PEDIOTIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PEDIOTIC (PEDIOTIC).
PEDIOTIC contains hydrocortisone, neomycin, and polymyxin B. Neomycin and polymyxin B are antibiotics that inhibit bacterial protein synthesis and disrupt bacterial cell membrane integrity, respectively. Hydrocortisone is a corticosteroid that suppresses inflammation by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis.
| Metabolism | Systemic absorption of neomycin and polymyxin B is minimal when applied to intact skin. Hydrocortisone is metabolized in the liver via reduction and glucuronidation. Enzymes: primarily CYP3A4 for hydrocortisone. |
| Excretion | Renal elimination of absorbed drug (primarily unchanged) accounts for <10% of topically applied dose; fecal/biliary routes negligible. |
| Half-life | Not established for topical otic use; systemic absorption is minimal. If absorbed, terminal half-life of dexamethasone is approximately 3-4 hours. |
| Protein binding | Dexamethasone: ~77% bound to albumin; neomycin: about 10-30% bound to serum proteins; polymyxin B: less than 10% bound. |
| Volume of Distribution | Not applicable for topical otic use; systemic absorption <10%. For IV dexamethasone: Vd ~0.75-1.3 L/kg (reflects distribution into total body water). |
| Bioavailability | Topical otic: <10% systemic absorption (minimal via intact tympanic membrane; higher if mucosa/tympanum perforated). Oral/parenteral not applicable. |
| Onset of Action | Within 24-48 hours of topical otic administration for reduction of inflammation and bacterial eradication. |
| Duration of Action | Typically 5-7 days after completion of 7-10 day course; clinical resolution of otitis externa. |
Instill 4 drops into the affected ear(s) twice daily for 7-10 days.
| Dosage form | SUSPENSION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Children: 4 drops into affected ear(s) twice daily for 7-10 days. |
| Geriatric use | No specific dose adjustment; use same as adult dosing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PEDIOTIC (PEDIOTIC).
| Breastfeeding | It is not known whether PEDIOTIC components are excreted in human milk following otic administration. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman. The M/P ratio is not available. |
| Teratogenic Risk | PEDIOTIC contains neomycin, polymyxin B, and hydrocortisone. Systemic absorption is minimal with otic administration. No adequate and well-controlled studies in pregnant women. Animal studies with neomycin show evidence of impaired fertility and fetal harm at high doses; polymyxin B is not teratogenic in animals; hydrocortisone is generally considered low risk in pregnancy with minimal absorption. Risk cannot be ruled out; use only if clearly needed. |
■ FDA Black Box Warning
WARNING: OTOTOXICITY. This product contains neomycin, which can cause irreversible sensorineural hearing loss, especially when used in patients with perforated tympanic membranes or in middle ear applications. Avoid use in patients with tympanic membrane perforation or in middle ear surgery.
| Serious Effects |
Hypersensitivity to any component; viral, fungal, or tuberculous infections of the ear; tympanic membrane perforation; ophthalmic use.
| Precautions | Avoid prolonged use to prevent sensitization or overgrowth of nonsusceptible organisms. Discontinue if irritation or hypersensitivity occurs. Use with caution in patients with perforated tympanic membranes due to risk of ototoxicity. Prolonged use of corticosteroids may lead to suppression of local immune response or adrenal suppression. |
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| Fetal Monitoring | No specific maternal-fetal monitoring is required. If ototoxicity from neomycin is a concern, monitor for hearing loss or dizziness. Audiometric testing may be considered if prolonged use or high doses are used. |
| Fertility Effects | No human data on fertility effects. Animal studies with neomycin have shown impaired fertility at high doses. The relevance to humans is unknown. |