爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

astrazeneca ab - ciclesonide - pressurised inhalation, solution - 160 microgram(s) - glucocorticoids; ciclesonide

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

astrazeneca ab - ciclesonide - pressurised inhalation, solution - 80 microgram(s) - glucocorticoids; ciclesonide

新加坡 - 英文 - HSA (Health Sciences Authority)

galderma singapore private limited - clobetasol propionate - lotion - 0.05% - clobetasol propionate 0.05%

新加坡 - 英文 - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - mometasone furoate; salicylic acid - ointment - 1 mg/g - mometasone furoate 1 mg/g; salicylic acid 50 mg/g

新加坡 - 英文 - HSA (Health Sciences Authority)

galderma singapore private limited - fluocinolone acetonide; hydroquinone; tretinoin - cream - 0.1 mg/g - fluocinolone acetonide 0.1 mg/g; hydroquinone 40 mg/g; tretinoin 0.5 mg/g

美国 - 英文 - NLM (National Library of Medicine)

apotex corp. - mometasone (unii: 8hr4qj6dw8) (mometasone - unii:8hr4qj6dw8) - mometasone 50 ug - mometasone furoate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. mometasone furoate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult 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 [see warnings and precautions (5.3), description (11)]. risk summary mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (mrhd) on a mcg/m2 or auc basis [see data]. however, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  data animal data in an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (mrdid) (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). no toxicity was observed with a dose that produced an exposure less than the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above).  in an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above).  in another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). there were no findings at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg).  embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. in the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the mrdid (on mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). in the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the mrdid (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). at approximately 110 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. no effects were observed at a dose approximately 6 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg). risk summary there are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. however, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition.  the safety and effectiveness of mometasone furoate nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see adverse reactions (6.1) and clinical studies (14.1)]. use of mometasone furoate nasal spray forthis indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see clinical studies (14.1)].  the safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. the primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. a total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). the results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. the adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps. effect of growth controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for "catch up" growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose. a clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. no statistically significant effect on growth velocity was observed for mometasone furoate nasal spray compared to placebo following one year of treatment. no evidence of clinically relevant hpa axis suppression was observed following a 30-minute cosyntropin infusion. the potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. a total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.   concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see clinical pharmacology (12.3)] .

美国 - 英文 - NLM (National Library of Medicine)

amneal pharmaceuticals llc - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 50 ug - mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. mometasone furoate  nasal spray 50 mcg is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult 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 [see warnings and precautions (5.3), description (11)] . risk summary mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (mrhd) on a mcg/m2 or auc basis [see data] . however, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (mrdid) (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). no toxicity was observed with a dose that produced an exposure less than the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). in an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). in another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). there were no findings at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg). embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. in the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). in the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the mrdid (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). at approximately 110 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. no effects were observed at a dose approximately 6 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg). risk summary there are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. however, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition. the safety and effectiveness of mometasone furoate  nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see adverse reactions (6.1)  and clinical studies (14.1)] . use of mometasone furoate  nasal spray for this indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see clinical studies (14.1)] .  the safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. the primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. a total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). the results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. the adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps. effect on growth controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose. a clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. no statistically significant effect on growth velocity was observed for mometasone furoate  nasal spray compared to placebo following one year of treatment. no evidence of clinically relevant hpa axis suppression was observed following a 30-minute cosyntropin infusion. the potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. a total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients. concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see clinical pharmacology (12.3)] . mometasone furoate (moe met’ a sone fure’ oh ate) nasal spray, 50 mcg for use in your nose only. read the patient instructions for use carefully before you start to use your mometasone furoate nasal spray. if you have any questions, ask your healthcare provider. shake the bottle well before each use. - remove the plastic cap (see figure 1). - before you use mometasone furoate for the first time, prime the pump by pressing downward on the shoulders of the white nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (see figure 2). do not pierce the nasal applicator. press down and release the pump 10 times or until a fine spray appears. do not spray into eyes. the pump is now ready to use. the pump may be stored unused for up to 1 week without repriming. if unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears. - gently blow your nose to clear the nostrils. close 1 nostril. tilt your head forward slightly, keep the bottle upright, carefully insert the nasal applicator into the other nostril (see figure 3). do not spray directly onto the nasal septum (the wall between the two nostrils). - for each spray, hold the spray bottle upright and press firmly downward 1 time on the shoulders of the white nasal applicator using your index and middle fingers while supporting the base of the bottle with your thumb. breathe gently inward through the nostril (see figure 4). note: it is important to keep the mometasone furoate unit in an upright orientation (as seen in figure 4). failure to do so may result in an incomplete or non-existent spray. note: it is important to keep the mometasone furoate unit in an upright orientation (as seen in figure 4). failure to do so may result in an incomplete or non-existent spray. - then breathe out through the mouth. - repeat in the other nostril. - wipe the nasal applicator with a clean tissue and replace the plastic cap. each bottle of mometasone furoate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. do not use the bottle of mometasone furoate nasal spray after 120 sprays. additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of mometasone furoate nasal spray, and throw away the bottle even if it has medicine still left in. do not count any sprays used for priming the device. talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine. pediatric use: administration to children should be supervised by an adult. steps 1 through 7 from the patient instructions for use  should be followed. cleaning: do not try to unblock the nasal applicator with a sharp object. please see patient instructions for cleaning applicator. patient instructions for cleaning applicator - to clean the nasal applicator, remove the plastic cap (see figure 5).                   figure 5                   figure 5 - pull gently upward on the white nasal applicator to remove (see figure 6).                      figure 6                      figure 6 - soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry (see figure 7). do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. figure 7 4. rinse the plastic cap under cold water and dry (see figure 8). figure 8   5. put the nasal applicator back together making sure the pump stem is reinserted into the applicator’s center hole (see figure 9). figure 9 6. reprime the pump by pressing downward on the shoulders of the white nasal applicator using your index and middle fingers while holding the base of the bottle with your thumb. press down and release the pump 2 times or until a fine spray appears. do not spray into eyes. the pump is now ready to use. the pump may be stored unused for up to 1 week without repriming. if unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears (see figure 10). figure 10 7. replace the plastic cap (see figure 11). figure 11 this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj  08807 rev. 08-2022-03

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - mometasone (unii: 8hr4qj6dw8) (mometasone - unii:8hr4qj6dw8) - mometasone 50 ug - mometasone furoate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. mometasone furoate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult 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  [see warnings and precautions ( 5.3), description ( 11)]. risk summary mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (mrhd) on a mcg/m 2 or auc basis [see data]. however, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  data animal data in an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (mrdid) (on a mcg/m 2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the mrdid (on a mcg/m 2 basis with a maternal subcutaneous dose of 180 mcg/kg). no toxicity was observed with a dose that produced an exposure less than the mrdid (on a mcg/m 2 basis with maternal topical dermal doses of 20 mcg/kg and above).  in an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the mrdid (on a mcg/m 2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the mrdid (on a mcg/m 2 basis with maternal topical dermal doses of 300 mcg/kg and above).  in another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the mrdid (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg). there were no findings at a dose less than the mrdid (on a mcg/m 2 basis with a maternal subcutaneous dose of 7.5 mcg/kg).  embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. in the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the mrdid (on mcg/m 2 basis with maternal topical dermal doses of 150 mcg/kg and above). in the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the mrdid (on a mcg/m 2 basis with a maternal oral dose of 700 mcg/kg). at approximately 110 times the mrdid (on a mcg/m 2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. no effects were observed at a dose approximately 6 times the mrdid (on a mcg/m 2 basis with a maternal oral dose of 140 mcg/kg). risk summary there are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. however, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition.  the safety and effectiveness of mometasone furoate nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see adverse reactions ( 6.1) and clinical studies ( 14.1)]. use of mometasone furoate nasal spray forthis indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see clinical studies ( 14.1)].  the safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. the primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. a total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). the results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. the adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps. effect of growth controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for "catch up" growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose. a clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. no statistically significant effect on growth velocity was observed for mometasone furoate nasal spray compared to placebo following one year of treatment. no evidence of clinically relevant hpa axis suppression was observed following a 30-minute cosyntropin infusion. the potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. a total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.   concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see clinical pharmacology (12.3)] .

美国 - 英文 - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole 10 mg in 1 g - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes, and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible. there have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. in an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see data]. the available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data clotrimazole studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day revealed no evidence of fetotoxicity due to clotrimazole exposure. no increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation days 6 to 15. however, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. clotrimazole dosed at 200 mg/kg/day was maternally lethal, and therefore, fetuses were not evaluated in this group. also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. however, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see nonclinical toxicology ( error! hyperlink reference not valid. )] . oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. no evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. betamethasone dipropionate betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. the abnormalities observed included umbilical hernias, cephalocele, and cleft palates. risk summary there are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clotrimazole and betamethasone dipropionate cream and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see use in specific populations ( error! hyperlink reference not valid. )] . the use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended. adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. in open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. in another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. 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 when they are treated with topical corticosteroids. they are, therefore also at greater risk of adrenal 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. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see warnings and precautions ( error! hyperlink reference not valid. )]. avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis. clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. however, greater sensitivity of some older individuals cannot be ruled out. the use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended. postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin.

美国 - 英文 - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate cream (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. the available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. risk summary there are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. it is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. use of betamethasone dipropionate cream (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for hpa axis suppression [see warnings and precautions (5.1) ]. in an open-label hpa axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented) was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). in 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dl pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dl and/or an increase of <7 mcg/dl from the baseline cortisol. out of the 19 subjects with hpa axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and 3 of the 4 (75%) had complete recovery of hpa axis function. the proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids. rare systemic effects such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. avoid use of betamethasone dipropionate cream (augmented) in the treatment of diaper dermatitis. clinical trials of betamethasone dipropionate cream (augmented) included 104 subjects who were 65 years of age and over and 8 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 patients. however, greater sensitivity of some older individuals cannot be ruled out.