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Combinations of Corticosteroids with AntibacterialsOphthalmological Corticosteroid and Anti-infective CombinationsOtic Corticosteroid/anti-infective CombinationsTopical Aminoglycosides, Plain or in CombinationTopical Polypeptide Anti-infectives, Plain or in Combination
Corticosteroid anti-inflammatory and antibiotic combinationTreats primarily gram-negative, aerobic bacteria, but are also effective against Staphylococcus aureusAvailable in ophthalmic, otic, and topical forms
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
AK-Spore HC/AK-Spore HC Ophthalmic/Cortisporin/Hydrocortisone, Neomycin, Polymyxin B Ophthalmic Susp: 1mL, 1-3.5-10000UAK-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, 1-3.5-10000UAK-Spore HC/AK-Spore HC Otic/Antibiotic Otic/Cortisporin/Cortomycin/Hydrocortisone, Neomycin, Polymyxin B/Oticin HC/Otimar/Oti-Sone/Otocidin Auricular (Otic) Sol: 1mL, 1-3.5-10000UCortisporin Topical Cream: 1g, 0.5-3.5-10000U
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.
Maximum dosage information not available.
Maximum dosage information for otic product not available; safety and efficacy of ophthalmic and topical products not established.
No dosage adjustment is needed.
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.
AK-Spore HC :- Store between 59 to 77 degrees FAK-Spore HC Ophthalmic:- Store between 59 to 77 degrees FAK-Spore HC Otic:- Store between 59 to 77 degrees FAntibiotic Otic:- Store between 59 to 77 degrees FAural :- Store between 59 to 77 degrees FCortisporin:- Store between 59 to 77 degrees FCortomycin :- Store between 59 to 77 degrees FDuomycin-HC:- Store between 59 to 77 degrees FOticin HC:- Store between 59 to 77 degrees FOtimar:- Store between 59 to 77 degrees FOti-Sone:- Store between 59 to 77 degrees FOtocidin:- Store at controlled room temperature (between 68 and 77 degrees F)Pediotic:- Store between 59 to 77 degrees FUad :- Store between 59 to 77 degrees F
NOTE: This monograph discusses the use of the neomycin, polymyxin B, and hydrocortisone in combination for inflammatory and infectious conditions of the ear, eyes, or skin. Clinicians may wish to consult the individual monographs for more information about the specific contraindications and precautions of each agent.
Neomycin; polymyxin B; hydrocortisone products are contraindicated in patients who are allergic to any of the components including those patients with aminoglycoside hypersensitivity or neomycin hypersensitivity. Patients should be monitored for the development of neomycin hypersensitivity, and the patient should discontinue treatment if symptoms are observed. Long-term use of neomycin products may place the patient at risk to develop neomycin hypersensitivity. Patients should avoid neomycin-containing products after the development of this reaction
The manufacturers recommend that neomycin; polymyxin B; hydrocortisone products not be used in patients with a fungal infection or viral infection including varicella-zoster(e.g., chickenpox) or other herpes infection (e.g., herpes simplex or vaccinia). The ophthalmic preparations are contraindicated in fungal infections of ocular structures, most viral infections of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and mycobacterial infection of the eye. The topical cream is not recommended in patients with cutaneous tuberculosis. Secondary infections, especially of fungi, may occur with prolonged use of neomycin; polymyxin B; hydrocortisone products. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. It is recommended that the topical cream not be used for longer than 7 days and the otic or ophthalmic preparations should not be used for longer than 10 days to avoid development of secondary infections.
Systemic absorption of neomycin may occur following application to denuded or damaged epithelium. Following systemic absorption of neomycin in patients with renal impairment or renal failure, there is a risk of developing ototoxicity that is irreversible and progressive even after the therapy is stopped.
Avoid ocular exposure of neomycin; polymyxin B; hydrocortisone topical cream or otic preparations. The ophthalmic preparations should never be directly introduced into the anterior chamber of the eye.
Neomycin; polymyxin B; hydrocortisone otic products should be avoided in patients with tympanic membrane perforation or with chronic otitis media because of the possibility of ototoxicity. Additionally, the acidity of the neomycin; polymyxin B; hydrocortisone otic solution may cause burning and stinging in patients with perforated tympanic membrane.
Signs and symptoms of exogenous hyperadrenocorticism can occur with the use of topical corticosteroids, including hypothalamic-pituitary-adrenal (HPA) suppression. Systemic absorption of topical steroids, such as neomycin; polymixin B; hydrocortisone, will be increased if an extensive body surface area is treated or if an occlusive dressing is used. In children, sufficient absorption of hydrocortisone may occur during prolonged use, causing growth inhibition, as well as other signs and symptoms of hyperadrenocorticism.
Neomycin; polymyxin B; hydrocortisone products are classified as FDA pregnancy risk category C. 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.
Neomycin; polymyxin B; hydrocortisone otic solutions may contain potassium metabisulfite that may cause allergic-type reactions and life-threatening or severe asthmatic episodes in patients with sulfite hypersensitivity; this product should be avoided in these patients. Although the overall incidence of sulfite sensitivity is low, people with asthma may be at increased risk.
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.
Ocular corticosteroids should be used with caution in patients with glaucoma. If neomycin; polymyxin B; hydrocortisone ophthalmic products are used for 10 days or longer, intraocular pressure should be routinely monitored due to the risk development of ocular hypertension or glaucoma. The initial prescription and renewal of the medication order beyond 20 ml should be made only after examination of the patient with aid of magnification such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Use of neomycin; polymyxin B; hydrocortisone ophthalmic products after cataract surgery may delay healing and increase the incidence of filtering blebs.
Patients who wear contact lenses should avoid wearing them while being treated with neomycin; polymyxin B; hydrocortisone ophthalmic products for an ocular infection.
Geriatric patients are more likely to have damaged skin through aging, and this may increase the risk of side effects from neomycin; polymyxin B; hydrocortisone combination products. Corticosteroid-containing skin preparations should only be used for brief periods and infrequently in older patients. Clinical studies did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
anaphylactoid reactions / Rapid / 0-1.0hearing loss / Delayed / Incidence not knownskin atrophy / Delayed / Incidence not knownocular hypertension / Delayed / Incidence not knownkeratitis / Delayed / Incidence not knowncorneal erosion / Delayed / Incidence not knownrenal failure (unspecified) / Delayed / Incidence not known
erythema / Early / 0-1.0superinfection / Delayed / Incidence not knowncontact dermatitis / Delayed / Incidence not knownconjunctivitis / Delayed / Incidence not knowncataracts / Delayed / Incidence not knownblurred vision / Early / Incidence not knownconjunctival hyperemia / Early / Incidence not known
pruritus / Rapid / 0-1.0rash / Early / 0-1.0miliaria / Delayed / Incidence not knownxerosis / Delayed / Incidence not knownskin hypopigmentation / Delayed / Incidence not knownfolliculitis / Delayed / Incidence not knownstriae / Delayed / Incidence not knownskin irritation / Early / Incidence not knownocular irritation / Rapid / Incidence not knownocular pruritus / Rapid / Incidence not known
There are no drug interactions associated with Neomycin; Polymyxin B; Hydrocortisone products.
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.
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.