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

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puretek corporation - mupirocin (unii: d0gx863oa5) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g

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)

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)

cardinal health - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 20 mg in 1 g

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

glenmark pharmaceuticals inc., usa - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - pirnuo 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). pirnuo cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of pirnuo cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin 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 miscarriage 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 cream [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pirnuo cream and any potential adverse effects on the breastfed child from pirnuo cream 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 pirnuo cream should be thoroughly washed prior to breastfeeding. the safety and effectiveness of mupirocin cream have been established in the age-groups of 3 months to 16 years. use of pirnuo cream in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see clinical studies (14)] . in 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. no overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

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

encube ethicals private limited - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin cream usp, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of staphylococcus aureus (s. aureus) and streptococcus pyogenes (s. pyogenes). mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin 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 are

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

alembic pharmaceuticals inc. - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 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) . mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin 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 miscarriage 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 prenatal 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 cream [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mupirocin cream and any potential adverse effects on the breastfed child from mupirocin cream 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 cream should be thoroughly washed prior to breastfeeding. the safety and effectiveness of mupirocin cream have been established in the age-groups 3 months to 16 years. use of mupirocin cream in these age-groups is supported by evidence from adequate and well‑controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see clinical studies (14)] . in 2 adequate and well‑controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. no overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

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

aleor dermaceuticals limited - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 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) . mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin 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 misc

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

padagis israel pharmaceuticals ltd - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin 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). mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin 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