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AK-Spore HC
Classes
Combinations of Corticosteroids with Antibacterials
Ophthalmological Corticosteroid and Anti-infective Combinations
Otic Corticosteroid/anti-infective Combinations
Topical Aminoglycosides, Plain or in Combination
Topical Polypeptide Anti-infectives, Plain or in Combination
Administration
Apply sparingly in a thin film to the affected area. If conditions permit, the cream should be gently rubbed into the affected area.
Avoid application to eyes.
To avoid risk of infection, use one open bottle per individual patient.
For topical ophthalmic administration only.
Instruct patient on proper instillation of eye suspension. Shake well before using.
Patients should not wear contact lenses if they have an ocular infection.
Do not to touch the tip of the dropper to the eye, eyelid, fingertips, or other surface.
Keep the bottle tightly closed when not in use.
To avoid risk of infection, use one open bottle per individual patient.
For use in the ear only. Do not use in eyes.
Avoid touching the dropper to the ear, fingers, or other objects to preserve the sterility of the solution.
Keep the bottle tightly closed when not in use.
To avoid risk of infection, use one open bottle per individual patient.
Otic suspension: Shake well before using.
The external auditory canal should be thoroughly cleaned and dried with a sterile cotton applicator.
Patients should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for a few minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the external ear canal, and then the cotton may be saturated with the solution. This wick should be kept moist by adding additional solution every 4 hours. The wick should be replaced at least once every 24 hours.
Adverse Reactions
anaphylactoid reactions / Rapid / 0-1.0
hearing loss / Delayed / Incidence not known
skin atrophy / Delayed / Incidence not known
ocular hypertension / Delayed / Incidence not known
keratitis / Delayed / Incidence not known
corneal erosion / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
erythema / Early / 0-1.0
superinfection / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
blurred vision / Early / Incidence not known
conjunctival hyperemia / Early / Incidence not known
pruritus / Rapid / 0-1.0
rash / Early / 0-1.0
miliaria / Delayed / Incidence not known
xerosis / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
striae / Delayed / Incidence not known
skin irritation / Early / Incidence not known
ocular irritation / Rapid / Incidence not known
ocular pruritus / Rapid / Incidence not known
Common Brand Names
AK-Spore HC, AK-Spore HC Ophthalmic, AK-Spore HC Otic, Antibiotic Otic, Aural, Cortisporin, Cortomycin, Duomycin-HC, Oti-Sone, Oticin HC, Otimar, Otocidin, Pediotic, Uad
Dea Class
Rx
Description
Corticosteroid anti-inflammatory and antibiotic combination
Treats primarily gram-negative, aerobic bacteria, but are also effective against Staphylococcus aureus
Available in ophthalmic, otic, and topical forms
Dosage And Indications
NOTE: If the infection does not improve after 1 week of treatment, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
4 drops in affected ear(s) 3 to 4 times daily. Treatment should not be continued longer than 10 days.
3 drops in affected ear(s) 3 to 4 times daily. Treatment should not be continued longer than 10 days.
1 to 2 drops in affected eye(s) every 3 to 4 hours, depending upon the severity of the infection. The suspension may be used more frequently if necessary. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation.
Apply as a thin film topically to the affected area 2 to 4 times daily. Therapy should be limited to 7 days.
Dosing Considerations
No dosage adjustment is needed.
No dosage adjustment is needed.
Drug Interactions
There are no drug interactions associated with Neomycin; Polymyxin B; Hydrocortisone products.
How Supplied
AK-Spore HC/AK-Spore HC Ophthalmic/Cortisporin/Hydrocortisone, Neomycin, Polymyxin B Ophthalmic Susp: 1mL, 1-3.5-10000U
AK-Spore HC/AK-Spore HC Otic/Antibiotic Otic/Aural/Cortisporin/Cortomycin/Duomycin-HC/Hydrocortisone, Neomycin, Polymyxin B/Oticin HC/Otimar/Oti-Sone/Pediotic/Uad Auricular (Otic) Susp: 1mL, 1-3.5-10000U
AK-Spore HC/AK-Spore HC Otic/Antibiotic Otic/Cortisporin/Cortomycin/Hydrocortisone, Neomycin, Polymyxin B/Oticin HC/Otimar/Oti-Sone/Otocidin Auricular (Otic) Sol: 1mL, 1-3.5-10000U
Maximum Dosage
Maximum dosage information not available.
Maximum dosage information not available.
Maximum dosage information not available.
Maximum dosage information for otic product not available; safety and efficacy of ophthalmic and topical products not established.
Maximum dosage information for otic product not available; safety and efficacy of ophthalmic and topical products not established.
Mechanism Of Action
Neomycin: Neomycin is bacteriocidal. It inhibits bacterial protein synthesis through irreversible binding to the 30S ribosomal subunit of susceptible bacteria. Neomycin is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. Neomycin may also inhibit DNA polymerase.
Polymyxin B: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B is bactericidal against most gram-negative bacilli; however, some Proteus and Serratia species may be resistant. Polymyxin B has no in vitro activity against gram-positive organisms.
Hydrocortisone: The antiinflammatory activity of hydrocortisone is thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of the precursor molecule arachidonic acid.
Pharmacokinetics
Neomycin; polymyxin B; hydrocortisone combination products are applied topically to the ear, eye, or skin. Systemic absorption may occur in some "at risk" individuals. After systemic absorption, neomycin and polymyxin B are excreted by the kidney.
Except when applied to large areas or for an extended period of time, systemic absorption of topical neomycin; polymyxin B; hydrocortisone is negligible. Hydrocortisone is metabolized in the skin. Polymyxin B has a high affinity for cell membranes, so there is little systemic absorption even when applied to open wounds. Neomycin may be absorbed systemically if applied to denuded or damaged epithelium.
Pregnancy And Lactation
Caution is warranted with the use of neomycin; polymyxin B; hydrocortisone products during pregnancy. Topical corticosteroids have been shown to be teratogenic in animals. There are no adequate and well controlled studies in pregnant women, therefore topical corticosteroid-containing products should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Because of the minimal systemic absorption of neomycin; polymyxin B; hydrocortisone after topical otic/ophthalmic administration, there is expected to be minimal risk of maternal and fetal toxicity when administered during pregnancy.
The manufacturer recommends that neomycin; polymyxin B; hydrocortisone products should be used cautiously in women who are breast-feeding. Hydrocortisone appears in breast milk following oral administration and there is a minimal possibility of systemic absorption following topical 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. Topical, otic, and ophthalmic use of neomycin and polymyxin B would result in minimal absorption. To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Oral ingestion by the nursing infant would also result in minimal absorption. Only water-miscible cream products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. Topical creams should not be applied directly to the breast during lactation if 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.