"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® Suspension Sterile
(neomycin and polymyxin B sulfates and hydrocortisone) Otic Suspension, USP
PEDIOTIC® Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension) is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.001% (added as a preservative) and the inactive ingredients cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol, and Water for Injection. Sulfuric acid may be added to adjust pH. PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® Suspension has a minimum pH of 4.1, which is less acidic than the minimum pH of 3.0 for CORTISPORIN® Otic Suspension.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is:
What are the possible side effects of hydrocortisone, neomycin, and polymyxin B otic?
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...
What are the precautions when taking neomycin, polymyxin b and hydrocortisone (Pediotic)?
Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin), or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like sulfites, thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an ear infection caused by a virus (e.g., herpes simplex, varicella).
Last reviewed on RxList: 2/23/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Pediotic Information
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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