Some drugs may have Authority Required (Streamlined) status which does not require an explicit approval from Medicare, instead the doctor can use the Authority code found in the published Schedule for a given drug/indication. Like most aminoglycosides, Otodex is not recommended for use during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of using it if you are pregnant. Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, Otodex is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of using it if you are pregnant. Some PBS medications are restricted and require prior approval from Medicare before a doctor is able to prescribe them on the PBS. This prior approval to prescribe grants the doctor the Authority to prescribe the desired medicine and have it funded under the PBS. Framycetin sulfate, gramicidin and dexamethasone (as sodium metasulfobenzoate). 2 Qualitative and Quantitative Composition

Your doctor may decide to adjust your dosage if necessary or ask you to use Otodex in a different way, according to his or her judgment.Dexamethasone is a highly potent topical corticosteroid. Its topical superiority is particularly apparent in cases in which other corticosteroids have failed. Aminoglycoside antibiotics may cause irreversible, partial or total deafness when applied topically to open wounds or damaged skin. This effect is aggravated by renal or hepatic impairment and by prolonged duration of treatment. The treatment should not be continued after resolution of symptoms.

Frequency not known: Hypersensitivity reactions, usually of the delayed type, may occur, leading to irritation, burning, stinging, itching and dermatitis.Sofradex ®, Otodex ® for bacterial infection. Refer to Ear, Nose, Throat and Dental Infections: Paediatric Empiric Guidelines - ChAMP Prescriptions must be written on an Authority Prescription Form, and the approval number must be noted on the prescription. Pharmacists cannot dispense the item as a pharmaceutical benefit unless it has been approved by Medicare Australia (indicated by the presence of the approval number). A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. How do I use Otodex? Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. It also contains polysorbate 80, industrial methylated spirit, citric acid monohydrate, sodium citrate dihydrate, lithium chloride, sodium hydroxide, hydrochloric acid, purified water and is preserved with phenethyl alcohol.