COR-OTICIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COR-OTICIN (COR-OTICIN).
COR-OTICIN is a combination product containing hydrocortisone (a corticosteroid with anti-inflammatory and immunosuppressive properties) and neomycin (an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit) and polymyxin B (a polymyxin antibiotic that disrupts bacterial cell membrane permeability).
| Metabolism | Hydrocortisone is primarily metabolized in the liver via reduction, conjugation (glucuronidation and sulfation), and CYP3A4-mediated oxidation. Neomycin is minimally metabolized and is excreted largely unchanged. Polymyxin B is not significantly metabolized; elimination mainly via renal tubular secretion. |
| Excretion | Renal (60-80% unchanged), fecal/biliary (5-10%) |
| Half-life | Terminal half-life 4-6 hours; prolonged in renal impairment (up to 12-15 hours) |
| Protein binding | 70-80% primarily to albumin |
| Volume of Distribution | 0.3-0.5 L/kg; distributes into total body water |
| Bioavailability | Oral: 70-80% (first-pass effect minimal); Intramuscular: approximately 90% |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes |
| Duration of Action | 4-8 hours depending on dose and renal function |
| Molecular Weight | 416.5 |
1-2 drops in each affected ear twice daily for 7 days.
| Dosage form | SUSPENSION/DROPS |
| Renal impairment | No adjustment required. |
| Liver impairment | No adjustment required. |
| Pediatric use | 1 drop in each affected ear twice daily for 7 days. |
| Geriatric use | Same as adult dosing; no specific adjustment required. |
| 1st trimester | Avoid during first trimester unless essential. Animal studies show teratogenic effects; no adequate human studies. |
| 2nd trimester | Use only if clearly needed. Potential risk of intrauterine growth restriction and adrenal suppression in fetus. |
| 3rd trimester | Use with caution; may cause neonatal adrenal suppression if used near term. |
Clinical note
Comprehensive clinical and safety monograph for COR-OTICIN (COR-OTICIN).
| Placental transfer | Crosses placenta; degree of transfer is significant with systemic absorption. Topical use may result in lower transfer. |
| Breastfeeding | Excreted in breast milk in low amounts; unlikely to cause adverse effects in infant at therapeutic doses. However, high doses or prolonged use may suppress infant adrenal function. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any componentUntreated bacterial, fungal, or viral infections at application sitePerioral dermatitisRosacea
| Precautions | Prolonged use may result in overgrowth of nonsusceptible organisms including fungi, Ototoxicity: neomycin may cause irreversible cochlear damage if absorbed through the middle ear; avoid use in patients with tympanic membrane perforation, Systemic absorption of hydrocortisone may suppress hypothalamic-pituitary-adrenal (HPA) axis, Sensitization to neomycin may develop with continued use, Avoid prolonged treatment (>10 days) due to increased risk of superinfection |
| Food/Dietary | No clinically relevant food interactions. |
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| Lactation Rating |
| L2 - Safer |
| Teratogenic Risk | First trimester: Limited human data; animal studies show increased risk of cleft palate and neural tube defects at high doses. Second and third trimesters: Associated with intrauterine growth restriction, preterm birth, and neonatal adrenal suppression. |
| Fetal Monitoring | Maternal: Blood pressure, blood glucose, serum electrolytes, and adrenal function. Fetal: Ultrasound for growth and amniotic fluid volume; consider fetal echocardiogram for potential cardiac effects. |
| Fertility Effects | May suppress hypothalamic-pituitary-adrenal axis, leading to menstrual irregularities and anovulation. Reversible upon dose reduction or discontinuation. |
| Clinical Pearls |
| COR-OTICIN is a fixed-dose combination of hydrocortisone and acetic acid used for otic infections. Hydrocortisone reduces inflammation and itching; acetic acid restores acidic pH to inhibit bacterial/fungal growth. Use only for external ear infections (otitis externa); contraindicated in tympanic membrane perforation to avoid ototoxicity. Shake well before use. Avoid prolonged use (>10 days) to prevent fungal superinfection. |
| Patient Advice | Instill 3-5 drops into the affected ear(s) 3-4 times daily for up to 10 days. · Lie on side with affected ear up for 5 minutes after instillation. · Do not touch dropper tip to ear or surfaces. · Do not use if you have a perforated eardrum (history of ear surgery, ear tube, or ear pain with drainage). · Discontinue and contact doctor if symptoms worsen or persist after 7 days. |