Neomycin And Polymyxin B Sulfates And Dexamethasone
Neomycin, Polymyxin B Sulfates, Dexamethasone
Padagis Us Llc
Human Prescription Drug
NDC 0574-4160Neomycin And Polymyxin B Sulfates And Dexamethasone also known as Neomycin, Polymyxin B Sulfates, Dexamethasone is a human prescription drug labeled by 'Padagis Us Llc'. National Drug Code (NDC) number for Neomycin And Polymyxin B Sulfates And Dexamethasone is 0574-4160. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Neomycin And Polymyxin B Sulfates And Dexamethasone drug includes Dexamethasone - 1 mg/g Neomycin Sulfate - 3.5 mg/g Polymyxin B Sulfate - 10000 [USP'U]/g . The currest status of Neomycin And Polymyxin B Sulfates And Dexamethasone drug is Active.
Drug Information:
| Drug NDC: | 0574-4160 |
| 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 Dexamethasone |
| 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, Polymyxin B Sulfates, Dexamethasone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Padagis Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | DEXAMETHASONE - 1 mg/g
NEOMYCIN SULFATE - 3.5 mg/g
POLYMYXIN B SULFATE - 10000 [USP'U]/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 03 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | ANDA062938 |
| 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: | Padagis US LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309679
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 7S5I7G3JQL
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 |
|---|
| 0574-4160-35 | 1 TUBE in 1 CARTON (0574-4160-35) / 3.5 g in 1 TUBE | 03 Jul, 2014 | 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 dexamethasone neomycin, polymyxin b sulfates, dexamethasone dexamethasone dexamethasone neomycin sulfate neomycin polymyxin b sulfate polymyxin b petrolatum mineral oil
Indications and Usage:
Indications and usage: for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye pathogens: staphylococcus aureus, escherichia coli, ha
Read more...emophilus influenzae, klebsiella/enterobacter species, neisseria species, and pseudomonas aeruginosa . this product does not provide adequate coverage against: serratia marcescens and streptococci, including streptococcus pneumoniae .
Warnings:
Warnings: not for injection. use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). employment of steroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. in acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection. in those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. if this product is used for 10 days or longer, intraocular pressure (iop) should be routinely monitored even though it may be difficult in children and uncooperative
Read more...patients. steroids should be used with caution in the presence of glaucoma. iop should be checked frequently. the use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. products containing neomycin sulfate may cause cutaneous sensitization. sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, uticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. if hypersensitivity develops during use of the product, treatment should be discontinued. cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Dosage and Administration:
Dosage and administration: apply a small amount into the conjunctival sac(s) up to three or four times daily. how to apply neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment: 1. tilt your head back. 2. place a finger on your cheek just under your eye and gently pull down until a "v" pocket is formed between your eyeball and your lower lid. 3. place a small amount (about 1/2 inch) of neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment in the "v" pocket. do not let the tip of the tube touch your eye. 4. look downward before closing your eye. not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in precautions above.
Contraindications:
Contraindications: neomycin and polymixin b sulfates and dexamethasone opthalmic ointment is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. mycobacterial infection of the eye. fungal diseases of ocular structures. neomycin and polymixin b sulfates and dexamethasone opthalmic ointment is also contraindicated in individuals with known or suspected hypersensitivity to a component of the medication. (hypersensitivity to the antibiotic component occurs at a higher rate than for the other components.)
Adverse Reactions:
Adverse reactions: adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. exact incidence figures are not available since no denominator of treated patients is available. reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. the reactions due to the steroid component are: elevation of iop with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. secondary infection: the development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. the possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been us
Read more...ed. keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. secondary bacterial ocular infection following suppression of host responses also occurs. additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and stevens-johnson syndrome. to report suspected adverse reactions, contact perrigo at 1-866-634-9120, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Description: neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment usp is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. the chemical structure for the active ingredient neomycin sulfate is: neomycin b (r 1 =h, r 2 =ch 2 nh 2 ) neomycin c (r 1 =ch 2 nh 2 , r 2 =h) the chemical structure for the active ingredient polymyxin b sulfate is: polymyxin b 1 (r=ch 3 ) polymyxin b 2 (r=h) dab= α, γ-diaminobutyric acid the chemical structure for the active ingredient dexamethasone is: c 22 h 29 fo 5 mw = 392.47 established name: dexamethasone chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, ( 11β,16α)-. each gram contains: active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin b sulfate 10,000 units, dexamethasone 0.1%. inactives: white petrolatum, mineral oil. chemical-structure-1.jpg chemical-structure-2.jpg chemical-structure-3.jpg
Clinical Pharmacology:
Clinical pharmacology: corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. since corticosteroids may inhibit the body's defense mechanism against infections, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. when a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained. the relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.
How Supplied:
How supplied: neomycin and polymixin b sulfates and dexamethasone ophthalmic ointment usp is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. (ndc 0574- 4160 -35). storage: store at 20°-25°c (68°-77°f) [see usp controlled room temperature]. manufactured for perrigo minneapolis, mn 55427 1r200 rc j4 rev 02-18 cd ini 1113 r0218
Package Label Principal Display Panel:
Principal display panel - carton rx only ndc 0574-4160-35 neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment usp net wt 3.5 g (1/8 oz) sterile the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. neomycin-and-polymyxin-b-sulfates-and-dexamethasone-opthalmic-ointment-carton serialization-template