. . "Pediotic (Suspension)" . "Therapy with this product should be limited to 10 consecutive\ndays. The external auditory canal should be thoroughly\ncleansed and dried with a sterile cotton applicator. For\nadults, 4 drops of the suspension should be instilled into the affected ear\n3 or 4 times daily. For infants and children, 3 drops are suggested because\nof the smaller capacity of the ear canal. The patient\nshould lie with the affected ear upward and then the drops should be instilled.\nThis position should be maintained for 5 minutes to facilitate penetration\nof the drops into the ear canal. Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the\ncanal and then the cotton may be saturated with the suspension. This wick\nshould be kept moist by adding further suspension every 4 hours. The wick\nshould be replaced at least once every 24 hours. SHAKE\nWELL BEFORE USING." . "PEDIOTIC Suspension (neomycin and polymyxin\nB sulfates and hydrocortisone otic suspension) is a sterile antibacterial\nand anti-inflammatory suspension for otic use. Each mL contains: neomycin\nsulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent\nto 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains\nthimerosal 0.001% (added as a preservative) and the inactive ingredients cetyl\nalcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene\nglycol, and Water for Injection. Sulfuric acid may be added to adjust pH.\nPEDIOTIC Suspension has a minimum pH of 4.1, which is less\nacidic than the minimum pH of3.0 for CORTISPORIN Otic Suspension. Neomycin\nsulfate is the sulfate salt of neomycin B and C, which are produced by the\ngrowth of Streptomyces fradiae Waksman\n(Fam. Streptomycetaceae). It has a potency equivalent of not less than 600\nmcg of neomycin standard per mg, calculated on an anhydrous basis. The structural\nformulae are: Polymyxin B sulfate is the sulfate\nsalt of polymyxin Band B, which are produced by the\ngrowth of Bacillus polymyxa (Prazmowski)\nMigula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin\nB units per mg, calculated on an anhydrous basis. The structural formulae\nare: Hydrocortisone, 11\uFFFD\uFFFD, 17, 21-trihydroxypregn-4-ene-3,20-dione,\nis an anti-inflammatory hormone. Its structural formula is:" . "Corticoids suppress the inflammatory response to a variety\nof agents and they may delay healing. Since corticoids may inhibit the body's\ndefense mechanism against infection, a concomitant antimicrobial drug may\nbe used when this inhibition is considered to be clinically significant in\na particular case. The anti-infective components in\nthe combination are included to provide action against specific organisms\nsusceptible to them. Neomycin sulfate and polymyxin B sulfate together are\nconsidered active against the following microorganisms: Staphylococcus\naureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter\n species, Neisseria species,\nand Pseudomonas aeruginosa. This product\ndoes not provide adequate coverage against Serratia\nmarcescens and streptococci, including Streptococcus\npneumoniae. The relative potency of corticosteroids\ndepends on the molecular structure, concentration, and release from the vehicle." . . "This product is contraindicated in those individuals who\nhave shown hypersensitivity to any of its components, and in herpes simplex,\nvaccinia, and varicella infections." . "Bottle of 7.5 mL with sterilized dropper (NDC 61570-038-75).\nStore at 15\uFFFD\uFFFDto 25\uFFFD\uFFFDC (59\uFFFD\uFFFDto 77\uFFFD\uFFFDF)." . . . . . . . . . "General: As with other antibacterial preparations, prolonged use\nmay result in overgrowth of non-susceptible organisms, including fungi. If\nthe infection is not improved after 1 week, cultures and susceptibility tests\nshould be repeated to verify the identity of the organism and to determine\nwhether therapy should be changed. Treatment should\nnot be continued for longer than 10 days. Allergic\ncross-reactions may occur which could prevent the use of any or all of the\nfollowing antibiotics for the treatment of future infections: kanamycin, paromomycin,\nstreptomycin, and possibly gentamicin.
Information for Patients: Avoid contaminating the dropper with material from the ear,\nfingers, or other source. This caution is necessary if the sterility of the\ndrops is to be preserved. If sensitization or irritation\noccurs, discontinue use immediately and contact your physician. Do\nnot use in the eyes. SHAKE WELL BEFORE USING.
Laboratory Tests: Systemic effects of excessive levels of hydrocortisone may\ninclude a reduction in the number of circulating eosinophils and a decrease\nin urinary excretion of 17-hydroxycorticosteroids.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals (rats, rabbits, mice) showed\nno evidence of carcinogenicity attributable to oral administration of corticosteroids.
Pregnancy:
Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to\nbe teratogenic in rabbits when applied topically at concentrations of 0.5%\non days 6 to 18 of gestation and in mice when applied topically at a concentration\nof 15% on days 10 to 13 of gestation. There are no adequate and well-controlled\nstudies in pregnant women. Corticosteroids should be used during pregnancy\nonly if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Hydrocortisone appears in human milk following oral administration\nof the drug. Since systemic absorption of hydrocortisone may occur when applied\ntopically, caution should be exercised when PEDIOTIC is used\nby a nursing woman.
Pediatric Use: The safety and effectiveness of PEDIOTIC in\notitis externa have been established in the pediatric age group 2 years to\n16 years of age. There is inadequate data to establish safety and effectiveness\nin otitis externa for pediatric patients under 2 years of age.
Geriatric Use: Clinical studies of PEDIOTIC did not include\nsufficient numbers of subjects aged 65 and over to determine whether they\nrespond differently from younger subjects. Other reported clinical experience\nhas not identified differences in responses between the elderly and younger\npatients." . "neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate" . "Pediotic (Suspension)" . "Neomycin occasionally causes skin sensitization. Ototoxicity\nand nephrotoxicity have also been reported . Adverse reactions\nhave occurred with topical use of antibiotic combinations including neomycin\nand polymyxin B. Exact incidence figures are not available since no denominator\nof treated patients is available. The reaction occurring most often is allergic\nsensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced\nallergic skin reactions occurred in two of 2,175 (0.09%) individuals in the\ngeneral population.In another study, the incidence was found\nto be approximately 1%. The following local\nadverse reactions have been reported with topical corticosteroids, especially\nunder occlusive dressings: burning, itching, irritation, dryness, folliculitis,\nhypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,\nallergic contact dermatitis, maceration of the skin, secondary infection,\nskin atrophy, striae, and miliaria. Stinging and burning have been reported\nrarely when this drug has gained access to the middle ear." . "Neomycin can induce permanent sensorineural hearing loss\ndue to cochlear damage, mainly destruction of hair cells in the organ of Corti.\nThe risk is greater with prolonged use. Therapy should be limited to 10 consecutive\ndays . Patients being treated with eardrops containing neomycin should\nbe under close clinical observation. Pediotic Suspension\nshould not be used in any patient with a perforated tympanic membrane. Discontinue\npromptly if sensitization or irritation occurs. Neomycin\nsulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity\nreactions (primarily skin rash) due to topical neomycin is not known. When\nusing neomycin-containing products to control secondary infection in the chronic\ndermatoses, such as chronic otitis externa or stasis dermatitis, it should\nbe borne in mind that the skin in these conditions is more liable than is\nnormal skin to become sensitized to many substances, including neomycin. The\nmanifestation of sensitization to neomycin is usually a low-grade reddening\nwith swelling, dry scaling, and itching; it may be manifest simply as a failure\nto heal. Periodic examination for such signs is advisable, and the patient\nshould be told to discontinue the product if they are observed. These symptoms\nregress quickly on withdrawing the medication. Neomycin-containing applications\nshould be avoided for the patient thereafter." . "For the treatment of superficial bacterial infections of\nthe external auditory canal caused by organisms susceptible to the action\nof the antibiotics, and for the treatment of infections of mastoidectomy and\nfenestration cavities caused by organisms susceptible to the antibiotics." . . . "Pediotic" .