OTOCORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).
Otocort is a combination product containing hydrocortisone (a corticosteroid), neomycin (an aminoglycoside antibiotic), and polymyxin B (a polymyxin antibiotic). Hydrocortisone suppresses inflammation by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis. Neomycin binds to bacterial 30S ribosomal subunit, inhibiting protein synthesis. Polymyxin B disrupts bacterial cell membrane permeability by binding to lipopolysaccharides.
| Metabolism | Hydrocortisone is metabolized primarily in the liver via reduction and conjugation; neomycin and polymyxin B are not significantly metabolized systemically after topical otic administration. |
| Excretion | Otocort is a combination product containing hydrocortisone, neomycin, and polymyxin B. The corticosteroid component undergoes hepatic metabolism with renal excretion of metabolites (<5% unchanged). Neomycin is minimally absorbed (3-6% from intact skin, higher from wounds) and excreted renally as unchanged drug (30-50%) and metabolites. Polymyxin B is not significantly absorbed through intact skin or tympanic membrane; systemic absorption negligible. Renal excretion of polymyxin B is slow (40-60% over 72 hours) via glomerular filtration. Fecal elimination accounts for <5% of absorbed dose for all components. |
| Half-life | Hydrocortisone: plasma half-life 1.5-2 hours, biological half-life 8-12 hours due to intracellular receptor binding. Neomycin: terminal half-life 2-4 hours in patients with normal renal function; may prolong to 12-24 hours in renal impairment. Polymyxin B: terminal half-life 6-8 hours in normal renal function; significantly prolonged in renal failure (up to 2-3 days). Clinical context: Topical/otic application yields negligible systemic concentrations, so half-life is relevant only if significant absorption occurs (e.g., damaged tympanic membrane). |
| Protein binding | Hydrocortisone: ~90% bound to corticosteroid-binding globulin (CBG) and albumin. Neomycin: negligible protein binding (<10%). Polymyxin B: ~50-60% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Hydrocortisone: Vd ~0.3-0.5 L/kg (distributes into total body water). Neomycin: Vd ~0.2-0.3 L/kg (extracellular fluid; poor intracellular penetration). Polymyxin B: Vd ~0.3-0.4 L/kg (restricted to extracellular space, does not cross blood-brain barrier). Clinical meaning: Ototopical application yields high local concentrations with negligible systemic distribution unless barrier is breached. |
| Bioavailability | Otic/topical: Systemic bioavailability negligible (<1% for intact tympanic membrane and skin). If tympanic membrane is perforated, neomycin and polymyxin B absorption may reach 10-20% of applied dose; hydrocortisone up to 5%. Oral bioavailability: not applicable for otic/topical route (if ingested, hydrocortisone ~95%, neomycin <3%, polymyxin B not absorbed orally). Bioavailability data for IM/IV routes not relevant to this formulation. |
| Onset of Action | Otic administration: Hydrocortisone anti-inflammatory effect begins within 24-48 hours of application as local tissue concentrations achieve therapeutic levels. Neomycin antibacterial effect: immediate upon contact with bacteria (bactericidal concentration achieved in minutes to hours). Polymyxin B: onset of antibacterial action within 30-60 minutes. Systemic effects not expected with topical otic use. |
| Duration of Action | Hydrocortisone: local anti-inflammatory effect persists for 6-12 hours after single application; clinical improvement noted after 2-3 days of regular dosing. Neomycin: bactericidal effect lasts 6-8 hours; requires q.i.d. dosing to maintain effective concentrations. Polymyxin B: duration 6-8 hours. Duration of therapy typically 7-10 days; prolonged use increases risk of sensitization and superinfection. |
| Molecular Weight | 362.46 |
1-2 drops into affected ear(s) twice daily; otic route.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required; systemic absorption negligible. |
| Liver impairment | No dose adjustment required; systemic absorption negligible. |
| Pediatric use | 1-2 drops into affected ear(s) twice daily for children ≥2 years; safety not established for <2 years. |
| Geriatric use | No dose adjustment required; use same as adult dosing. |
| 1st trimester | Avoid use; contains neomycin which may cause ototoxicity and is potentially teratogenic. Corticosteroids have been associated with cleft palate in animal studies. |
| 2nd trimester | Use only if clearly needed; limited data but risk of fetal growth restriction and adrenal suppression with prolonged corticosteroid use. |
| 3rd trimester | Use only if clearly needed; prolonged use of corticosteroids may lead to fetal adrenal suppression and growth restriction. |
Clinical note
Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).
| Placental transfer | Corticosteroids cross the placenta (hydrocortisone transferred partially, converted to prednisolone). Neomycin likely crosses but degree unknown; minimal systemic absorption from topical use. |
| Breastfeeding | Limited systemic absorption after topical application; however, use on large areas or broken skin may lead to significant exposure. Consider risk of ototoxicity from neomycin. Usually considered compatible with caution. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any componentTuberculous infectionsHerpes simplex keratitisFungal infectionsViral infections (e.g., vaccinia, varicella)
| Precautions | Prolonged use may lead to overgrowth of non-susceptible organisms including fungi, Risk of ototoxicity with neomycin if the tympanic membrane is perforated, Systemic absorption of hydrocortisone may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Use with caution in patients with perforated tympanic membrane |
| Food/Dietary | No significant food interactions. Avoid alcohol as it may worsen dizziness if present. |
| Clinical Pearls |
Loading safety data…
| Lactation Rating | L3 (Moderate Risk) |
| Teratogenic Risk | FDA Pregnancy Category C (based on animal studies; no adequate human studies). In first trimester: potential for minor skeletal anomalies (based on animal data). Second and third trimesters: risk of intrauterine growth restriction (IUGR), premature closure of ductus arteriosus with prolonged use, and fetal adrenal suppression. Avoid high-dose/systemic use during pregnancy. |
| Fetal Monitoring | Maternal: assess adrenal function if prolonged use. Fetal: ultrasound monitoring for growth restriction if repeated high-dose use; ductal Doppler if used beyond 20 weeks gestation. |
| Fertility Effects | No known direct effect on fertility. High-dose systemic glucocorticoids may impair spermatogenesis or ovarian function, but topical application unlikely to affect fertility. |
| OTOCORT (hydrocortisone, neomycin, polymyxin B, and bacitracin) is an otic suspension for topical use only. Not for injection or ophthalmic use. Shake well before use. Avoid prolonged use (>10 days) to prevent superinfection or ototoxicity if tympanic membrane is perforated. Contraindicated in viral or fungal infections. Use with caution in patients with perforated tympanic membrane due to risk of ototoxicity from neomycin. |
| Patient Advice | For ear use only. Do not swallow or inject. · Shake the bottle well before each use. · Lie on your side with the affected ear up for 5 minutes after instilling drops. · Do not touch the dropper tip to any surface to avoid contamination. · Use exactly as prescribed for the full duration, even if symptoms improve. · Inform your doctor if you experience hearing loss, ringing in the ears, or dizziness. · Avoid getting water in the ear while using this medication. · Do not use if you have a ruptured eardrum or ear discharge. |