Neomycin And Polymyxin B Sulfates And Hydrocortisone
Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
Nucare Pharmaceuticals,inc.
Human Prescription Drug
NDC 68071-2735Neomycin And Polymyxin B Sulfates And Hydrocortisone also known as Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone is a human prescription drug labeled by 'Nucare Pharmaceuticals,inc.'. National Drug Code (NDC) number for Neomycin And Polymyxin B Sulfates And Hydrocortisone is 68071-2735. This drug is available in dosage form of Solution. 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 [iU]/mL . The currest status of Neomycin And Polymyxin B Sulfates And Hydrocortisone drug is Active.
Drug Information:
| Drug NDC: | 68071-2735 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Neomycin And Polymyxin B Sulfates And Hydrocortisone |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nucare Pharmaceuticals,inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE - 10 mg/mL
NEOMYCIN SULFATE - 3.5 mg/mL
POLYMYXIN B SULFATE - 10000 [iU]/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | AURICULAR (OTIC)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Mar, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA062423 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | NuCare Pharmaceuticals,Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204423
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0368071273519
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WI4X0X7BPJ
057Y626693
19371312D4
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [CS]
Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
Polymyxin-class Antibacterial [EPC]
Polymyxins [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68071-2735-1 | 10 mL in 1 BOTTLE (68071-2735-1) | 26 May, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Neomycin and polymyxin b sulfates and hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone propylene glycol hydrochloric acid water neomycin sulfate neomycin polymyxin b sulfate polymyxin b hydrocortisone hydrocortisone potassium metabisulfite glycerin
Indications and Usage:
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.
Warnings:
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 b
Read more...orne 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.
Dosage and Administration:
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.
Contraindications:
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).
Adverse Reactions:
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 mi
Read more...liaria. stinging and burning have been reported when this product has gained access to the middle ear. to report suspected adverse reactions, contact sandoz inc., at 1-800-525-8747 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
Pregnancy: 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.
Pediatric Use:
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 age. 1
Geriatric Use:
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.
Description:
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: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin b sulfate equivalent to 10,000 polymyxin b units, and hydrocortisone 10 mg (1%). the vehicle contains potassium metabisulfite 0.1% (added as a preservative) and the inactive ingredients glycerin, propylene glycol, hydrochloric acid, and water for injection. 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 mcg of neomycin standard per mg, calculated on an anhydrous basis. the structural formulae are: neomycin b (r 1 =h, r 2 =ch 2 nh 2 ) neomycin c (r 1 =ch 2 nh 2 , r 2 =h) 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 mg, 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: neomycin polymyxin polymyxin-text hydrocortisone
Clinical Pharmacology:
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 and Mutagenesis and Impairment of Fertility:
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:
How supplied: bottle of 10 ml with sterilized dropper ndc 68071-2735-1 store at 15 ° to 25 ° c (59 ° to 77 ° f). rx only also available: neomycin and polymyxin b sulfates and hydrocortisone otic suspension, usp drop-tainer* bottle containing 10 ml ndc 61314-645-11. * drop-tainer is a registered trademark of alcon research, ltd.
Information for Patients:
Information for patients: avoid contaminating the dropper 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.
Package Label Principal Display Panel:
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