Purpose:
Purpose antiseptic
Purpose skin protectant
Product Elements:
Dermacinrx clorhexacin mupirocin ointment mupirocin mupirocin polyethylene glycol, unspecified mupirocin mupirocin antiseptic skin cleanser chlorhexidine gluconate coco diethanolamide hydroxyethyl cellulose (2000 cps at 1%) isopropyl alcohol lauramine oxide water tridecyl alcohol gluconolactone peg-75 lanolin chlorhexidine gluconate chlorhexidine skin repair complex dimethicone kukui nut oil aloe vera leaf butylene glycol caprylyl glycol safflower oil cetyl alcohol chlorphenesin dimethicone/diene dimethicone crosspolymer edetate disodium glycerin glyceryl monostearate levomenol calcium pantothenate carthamus tinctorius seed oleosomes maltodextrin niacinamide pyridoxine hydrochloride silicon dioxide sodium ascorbyl phosphate .alpha.-tocopherol acetate, dl- ginger peg-100 stearate pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) phenoxyethanol water hyaluronate sodium stearic acid trolamine dimethicone dimethicone
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 .
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 mupirocin ointment usp, 2% is not for ophthalmic 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
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 keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Dosage and administration a small amount of mupirocin ointment usp, 2% 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.
Directions 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
Read more...cover the skin or wound area and wash gently rinse again thoroughly
Directions apply cream liberally as needed
Contraindications:
Contraindications this drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
Adverse Reactions:
Adverse reactions the following local adverse reactions have been reported in connection with the use of mupirocin ointment usp, 2%: burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. systemic reactions to mupirocin ointment usp, 2% have occurred rarely.
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 and polyethylene glycol 3350. 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-β-methyl-2h-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 500.62. the chemical structure is: image description
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 administration, mupirocin is rapidly metabolized. the principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. in a study 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. 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 gr
Read more...am-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 studies (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 .
Clinical Studies:
Clinical studies the efficacy of topical mupirocin ointment usp, 2% in impetigo was tested in two studies. in the first, patients with impetigo were randomized to receive either mupirocin ointment usp, 2% or vehicle placebo three times daily for 8 to 12 days. clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment usp, 2% (n=49) and 35% for vehicle placebo (n=51). pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment usp, 2% and 62% for vehicle placebo. there were no side effects reported in the group receiving mupirocin ointment usp, 2%. in the second study, patients with impetigo were randomized to receive either mupirocin ointment usp, 2% three times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. there was a follow-up visit 1 week after treatment ended. clinical efficacy rates at the follow-up visit in t
Read more...he evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment usp, 2% (n=29) and 78.5% for erythromycin (n=28). pathogen eradication rates in the evaluable patient populations were 100% for both test groups. there were no side effects reported in the group receiving mupirocin ointment. pediatrics - there were 91 pediatric patients aged 2 months to 15 years in the first study described above. clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment usp, 2% (n=42) and 36% for vehicle placebo (n=49). in the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment usp, 2%. the age range of the pediatric patients was 7 months to 13 years. the clinical efficacy rate for mupirocin ointment usp, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).
How Supplied:
How supplied mupirocin ointment usp, 2% is available as follows: 22 gram tube (ndc 45802-112-22) store at 20-25°c (68-77°f) [see usp controlled room temperature]. *bactroban nasal ® is a registered trademark of glaxosmithkline.
Package Label Principal Display Panel:
Dermacinrx ® clorhexacin - carton image description