Adult Dosing

Acute otitis externa

• 4 drops in infected ear(s) bid x 7 days
• Note: Indicated for Staphylococcus aureus and Pseudomonas aeruginosa infections

Pediatric Dosing

Acute otitis media (child 6 months)

• 4 drops in infected ear(s) bid x 7 days through tympanostomy tubes

Acute otitis externa (child 6 months)

• 4 drops in infected ear(s) bid x 7 days

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute otitis externa
• Acute otitis media in pediatric patients with tympanostomy tubes

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to quinolones
• Viral infections of the external canal including herpes simplex infections

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• For otic use only; not for ophthalmic use
• Suspend therapy at the first appearance of a skin rash or any other sign of hypersensitivity. Institute immediate emergency treatment if serious acute hypersensitivity reactions occur
• It may result in overgrowth of nonsusceptible organisms, including yeast and fungi
• If no therapeutic response observed in a week of treatment, obtain cultures to guide further treatment
• After full course of therapy if otorrhea persists or if within six months there are two or more otorrhea episodes, evaluate to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor

Supplemental Patient Information

• Use the ear drops for the period prescribed by the doctor, even if the symptoms improve

Pregnancy Category:C

Breastfeeding: Safety unknown; topical dexamethasone has not been studied during breastfeeding. Short-term application would pose a risk to the breastfed infant by passage into breastmilk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 December 2010). Ciprofloxacin is compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting ciprofloxacin. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 15 December 2010 ). According to the manufacturer data, it is not known whether topical otic administration could result in sufficient systemic absorption to produce detectable quantities in human milk. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• EENT: Ear discomfort, ear pain, ear pruritus, ear debris, erythema, ear congestion
• MISC: Secondary infection

Ciprofloxacin

• Fluoroquinolone antibiotic; interfere with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA
• Peak plasma concentration is 0.543 ng/mL to 3.45 ng/mL
• Metabolism: Unknown; CYP450: Unknown
• Excretion: Unknown
• Half-life: Unknown

Dexamethasone

• Corticosteroid; suppresses inflammation and the normal immune response
• Minimally absorbed after otic administration
• Metabolized in the liver by CYP3A4
• Renally excreted
• Half-life: 1.8-3.5 hrs
• Peak plasma concentrations of ciprofloxacin/dexamethasone occurred within 15 minutes to 2 hours after dose

US Trade Name(s)

• Ciprodex

US Availability

Ciprodex (ciprofloxacin/dexamethasone)

• SUSP: 0.3%/0.1%

Canadian Trade Name(s)

• Ciprodex

Canadian Availability

Ciprodex (ciprofloxacin/dexamethasone)

• SUSP: 0.3%/0.1%

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Otic Agents; Topical

Antimicrobials (+/- Steroid) Antimicrobials

ENT

Otic Agents; Topical

Antimicrobials (+/- Steroid) Antimicrobials

Infectious Disease

Otic Agents; Topical

Antimicrobials (+/- Steroid) Antimicrobials