Polymyxin B Sulfate And Trimethoprim

Remedyrepack Inc.
Human Prescription Drug
NDC 70518-1735

Polymyxin B Sulfate And Trimethoprim is a human prescription drug labeled by 'Remedyrepack Inc.'. National Drug Code (NDC) number for Polymyxin B Sulfate And Trimethoprim is 70518-1735. 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:	70518-1735
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:	Remedyrepack 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:	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:	14 Dec, 2018
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:	REMEDYREPACK INC.
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
70518-1735-0	10 mL in 1 BOTTLE, PLASTIC (70518-1735-0)	14 Dec, 2018	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.

Other medicines with the same generic name

Product Elements:

Polymyxin b sulfate and trimethoprim polymyxin b sulfate and trimethoprim benzalkonium chloride sodium chloride sulfuric acid water sodium hydroxide polymyxin b sulfate polymyxin b trimethoprim sulfate trimethoprim

Indications and Usage:

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:

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.

General Precautions:

General as with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. if superinfection occurs, appropriate therapy should be initiated.

Dosage and Administration:

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:

Contraindications polymyxin b sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

Adverse Reactions:

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. 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 animal reproduction studies have not been conducted with polymyxin b sulfate. it is not known whether polymyxin b sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose. in some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose. while there are no large well-controlled studies on the use of trimethoprim in pregnant women, brumfitt and pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole. the incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. there were no abno Read more...

rmalities in the 10 children whose mothers received the drug during the first trimester. in a separate survey, brumfitt and pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter. because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects the oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.

Pediatric Use:

Pediatric use safety and effectiveness in children below the age of 2 months have not been established [see warnings ] .

Geriatric Use:

Geriatric use no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Description:

Description polymyxin b sulfate and trimethoprim ophthalmic solution is a sterile antimicrobial solution for topical ophthalmic use. it has 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: 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 formula are: contains : actives: polymyxin b sulfate 10,000 units/ml; trimethoprim sulfate equivalent to trimethoprim 1 mg/ml. preservative: benzalkonium chloride 0.04 mg/ml. inactives: sodium chloride; sulfuric acid; and purified water. may also contain sodium hydroxide for ph adjustment. trimethoprim-chemical polymyxin

Clinical Pharmacology:

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 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 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. p Read more...

eak serum 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 .

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility carcinogenesis: long-term studies in animals to evaluate carcinogenic potential have not been conducted with polymyxin b sulfate or trimethoprim. mutagenesis: trimethoprim was demonstrated to be non-mutagenic in the ames assay. in studies at two laboratories no chromosomal damage was detected in cultured chinese hamster ovary cells at concentrations approximately 500 times human plasma levels after oral administration; at concentrations approximately 1,000 times human plasma levels after oral administration in these same cells, a low level of chromosomal damage was induced at one of the laboratories. studies to evaluate mutagenic potential have not been conducted with polymyxin b sulfate. impairment of fertility: polymyxin b sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. no adverse effects on fertility or general reproductive performance were observed in rats Read more...

given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.

How Supplied:

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: 70518-1735-00 packaging: 10 ml in 1 bottle plastic type 0 storage: store at 15Â° to 25Â°c (59Â° to 77Â°f) and protect from light. repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-8762

Information for Patients:

Information for patients avoid contaminating the applicator tip with material from the eye, fingers, or other source. this precaution is necessary if the sterility of the drops is to be maintained. if redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician. patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections. repackaged by / distributed by: remedyrepack inc. 625 kolter drive, indiana, pa 15701 (724) 465-8762

Package Label Principal Display Panel:

Drug: polymyxin b sulfate and trimethoprim generic: polymyxin b sulfate and trimethoprim dosage: solution adminstration: ophthalmic ndc: 70518-1735-0 packaging: 10 ml in 1 bottle, plastic active ingredient(s): trimethoprim sulfate 1mg in 1ml polymyxin b sulfate 10000[usp'u] in 1ml inactive ingredient(s): benzalkonium chloride sodium chloride sulfuric acid water sodium hydroxide mm1

Comments/ Reviews:

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