Neomycin And Polymyxin B Sulfates And Hydrocortisone also known as Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Neomycin And Polymyxin B Sulfates And Hydrocortisone is 63187-308. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Neomycin And Polymyxin B Sulfates And Hydrocortisone drug includes Hydrocortisone - 10 mg/mL Neomycin Sulfate - 3.5 mg/mL Polymyxin B Sulfate - 10000 [USP'U]/mL . The currest status of Neomycin And Polymyxin B Sulfates And Hydrocortisone drug is Active.

Neomycin and polymyxin b sulfates and hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone hydrocortisone hydrocortisone neomycin sulfate neomycin polymyxin b sulfate polymyxin b cetyl alcohol polysorbate 80 propylene glycol water sulfuric acid thimerosal

Indlcatlons and usage for the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

Warnings neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of corti. the risk is greater with prolonged use. therapy should be limited to 10 consecutive days (see precautions - general ). patients being treated with eardrops containing neomycin should be under close clinical observation. neomycin and polymyxin b sulfates and hydrocortisone otic suspension should not be used in any patient with a perforated tympanic membrane. discontinue promptly if sensitization or irritation occurs. neomycin sulfate may cause cutaneous sensitization. a precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. 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 m Read more...

General: as with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. if the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed. treatment should not be continued for longer than 10 days. allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Dosage and admlnlstratlon 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.

Contraindications 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 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 mili Read more...

Pediatric use: the safety and effectiveness of neomycin and polymyxin b sulfates and hydrocortisone otic suspension 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 age. 1

Geriatric use: clinical studies of neomycin and polymyxin b sulfates and hydrocortisone otic suspension 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.

Description 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: polymyxin b sulfate is the sulfate salt of polymyxin b 1 and b 2 , 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: c 21 h 30 o 5 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%. neomycin sulfate (structural formula) polymyxin b sulfate (structural formula) hydrocortisone (structural formula)

Clinical pharmacology 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.

Carcinogenesis, mutagenesis, impairment of fertility: long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

How supplied 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 63187-308-10 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.

Information for patients: avoid contaminating the 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. shake well before using.

Principal display panel ndc 63187-308-10 neomycin and polymyxin b sulfates and hydrocortisone otic suspension usp (sterile) [icon- ear] use in ears only 10 ml rx only 63187-308-10