Otopain

Per mL Polymyxin B sulfate 10,000 IU, neomycin 3.5 mg, fludrocortisone acetate 1 mg, lidocaine HCl 40 mg

Acute & chronic external otitis caused by bacteria sensitive to Polymyxin & Neomycin sulfate; if the anti-inflammatory & local anesth actions of corticosteroids are essentially needed.

Instill 4-5 drops 2-4 times daily, depending on the severity of the disease. Duration of therapy: 10 consecutive days.

Hypersensitivity. Not to be used if external auditory canal disorder is suspected or known to be due to cutaneous viral infection (eg, HSV or Varicella-zoster virus).

May cause cutaneous sensitization or irritation. Risk of ototoxicity is greater w/ prolonged use, not to be continued for >10 days. Not to be used in any patients w/ perforated tympani membrane due to its acidity which may cause burning & stinging. Repeat cultures & susceptibility tests to verify the identity of the organism & to determine whether therapy should be changed if infection is not improved after 1 wk. When used to control secondary infection in chronic dermatosis (eg, chronic otitis external), the skin in these conditions is more liable than normal skin to become sensitized to many substances. Contains Na metabisulfite which may cause allergic type reactions (including anaphylactic symptoms & life-threatening or less severe asthmatic episodes in certain susceptible people). Prolonged used may cause overgrowth of non-sensitive organisms (eg, fungus). Pregnancy.

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruption, hypopigmentation, peroral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae & malaria.

Concomitant use w/ penicillin groups & its derivatives should inhibit the bactericide activity.

Ear Anti-Infectives & Antiseptics / Ear Antiseptics with Corticosteroids

S02CA07 - fludrocortisone and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.

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