Соединенные Штаты - английский - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. none. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to

Соединенные Штаты - английский - NLM (National Library of Medicine)

proficient rx lp - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. none. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to

Соединенные Штаты - английский - NLM (National Library of Medicine)

remedyrepack inc. - mometasone (unii: 8hr4qj6dw8) (mometasone - unii:8hr4qj6dw8) - mometasone 50 ug - mometasone furoate nasal spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. mometasone furoate nasal spray 50 mcg is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older. mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. mometasone furoate nasal spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older. mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients. teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies in pregnant women. mometasone furoate nasal spray 50 mcg, like other corticosteroids, should be

Соединенные Штаты - английский - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 1 mg in 1 ml - mometasone furoate lotion (mometasone furoate topical solution 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. mometasone furoate lotion (mometasone furoate topical solution 0.1%) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects, pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometas

Соединенные Штаты - английский - NLM (National Library of Medicine)

torrent pharmaceuticals limited - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.           mometasone furoate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, a

Соединенные Штаты - английский - NLM (National Library of Medicine)

a-s medication solutions - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate incre

Соединенные Штаты - английский - NLM (National Library of Medicine)

sandoz inc. - mometasone furoate monohydrate (unii: mtw0weg809) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 50 ug - mometasone furoate monohydrate nasal spray is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. mometasone furoate monohydrate nasal spray is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older. mometasone furoate monohydrate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. mometasone furoate monohydrate nasal spray is indicated for the treatment of nasal polyps in patients 18 years of age and older. mometasone furoate monohydrate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients. risk summary there are no adequate and well-controlled clinical studies of mometasone furoate monohydrate nasal spray in pregnant women. in animal reproducti

Соединенные Штаты - английский - NLM (National Library of Medicine)

remedyrepack inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate ointment usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate ointment 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. in

Соединенные Штаты - английский - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. none. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to

Соединенные Штаты - английский - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. in mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. fetal survival was reduced at 180 mcg/kg. no toxicity was observed at 20 mcg/kg. (doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) in rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. a dose of 300 mcg/kg produced delays in ossification, but no malformations. (doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) in rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis). in an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. at 2800 mcg/kg most litters were aborted or resorbed. no toxicity was observed at 140 mcg/kg. (doses of 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) when rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. similar effects were not observed at 7.5 mcg/kg. (doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when mometasone furoate ointment is administered to a nursing woman. mometasone furoate ointment may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. since safety and efficacy of mometasone furoate ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. mometasone furoate ointment caused hpa axis suppression in approximately 27% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15% to 99%).the criteria for suppression were: basal cortisol level of ≤5 mcg/dl, 30-minute post-stimulation level of ≤18 mcg/dl, or an increase of <7 mcg/dl. follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed hpa axis function in 3 subjects, using these same criteria. long-term use of topical corticosteroids has not been studied in this population [see clinical pharmacology (12.2)] . because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of hpa axis suppression. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. mometasone furoate ointment should not be used in the treatment of diaper dermatitis. clinical trials of mometasone furoate ointment included 310 subjects who were 65 years of age and over and 57 subjects who were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. however, greater sensitivity of some older individuals cannot be ruled out.