Otic Corticosteroid/anti-infective Combinations
For application to the external ear canal only. Do not use in the eyes.
Carefully remove all cerumen and external debris to allow hydrocortisone; acetic acid to contact infected surfaces directly.
Prior to administration, the solution may be warmed by holding the bottle in the hand for 1 to 2 minutes.
Patients should lie with the affected ear upward. This position should be maintained for a few minutes to facilitate penetration of the drops into the external ear canal.
To promote continuous contact, a cotton wick should be inserted into the external ear canal and saturated with the solution. The wick should be kept moist (see Dosage). Repeat, if necessary, for the opposite ear. The wick should be replaced at least once every 24 hours. If preferred, the wick may be removed after 24 hours; however, the patient should continue to instill the drops as directed for as long as indicated.
Care should be taken to avoid contamination. Each dropper is for use by a single patient only. Do not touch the tip of the dropper to the ear, fingertips, or other surface.
Do not rinse the dropper after use; keep container tightly closed.
superinfection / Delayed / Incidence not known
skin irritation / Early / Incidence not known
Common Brand Names
Acetasol HC, Otomycet-HC, VoSoL HC
Otic solution containing a steroid and acetic acid
Used for otitis externa
Hydrocortisone has anti-inflammatory and antipruritic properties; acetic acid has antifungal and antibacterial action
Dosage And Indications
NOTE: If the infection does not improve after 1 week of treatment, cultures and susceptibility tests should be performed to determine whether therapy should be changed.
Otic dosage Adults, Geriatric, Adolescents, and Children >= 3 years
Insert a cotton wick into the external ear canal and saturate with the solution. Keep wick moist by adding 3 to 5 drops of solution every 4 to 6 hours. Replace wick at least once every 24 hours. If preferred, the wick may be removed after 24 hours; however, continue to instill 3 to 5 drops into the ear(s) 3 to 4 times daily for as long as indicated. The lower end of the dosage range is usually recommended in children.
No dosage adjustment is needed.Renal Impairment
No dosage adjustment is needed.
There are no drug interactions associated with Hydrocortisone; Acetic Acid products.
Acetasol HC/Hydrocortisone, Acetic Acid/Hydrocortisone, Acetic Acid, Glacial/Otomycet-HC/VoSoL HC Auricular (Otic) Sol: 1-2%
Maximum dosage information is not available.Elderly
Maximum dosage information is not available.Adolescents
Maximum dosage information is not available.Children
>= 3 years: Maximum dosage information is not available.
< 3 years: Safety and efficacy have not been established.
Mechanism Of Action
Hydrocortisone: Hydrocortisone is indicated when otitis externa is complicated by inflammation or itching. Topical application of hydrocortisone produces anti-inflammatory, antipruritic, and vasoconstrictor actions. The activity is thought to result at least in part from binding with a steroid receptor. The anti-inflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Tachyphylaxis to the anti-inflammatory effects of corticosteroids may occur with repeated application; withdrawal of the drug restores response.
Acetic acid: Acetic acid is an organic acid with bacteriostatic and fungistatic properties. Acetic acid penetrates the bacterial cell wall and disrupts the cell membrane. Acetic acid is considered active against the following microorganisms: Aspergillus sp., Pseudomonas sp., and Candida sp.
Hydrocortisone; acetic acid is administered as an otic solution. There are no specific pharmacokinetic data describing hydrocortisone; acetic acid.Other Route(s)
Hydrocortisone is metabolized in the skin. Acetic acid is completely oxidized by the body and does not affect systemic pH. Except when applied to large areas or for an extended period of time, systemic absorption of these agents is negligible.
Pregnancy And Lactation
No data are provided by the manufacturer regarding the use of hydrocortisone; acetic acid otic solution during pregnancy. Significant systemic absorption of the otic product components is not expected in normal prescription use.
The manufacturer does not make any recommendations for the use of hydrocortisone; acetic acid otic solution during breast-feeding. Drugs, such as acetic acid, administered via the otic route generally exert a local effect and may result in minimal systemic absorption; clinically significant breast milk concentrations are not expected. Hydrocortisone is excreted into breast milk after systemic administration. Trace amounts of endogenous hydrocortisone (cortisol) are excreted in breast milk; however, no reports of exogenous hydrocortisone excretion into breast milk exist. The American Academy of Pediatrics (AAP) states that another steroid, prednisone, is usually compatible with breast-feeding. Another report states that systemic steroids used in asthma patients are compatible with breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.