Pediotic

Pediotic

Pediotic Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pediotic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension) is a combination of antibiotics (neomycin and polymyxin B) and a steroid (hydrocortisone) used to treat ear infections caused by bacteria. This medication is available in generic form. Common side effects include temporary stinging or burning of your ear for a minute or two when applied.

For adults, the dose of Pediotic Suspension is 4 drops instilled into the affected ear 3 or 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal. Use for 10 consecutive days. Pediotic Suspension may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Pediotic Suspension should be used only if prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Pediotic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pediotic in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;
  • severe burning, stinging, or other irritation when using the medication;
  • new signs of infection;
  • hearing loss; or
  • urinating less than usual or not at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pediotic (Neomycin, Polymyxin B and Hydrocortisone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pediotic Overview - Patient Information: Side Effects

SIDE EFFECTS: This medication may temporarily sting or burn your ear for a minute or two when applied. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but very serious side effect occurs: hearing problems (e.g., hearing loss).

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), redness of the ears, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pediotic (Neomycin, Polymyxin B and Hydrocortisone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pediotic FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population.2 In another study, the incidence was found to be approximately 1%.3

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Stinging and burning have been reported rarely when this drug has gained access to the middle ear.

Read the entire FDA prescribing information for Pediotic (Neomycin, Polymyxin B and Hydrocortisone) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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