CLASSESCombinations of Corticosteroids with Antibacterials Show
DESCRIPTIONCorticosteroid anti-inflammatory and antibiotic combination COMMON BRAND NAMESAK-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 HOW SUPPLIEDAK-Spore HC/AK-Spore HC Ophthalmic/Cortisporin/Hydrocortisone, Neomycin, Polymyxin B Ophthalmic Susp: 1mL, 1-3.5-10000U DOSAGE & INDICATIONSFor the treatment of superficial bacterial infections of the external auditory canal (i.e., otitis externa) caused by susceptible organisms, and for the treatment of infections of mastoidectomy and fenestration caused by susceptible organisms. Otic dosage (solution or suspension) 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. Adults 4 drops in affected ear(s) 3 to 4 times daily. Treatment should not be continued longer than 10 days. Infants, Children, and Adolescents 3 drops in affected ear(s) 3 to 4 times daily. Treatment should not be continued
longer than 10 days. For the treatment of corticosteroid-responsive inflammatory ocular conditions and where bacterial ophthalmic infection or a risk of bacterial ophthalmic infection exists (e.g., inflammation of palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in bacterial conjunctivitis is accepted to obtain a decrease in edema and inflammation; also in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign objects). Ophthalmic dosage Adults 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. For the treatment of corticosteroid-responsive dermatoses with secondary infection. Topical dosage (topical cream or ointment) Adults Apply as a thin film topically to the affected area 2 to 4 times daily. Therapy should be limited to 7 days. MAXIMUM DOSAGEAdults Maximum dosage information not available. Geriatric Maximum dosage information not available. Adolescents Maximum dosage information not available. Children Maximum dosage information for otic product not available; safety and efficacy of ophthalmic and topical products not established. Infants Maximum dosage information for otic product not available; safety and efficacy of ophthalmic and topical products not established. DOSING CONSIDERATIONSHepatic Impairment No dosage adjustment is needed. Renal Impairment No dosage adjustment is needed. ADMINISTRATIONTopical Administration Cream/Ointment/Lotion Formulations Apply sparingly in a thin film to the affected area. If conditions permit, the cream should be gently rubbed into the affected area. Ophthalmic Administration For topical ophthalmic administration only. Otic Administration For use in the ear only. Do not use in eyes. STORAGEAK-Spore HC : CONTRAINDICATIONS / PRECAUTIONSGeneral Information 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. Aminoglycoside hypersensitivity, neomycin hypersensitivity 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 Fungal infection, herpes infection, tuberculosis, varicella, viral infection 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. Renal failure, renal impairment 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. Ocular exposure 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. Otitis media, tympanic membrane perforation 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. Hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing 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. Pregnancy 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. Asthma, sulfite hypersensitivity 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. Breast-feeding 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. Glaucoma, surgery 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. Contact lenses Patients who wear contact lenses should avoid wearing them while being treated with neomycin; polymyxin B; hydrocortisone ophthalmic products for an ocular infection. Geriatric 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. ADVERSE REACTIONSSevere anaphylactoid reactions / Rapid / 0-1.0 Moderate erythema / Early / 0-1.0 Mild pruritus / Rapid / 0-1.0 DRUG INTERACTIONSThere are no drug interactions associated with Neomycin; Polymyxin B; Hydrocortisone products. PREGNANCY AND LACTATIONPregnancy 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. 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. MECHANISM OF ACTIONNeomycin: 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. PHARMACOKINETICSNeomycin; 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. Topical Route 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. How long do you leave neomycin in your ear?Squeeze the bottle gently to put the prescribed number of drops in the ear canal. Stay in this position for 30 to 60 seconds to help the drops soak into the ear. Repeat the steps for the other ear if both ears are infected. Do not use your medicine more often than directed.
How long does it take neomycin ear drops to work?Hydrocortisone - neomycin - polymyxin B ear drops are used to treat certain bacterial infections of the outer ear canal. This medication should start to work within 48 hours.
How many times a day do you use neomycin and polymyxin?Adults and children 2 years of age and older—Use one or two drops in the affected eye 4 to 6 times a day. Your doctor may tell you to use the drops more often during severe infections.
How long do you leave ear drops in?Inserting ear drops
Place drops inside the ear. Follow your doctor's instructions (or the directions on the label) for how many drops to use. Gently wiggle the outer ear or pull the ear up and back to help the drops get into the ear. It's important to keep the liquid in the ear canal for 3 to 5 minutes.
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Neomycin and polymyxin b sulfates and hydrocortisone otic solution directions
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