Purpose:
Purpose antiseptic
Purpose skin protectant
Product Elements:
Nusurgepak surgical prep/carepak chlorhexidine gluconate, mupirocin, dimethicone antiseptic skin cleanser chlorhexidine gluconate hydroxyethyl cellulose (2000 cps at 1%) isopropyl alcohol lauramine oxide water tridecyl alcohol gluconolactone coco diethanolamide peg-75 lanolin chlorhexidine gluconate chlorhexidine mupirocin mupirocin mupirocin mupirocin polyethylene glycol 400 polyethylene glycol 3350 thera dimethicone body shield dimethicone kukui nut oil aloe vera leaf calcium pantothenate maltodextrin niacinamide pyridoxine hydrochloride silicon dioxide sodium ascorbyl phosphate .alpha.-tocopherol acetate, dl- levomenol butylene glycol caprylyl glycol safflower oil cetyl alcohol chlorphenesin edetate disodium glycerin glyceryl monostearate peg-100 stearate phenoxyethanol water hyaluronate sodium stearic acid trolamine ginger dimethicone dimethicone
Indications and Usage:
1 indications and usage mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of staphylococcus aureus (s. aureus) and streptococcus pyogenes (s. pyogenes) . mupirocin ointment is an rna synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of staphylococcus aureus and streptococcus pyogenes . ( 1 )
Uses surgical hand scrub : significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing
Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin
Warnings:
Warnings for external use only. do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of children if swallowed, get medical help or
Read more... contact a poison control center right away.
Warnings for external use only do not use on deep or puncture wounds animal bites serious burns when using this product do not get into eyes stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Warnings and Cautions:
5 warnings and precautions click here to enter warnings and precautions severe allergic reactions: anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including mupirocin ointment. ( 5.1 ) eye irritation: avoid contact with eyes. ( 5.2 ) local irritation: discontinue in the event of sensitization or severe local irritation. ( 5.3 ) clostridium difficile -associated diarrhea (cdad): if diarrhea occurs, evaluate patients for cdad. ( 5.4 ) potential for microbial overgrowth: prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) risk associated with mucosal use: mupirocin ointment is not formulated for use on mucosal surfaces. a separate formulation, â bactroban nasal ointment, is available for intranasal use. ( 5.6 ) risk of polyethylene glycol absorption: mupirocin ointment should not be used where absorption of large quantities of polyethylene glycol is possible,
Read more...especially if there is evidence of moderate or severe renal impairment. ( 5.7 ) risk associated with use at intravenous sites: mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance. ( 5.8 ) 5.1 severe allergic reactions systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including mupirocin ointment [see adverse reactions ( 6.2 )]. 5.2 eye irritation avoid contact with the eyes. in case of accidental contact, rinse well with water. 5.3 local irritation in the event of a sensitization or severe local irritation from mupirocin ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted. 5.4 clostridium difficile -associated diarrhea clostridium difficile- associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents 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 strains 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 2 months after the administration of antibacterial 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. 5.5 potential for microbial overgrowth as with other antibacterial products, prolonged use of mupirocin ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [see dosage and administration ( 2 )]. 5.6 risk associated with mucosal use mupirocin ointment is not formulated for use on mucosal surfaces. intranasal use has been associated with isolated reports of stinging and drying. a separate formulation, â bactroban (mupirocin calcium) nasal ointment, is available for intranasal use. 5.7 risk of polyethylene glycol absorption polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. in common with other polyethylene glycol-based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. 5.8 risk associated with use at intravenous sites mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.
Do Not Use:
Warnings for external use only. do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. these may be signs of a serious condition. keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only do not use on deep or puncture wounds animal bites serious burns when using this product do not get into eyes stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
When Using:
When using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin
When using this product do not get into eyes
Dosage and Administration:
2 dosage and administration for topical use only . apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. cover the treated area with gauze dressing if desired. re-evaluate patients not showing a clinical response within 3 to 5 days. mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use [see warnings and precautions ( 5.2 , 5.6 )]. do not apply mupirocin ointment concurrently with any other lotions, creams or ointments [see clinical pharmacology ( 12.3 )]. for topical use only. ( 2 ) apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. ( 2 ) re-evaluate patients not showing a clinical response within 3 to 5 days. ( 2 ) not for intranasal, ophthalmic, or other mucosal use. ( 2 )
Direction use with care in premature infants and infants under 2 months of age. these products may cause irritation or chemical burns. surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to c
Read more...over the skin or wound area and wash gently rinse again thoroughly
Directions cleanse skin with thera tm moisturizing body cleanser or thera tm foaming body cleanser apply cream liberally until entire area is covered apply as needed
Stop Use:
Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Dosage Forms and Strength:
3 dosage forms and strengths each gram of mupirocin ointment contains 20 mg mupirocin usp in a water-miscible ointment base supplied in 22-gram tubes. ointment: each gram contains 20 mg mupirocin usp in a water-miscible ointment base supplied in 22-gram tubes. ( 3 )
Contraindications:
4 contraindications mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. ( 4 )
Adverse Reactions:
6 adverse reactions the following adverse reactions are discussed in more detail in other sections of the labeling: severe allergic reactions [see warnings and precautions ( 5.1 )] eye irritation [see warnings and precautions ( 5.2 )] local irritation [see warnings and precautions ( 5.3 )] clostridium difficile -associated diarrhea [see warnings and precautions ( 5.4 )] the most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) to report suspected adverse reactions, contact glenmark pharmaceuticals inc., usa at 1-888-721-7115 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. 6.1 clinical trials experience because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. the following local adverse reactions were reported by at least 1% of subject
Read more...s in connection with the use of mupirocin ointment in clinical trials: 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 were reported in less than 1% of subjects. 6.2 postmarketing experience in addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin ointment. because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. these reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin ointment. immune system disorders systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see warnings and precautions ( 5.1 )].
Use in Specific Population:
8 use in specific populations click here to enter use in specific populations 8.1 pregnancy pregnancy category b. there are no adequate and well-controlled studies of mupirocin ointment in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day in both species. this dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. there was no evidence of fetal harm due to mupirocin. 8.3 nursing mothers it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when mupirocin ointment is administered to a nursing woman. 8.4 pediatric use the safety and effectiveness of mupirocin ointment have b
Read more...een 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 ( 14 )].
Use in Pregnancy:
8.1 pregnancy pregnancy category b. there are no adequate and well-controlled studies of mupirocin ointment in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day in both species. this dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. there was no evidence of fetal harm due to mupirocin.
Pediatric Use:
8.4 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 ( 14 )].
Description:
11 description mupirocin ointment usp 2% contains the rna synthetase inhibitor antibacterial, mupirocin usp. 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-3,4dihydroxy-Ã-methyl-2 h -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. the molecular formula of mupirocin usp is c 26 h 44 o 9 , and the molecular weight is 500.6. the chemical structure is: each gram of mupirocin ointment usp 2% contains 20 mg mupirocin usp in a water-miscible ointment base (polyethylene glycol ointment, n.f.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. structure
Clinical Pharmacology:
12 clinical pharmacology click here to enter clinical pharmacology 12.1 mechanism of action mupirocin is an rna synthetase inhibitor antibacterial [see microbiology ( 12.4 )]. 12.3 pharmacokinetics absorption 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 (less than 1.1 nanogram mupirocin per milliliter of whole blood). measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. the effect of the concurrent application of mupirocin ointment with other drug products has not been studied [see dosage and administration ( 2 )]. elimination in a trial conducted in 7 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. metabolism: following intravenous or oral administration, mupirocin is rapidly metabolized. the
Read more...principal metabolite, monic acid, demonstrates no antibacterial activity. excretion: monic acid is predominantly eliminated by renal excretion. special populations renal impairment: the pharmacokinetics of mupirocin have not been studied in individuals with renal insufficiency. 12.4 microbiology mupirocin is an rna synthetase inhibitor antibacterial produced by fermentation using the organism pseudomonas fluorescens. mechanism of action mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyltransfer rna (trna) synthetase. mupirocin is bactericidal at concentrations achieved by topical administration. mupirocin is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (mics) of mupirocin has not been determined. mechanism of resistance when mupirocin resistance occurs, it results from the production of a modified isoleucyl-trna synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-trna synthetase. high-level plasmid-mediated resistance (mic =512 mcg/ml) has been reported in increasing numbers of isolates of s. aureus and with higher frequency in coagulase-negative staphylococci. mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci. cross resistance due to its mode of action, mupirocin does not demonstrate cross resistance with other classes of antimicrobial agents. antimicrobial activity mupirocin has been shown to be active against susceptible isolates of s. aureus and s. pyogenes , both in vitro and in clinical trials [see indications and usage ( 1 )]. the following in vitro data are available, but their clinical significance is unknown. mupirocin is active against most isolates of staphylococcus epidermidis. susceptibility testing high-level mupirocin resistance (=512 mcg/ml) may be determined using standard disk diffusion or broth microdilution tests. 1,2 because of the occurrence of mupirocin resistance in methicillin-resistant s. aureus (mrsa), it is appropriate to test mrsa populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method. 3,4,5
Mechanism of Action:
12.1 mechanism of action mupirocin is an rna synthetase inhibitor antibacterial [see microbiology ( 12.4 )].
Pharmacokinetics:
12.3 pharmacokinetics absorption 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 (less than 1.1 nanogram mupirocin per milliliter of whole blood). measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. the effect of the concurrent application of mupirocin ointment with other drug products has not been studied [see dosage and administration ( 2 )]. elimination in a trial conducted in 7 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. metabolism: following intravenous or oral administration, mupirocin is rapidly metabolized. the principal metabolite, monic acid, demonstrates no antibacterial activity. excretion: monic acid is predominantly eliminated by renal excretion. special populations renal impair
Read more...ment: the pharmacokinetics of mupirocin have not been studied in individuals with renal insufficiency.
Nonclinical Toxicology:
13 nonclinical toxicology click here to enter nonclinical toxicology 13.1 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 with mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. neither evidence of impaired fertility nor impaired reproductive performance attributable to mupirocin w
Read more...as observed.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
13.1 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 with mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. neither evidence of impaired fertility nor impaired reproductive performance attributable to mupirocin was observed.
Clinical Studies:
14 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. in the second trial, subjects with impetigo were randomized to receive either mupirocin ointment 3 times daily or 30 to 40 mg per 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 included) were 93% for mupirocin ointment (n = 29) and 78.5% for erythr
Read more...omycin (n = 28). pathogen eradication rates in the evaluable populations were 100% for both test groups. 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:
16 how supplied/storage and handling mupirocin ointment usp 2% is supplied in 22-gram tubes. each gram of mupirocin ointment usp contains 20 mg mupirocin usp in a water-miscible ointment base. ndc 68462-180-22 22-gram tube (1 tube per carton) store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Information for Patients:
17 patient counseling information advise the patient to read the fda-approved patient labeling ( patient information ). advise the patient to administer mupirocin ointment as follows: use mupirocin ointment only as directed by the healthcare provider. it is for external use only. avoid contact of mupirocin ointment with the eyes. if mupirocin ointment gets in the eyes, rinse thoroughly with water. do not use mupirocin ointment in the nose. wash your hands before and after applying mupirocin ointment. use a gauze pad or cotton swab to apply a small amount of mupirocin ointment to the affected area. the treated area may be covered by gauze dressing if desired. report to the healthcare provider any signs of local adverse reactions. mupirocin ointment should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or
Read more...tongue, or wheezing occur [see warnings and precautions ( 5.1 )]. if impetigo has not improved in 3 to 5 days, contact the healthcare provider. â bactroban is a registered trademark of the gsk group of companies. manufactured by: glenmark pharmaceuticals ltd. colvale-bardez, goa 403 513, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1 (888)721-7115 www.glenmarkpharma.com/usa december 2015
Package Label Principal Display Panel:
Mupirocin ointment usp package/label principal display panel ndc 68462-180-22 mupirocin ointment usp, 2% - 22 g ointment-tube
Package label and principal display panel ndc 0116-1061-08 dyna-hex 4 ® (chlorhexidine gluconate 4% solution) antiseptic contains: 4% chlorhexidine gluconate distributed by: xttrium laboratories, inc., mount prospect, il 60056 for external use only net contents: 4 fl oz (237 ml) dyna-hex 4 principal display panel
Dimethicone package labeling image of 4 fl oz label
Nusurgepak surgical prep/carepak package labeling nusurgepak surgical prep/carepak
Further Questions:
Questions or comments? call 1-800-587-3721 monday through friday 8:00 am to 4:30 pm cst