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

a-s medication solutions - 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)

a-s medication solutions - 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 popula

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

rpk pharmaceuticals, inc. - 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 popula

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

medimetriks pharmaceuticals, inc. - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g - centany® ointment is indicated for the topical treatment of impetigo due to: staphylococcus aureus and streptococcus pyogenes . centany® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components. pregnancy category b there are no adequate and well-controlled studies of centany® ointment in pregnant women. because animal 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 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. 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 centany® ointment is administered to a nursing woman. the safety and effectiveness o

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

medimetriks pharmaceuticals inc - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g - centany® ointment is indicated for the topical treatment of impetigo due to: staphylococcus aureus and streptococcus pyogenes . centany® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components. pregnancy category b there are no adequate and well-controlled studies of centany® ointment in pregnant women. because animal 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 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. 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 centany® ointment is administered to a nursing woman. the safety and effectiveness o

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

ax pharmaceutical corp - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) -

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) ].

Australia - English - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - mupirocin calcium, quantity: 21.5 mg/g (equivalent: mupirocin, qty 20 mg/g) - ointment - excipient ingredients: white soft paraffin; bis-diglyceryl polyacyladipate-2 - medicianz mupirocin nasal ointment is indicated for the elimination of nasal carriage of staphylococci, including methicillin resistant staphylococcus aureus (mrsa).

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

preferred 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)

orthoneutrogena, division of ortho-mcneil pharmaceutical, inc. - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - ointment - centany (mupirocin ointment),2% is indicated for the topical treatment of impetigo due to: staphylococcus aureus and streptococcus pyogenes . this drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.