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

par pharmaceutical, inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none r isk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations] . animal reproduction studies have not been conducted with ephedrine sulfate. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. c linical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. th

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

sandoz inc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations ). in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data ]. the estimated

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

nexus pharmaceuticals inc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injectionn, usp is indicated in the treatment of allergic disorders, such as bronchial asthma the drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotensionn frequently ooccurs. in stokes-adams syndromeme with complete heart block, ephedrine has a value similar to that of epinephrine. it is indicated as a central nervous system stimulant in narcolepsy and depressive states. it is also used in myasthenia gravis. allergic reactions to ephedrine sulfate are rare. the hypersensitivity, if known, is a specific contraindication. patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate. prolonged abuse of ephedrine sulfate injection, usp can lead to symptoms of paranoid schizophrenia. when this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils. some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. t

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

akorn - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injection, usp is indicated in the treatment of allergic disorders, such as bronchial asthma the drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotension frequently occurs. in stokes-adams syndrome with complete heart block, ephedrine has a value similar to that of epinephrine. it is indicated as a central nervous system stimulant in narcolepsy and depressive states. it is also used in myasthenia gravis. allergic reactions to ephedrine sulfate are rare. the hypersensitivity, if known, is a specific contraindication. patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate. prolonged abuse of ephedrine sulfate injection, usp can lead to symptoms of paranoid schizophrenia. when this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils. some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. tempor

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

akorn - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations ]. animal reproduction studies have not been conducted with ephedrine sulfate. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these

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

par pharmaceutical, inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none r isk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations] . animal reproduction studies have not been conducted with ephedrine sulfate. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. c linical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. th

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

akorn - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations ]. animal reproduction studies have not been conducted with ephedrine sulfate. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these

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

hf acquisition co llc, dba healthfirst - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none 8.1 pregnancy risk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations]. animal reproduction studies have not been conducted with ephedrine sulfate. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports describe umbilical artery ph of ≤7.2 at the time of delivery [see clinical pharmacology 12-12.3]. monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible. 8.2 lactation risk summary limited published literature reports that ephedrine is present in human milk. however, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 renal impairment ephedrine and its metabolite are excreted in urine. in patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. monitor patients with renal impairment carefully after the initial bolus dose for adverse events.

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

amneal pharmaceuticals llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population are 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.   clinical considerations disease-associated maternal and/or embryofetal risk untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. a decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports describe umbilical artery ph of ≤7.2 at the time of delivery [see clinical pharmacology 12.3] . monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible.   data animal data decreased fetal body weights were observed when pregnant rats were administered intravenous bolus doses of 60 mg/kg ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6 to 17. this dose was associated with evidence of maternal toxicity (decreased body weight of dams and abnormal head movements). no malformations or fetal deaths were noted at this dose. no effects on fetal body weight were noted at 10 mg/kg (1.9 times the mrhd of 50 mg). no evidence of malformations or embryo-fetal toxicity were noted in pregnant rabbits administered intravenous bolus doses up to 20 mg/kg ephedrine sulfate (7.7 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6 to 20. this dose was associated with expected pharmacological maternal effects (increased respiration rate, dilated pupils, piloerection). decreased fetal survival and body weights in the presence of maternal toxicity (increased mortality) were noted when pregnant dams were administered intravenous bolus doses of 60 mg/kg epinephrine sulfate (approximately 12 times the mrhd based on body surface area) from gd 6 through lactation day 20. no adverse effects were noted at 10 mg/kg (1.9 times the mrhd). risk summary a single published case report indicates that ephedrine is present in human milk. however, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. the safety and effectiveness of ephedrine sulfate in pediatric patients have not been established. animal toxicity data in a study in which juvenile rats were administered intravenous bolus doses of 2, 10, or 60 mg/kg ephedrine sulfate daily from postnatal day 35 to 56, an increased incidence of mortality was noted at the high dose of 60 mg/kg. the no-adverse-effect level was 10 mg/kg (approximately 1.9 times a maximum daily dose of 50 mg in a 60 kg person based on body surface area). clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ephedrine and its metabolite are excreted in urine. in patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. monitor patients with renal impairment carefully after the initial bolus dose for adverse events.

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

fresenius kabi usa, llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimate