Polymyxin B Sulfate And Trimethoprim
Direct Rx
Human Prescription Drug
NDC 61919-115Polymyxin B Sulfate And Trimethoprim is a human prescription drug labeled by 'Direct Rx'. National Drug Code (NDC) number for Polymyxin B Sulfate And Trimethoprim is 61919-115. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Polymyxin B Sulfate And Trimethoprim drug includes Polymyxin B Sulfate - 10000 [USP'U]/mL Trimethoprim Sulfate - 1 mg/mL . The currest status of Polymyxin B Sulfate And Trimethoprim drug is Active.
Drug Information:
| Drug NDC: | 61919-115 |
| 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: | Polymyxin B Sulfate And Trimethoprim |
| 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: | Polymyxin B Sulfate And Trimethoprim |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Direct Rx |
| 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: | POLYMYXIN B SULFATE - 10000 [USP'U]/mL
TRIMETHOPRIM SULFATE - 1 mg/mL
|
| 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: | 15 Mar, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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: | ANDA064211 |
| 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: | DIRECT RX
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 244967
|
| 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. |
| UNII: | 19371312D4
E377MF8EQ8
|
| 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: | Cytochrome P450 2C8 Inhibitors [MoA]
Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
Dihydrofolate Reductase Inhibitors [MoA]
Organic Cation Transporter 2 Inhibitors [MoA]
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 |
|---|
| 61919-115-10 | 10 mL in 1 BOTTLE, PLASTIC (61919-115-10) | 15 Mar, 2017 | 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:
Polymyxin b sulfate and trimethoprim polymyxin b sulfate and trimethoprim sodium chloride sulfuric acid water benzalkonium chloride sodium hydroxide polymyxin b sulfate polymyxin b trimethoprim sulfate trimethoprim
Indications and Usage:
Polymyxin b sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: staphylococcus aureus, staphylococcus epidermidis, streptococcus pneumoniae, streptococcus viridans, haemophilus influenzae and pseudomonas aeruginosa.* *efficacy for this organism in this organ system was studied in fewer than 10 infections.
Warnings:
Not for injection into the eye. if a sensitivity reaction to polymyxin b sulfate and trimethoprim ophthalmic solution occurs, discontinue use. polymyxin b sulfate and trimethoprim ophthalmic solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
Dosage and Administration:
In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.
Contraindications:
Polymyxin b sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions:
The most frequent adverse reaction to polymyxin b sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. this may occur on instillation, within 48 hours, or at any time with extended use. there are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. photosensitivity has been reported in patients taking oral trimethoprim.
Description:
Polymyxin b sulfate and trimethoprim ophthalmic solution is a sterile antimicrobial solution for topical ophthalmic use. it has a ph of 4.0 to 6.2 and osmolality of 270 to 310 mosm/kg. chemical names: trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula: [trimethoprim-chemical] 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 mg, calculated on an anhydrous basis. the structural formula are: [polymyxin-chemical] [polymyxin-text] contains: actives: polymyxin b sulfate 10,000 units/ml; trimethoprim sulfate equivalent to trimethoprim 1mg/ml. preservative: benzalkonium chloride 0.04 mg/ml. inactives: sodium chloride; sulfuric acid and purified water. may also contain sodium hydroxide for ph adjustment.
Clinical Pharmacology:
Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. this binding is very much stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore selectively interferes with bacterial biosynthesis of nucleic acids and proteins. polymyxin b, a cyclic lipopeptide antibiotic, is rapidly bactericidal for a variety of gram-negative organisms, especially pseudomonas aeruginosa. it increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin b per ml. peak s
Read more...erum concentrations were approximately 0.03 mcg/ml trimethoprim and 1 unit/ml polymyxin b. microbiology: in vitro studies have demonstrated that the anti-infective components of polymyxin b sulfate and trimethoprim ophthalmic solution are active against the following bacterial pathogens that are capable of causing external infections of the eye: trimethoprim: staphylococcus aureus and staphylococcus epidermidis, streptococcus pyogenes, streptococcus faecalis, streptococcus pneumoniae, haemophilus influenzae, haemophilus aegyptius, escherichia coli, klebsiella pneumoniae, proteus mirabilis (indole-negative), proteus vulgaris (indolepositive), enterobacter aerogenes, and serratia marcescens. polymyxin b: pseudomonas aeruginosa, escherichia coli, klebsiella pneumoniae, enterobacter aerogenes and haemophilus influenzae.
How Supplied:
Polymyxin b sulfate and trimethoprim ophthalmic solution, usp is a sterile solution. each ml contains trimethoprim sulfate equivalent to 1 mg trimethoprim and polymyxin b sulfate 10,000 units in a plastic dropper bottle of 10 ml (ndc 61314-628-10). storage: store at 15° - 25°c (59° - 77°f) and protect from light. rx only
Package Label Principal Display Panel:
115