^Description Section
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is a sterile antibacterial and anti-inflammatory suspension for otic use.
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:
[Neomycin Sulfate (structural formula)]
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:
[Polymyxin B Sulfate (structural formula)]
Hydrocortisone 11β,17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is:
[Hydrocortisone (structural formula)]
C21H30O5
Mol. Wt. 362.47
Each mL Contains:
ACTIVES: Hydrocortisone, 10 mg (1%), Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate, equal to 10,000 polymyxin B units; INACTIVES: Cetyl Alcohol (0.9%), Polysorbate 80, Propylene Glycol, Purified Water. Sulfuric Acid may be added to adjust pH (3.0 - 7.0). PRESERVATIVE ADDED: Thimerosal 0.01%.
^Contraindications Section
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.
^Adverse Reactions Section
^Precautions Section
^References Section
0.1 Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123: 1193-1200. 0.2 Leyden JJ and Kligman AM. Contact dermatitis to neomycin sulfate. JAMA. 1979; 242: 1276-1278. 0.3 Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odom RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine: relationship between age, sex, history of exposure, and reactivity to standard patch and use tests in general population. Arch Dermatol. 1979; 115: 959-962.
Revised: January 2013
Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated
9115702 (Folded) 9115602 (Flat) Prod. No. 06509
^Indications & Usage Section
^Warnings Section
^Dosage & Administration Section
Therapy with this product should be limited to 10 consecutive days.
The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
For adults, 4 drops of the suspension should be instilled into the affected ear 3 to 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours.
SHAKE WELL BEFORE USING.
^Package Label.principal Display Panel
^How Supplied Section
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is supplied in a white plastic dropper bottle in the following size:
10 mL bottles - NDC 24208-635-62
Storage:
Store at 15°-25°C (59°-77°F).
FOR OTIC USE ONLY
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
KEEP OUT OF REACH OF CHILDREN.
^Clinical Pharmacology Section
Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle. Close