Ciprodex Otic

Otic Corticosteroid/anti-infective Combinations

The suspension should be warmed by holding the bottle in the hand for 1—2 minutes to avoid the dizziness which may result from instillation of a cold solution into the ear canal. Shake well immediately before using.
The patient should lie with the affected ear upward during installation of the drops. The patient should continue to lie with the affected ear upward for 30—60 seconds to facilitate penetration of the drops into the ear. Administration may be repeated, if necessary, for the opposite ear.

hearing loss / Delayed / 0-1.0

candidiasis / Delayed / 0-1.0
erythema / Early / 0.4-0.4
antimicrobial resistance / Delayed / Incidence not known

otalgia / Early / 0.4-2.3
pruritus / Rapid / 1.5-1.5
dizziness / Early / 0-1.0
tinnitus / Delayed / 0-1.0
irritability / Delayed / 0.5-0.5
dysgeusia / Early / 0.5-0.5
vomiting / Early / Incidence not known
headache / Early / Incidence not known

Ciprodex Otic

Rx

Fluoroquinolone/corticosteroid combination otic suspension used for the topical treatment of selected ear infections, including acute otitis media due to susceptible organisms in children with tympanostomy tubes aged 6 months and older; also used for acute otitis externa (e.g., swimmer's ear).

4 drops in the affected ear(s) twice daily for 7 days.

4 drops instilled into the affected ear twice daily for 7 days.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Ciprofloxacin; Dexamethasone products.

Ciprodex Otic/Ciprofloxacin Hydrochloride, Dexamethasone/Ciprofloxacin, Dexamethasone Auricular (Otic) Susp: 0.3-0.1%

8 drops/day to affected ear(s).

8 drops/day to affected ear(s).

8 drops/day to affected ear(s).

8 drops/day to affected ear(s).

>= 6 months: 8 drops/day to affected ear(s).
< 6 months: No maximum dosage information available; safety and efficacy have not been established.

•Ciprofloxacin: Ciprofloxacin is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription and topoisomerase IV, an enzyme that helps separate the daughter DNA molecules. In gram-negative bacteria, the primary target is the DNA gyrase A subunit, while the primary target in gram-positive bacteria is generally topoisomerase IV.
•Dexamethasone: The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid.

Ciprofloxacin; dexamethasone otic suspension (Ciprodex Otic) is administered topically to the ear. 

Pharmacokinetics of ciprofloxacin and dexamethasone following topical administration to the ear were not evaluated. Plasma concentrations of ciprofloxacin were not measured; the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (i.e., <= 0.05 mcg/mL). Similarly, the predicted plasma concentrations of dexamethasone resulting from topical administration to the ear are not expected to be distinguishable from normal endogenous cortisol concentrations given the limited duration and extent of application; however, systemic absorption of topical corticosteroids may occur with prolonged or excessive use.

There are no available data on ciprofloxacin; dexamethasone topical otic use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, developmental toxicity and embryotoxicity have been observed following ophthalmic and oral administration of dexamethasone. Because of the minimal systemic absorption of ciprofloxacin and dexamethasone after topical otic administration, there is expected to be minimal risk for maternal and fetal toxicity when administered during pregnancy. Animal studies have not been conducted with ciprofloxacin; dexamethasone otic.

It is not known whether ciprofloxacin and dexamethasone are present in human breast milk after topical otic administration. Ciprofloxacin is present in human milk after oral administration; however, because of the minimal systemic absorption of ciprofloxacin after topical otic administration, breast-feeding is not expected to result in the exposure of the infant to ciprofloxacin. Systemically administered corticosteroids appear in human milk and dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects. However, it is not known whether topical otic administration could result in systemic absorption that is sufficient to product detectable quantities of dexamethasone in human milk. There are no data of the effects of ciprofloxacin or dexamethasone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ciprofloxacin; dexamethasone and any potential adverse effects on the breast-fed child.