Dex-Otic

/ Teva

Adults 2-3 drops into the affected ear, 3-4 times daily. Children 1-2 drops into the affected ear, 3-4 times daily. The product can be used within 3 months from first opening of the bottle.

Inflammatory conditions and superficial bacterial infections of the external auditory canal, caused by staphylococci, Pseudomonas, Proteus and other Gram-positive and Gram-negative bacteria susceptible to these antibiotics

Known hypersensitivity to any ingredient of the preparation. Patients who have demonstrated hypersensitivity to cross-sensitizing substances such as aminoglycosides and other related antibiotics. Topical corticosteroids are contraindicated in fungal infections, tuberculosis of the skin, vaccinia, varicella and herpes simplex. This preparation should not be applied in the external auditory canal of patients with known or suspected perforated eardrums because of the possibility of ototoxicity caused by neomycin. This preparation is not intended for ophthalmic use.

NOTE: Ototoxicity and nephrotoxicity have been reported with the topical use of neomycin. The likelihood of their occurrence may be increased if the patient is being concurrently treated with an aminoglycoside antibiotic. Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, use of this preparation in large quantities or large areas for prolonged periods of time is not recommended in instances where significant systemic absorption may occur. Polymyxin B sulfate has also neurotoxic and nephrotoxic potential.
If sensitization or irritation occurs, discontinue use. If the sensitivity is attributed to the antibiotic component, neomycin-containing preparations should be avoided by the patient in the future. Allergic cross-reactions may occur which could prevent use of any or all of the aminoglycoside antibiotics for the treatment of future infections. When using neomycin-containing preparations to control secondary infection in chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin is more liable to become sensitive to other substances, including neomycin. If local infection should continue or become severe, or in the presence of systemic infection, appropriate antimicrobial therapy should be instituted. If a favorable response is not obtained, the use of this preparation should be temporarily discontinued, until the infection has been controlled. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption and suitable precautions will be required in patients with electrolyte imbalance, gastrointestinal disturbances, diabetes, myopathy, cataract, renal or hepatic impairment, osteoporosis and hemorrhage. As with other antibiotic-containing topical preparations, prolonged use may result in an overgrowth of non-susceptible fungi. The possibility of persistent fungal infections of the ear should be considered after prolonged steroid dosing. Appropriate measures should be taken if this occurs. All topically active corticosteroids possess the potential to suppress the pituitaryadrenal axis following absorption. Development of adverse systemic effects due to the cortisone component is considered to be unlikely, but the recommended dosage should not be exceeded.

This preparation is usually well tolerated. Stinging and burning may occur if the preparation gains access to the middle ear. Signs of a sensitivity reaction to neomycin may also appear, usually as a low-grade reddening with swelling, dry scaling or itching, or simply as a failure to heal. During long-term use of neomycin-containing preparations, periodic examination for such signs is recommended. If they occur, patients should be advised to discontinue treatment. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter. Allergic cross-reactions may occur which could prevent the future use of any or all the following antibiotics for the treatment of infections: kanamycin, paromomycin, streptomycin, gentamicin. The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching , irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Infections may be masked or enhanced and new infections may appears during corticosteroid use due to suppression of the immune response.

Following significant systemic absorption, both neomycin and polymyxin B sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents. However, the neuromuscular blocking activity of neomycin sulfate and polymyxin B sulfate is unlikely to present a hazard during use of this preparation.

Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born to mothers who have been treated with large amounts of corticosteroids or for prolonged periods of time, should be observed carefully for signs of hypoadrenalism. Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity, thus, use of this preparation is not usually recommended during pregnancy.
Use in Breastfeeding: It is not known whether topical application of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, caution should be exercised when topical corticosteroids are applied to nursing women. There is little information to demonstrate the possible effect of topically applied neomycin in lactation.