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owen laboratories, inc. - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide .5 mg in 1 g - desonide cream and lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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actavis pharma, inc. - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide cream and lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. desonide cream and lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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apotex corp. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - budesonide nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.2) ]. teratogenic effects: pregnancy category b. the impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., pulmicort turbuhaler) and intranasally administered budesonide (i.e., budesonide nasal spray). the results from population-based prospective cohort epidemiological studies reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during ea

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taro pharmaceuticals u.s.a., inc. - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide cream, 0.05% and desonide ointment, 0.05% are low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician. desonide cream, 0.05% and desonide ointment, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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amneal pharmaceuticals of new york llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. limitations of use: - budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11), adverse reactions (6.2)] . risk summary there are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (mrhdid), but these effects were not seen in rats that received inhaled doses approximately 2 times the mrhdid (see data ). studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans. the estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. labor or delivery there are no well-controlled human studies that have investigated the effects of budesonide inhalation suspension during labor and delivery. data human data studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995-1997 (i.e. swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), the period when most major organ malformations occur. the rate of recorded congenital malformations was similar compared to the general population rate (3.8% vs. 3.5%, respectively). in addition, after exposure to inhaled budesonide, the number of infants born with orofacial clefts was similar to the expected number in the normal population (4 children vs. 3.3, respectively). these same data were utilized in a second study bringing the total to 2534 infants whose mothers were exposed to inhaled budesonide. in this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%). animal data in a fertility and reproduction study, male rats were subcutaneously dosed for 9 weeks and females for 2 weeks prior to pairing and throughout the mating period. females were dosed up until weaning of their offspring. budesonide caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at doses 0.2 times the mrhdid (on a mcg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and above). no such effects were noted at a dose 0.05 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 5 mcg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, budesonide produced fetal loss, decreased fetal weight, and skeletal abnormalities at doses 0.5 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 25 mcg/kg/day). in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6 to 15, budesonide produced similar adverse fetal effects at doses approximately 5 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 500 mcg/kg/day). in another embryo-fetal development study in pregnant rats, no structural abnormalities or embryocidal effects were seen at doses approximately 2 times the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 250 mcg/kg/day). in a peri-and post-natal development study, rats dosed from gestation day 15 to postpartum day 21, budesonide had no effects on delivery, but did have an effect on growth and development of offspring. offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at doses less than 0.2 times the mrhdid and higher (on a mcg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). these findings occurred in the presence of maternal toxicity. risk summary there are no available data on the effects of budesonide inhalation suspension on the breastfed child or on milk production. budesonide, like other inhaled corticosteroids, is present in human milk [see data]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for budesonide and any potential adverse effects on the breastfed infant from budesonide or from the underlying maternal condition. data human data with budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother [see clinical pharmacology (12.3)] . safety and effectiveness in children six months to 12 months of age has been evaluated but not established. safety and effectiveness in children 12 months to 8 years of age have been established [see clinical pharmacology (12.2), and adverse reactions (6.1)] . a 12-week study in 141 pediatric patients 6 to 12 months of age with mild to moderate asthma or recurrent/persistent wheezing was conducted. all patients were randomized to receive either 0.5 mg or 1 mg of budesonide inhalation suspension or placebo.  adrenal-axis function was assessed with an acth stimulation test at the beginning and end of the study, and mean changes from baseline in this variable did not indicate adrenal suppression in patients who received budesonide inhalation suspension versus placebo. however, on an individual basis, 7 patients in this study (6 in the budesonide inhalation suspension treatment arms and 1 in the placebo arm) experienced a shift from having a normal baseline stimulated cortisol level to having a subnormal level at week 12 [see clinical pharmacology (12.2)] . pneumonia was observed more frequently in patients treated with budesonide inhalation suspension than in patients treated with placebo, (n = 2, 1, and 0) in the budesonide inhalation suspension 0.5 mg, 1 mg, and placebo groups, respectively. a dose dependent effect on growth was also noted in this 12-week trial. infants in the placebo arm experienced an average growth of 3.7 cm over 12 weeks compared with 3.5 cm and 3.1 cm in the budesonide inhalation suspension 0.5 mg and 1 mg arms respectively. this corresponds to estimated mean (95% ci) reductions in 12-week growth velocity between placebo and budesonide inhalation suspension 0.5 mg of 0.2 cm (-0.6 to 1.0) and between placebo and budesonide inhalation suspension 1 mg of 0.6 cm (-0.2 to 1.4). these findings support that the use of budesonide inhalation suspension in infants 6 to 12 months of age may result in systemic effects and are consistent with findings of growth suppression in other studies with inhaled corticosteroids. controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. in these studies, the mean reduction in growth velocity was approximately one centimeter per year (range 0.3 to 1.8 cm per year) and appears to be related to dose and duration of exposure. 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 orally inhaled corticosteroids, including the impact on final adult height, are unknown. the potential for “catch up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. in a study of asthmatic children 5 to 12 years of age, those treated with budesonide administered via a dry powder inhaler 200 mcg twice daily (n=311) had a 1.1-centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. by the end of four years, children treated with the budesonide dry powder inhaler and children treated with placebo had similar growth velocities. conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study. the growth of pediatric patients receiving inhaled corticosteroids, including budesonide inhalation suspension should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks and benefits associated with alternative therapies. to minimize the systemic effects of inhaled corticosteroids, including budesonide inhalation suspension, each patient should be titrated to his/her lowest effective dose [see dosage and administration (2) and warnings and precautions (5.8)] . of the 215 patients in 3 clinical trials of budesonide inhalation suspension in adult patients, 65 (30%) were 65 years of age or older, while 22 (10%) were 75 years of age or older. no overall differences in safety were observed between these patients and younger patients, and other reported clinical or medical surveillance experience has not identified differences in responses between the elderly and younger patients. formal pharmacokinetic studies using budesonide inhalation suspension have not been conducted in patients with hepatic impairment. however, since budesonide is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of budesonide in plasma. therefore, patients with hepatic disease should be closely monitored.

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cipla usa inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. limitations of use : -   budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: •  primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. • hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11),adverse reactions(6.2) ]. risk summary there are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, w

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

preferred pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: the use of budesonide inhalation suspension is contraindicated in the following conditions: studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (ie, swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), th

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

mayne pharma inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations ]. in animal reproduction studies with pregnant rats and rabbits, administration of

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

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: • budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use

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

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: the use of budesonide inhalation suspension is contraindicated in the following conditions: teratogenic effects: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 1