Neomycin And Polymyxin B Sulfates And Hydrocortisone Solution/ Drops Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use; therefore, duration of therapy should be limited to 10 consecutive days (see PRECAUTIONS: General).
Patients being treated with eardrops containing neomycin should be under close clinical observation. Due to its acidity which may cause burning and stinging. Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP should not be used in any patients with a perforated tympanic membrane.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. Discontinue this product promptly if sensitization or irritation occurs.
When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. The symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
There is currently no drug history available for this drug.
Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is a sterile, clear, slightly yellow, antibacterial and anti-inflammatory solution for otic use.
Each mL Contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units, Hydrocortisone 10 mg (1%); INACTIVES: Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate, Glycerin, Water for Injection. The pH range is 2 to 4.5.
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 micrograms of neomycin standard per milligram, 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 milligram, 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: