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Solution USP (Sterile) · Physicians Total Care, Inc.
Dosage Form
Solution USP (Sterile)
Manufacturer
Physicians Total Care, Inc.
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
FOR USE IN THE EARS ONLY
NOT FOR USE IN THE EYES
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
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, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three 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 solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).
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 when this product has gained access to the middle ear.
Teratogenic Effects
Pregnancy Category C: Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when neomycin and polymyxin B sulfates and hydrocortisone otic solution is used by a nursing woman.
The safety and effectiveness of neomycin and polymyxin B sulfates and hydrocortisone otic solution in otitis externa have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age1.
Clinical studies of neomycin and polymyxin B sulfates and hydrocortisone otic solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Store between 15°-30°C (59°- 86°F).
Securely tighten cap between uses.
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT
KEEP OUT OF REACH OF CHILDREN.
Avoid contaminating bottle tip with material from the ear, fingers or other source. This caution is necessary if the sterility of the drops is to be preserved.
If sensitization or irritation occurs, discontinue use immediately and contact your physician.
Do not use in the eyes.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is a sterile antibacterial and anti-inflammatory solution for otic use.
Each mL Contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Hydrocortisone 10 mg (1%). INACTIVES: Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate, Glycerin, Purified Water. The pH range is 2.0 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:
[image: id_131e1218-b0f1-4561-873c-453a640b2d64]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:
[image: id_1da67191-0122-4c34-8bc6-53128cc2944b]Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:
[image: id_ae517b88-e899-40d4-ba99-eedcc5b688ef]C21H30O5 Mol. Wt. 362.47
NDC 54868-0736-1
[icon- ear] Neomycin and
Polymyxin B
Sulfates and
Hydrocortisone Otic
SOLUTION
USP (Sterile)
USE IN EARS ONLY
Rx only
10 mL
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is supplied in a white plastic dropper bottle in the following size:
10 mL - NDC 54868-0736-1
Photos of the product and/or packaging supplied by the manufacturer.
Rx only
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.
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.
Distributed by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
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