Mupirocin

Proficient Rx Lp
Human Prescription Drug
NDC 63187-151

Mupirocin is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Mupirocin is 63187-151. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Mupirocin drug includes Mupirocin - 20 mg/g . The currest status of Mupirocin drug is Active.

Drug Information:

Drug NDC:	63187-151
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:	Mupirocin
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:	Mupirocin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Proficient Rx Lp
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:	MUPIROCIN - 20 mg/g
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:	23 Sep, 2005
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:	ANDA065170
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, 2024
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:	Proficient Rx LP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	106346
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:	0363187151225
UPC stands for Universal Product Code.
NUI:	N0000175515 N0000175516
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	D0GX863OA5
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:	RNA Synthetase Inhibitors [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:	RNA Synthetase Inhibitor Antibacterial [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:	RNA Synthetase Inhibitor Antibacterial [EPC] RNA Synthetase Inhibitors [MoA]
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
63187-151-22	1 TUBE in 1 CARTON (63187-151-22) / 22 g in 1 TUBE	01 Sep, 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.

Other medicines with the same generic name

Product Elements:

Mupirocin mupirocin mupirocin mupirocin polyethylene glycol 400 polyethylene glycol 3350

Drug Interactions:

Drug interactions: the effect of the concurrent application of mupirocin ointment and other drug products has not been studied.

Indications and Usage:

Indications and usage mupirocin ointment usp, 2% is indicated for the topical treatment of impetigo due to: s. aureus and s. pyogenes .

Warnings:

Warnings avoid contact with the eyes. in case of accidental contact, rinse well with water. in the event of sensitization or severe local irritation from mupirocin ointment, usage should be discontinued. clostridium difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including mupirocin, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile . c. difficile produces toxins a and b which contribute to the development of cdad. hypertoxin producing isolates of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibacterial drug use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibact Read more...

erial agents. if cdad is suspected or confirmed, ongoing antibacterial drug use not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of c. difficile , and surgical evaluation should be instituted as clinically indicated.

Dosage and Administration:

Dosage and administration a small amount of mupirocin ointment should be applied to the affected area 3 times daily. the area treated may be covered with a gauze dressing if desired. patients not showing a clinical response within 3 to 5 days should be re-evaluated.

Contraindications:

Contraindications this drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

Adverse Reactions:

Adverse reactions the following local adverse reactions have been reported in connection with the use of mupirocin ointment: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects. systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.

Drug Interactions:

Drug interactions: the effect of the concurrent application of mupirocin ointment and other drug products has not been studied.

Use in Pregnancy:

Pregnancy: teratogenic effects: pregnancy category b: reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. there are, however, no adequate and well-controlled studies in pregnant women. because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use:

Pediatric use: the safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. use of mupirocin ointment in these age groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials (see clinical studies ).

Description:

Description each gram of mupirocin ointment usp, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, nf) consisting of polyethylene glycol 400 nf and polyethylene glycol 3350 nf. mupirocin is a naturally occurring antibiotic. the chemical name is ( e )-(2 s ,3 r ,4 r ,5 s )-5-[(2 s ,3 s ,4 s ,5 s )-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-Î²-methyl-2 h -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. the molecular formula of mupirocin is c 26 h 44 o 9 , and the molecular weight is 500.63. the chemical structure is: chemical structure

Clinical Pharmacology:

Clinical pharmacology application of 14 c-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. following intravenous or oral adminstration, mupirocin is rapidly metabolized. the principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. in a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. the pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency. microbiology: mupirocin is an antibacterial agent produced by fermentation using the organism pseudomonas fluorescens . it is active against a wide range of Read more...

gram-positive bacteria including methicillin-resistant staphylococcus aureus (mrsa). it is also active against certain gram-negative bacteria. mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-rna synthetase. due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents. resistance occurs rarely. however, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-trna synthetase. high-level plasmid-mediated resistance (mic >1024 mcg/ml) has been reported in some strains of s. aureus and coagulase-negative staphylococci. mupirocin is bactericidal at concentrations achieved by topical administration. however, the minimum bactericidal concentration (mbc) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (mic). in addition, mupirocin is highly protein bound (>97%), and the effect of wound secretions on the mics of mupirocin has not been determined. mupirocin has been shown to be active against most strains of s. aureus and streptococcus pyogenes , both in vitro and in clinical trials (see indications and usage ). the following in vitro data are available, but their clinical significance is unknown. mupirocin is active against most strains of staphylococcus epidermidis and staphylococcus saprophyticus .

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility: long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled dna synthesis, sediment analysis for dna strand breaks, salmonella reversion test (ames), escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice. reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Clinical Studies:

Clinical studies the efficacy of topical mupirocin ointment in impetigo was tested in 2 trials. in the first, subjects with impetigo were randomized to receive either mupirocin ointment or vehicle placebo 3 times daily for 8 to 12 days. clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment (n=49) and 35% for vehicle placebo (n=51). pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo. there were no side effects reported in the group receiving mupirocin ointment. in the second trial, subjects with impetigo were randomized to receive either mupirocin ointment 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. there was a follow-up visit 1 week after treatment ended. clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects inc Read more...

luded) were 93% for mupirocin ointment (n=29) and 78.5% for erythromycin (n=28). pathogen eradication rates in the evaluable populations were 100% for both test groups. there were no side effects reported in the group receiving mupirocin ointment. pediatrics: there were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n=42) and 36% for vehicle placebo (n=49). in the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment. the age range of the pediatric subjects was 7 months to 13 years. the clinical efficacy rate for mupirocin ointment (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

How Supplied:

How supplied mupirocin ointment usp, 2% is supplied in 22 g (ndc 63187-151-22) tubes. store at 20Â°-25Â°c (68Â°-77Â°f) [see usp controlled room temperature].

Information for Patients:

Information for patients: use this medication only as directed by the healthcare provider. it is for external use only. avoid contact with the eyes. if mupirocin ointment gets in or near the eyes, rinse thoroughly with water. the medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. if impetigo has not improved in 3 to 5 days, contact the healthcare provider.

Package Label Principal Display Panel:

Principal display panel - 22 g tube carton 63187-151-22

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.