CLASSES
Otic Corticosteroid/anti-infective Combinations
DESCRIPTION
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
COMMON BRAND NAMES
Acetasol HC, Otomycet-HC, VoSoL HC
HOW SUPPLIED
Acetasol HC/Hydrocortisone, Acetic Acid/Hydrocortisone, Acetic Acid, Glacial/Otomycet-HC/VoSoL HC Auricular (Otic) Sol: 1-2%
DOSAGE & INDICATIONS
For the treatment of superficial bacterial infections of the external auditory canal (i.e., otitis externa) caused by susceptible organisms.
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.
MAXIMUM DOSAGE
Adults
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.
DOSING CONSIDERATIONS
Hepatic Impairment
No dosage adjustment is needed.
Renal Impairment
No dosage adjustment is needed.
ADMINISTRATION
Otic Administration
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.
STORAGE
Generic:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Acetasol HC:
- Store at controlled room temperature (between 68 and 77 degrees F)
Otomycet-HC:
- Store at controlled room temperature (between 68 and 77 degrees F)
VoSoL HC:
- Store at controlled room temperature (between 68 and 77 degrees F)
CONTRAINDICATIONS / PRECAUTIONS
General Information
NOTE: This monograph discusses the use of hydrocortisone; acetic acid combination product for treatment of selected otic infections. Clinicians may wish to consult the individual drug monographs for more information about each specific agent.
Corticosteroid hypersensitivity
Hydrocortisone; acetic acid is contraindicated in patients with a known or suspected hypersensitivity to any of the product ingredients, such as hydrocortisone sensitivity (corticosteroid hypersensitivity). VoSoL HC also contains propylene glycol and benzethonium chloride. Discontinue use immediately if irritation or a rash develops.
Herpes infection, varicella
Hydrocortisone; acetic acid otic is listed by the manufacturer as being contraindicated in patients with herpes infection (e.g., herpes simplex or vaccinia) and varicella. It is recommended that hydrocortisone; acetic acid should not be used for longer than 10 days to avoid development of secondary infections. If the initial infection is not improved after 7 to 10 days of therapy, cultures are recommended to guide further treatment.
Tympanic membrane perforation
All otic medications are generally contraindicated in patients with tympanic membrane perforation (e.g., ruptured eardrum). Otic preparations, such as hydrocortisone; acetic acid, should be used sparingly to prevent accumulation of excess debris (i.e., cerumen) in the ear.
Ocular exposure, ophthalmic administration, parenteral administration
Avoid ocular exposure of hydrocortisone; acetic acid otic preparations. Hydrocortisone; acetic acid is not for ophthalmic administration or parenteral administration.
Children, infants, neonates
The safety and effectiveness of hydrocortisone; acetic acid in children below the age of 3, including infants and neonates, have not been established.
Pregnancy
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.
Breast-feeding
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.
ADVERSE REACTIONS
Moderate
superinfection / Delayed / Incidence not known
Mild
skin irritation / Early / Incidence not known
DRUG INTERACTIONS
There are no drug interactions associated with Hydrocortisone; Acetic Acid products.
PREGNANCY AND LACTATION
Pregnancy
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.
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.
PHARMACOKINETICS
Hydrocortisone; acetic acid is administered as an otic solution. There are no specific pharmacokinetic data describing hydrocortisone; acetic acid.
Other Route(s)
Otic Route
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.