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Ear (Otic) Preparations

Auralgan ® (benzocaine + antipyrine) carbamide peroxide (Debrox ®)
CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Ciprofloxacin and hydrocortisone - Cipro HC Otic ®:
Cortisporin ® (Hydrocortisone, polymyxin, neosporin) Ofloxacin (Floxin otic ®)
Triethanolamine (Cerumenex ®) Vosol Otic ® (acetic acid + propylene glycol)

Auralgan ® (benzocaine + antipyrine): top of page icon

 Indications:
ACUTE OTITIS MEDIA OF VARIOUS ETIOLOGIES
-Prompt relief of pain and reduction of inflammation in the congestive and serous stages.   -Adjuvant therapy during systemic antibiotic administration for resolution of the infection.

REMOVAL OF CERUMEN
Facilitates the removal of excessive or impacted cerumen.

Dosing:
ACUTE OTITIS MEDIA:  Instill Auralgan permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Auralgan and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

REMOVAL OF CERUMEN:  Before: Instill Auralgan three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
After: Auralgan is useful for drying out the canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Auralgan should be inserted into the meatus following instillation. 

Note: Do not rinse dropper after use.  Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.

DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.

Supplied:
Each mL contains:
Antipyrine ............................................ 54.0 mg
Benzocaine ........................................... 14.0 mg
Glycerin dehydrated q.s. to ..................... 1.0 mL

carbamide peroxide (Debrox ®): top of page icon

Facilitate ear wax removal:
Mechanism of Action
Carbamide peroxide releases hydrogen peroxide which serves as a source of nascent oxygen upon contact with catalase. Softens impacted cerumen due to its foaming action

Dosage:  [Otic preparation should not be used for >4 days.]
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
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Children >/= 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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Supplied:
Solution, otic: 6.5% (15 mL)
Debrox®: 6.5% (15 mL, 30 mL)

CIPRODEX®  (ciprofloxacin 0.3% and dexamethasone 0.1%) top of page icon

Indications:  CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:  Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Dosing:
(Shake well before use).
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (age 6 months and older) through tympanostomy tubes is:

Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Acute Otitis Externa

The recommended dosage regimen for the treatment of acute otitis externa is: For patients (age 6 months and older): Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.

Supplied:  CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension.

Ciprofloxacin and hydrocortisone - Cipro HC Otic ®: top of page icon

Dosing: Otitis externa: The recommended dosage for all patients is three drops of the suspension in the affected ear twice daily for 7 days. 

[Children >1 year of age and Adults: Otic: The recommended dosage for all patients is three drops of the suspension in the affected ear twice daily for seven day; twice-daily dosing schedule is more convenient for patients than that of existing treatments with hydrocortisone, which are typically administered three or four times a day]

Supplied: Otic suspension: Ciprofloxacin 0.2% and hydrocortisone 1% (10 ml)

Cortisporin ® (Hydrocortisone, polymyxin, neosporin): top of page icon

Duration of use should be limited to 10 days unless otherwise directed by the physician
Otic solution is used only for swimmer's ear (infections of external auditory canal)

Dosage:
Otic:
Children: Instill 3 drops into affected ear 3-4 times/day
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Adults: Instill 4 drops 3-4 times/day; otic suspension is the preferred otic preparation
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Administration
Shake suspension well before using. Otic solution should not be used when the integrity of the tympanic membrane is in question.

Supplied:
Solution, otic (AntibiOtic® Ear; Cortisporin®): Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per mL (10 mL)

Suspension, otic: Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per mL (10 mL)

Ofloxacin (Floxin otic ®):  top of page icon

Dosing:
Acute otitis media with tympanostomy tubes: Children 1-12 years: Instill 5 drops (or the contents of 1 single-dose container) into affected ear(s) twice daily for 10 days

Chronic suppurative otitis media with perforated tympanic membranes: Children >12 years and Adults: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear twice daily for 14 days

Otitis externa:
Children 6 months to 13 years: Instill 5 drops (or the contents of 1 single-dose container) into affected ear(s) once daily for 7 days

Children >/= 13 years and Adults: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear(s) once daily for 7 days

Supplied:
Solution, otic:
Floxin®: 0.3% (5 mL, 10 mL) [contains benzalkonium chloride]

Floxin® Otic Singles™: 0.3% (0.25 mL) [contains benzalkonium chloride; packaged as 2 single-dose containers per pouch, 10 pouches per carton, total net volume 5 mL]

Triethanolamine (Cerumenex ®):  top of page icon

Facilitate ear wax removal:
Mechanism of Action
CERUMENEX Eardrops emulsify and disperse excess or impacted earwax. The triethanolamine polypeptide oleate, a surfactant, in a hygroscopic vehicle lyses cerumen to facilitate removal by subsequent water irrigation.

Dosage
Children and Adults: Otic: Fill ear canal, insert cotton plug; allow to remain 15-30 minutes; flush ear with lukewarm water as a single treatment; if a second application is needed for unusually hard impactions, repeat the procedure

Supplied:
Solution, otic: 10% (6 mL, 12 mL)

Vosol Otic ® (acetic acid + propylene glycol):  top of page icon

Indications:  For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

CLINICAL PHARMACOLOGY
Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues

Dosing:
Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated.

Supplied:  Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles.)

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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