الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

zydus lifesciences limited - 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 extended-release 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, a

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

american health packaging - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide capsules is indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules is 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 is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules. 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 misca

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mayne pharma inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

carilion materials management - 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. 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. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). anaphylactic reactions have occurred [ ]. see adverse reactions (6.2) budesonide was teratogenic and embryocidal in rabbits and rats. budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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 abnormaliti

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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, wa

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

cardinal health 107, llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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: the use of budesonide inhalation suspension is contraindicated in the following conditions: 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 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 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 6-15, 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 inhalation suspension and any potential adverse effects on the breastfed infant from budesonide inhalation suspension 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), 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 once daily. 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), 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. budesonide (bew deh so nide) inhalation suspension 2 ml vials containing 0.25 mg or 0.5 mg for inhalation only. do not swallow. only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. do not use with an ultrasonic nebulizer. read the patient information that comes with budesonide inhalation suspension before your child starts using it and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your child’s medical condition or treatment. if you have any questions about budesonide inhalation suspension, ask your healthcare provider or pharmacist. what is budesonide inhalation suspension? budesonide inhalation suspension is an inhaled corticosteroid medicine. budesonide inhalation suspension is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. inhaled corticosteroids help to decrease inflammation in the lungs. inflammation in the lungs can lead to asthma symptoms. budesonide inhalation suspension helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms. budesonide inhalation suspension does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. always have a short-acting beta2 -agonist medicine (rescue inhaler) with you to treat sudden symptoms. if your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child. it is not known if budesonide inhalation suspension is safe or effective in children younger than 12 months or older than 8 years. who should not use budesonide inhalation suspension? do not use budesonide inhalation suspension: what should i tell my healthcare provider before using budesonide inhalation suspension? before your child uses budesonide inhalation suspension, tell your healthcare provider if your child: budesonide inhalation suspension may not be right for children who have had any of these types of infections. tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. using budesonide inhalation suspension with certain other medicines may affect each other causing side effects. especially tell your healthcare provider if your child takes: ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. know the medicines your child takes. keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine. how should i use budesonide inhalation suspension? what are the possible side effects of budesonide inhalation suspension? budesonide inhalation suspension may cause serious side effects including: call your healthcare provider or get medical help right away if your child has any of the serious side effects listed above. the most common side effects of budesonide inhalation suspension include: tell your healthcare provider if your child has any side effect that bothers him or her or that does not go away. for more information, ask your healthcare provider or pharmacist. call your healthcare provider for medical advice about side effects. you may report side effects to teva pharmaceuticals usa, inc. at 1-888-838-2872 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch. how should i store budesonide inhalation suspension? keep budesonide inhalation suspension and all medicines out of the reach of children. general information about budesonide inhalation suspension medicines are sometimes prescribed for conditions other than those listed in a patient information leaflet. do not use budesonide inhalation suspension for a condition for which it was not prescribed. do not give budesonide inhalation suspension to other people, even if they have the same symptoms that you have. it may harm them. this patient information leaflet summarizes the most important information about budesonide inhalation suspension. if you would like more information, talk with your healthcare provider. you can ask your pharmacist or healthcare provider for information about budesonide inhalation suspension that is written for health professionals. for more information, call 1-888-838-2872. what are the ingredients in budesonide inhalation suspension? active ingredient: budesonide inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, tri-sodium citrate dihydrate and water for injection. patient instructions for use important: budesonide inhalation suspension is only for use with a jet nebulizer machine. make sure you know how to use your jet nebulizer machine before your child uses budesonide inhalation suspension. budesonide inhalation suspension is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs. the face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask. 1. budesonide inhalation suspension vials come in a sealed protective aluminum foil envelope. 2. gently shake the budesonide inhalation suspension vial using a circular motion as shown in figure 1 . 3. hold the budesonide inhalation suspension vial upright without squeezing the vial and open by twisting off the top as shown in figure 2 . 4. place the open end of the budesonide inhalation suspension vial into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the vial into the nebulizer medicine cup as shown in figure 3 . throw away the empty vial. 5. use your jet nebulizer as directed.  all brand names listed are the registered trademarks of their respective owners and are not trademarks of teva pharmaceuticals usa. manufactured in england by: norton healthcare limited t/a ivax pharmaceuticals uk runcorn, cheshire wa7 3fa england manufactured for: teva pharmaceuticals usa, inc. north wales, pa 19454 distributed by: cardinal health dublin, oh 43017 l55575900424 rev. a 10/2019