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Pronunciation |
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(KAR
ba mide per OKS
ide) |
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U.S. Brand
Names |
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Auro® Ear Drops [OTC]; Debrox®
Otic [OTC]; ERO Ear [OTC]; Gly-Oxide® Oral [OTC]; Mollifene®
Ear Wax Removing Formula
[OTC]; Murine® Ear Drops [OTC]; Orajel®
Perioseptic®[OTC]; Proxigel® Oral
[OTC] |
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Generic
Available |
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Yes |
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Synonyms |
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Urea Peroxide |
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Pharmacological Index |
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Otic Agent, Cerumenolytic |
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Use |
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Relief of minor inflammation of gums, oral mucosal surfaces and lips
including canker sores and dental irritation; emulsify and disperse ear
wax |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Otic preparation should not be used in patients with a perforated tympanic
membrane; ear drainage, ear pain or rash in the ear; do not use in the eye; do
not use otic preparation longer than 4 days; oral preparation should not be used
in children <3 years |
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Warnings/Precautions |
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Oral: With prolonged use of oral carbamide peroxide, there is a potential for
overgrowth of opportunistic organisms; damage to periodontal tissues; delayed
wound healing; should not be used for longer than 7 days
Otic: Do not use if ear drainage or discharge, ear pain, irritation, or rash
in ear; should not be used for longer than 4 days |
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Adverse
Reactions |
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1% to 10%:
Local: Irritation, redness
Miscellaneous: Superinfections |
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Drug
Interactions |
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No data reported |
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Stability |
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Store in tight, light-resistant containers; oral gel should be stored under
refrigeration |
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Mechanism of
Action |
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Carbamide peroxide releases hydrogen peroxide which serves as a source of
nascent oxygen upon contact with catalase; deodorant action is probably due to
inhibition of odor-causing bacteria; softens impacted cerumen due to its foaming
action |
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Pharmacodynamics/Kinetics |
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Onset of effect: Slight disintegration of hard ear wax in 24
hours |
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Usual Dosage |
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Children and Adults:
Oral solution (should not be used for >7 days): Oral preparation should
not be used in children <3 years of age; apply several drops undiluted on
affected area 4 times/day after meals and at bedtime; expectorate after 2-3
minutes or place 10 drops onto tongue, mix with saliva, swish for
several minutes, expectorate
Otic:
Children <12 years: Tilt head sideways and individualize the dose
according to patient size; 3 drops (range: 1-5 drops) twice daily for up to 4
days, tip of applicator should not enter ear canal; keep drops in ear for
several minutes by keeping head tilted and placing cotton in ear
Children greater than or equal to 12 years and Adults: Tilt head sideways and
instill 5-10 drops twice daily up to 4 days, tip of applicator should not enter
ear canal; keep drops in ear for several minutes by keeping head tilted and
placing cotton in ear |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Contact physician if dizziness or otic redness, rash, irritation, tenderness,
pain, drainage, or discharge develop; do not drink or rinse mouth for 5 minutes
after oral use of gel |
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Nursing
Implications |
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Patient may complain of foaming |
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Dosage Forms |
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Gel, oral (Proxigel®): 10% (34 g)
Solution:
Oral:
Gly-Oxide®: 10% in glycerin (15 mL, 60 mL)
Orajel® Perioseptic®: 15% in
glycerin (13.3 mL)
Otic (Auro® Ear Drops, Debrox®,
Mollifene® Ear Wax Removing, Murine®
Ear Drops): 6.5% in glycerin (15 mL, 30 mL)
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