Neomycin Polymyxin B Sulfates And Dexamethasone
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone Suspension/ Drops
Directrx
Human Prescription Drug
NDC 72189-320Neomycin Polymyxin B Sulfates And Dexamethasone also known as Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone Suspension/ Drops is a human prescription drug labeled by 'Directrx'. National Drug Code (NDC) number for Neomycin Polymyxin B Sulfates And Dexamethasone is 72189-320. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Neomycin Polymyxin B Sulfates And Dexamethasone drug includes Dexamethasone - 1 mg/mL Neomycin Sulfate - 3.5 mg/mL Polymyxin B Sulfate - 10000 [USP'U]/mL . The currest status of Neomycin Polymyxin B Sulfates And Dexamethasone drug is Active.
Drug Information:
| Drug NDC: | 72189-320 |
| 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 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 Sulfate, Polymyxin B Sulfate And Dexamethasone Suspension/ Drops |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Directrx |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension/ Drops |
| 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/mL
NEOMYCIN SULFATE - 3.5 mg/mL
POLYMYXIN B SULFATE - 10000 [USP'U]/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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 Jan, 2022 |
| 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: | ANDA064135 |
| 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: | DirectRx
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309680
|
| 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. |
| 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 |
|---|
| 72189-320-05 | 5 mL in 1 BOTTLE (72189-320-05) | 18 Jan, 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 polymyxin b sulfates and dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops hydrochloric acid sodium hydroxide neomycin sulfate neomycin polymyxin b sulfate polymyxin b dexamethasone dexamethasone sodium chloride polysorbate 20 water benzalkonium chloride hypromellose, unspecified
Indications and Usage:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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, haemophilus influ
Read more...enzae, klebsiella/enterobacter species, neisseria species, and pseudomonas aeruginosa. this product does not provide adequate coverage against: serratia marcescens and streptococci, including streptococcus pneumoniae.
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 a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. if
Read more... 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 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. neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension is not for injection. it should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye. 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, urticaria, 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:
One to two drops in the conjunctival sac(s). in severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. in mild disease, drops may be used up to four to six times daily. not more than 20 ml should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in precautions above.
Contraindications:
Neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Adverse Reactions:
Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid 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 ingredient are allergic sensitizations. the reactions due to the corticosteroid component are: elevation of iop with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. corticosteroid-containing preparations have also been reported to cause perforation of the globe. keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and stevens-johnson syndrome. to report suspected adve
Read more...rse reactions, contact bausch & lomb incorporated at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension, usp is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. the chemical structure for the active ingredient, dexamethasone, is: c22h29fo5 392.46 established name: dexamethasone chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β,16α)-. the other active ingredients are neomycin sulfate and polymyxin b sulfate. the structural formula for neomycin sulfate is: c23h46n6o13âÏh2so4máµ£ 615 (base) the structural formula for polymyxin b sulfate is: c56h98n16o13 1203.48 each ml contains: actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin b sulfate 10,000 units, dexamethasone 0.1%. inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust ph), purified water, benzalkonium chloride 0.004% (preservative).
Clinical Pharmacology:
Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. since corticosteroids may inhibit the bodyâs defense mechanism against infection, 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:
Neomycin and polymyxin b sulfates and dexamethasone ophthalmic suspension, usp is supplied as a sterile ophthalmic suspension in a white, low density polyethylene extended lldpe drop tip bottle with a white, polypropylene cap: ndc 24208-830-60 - 5 ml in 10 ml bottle storage: store between 15° to 25°c (59° to 77°f). store upright. keep out of reach of children. distributed by: bausch + lomb, a division of bausch health us, llc bridgewater, nj 08807 usa manufactured by: bausch & lomb incorporated tampa, fl 33637 usa © 2020 bausch & lomb incorporated or its affiliates rev. 09/2020 9114205 (folded) 9114305 (flat)
Package Label Principal Display Panel:
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