as directed by the health care provider.
Children < 12 years (for the otic products) and children < 2 years (for the oral products) should use carbamide peroxide with caution. The manufacturers recommend that caregivers of children in these age groups, including neonates and infants, seek the advice of a health care professional prior to use.
An animal study demonstrated the possible carcinogenic effects of hydrogen peroxide (a component of carbamide peroxide) alone or when combined with a carcinogen that mimicked the oral conditions of a frequent tobacco smoker. It may be prudent to advise patients to refrain from tobacco smoking while using carbamide peroxide products.
Information is not available about the safety of carbamide peroxide use during breast-feeding. However, maternal absorption would be expected to be low. With short-term use by the mother, neither otic products or products used for whitening of teeth or other oral care should pose great risk to a nursing infant.
Information is not available about the use of carbamide peroxide in pregnancy. Significant systemic absorption of the otic product components is not expected with normal use of limited duration (i.e., 4 days); it is unlikely that any significant concentration reaches the fetus. Absorption characteristics of the topical oral products (e.g., teeth whitening or other oral care products) are not known. Many experts recommend delaying teeth whitening until after pregnancy, although there is no known specific hazard resulting from tooth whitening during pregnancy; pregnant patients should consult a dentist along with their health care provider prior to considering use of these products. No adequate and well-controlled studies have been conducted in pregnant women; the estimated risk category of these products most closely corresponds with FDA pregnancy risk category C.
For cerumen removal:
Otic dosage (products marked for otic use only):
Adults, Adolescents, and Children 12 years and older: Instill 5 to 10 drops twice daily in the affected ear(s) for up to 4 days. Keep drops in ear for 5 minutes by keeping head tilted or placing cotton in ear. Do not use for more than 4 days.
Children younger than 12 years*: Instill 3 drops (range: 1 to 5 drops) twice daily in the affected ear(s) for up to 4 days. Dosage should be individualized according to patient size. Do not use for more than 4 days. The manufacturer recommends against use in children younger than 12 years unless supervised by a health care provider.
For the relief of minor inflammation of the gums, oral mucosal surfaces and lips including canker sores (aphthous ulcer) and as an adjunct to dental irritation (dental pain*, gingivitis*, periodontitis*, or stomatitis*):
Oral dosage (oral topical solution):
Adults, Adolescents, and Children 2 years and older: Apply several drops undiluted to affected area of the mouth 4 times per day (after meals and at bedtime); expectorate after 2 to 3 minutes. Do not use for more than 7 days.
Children younger than 2 years: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Elderly
No maximum dosage information is available.
-Adolescents
No maximum dosage information is available.
-Children
>= 2 years: No maximum dosage information is available.
< 2 years: Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage guidelines are available; it appears no dosage adjustment is needed.
Patients with Renal Impairment Dosing
No dosage guidelines are available; it appears no dosage adjustment is needed.
*non-FDA-approved indication
There are no drug interactions associated with Carbamide Peroxide products.
Carbamide peroxide releases hydrogen peroxide and oxygen upon contact with tissue enzymes. The release of oxygen results in a weak antibacterial effect, deodorant action and effervescence that aids in removal of debris. Carbamide peroxide helps to soften impacted cerumen and debrides oral lesions through its foaming action. Many otic preparations also contain anhydrous glycerin that has emollient and humectant properties.
Carbamide peroxide is administered topically to the ear canal or to the oral mucosa. Significant systemic absorption is not anticipated with short-term clinical use, as the drug dissociates into hydrogen peroxide and oxygen.