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amneal pharmaceuticals ny llc - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin capsules are indicated for: - management of neuropathic pain associated with diabetic peripheral neuropathy - management of postherpetic neuralgia - adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older -   management of fibromyalgia - management of neuropathic pain associated with spinal cord injury pediatric use information is approved for pfizer’s lyrica (pregabalin) capsules. however, due to pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. to provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate and well-controlled studies with pregabalin in pregnant women. however, in animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (auc) greater than or equal to 16 times human exposure at the maximum recommended dose (mrd) of 600 mg/day [see data] . in an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. the no-effect dose for developmental toxicity was approximately twice the human exposure at mrd. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. advise pregnant women of the potential risk to a fetus. data animal data when pregnant rats were given pregabalin (500, 1,250, or 2,500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at greater than or equal to 1,250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. fetal body weights were decreased at the highest dose. the low dose in this study was associated with a plasma exposure (auc) approximately 17 times human exposure at the mrd of 600 mg/day. a no-effect dose for rat embryo-fetal developmental toxicity was not established. when pregnant rabbits were given pregabalin (250, 500, or 1,250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose. the no-effect dose for developmental toxicity in rabbits (500 mg/kg) was associated with a plasma exposure approximately 16 times human exposure at the mrd. in a study in which female rats were dosed with pregabalin (50, 100, 250, 1,250, or 2,500 mg/kg) throughout gestation and lactation, offspring growth was reduced at greater than or equal to 100 mg/kg and offspring survival was decreased at greater than or equal to 250 mg/kg. the effect on offspring survival was pronounced at doses greater than or equal to 1,250 mg/kg, with 100% mortality in high-dose litters. when offspring were tested as adults, neurobehavioral abnormalities (decreased auditory startle responding) were observed at greater than or equal to 250 mg/kg and reproductive impairment (decreased fertility and litter size) was seen at 1,250 mg/kg. the no-effect dose for pre- and postnatal developmental toxicity in rats (50 mg/kg) produced a plasma exposure approximately 2 times human exposure at the mrd. in the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures greater than or equal to 50 times the mean human exposure (auc(0 to 24) of 123 mcg•hr/ml) at the mrd. risk summary small amounts of pregabalin have been detected in the milk of lactating women. a pharmacokinetic study in lactating women detected pregabalin in breast milk at average steady-state concentrations approximately 76% of those in maternal plasma. the estimated average daily infant dose of pregabalin from breast milk (assuming mean milk consumption of 150 ml/kg/day) was 0.31 mg/kg/day, which on a mg/kg basis would be approximately 7% of the maternal dose [see data] . the study did not evaluate the effects of pregabalin on milk production or the effects of pregabalin on the breastfed infant. based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant [see nonclinical toxicology (13.1)] . available clinical study data in patients greater than 12 years of age do not provide a clear conclusion about the potential risk of tumorigenicity with pregabalin [see warnings and precautions (5.9)] . because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin. data a pharmacokinetic study in ten lactating women, who were at least 12 weeks postpartum, evaluated the concentrations of pregabalin in plasma and breast milk. pregabalin 150 mg oral capsule was given every 12 hours (300 mg daily dose) for a total of four doses. pregabalin was detected in breast milk at average steady-state concentrations approximately 76% of those in maternal plasma. the estimated average daily infant dose of pregabalin from breast milk (assuming mean milk consumption of 150 ml/kg/day) was 0.31 mg/kg/day, which on a mg/kg basis would be approximately 7% of the maternal dose. the study did not evaluate the effects of pregabalin on milk production. infants did not receive breast milk obtained during the dosing period, therefore, the effects of pregabalin on the breast fed infant were not evaluated. infertility male effects on spermatogenesis in a randomized, double-blind, placebo-controlled non-inferiority study to assess the effect of pregabalin on sperm characteristics, healthy male subjects received pregabalin at a daily dose up to 600 mg (n=111) or placebo (n=109) for 13 weeks (one complete sperm cycle) followed by a 13-week washout period (off-drug). a total of 65 subjects in the pregabalin group (59%) and 62 subjects in the placebo group (57%) were included in the per protocol (pp) population. these subjects took study drug for at least 8 weeks, had appropriate timing of semen collections and did not have any significant protocol violations. among these subjects, approximately 9% of the pregabalin group (6/65) vs. 3% in the placebo group (2/62) had greater than or equal to 50% reduction in mean sperm concentrations from baseline at week 26 (the primary endpoint). the difference between pregabalin and placebo was within the pre-specified non-inferiority margin of 20%. there were no adverse effects of pregabalin on sperm morphology, sperm motility, serum fsh or serum testosterone levels as compared to placebo. in subjects in the pp population with greater than or equal to 50% reduction in sperm concentration from baseline, sperm concentrations were no longer reduced by greater than or equal to 50% in any affected subject after an additional 3 months off-drug. in one subject, however, subsequent semen analyses demonstrated reductions from baseline of greater than or equal to 50% at 9 and 12 months off-drug. the clinical relevance of these data is unknown. in the animal fertility study with pregabalin in male rats, adverse reproductive and developmental effects were observed [see nonclinical toxicology (13.1)]. neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuropathic pain associated with spinal cord injury safety and effectiveness in pediatric patients have not been established. fibromyalgia safety and effectiveness in pediatric patients have not been established. a 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years, at pregabalin total daily doses of 75 to 450 mg per day. the primary efficacy endpoint of change from baseline to week 15 in mean pain intensity (derived from an 11-point numeric rating scale) showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. the most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. the overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. adjunctive therapy for partial-onset seizures safety and effectiveness in pediatric patients below the age of 1 month have not been established. juvenile animal data in studies in which pregabalin (50 to 500 mg/kg) was orally administered to young rats from early in the postnatal period (postnatal day 7) through sexual maturity, neurobehavioral abnormalities (deficits in learning and memory, altered locomotor activity, decreased auditory startle responding and habituation) and reproductive impairment (delayed sexual maturation and decreased fertility in males and females) were observed at doses greater than or equal to 50 mg/kg. the neurobehavioral changes of acoustic startle persisted at greater than or equal to 250 mg/kg and locomotor activity and water maze performance at greater than or equal to 500 mg/kg in animals tested after cessation of dosing and, thus, were considered to represent long-term effects. the low effect dose for developmental neurotoxicity and reproductive impairment in juvenile rats (50 mg/kg) was associated with a plasma pregabalin exposure (auc) approximately equal to human exposure at the maximum recommended dose of 600 mg/day. a no-effect dose was not established. information describing a clinical study in which efficacy was not demonstrated in patients is approved for pfizer inc.’s lyrica® (pregabalin) products. additional pediatric use information is approved for pfizer’s lyrica (pregabalin) capsules. however, due to pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. in controlled clinical studies of pregabalin in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older. in controlled clinical studies of pregabalin in neuropathic pain associated with postherpetic neuralgia, 282 patients were 65 to 74 years of age, and 379 patients were 75 years of age or older. in controlled clinical studies of pregabalin in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older. no overall differences in safety and efficacy were observed between these patients and younger patients. in controlled clinical studies of pregabalin in fibromyalgia, 106 patients were 65 years of age or older. although the adverse reaction profile was similar between the two age groups, the following neurological adverse reactions were more frequent in patients 65 years of age or older: dizziness, vision blurred, balance disorder, tremor, confusional state, coordination abnormal, and lethargy. pregabalin is known to be substantially excreted by the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function. because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see dosage and administration (2.7)] . pregabalin is eliminated primarily by renal excretion and dose adjustment is recommended for adult patients with renal impairment [see dosage and administration (2.7) and clinical pharmacology (12.3)]. the use of pregabalin in pediatric patients with compromised renal function has not been studied. pregabalin is a schedule v controlled substance. pregabalin is not known to be active at receptor sites associated with drugs of abuse. as with any cns active drug, carefully evaluate patients for history of drug abuse and observe them for signs of pregabalin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior). in a study of recreational users (n=15) of sedative/hypnotic drugs, including alcohol, pregabalin (450 mg, single dose) received subjective ratings of "good drug effect," "high" and "liking" to a degree that was similar to diazepam (30 mg, single dose). in controlled clinical studies in over 5,500 patients, 4% of pregabalin-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1% to 12%. in clinical studies, following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache or diarrhea [see warnings and precautions (5.6)] , consistent with physical dependence. in the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis.

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astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 50 mg - lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline brca -mutated (gbrcam ) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza. none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , lynparza can cause fetal harm when administered to a pregnant woman. there are no available data on lynparza use in pregnant women to inform the drug associated risk. in an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 400 mg twice daily [see data] . apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. the estimated background risk of major birth d

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astrazeneca pharmaceuticals lp - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - anastrozole 1 mg - arimidex is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. arimidex is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. arimidex is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with er-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to arimidex. arimidex may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. arimidex is contraindicated in women who are or may become pregnant. there are no adequate and well-controlled studies in pregnant women using arimidex. if arimidex is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a

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astrazeneca pharmaceuticals lp - vandetanib (unii: yo460oq37k) (vandetanib - unii:yo460oq37k) - vandetanib 100 mg - caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. do not use in patients with congenital long qt syndrome [see boxed warning ]. pregnancy category d [see warnings and precautions (5.14) ] risk summary based on its mechanism of action, caprelsa can cause fetal harm when administered to a pregnant woman. vandetanib is embryotoxic, fetotoxic, and teratogenic in rats, at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. if caprelsa is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. animal data when vandetanib was administered to female rats prior to mating and through the first week of pregnancy at a do

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astrazeneca pharmaceuticals lp - goserelin acetate (unii: 6yuu2pv0u8) (goserelin - unii:0f65r8p09n) - goserelin 10.8 mg - zoladex is indicated for use in combination with flutamide for the management of locally confined stage t2b-t4 (stage b2-c) carcinoma of the prostate. treatment with zoladex and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see dosage and administration (2.1) and clinical studies (14.1)]. zoladex is indicated in the palliative treatment of advanced carcinoma of the prostate [see dosage and administration (2.2) and clinical studies (14.2)] . in controlled studies of patients with advanced prostatic cancer comparing zoladex 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. additionally, duration of survival was similar between the two treatment arms in a major comparative trial. in controlled studies of patients with advanced prostatic cancer, zoladex 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved wit

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astrazeneca pharmaceuticals lp - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - casodex 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. casodex 150 mg daily is not approved for use alone or with other treatments [see clinical studies (14.2)]. casodex is contraindicated in: casodex is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported. casodex has no indication for women, and should not be used in this population. casodex can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . risk summary casodex is contraindicated for use in pregnant women because it can cause fetal harm. casodex is not indicated for use in females. there are no human data on the use of casodex in pregnant women. in animal reproduction studies, oral administration of bicalutamide to p

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astrazeneca pharmaceuticals lp - goserelin acetate (unii: 6yuu2pv0u8) (goserelin - unii:0f65r8p09n) - goserelin 3.6 mg - zoladex is indicated for use in combination with flutamide for the management of locally confined stage t2b-t4 (stage b2-c) carcinoma of the prostate. treatment with zoladex and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see dosage and administration (2.1) and clinical studies (14.1)]. zoladex is indicated in the palliative treatment of advanced carcinoma of the prostate [see dosage and administration (2.2) and clinical studies (14.2)]. zoladex is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. experience with zoladex for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months [see dosage and administration (2.3) and clinical studies (14.3)]. zoladex is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding [see dosage and administration (2.4) and cl

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astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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astrazeneca pharmaceuticals lp - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e), budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - airsupra is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older. airsupra is contraindicated in patients with a history of hypersensitivity to albuterol, budesonide, or any of the excipients [see warnings and precautions (5.5), description (11)] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothertobaby pregnancy studies conducted by the organization of teratology information specialists at 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. available data from published case series, epidemiological studies and reviews with budesonide use in pregnant women have not identified a drug-related risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. the available epidemiological studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact. there are risks to the mother and fetus associated with asthma in pregnancy (see clinical considerations) . animal reproduction studies have not been conducted with airsupra, however, animal studies are available with its individual components, albuterol and budesonide. administration of albuterol to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than maximum recommended human daily inhalation dose (mrhdid) (see data) . 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 mrhdid in adults, but these effects were not seen in rats that received inhaled doses approximately 2.5 times the mrhdid in adults (see data) . experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans. the background risk of major birth defects and miscarriage of the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. 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 because of the potential for beta-agonist interference with uterine contractility, use of airsupra during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. airsupra has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2 -agonists, including albuterol. animal data albuterol in a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the mrhdid in adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid in adults (on a mg/m2 basis at a maternal dose of 2.5 mg/kg). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta2 -agonist. in a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid in adults (on a mg/m2 basis at a maternal dose of 50 mg/kg). in a study in pregnant rabbits, an albuterol/hfa-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the mrhdid on a mg/m2 basis. a study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. budesonide in a fertility and reproduction study, male rats were subcutaneously dosed with budesonide 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 in adults (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 in adults (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 6-18, budesonide produced fetal loss, decreased fetal weight, and skeletal abnormalities at doses 0.5 times the mrhdid in adults (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 in adults (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 2.5 times the mrhdid in adults (on a mcg/m2 basis at maternal inhalation doses up to 250 mcg/kg/day). in a peri- and post-natal development study, rats were 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 0.2 times the mrhdid in adults 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. there are no available data on the effects of airsupra on the breastfed child or on milk production. there are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low. 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 airsupra and any potential adverse effects on the breastfed child from airsupra or from the underlying maternal condition. one published study reports that budesonide is present in human milk following maternal inhalation of budesonide, which resulted in infant doses approximately 0.3% to 1% of the maternal weight-adjusted dosage and a milk to plasma ratio was approximately 0.5. budesonide was not detected in plasma, and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonide. for airsupra, the dose of budesonide available to the infant in breast milk, as a percentage of the maternal dose, would be expected to be similar. budesonide levels in plasma samples obtained from five infants at about 90 minutes after breastfeeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (< 0.02 nmol/l in four infants and < 0.04 nmol/l in one infant). the safety and effectiveness of airsupra have not been established in pediatric patients. a limited number of pediatric patients (4 to 17 years of age) were enrolled in the efficacy trial (mandala) to evaluate airsupra to reduce the risk of severe asthma exacerbations. the primary efficacy endpoint was time to first severe asthma exacerbation. results showed there were 9 patients with severe exacerbation events in 34 patients 12 to 17 years of age treated with airsupra 180 mcg/160 mcg and 7 patients with severe exacerbation events in 34 patients treated with albuterol (as mdi) [hr 1.44 (0.54, 3.87)]. there were 11 patients with severe exacerbation events in 41 patients 4 to 11 years of age treated with albuterol/budesonide (as-bd mdi) 180 mcg/80 mcg and 10 in the 42 patients 4 to 11 years of age treated with as mdi [hr: 1.09 (0.46, 2.56)]. these data are inadequate to make a determination regarding the safety or effectiveness of airsupra or as-bd 180 mcg/80 mcg in pediatric patients 4 to 17 years of age [see clinical studies (14)] . controlled clinical studies have shown that ics agents, including budesonide, one of the components of airsupra, may cause a reduction in growth velocity in pediatric patients. the effects of long-term treatment of pediatric patients with ics on final adult height are not known [see warnings and precautions (5.14)]. there were 741 patients 65 years of age and older in the clinical studies for asthma [see clinical studies (14)] . of the total number of airsupra-treated patients in these studies, 231 (19%) were 65 years of age and older, while 41 (3%) were 75 years of age and older. in general, no differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. as with other products containing beta2 -agonists, special caution should be observed when using airsupra in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug. all beta2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because geriatric patients are more likely to have decreased renal function, care should be taken when dosing, and it may be useful to monitor renal function. formal pharmacokinetic studies using airsupra 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 the plasma. therefore, patients with hepatic disease should be closely monitored. formal pharmacokinetic studies using airsupra have not been conducted in patients with renal impairment. airsupra® (ayr soo' prah) (albuterol and budesonide) inhalation aerosol, for oral inhalation use 120-inhalation canister read this instructions for use before you start using airsupra and each time you get a new refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information parts of your airsupra inhaler reading the puff indicator do not try to take a puff of medicine when the pointer is at 0 because you will not receive a full dose. before using your airsupra inhaler 1. write the use by date write the use by date (12 months after you open the foil pouch) on the actuator label using permanent ink. write the use by date on the actuator label. 2. prime your airsupra inhaler before first use take the cover off the mouthpiece by squeezing both sides of the cover while pulling it down. shake the inhaler well. hold your airsupra inhaler facing away from you and press down firmly on the top of the puff indicator to spray 1 test-puff into the air. repeat the priming steps for a total of 4 test-puffs. shake your airsupra inhaler before each test-puff. shake before each test-puff. repeat 4 times. extra puffs are provided for priming. do not skip priming. when and how to re-prime your airsupra inhaler re-prime your inhaler: to re-prime your inhaler: take the cover off the mouthpiece and spray 2 test-puffs into the air . shake your airsupra inhaler before each test-puff. shake before each test-puff. repeat 2 times.   extra puffs are provided for priming. do not skip priming. how to use your inhaler - inhaling your medicine 1. check take the cover off the mouthpiece. check the mouthpiece for foreign objects and remove objects before use. check inside mouthpiece. 2. shake and inhale shake well breathe out fully place the mouthpiece into your mouth and close your lips around the mouthpiece. start to breathe in deeply and slowly while spraying 1 puff . continue breathing in until you cannot anymore. remove the mouthpiece from your mouth. hold your breath for as long as you can or up to 10 seconds. 3. repeat 4. place the mouthpiece cover back on 5. rinse immediately repeat the shake and inhale step to take a second puff. place the mouthpiece cover back on the mouthpiece. rinse your mouth with water, if available (do not swallow the water). 2 puffs equals 1 dose. weekly rinse - rinsing your actuator 1 time each week 1. remove canister. remove the canister and set it aside. take the cover off the mouthpiece. 2. rinse through both ends rinse each end of the actuator with warm water for 30 seconds. shake off as much water as you can. do not use soap. do not dry with a towel or tissue. look into the mouthpiece and actuator to make sure any medicine build-up has been completely washed away. if there is any build-up, repeat the weekly rinse step 2 again. check inside mouthpiece and actuator. 3. air-dry let the actuator air-dry, such as overnight. 4. re-assemble and re-prime re-assemble airsupra when the actuator is fully dry. first , place the mouthpiece cover back on. after the mouthpiece cover is on, gently press the canister down into actuator. do not insert the canister while the mouthpiece cover is off. re-prime the inhaler by following the re-prime steps above. emergency inhaler use when wet if you need to use the inhaler before it is dry: storing your inhaler throwing away your airsupra inhaler throw away your airsupra inhaler in the household trash: do not reuse or use the actuator with medicine canisters from other inhalers. do not puncture or throw the canister into a fire or incinerator. ordering a new airsupra inhaler this instructions for use has been approved by the u.s. food and drug administration. issued: march 2024 airsupra® (ayr soo' prah) (albuterol and budesonide) inhalation aerosol, for oral inhalation use 28-inhalation canister read this instructions for use before you start using airsupra and each time you get a new refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information parts of your airsupra inhaler reading the puff indicator do not try to take a puff of medicine when the pointer is at 0 because you will not receive a full dose. before using your airsupra inhaler 1. write the use by date write the use by date (6 months after you open the foil pouch) on the actuator label using permanent ink. write the use by date on the actuator label. 2. prime your airsupra inhaler before first use take the cover off the mouthpiece by squeezing both sides of the cover while pulling it down. shake the inhaler well. hold your airsupra inhaler facing away from you and press down firmly on the top of the puff indicator to spray 1 test-puff into the air. repeat the priming steps for a total of 4 test-puffs. shake your airsupra inhaler before each test-puff. shake before each test-puff. repeat 4 times. extra puffs are provided for priming. do not skip priming. when and how to re-prime your airsupra inhaler re-prime your inhaler: to re-prime your inhaler: take the cover off the mouthpiece and spray 2 test-puffs into the air . shake your airsupra inhaler before each test-puff. shake before each test-puff. repeat 2 times.   extra puffs are provided for priming. do not skip priming. how to use your inhaler - inhaling your medicine 1. check take the cover off the mouthpiece. check the mouthpiece for foreign objects and remove objects before use. check inside mouthpiece. 2. shake and inhale shake well breathe out fully place the mouthpiece into your mouth and close your lips around the mouthpiece. start to breathe in deeply and slowly while spraying 1 puff . continue breathing in until you cannot anymore. remove the mouthpiece from your mouth. hold your breath for as long as you can or up to 10 seconds. 3. repeat 4. place the mouthpiece cover back on 5. rinse immediately repeat the shake and inhale step to take a second puff. place the mouthpiece cover back on the mouthpiece. rinse your mouth with water, if available (do not swallow the water). 2 puffs equals 1 dose. weekly rinse - rinsing your actuator 1 time each week 1. remove canister remove the canister and set it aside. take the cover off the mouthpiece. 2. rinse through both ends rinse each end of the actuator with warm water for 30 seconds. shake off as much water as you can. do not use soap. do not dry with a towel or tissue. look into the mouthpiece and actuator to make sure any medicine build-up has been completely washed away. if there is any build-up, repeat the weekly rinse step 2 again. check inside mouthpiece and actuator. 3. air-dry let the actuator air-dry, such as overnight. 4. re-assemble and re-prime re-assemble airsupra when the actuator is fully dry. first , place the mouthpiece cover back on. after the mouthpiece cover is on, gently press the canister down into actuator. do not insert the canister while the mouthpiece cover is off. re-prime the inhaler by following the re-prime steps above. emergency inhaler use when wet if you need to use the inhaler before it is dry: storing your inhaler throwing away your airsupra inhaler throw away your airsupra inhaler in the household trash: do not reuse or use the actuator with medicine canisters from other inhalers. do not puncture or throw the canister into a fire or incinerator. ordering a new airsupra inhaler this instructions for use has been approved by the u.s. food and drug administration. issued: march 2024

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

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