OTOCORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).

Breastfeeding	Excretion into human milk minimal. M/P ratio not established. Short-term topical use considered compatible with breastfeeding. Avoid application to breasts or large areas. Monitor infant for skin irritation or systemic effects.
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.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component","Perforated tympanic membrane (due to risk of ototoxicity)","Viral or fungal infections of the external ear","Mycobacterial infections"]

Clinical Precautions

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"]

Clinical Tips & Counseling

Drug interactions

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OTOCORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).

How it works

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OTOCORT (OTOCORT).

Breastfeeding	Excretion into human milk minimal. M/P ratio not established. Short-term topical use considered compatible with breastfeeding. Avoid application to breasts or large areas. Monitor infant for skin irritation or systemic effects.
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.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component","Perforated tympanic membrane (due to risk of ototoxicity)","Viral or fungal infections of the external ear","Mycobacterial infections"]