Aplosyn Otic

Fluocinolone acetonide, polymyxin B sulfate, neomycin sulfate.

Each mL of Aplosyn Otic Solution contains: Fluocinolone acetonide 250 mcg, Polymyxin B sulfate 10,000 units, Neomycin base (as sulfate) 3.5 mg.

Corticosteroid/Anti-Infective.
Fluocinolone acetonide + Polymyxin B sulfate + Neomycin sulfate (Aplosyn Otic) is a potent agent in the treatment of inflammatory and pruritic dermatoses. In relation to other corticosteroids used topically as adjunctive therapy, (Aplosyn Otic) has proved as effective and, in many instances, was effective when other agents gave inadequate therapeutic response.
Neomycin sulfate provides effective local antibacterial action against many gram-positive and gram-negative pathogens, such as Staphylococcus aureus, Streptococci and Proteus vulgaris, encountered in local infections of the ear and adjacent structures.
Polymyxin B sulfate is antibacterial for many gram-negative organisms, including Pseudomonas aeruginosa, a common cause of otitis externa; Escherichia coli and Aerobacter aerogenes. Neomycin sulfate and Polymyxin B sulfate have complementary action against such pathogens as Hemophilus, Corynebacterium, Neisseria, Klebsiella and Pneumococcus. Propylene glycol is a water-miscible vehicle with low surface tension which facilitates spreadability and penetration of the medication. Fluocinolone acetonide, Neomycin sulfate and Polymyxin B sulfate are highly soluble and stable in this vehicle. The relatively slow rate of evaporation maintains the solution state for an adequate time to allow distribution and contact with all parts of the lesion.

Aplosyn Otic Solution is intended for use in acute or chronic otitis externa with or without associated otitis media due to or complicated by organisms susceptible to Neomycin sulfate or Polymyxin B sulfate. This medication also has therapeutic value in the adjunctive management of acute or chronic dermatoses of the external ear whether of allergic, seborrheic or neurogenic origin such as atopic dermatitis, neurodermatitis, contact dermatitis, seborrheic dermatitis, chronic eczematous dermatitis and psoriasis vulgaris.

Aplosyn Otic Solution is intended for topical use only. The ear should be carefully cleansed and dried. Aplosyn Otic Solution may then be applied to the affected ear with the dropper or be used to saturate a wick placed in the external auditory canal. The suggested dosage is 3 to 4 drops, 2 to 4 times daily, or more frequently as required. It is advisable to warm the drops to body temperature before they are placed in the ear, in order to avoid caloric stimulation of the vestibular apparatus.

Topical corticosteroids are contraindicated in tuberculous, fungal and viral lesions of the skin. Aplosyn Otic solution with Neomycin sulfate and Polymyxin B sulfate is contraindicated in individuals with a history of hypersensitivity to any of its components. The preparation is not intended for ophthalmic use.

Aplosyn Otic (Fluocinolone acetonide) preparations are virtually non-sensitizing and non-irritating. Should sensitivity or idiosyncratic reactions occur, the agent should be discontinued and appropriate steps be taken. Because of the possibility of ototoxicity due to neomycin, otic preparations containing that antibiotic should be used with care in the individuals with a perforated eardrum or long standing chronic otitis media.
If local infections should continue or become severe, appropriate systemic antibacterial therapy, based on susceptibility testing should be considered.

Store at temperatures not exceeding 30°C.

Ear Antiseptics with Corticosteroids

S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.

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