dexamethasone/ciprofloxacin (Rx)

Frequency Not Defined

Alopecia

Dermatitis

Dysgeusia

Fungal dermatitis

Headache

Hyperesthesia

Migraine headache

Paresthesias

Pruritus

Rash

Urticaria

Contraindications

Hypersensitivity to any component (contains benzalkonium chloride)

Fungal or viral infections of external canal, including varicella and herpes simplex virus infections

Cautions

Discontinue if hypersensitivity or superinfection occurs

Reevaluate if no improvement is noted after 1 week

Prolonged use may result in overgrowth of non-susceptible bacteria and fungi

Otorrhea may occur; if it persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor

Tendon inflammation and/or rupture reported with systemic fluoroquinolones; exposure resulting from otic administration is substantially lower than systemic therapy; discontinue at first sign of tendon inflammation or pain

Pregnancy

There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; because of minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration, product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women

Animal reproduction studies have not been conducted; oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits not reported to cause fetal malformations; these doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA); with dexamethasone, malformations have been observed in animal studies after ocular and systemic administration

Lactation

Not known whether ciprofloxacin and dexamethasone are present in human milk following topical otic administration

Published literature reports presence of ciprofloxacin in human milk after oral administration to lactating women; however, because of minimal systemic absorption of ciprofloxacin following topical otic administration, breastfeeding is not expected to result in exposure of infant to ciprofloxacin

Systemically administered corticosteroids appear in human milk; dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; however, not known whether topical otic administration of drug could result in systemic absorption that is sufficient to produce detectable quantities of dexamethasone in human milk

There are no data on effects of ciprofloxacin or dexamethasone on milk production

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug combination and any potential adverse effects on breast-fed child from therapy

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Ciprofloxacin: Inhibits DNA gyrase and topoisomerase IV; bactericidal

Dexamethasone: Suppresses inflammatory response associated with bacterial infections

Absorption

Negligible systemic absorption

Peak plasma time: 15 min to 2 hr

Elimination

Excretion: Urine