Oto-Med Ear Drop

Therapeutic Class

Corticosteroids, Ear

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Ear Drop (NRN: 04-2044): Fludrocortisone acetate 0.1%, Neomycin Sulphate 0.44%, Polymyxin-B sulphate 0.12%.

Pack Size: 8 mL in Plastic bottle with dropper.

Pharmacology

Neomycin and Polymycin-B are broad spectrum antibiotics. Fludrocortisone Acetate is an anti-inflammatory/anti-allergic agent. These together with Lidocaine HCl, a local anaesthetic component of the product act synergistically in effecting the treatment of the ear infection.

Indications

Treatment of acute and chronic Otitis Externa, Otitis Media, Furunculosis of the Auricular Tube, allergic dermatosis of the Auricular area and Otalgia of various aetiologies.

Contra-indications

History of allergy to any component of the formulation and in patients with perforated ear drum or tympanic membrane

Precautions/Warnings

History of allergy to it and in patients with perforated ear drum or tympanic membrane.

Interactions

There are defined interactions with each component of Oto-med. It is therefore advisable to consult your healthcare practitioner in cases where other medications are been used.

Adverse Effects

Can produce reversible and irreversible cumulative ototoxicity affecting both Cochlear system (manifested as hearing loss) and the Vestibular system (manifested as dizziness or vertigo). Can produce hypersensitivity reactions.

Dosage & Administration

Oto-Med is to be instilled with the proper dropper into the external auricular tube at the dose of 4-5 drops, 2-4 times daily according to the seriousness of the condition, or as directed by the physician.

Storage/Handling Recommendations

Keep in a cool dry place and away from children.