NDC 49999-254 Neomycin And Polymyxin B Sulfates And Hydrocortisone

Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone

NDC Product Code 49999-254

NDC CODE: 49999-254

Proprietary Name: Neomycin And Polymyxin B Sulfates And Hydrocortisone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
  • Drug uses not available
  • This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 49999 - Lake Erie Medical Dba Quality Care Products Llc
    • 49999-254 - Neomycin And Polymyxin B Sulfates And Hydrocortisone

NDC 49999-254-10

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Neomycin And Polymyxin B Sulfates And Hydrocortisone with NDC 49999-254 is a a human prescription drug product labeled by Lake Erie Medical Dba Quality Care Products Llc. The generic name of Neomycin And Polymyxin B Sulfates And Hydrocortisone is neomycin sulfate, polymyxin b sulfate, hydrocortisone. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

Labeler Name: Lake Erie Medical Dba Quality Care Products Llc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Neomycin And Polymyxin B Sulfates And Hydrocortisone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NEOMYCIN SULFATE 3.5 mg/mL
  • POLYMYXIN B SULFATE 10000 [USP'U]/mL
  • HYDROCORTISONE 10 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • POTASSIUM METABISULFITE (UNII: 65OE787Q7W)
  • CUPRIC SULFATE (UNII: LRX7AJ16DT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Auricular (otic) - Administration to or by way of the ear.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lake Erie Medical Dba Quality Care Products Llc
Labeler Code: 49999
FDA Application Number: ANDA064053 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-29-1995 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Hydrocortisone, Neomycin, and Polymyxin

Hydrocortisone, Neomycin, and Polymyxin is pronounced as (hye droe kor' ti sone) (nee oh mye' sin) (pol i mix' in)

Why is hydrocortisone, neomycin, and polymyxin medication prescribed?
The combination of hydrocortisone, neomycin, and polymyxin eliminates bacteria that cause ear, eye, and skin infections and relieves pain, inflammation, redness, and itch...
[Read More]

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Neomycin And Polymyxin B Sulfates And Hydrocortisone Product Label Images

Neomycin And Polymyxin B Sulfates And Hydrocortisone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx only

Boxed Warning Section

FOR USE IN THE EARS ONLYNOT FOR USE IN THE EYES

Description:

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: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:C21H30O5 Mol. Wt. 362.47

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.

Indications And Usage:

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

Contraindications:

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).

Warnings:

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 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. These 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.

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.

Information For Patients:

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.

Laboratory Tests:

Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

Pregnancy:

Teratogenic EffectsPregnancy 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.

Nursing Mothers:

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.

Pediatric Use:

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.

Geriatric Use:

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.

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%.3The 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.

Dosage And Administration:

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.

How Supplied:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is supplied in a white plastic dropper bottle in the following size:10 mL - Prod. No. 10009

Storage:

Store between 15°-30°C (59°- 86°F).Securely tighten cap between uses.DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACTKEEP OUT OF REACH OF CHILDREN.

References:

  • 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.Leyden JJ. Kligman AM. Contact dermatitis to neomycin sulfate. JAMA 1979; 242: 276-1278.Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odum RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine: relationships between age, sex, history of exposure, and reactivity to standard patch tests and use tests in general population. Arch Dermatol 1979; 115:959-962.Revised February 2008Bausch & Lomb IncorporatedTampa, FL 33637©Bausch & Lomb Incorporated9072101 (Folded)9072201 (Flat)Prod. No. 10009

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