Oti-Sone

Oti-Sone is a brand name medication included in the following groups of medications: Corticosteroids acting locally, Corticosteroids for local oral treatment, Antiinflammatory Corticosteroids, Corticosteroids, weak group I, Corticosteroids, weak, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Glucocorticoids, Antiinfectives and antiseptics for local oral treatment, Other aminoglycosides, Other antibiotics for topical use, Polymyxins. For more information about Oti-Sone see its generics Hydrocortisone, Neomycin, polymyxin B

In the U.S.

• Antibiotic Otic
• Cort-Biotic
• Cortisporin
• Cortomycin
• Oti-Sone
• Pediotic

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Neomycin

Neomycin, polymyxin B, and hydrocortisone is a combination antibiotic and cortisone-like medicine. It is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems.

Neomycin, polymyxin B, and hydrocortisone preparation is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and hydrocortisone. It may not be specific to Oti-Sone. Please read with care.

You may warm the ear drops to body temperature (37 °C or 98.6 °F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.) Your doctor may have inserted a gauze or cotton wick into your ear and may want you to keep the wick moistened with this medicine. Your doctor also may have other directions for you, such as how long you should keep the wick in your ear or when you should return to your doctor to have the wick replaced. If you have any questions about this, check with your doctor.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic (ear drops) dosage forms:
  • For ear canal infection:
    • Adults—Use four drops in the ear three or four times a day.
    • Children—Use three drops in the ear three or four times a day.
  • For mastoid cavity infection:
    • Adults—Use four to ten drops in the ear every six to eight hours.
    • Children—Use four or five drops in the ear every six to eight hours.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Applies to hydrocortisone / neomycin / polymyxin b otic: otic solution, otic suspension

Hypersensitivity

Rare (less than 0.1%): Application site hypersensitivity[Ref]

Dermatologic

Rare (less than 0.1%): Local exfoliative dermatitis, skin atrophy, telangiectasia , stria, exacerbation of underlying skin conditions (including eczema)
Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, miliaria[Ref]

General

The most commonly reported side effect was hypersensitivity.[Ref]

Nervous system

Frequency not reported: Ototoxicity[Ref]

Immunologic

Frequency not reported: Secondary infection[Ref]

Local

Rare (less than 0.1%): Application site reaction including pain, irritation, edema, burning sensation, rash
Frequency not reported: Itching, dryness, stinging[Ref]

Renal

Frequency not reported: Nephrotoxicity[Ref]

Some side effects of Oti-Sone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.