VOSOL HC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOSOL HC (VOSOL HC).
Acetic acid provides antibacterial and antifungal activity by acidifying the ear canal and disrupting microbial cell membranes. Hydrocortisone suppresses inflammatory mediators.
| Metabolism | Acetic acid is metabolized via the Krebs cycle; hydrocortisone is hepatically metabolized primarily by CYP3A4. |
| Excretion | Renal: 95% as unchanged drug and metabolites; biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life: 2–4 hours. Clinical context: Short half-life necessitates frequent dosing for sustained effect; prolonged in renal impairment. |
| Protein binding | 90–95%, primarily to albumin. |
| Volume of Distribution | Vd: 0.3–0.5 L/kg; clinical meaning: moderate distribution into total body water, limited tissue penetration. |
| Bioavailability | Otic: 80–90% (local absorption with minimal systemic). |
| Onset of Action | Otic: 15–30 minutes for symptomatic relief. |
| Duration of Action | Otic: 4–6 hours; clinical note: Duration limited by drug clearance from the ear canal. |
Instill 5 drops into the affected ear(s) 3-4 times daily, or as directed by physician.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Children: Instill 3 drops into the affected ear(s) 3-4 times daily; use as directed by physician. |
| Geriatric use | No specific geriatric dosage adjustment; use same as adult dosing with caution for increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VOSOL HC (VOSOL HC).
| Breastfeeding | No data on excretion in human milk; topical otic use likely results in negligible systemic absorption. Use caution. M/P ratio unknown. |
| Teratogenic Risk | VOSOL HC (acetic acid, hydrocortisone) otic solution: Pregnancy Category C. No adequate human studies; avoid use unless clearly needed. Hydrocortisone crosses placenta; prolonged systemic use may increase risk of orofacial clefts (first trimester) and fetal adrenal suppression. Acetic acid is considered low risk. Second/third trimester: minimal systemic absorption from otic use, but theoretical risk of adrenal suppression with high doses. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component","Viral infections of the ear (e.g., herpes simplex, varicella)","Fungal infections unless treated with concomitant antifungal therapy"]
| Precautions | ["For external use only","Not for use in eyes","Discontinue if irritation or sensitization occurs","Prolonged use may result in overgrowth of non-susceptible organisms","Use caution in perforated tympanic membrane"] |
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| Fetal Monitoring | Monitor for signs of maternal ototoxicity (balance, hearing) with prolonged use. Fetal monitoring not typically required, but if systemic absorption suspected (high doses, prolonged use), assess fetal growth and adrenal function via ultrasound and postnatal evaluation. |
| Fertility Effects | No known effects on fertility from topical otic administration. Hydrocortisone at systemic doses may impair ovulation; negligible risk with otic use. |