United States - English - NLM (National Library of Medicine)

bryant ranch prepack - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - mupirocin ointment usp, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of staphylococcus aureus (s. aureus) and streptococcus pyogenes (s. pyogenes) . mupirocin ointment usp, 2% is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment usp, 2%. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology (12.3) ]. no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data: developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. this dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. in rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. there was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area. mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. this dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. the no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose. risk summary it is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. however, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin ointment [see clinical pharmacology (12.3) ]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin ointment and any potential adverse effects on the breastfed child from mupirocin ointment or from the underlying maternal condition. clinical considerations to minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin ointment usp, 2% should be thoroughly washed prior to breastfeeding. 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) ].

United States - English - NLM (National Library of Medicine)

glaxosmithkline llc - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g - bactroban cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of staphylococcus aureus (s. aureus) and streptococcus pyogenes (s. pyogenes) . bactroban cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of bactroban cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with bactroban cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of bacroban cream [see clinical pharmacology (12.3)] . no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscar

United States - English - NLM (National Library of Medicine)

glaxosmithkline llc - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g - bactroban nasal ointment is indicated for the eradication of nasal colonization with methicillin‑resistant staphylococcus aureus (mrsa) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of mrsa infection during institutional outbreaks of infections with this microorganism. bactroban nasal ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of bactroban nasal ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with bactroban nasal ointment in pregnant women. mupirocin absorption was negligible following repeated intranasal administration of bactroban nasal ointment [see clinical pharmacology 12.3)] , but the dose regimen used in this study did not mimic recommended clinical use. no developmental toxicity was observed in rats or rabbits treated with mupirocin

United States - English - NLM (National Library of Medicine)

central texas community health centers - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology ( 12.3)] . no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the est

United States - English - NLM (National Library of Medicine)

unit dose services - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology ( 12.3)] . no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the est

United States - English - NLM (National Library of Medicine)

directrx - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - mupirocin ointment usp, 2% is indicated for the topical treatment of impetigo due to: s. aureusand s. pyogenes. this drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology (12.3) ]. no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the esti

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology (12.3) ]. no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the esti

United States - English - NLM (National Library of Medicine)

unit dose services - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology (12.3) ]. no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the esti

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - 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 contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see clinical pharmacology (12.3)] . no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. the esti