États-Unis - anglais - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: - nausea and vomiting associated with motion sickness. - post-operative nausea and vomiting (ponv) associated with recovery from anesthesia and/or opiate analgesia and surgery. scopolamine transdermal system is contraindicated in patients with: - angle closure glaucoma [see warnings and precautions (5.1)]. - hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. reactions have included rash generalized and erythema [see adverse reactions (6.2), description (11)] . risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see dat

États-Unis - anglais - NLM (National Library of Medicine)

actavis pharma, inc. - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: - nausea and vomiting associated with motion sickness. - post-operative nausea and vomiting (ponv) associated with recovery from anesthesia and/or opiate analgesia and surgery. scopolamine is contraindicated in patients with: - angle closure glaucoma [see warnings and precautions (5.1)] . - hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. reactions have included rash generalized and erythema [see adverse reactions (6.2), description (11)] . risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see data) . in animal stu

États-Unis - anglais - NLM (National Library of Medicine)

golden state medical supply, inc. - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - methscopolamine bromide 5 mg

États-Unis - anglais - NLM (National Library of Medicine)

bryant ranch prepack - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for prevention of: scopolamine transdermal system is contraindicated in patients with: risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see data). in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defec

États-Unis - anglais - NLM (National Library of Medicine)

bryant ranch prepack - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for prevention of: scopolamine transdermal system is contraindicated in patients with: risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see data). in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defec

États-Unis - anglais - NLM (National Library of Medicine)

pharmaderm a division of fougera pharmaceuticals inc. - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - methscopolamine bromide 2.5 mg - adjunctive therapy for the treatment of peptic ulcer. methscopolamine bromide has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence or preventing complications. glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. pamine® 2.5 mg/pamine® forte 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

États-Unis - anglais - NLM (National Library of Medicine)

a-s medication solutions - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: scopolamine transdermal system is contraindicated in patients with: available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see data) . in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. 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,

États-Unis - anglais - NLM (National Library of Medicine)

ax pharmaceutical corp - butylscopolamine bromide (unii: 0gh9jx37c8) (butylscopolamine - unii:2z3e1of81v) - butylscopolamine 49.5 g in 50 g

États-Unis - anglais - NLM (National Library of Medicine)

novatris consumer health, inc. - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine 1 mg in 3 d - transderm scōp® is indicated in adults for prevention of nausea and vomiting associated with motion sickness. [see clinical studies (14.1)] transderm scōp® is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and/or opiate analgesia and surgery. [ see clinical studies (14.2)] transderm scōp is contraindicated in the following populations: - patients with angle closure glaucoma. [see adverse reactions (6)] - persons who are hypersensitive to the drug scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. [see drug interactions (7) and description (11)] pregnancy category c based on data from one prospective study of transderm scōp in cesarean delivery, the rate of newborn adverse events in both the transderm scōp and placebo groups were the same. the rates were 10.5% (12 events in 114 newborns) in both treatment groups. none of these events were considered life threatening or drug related. jaundice

États-Unis - anglais - NLM (National Library of Medicine)

baxter healthcare corporation - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine 1 mg in 3 d - transderm scŌp is indicated in adults for the prevention of: transderm scŌp is contraindicated in patients with: risk summary eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. avoid use of transderm scop in patients with severe preeclampsia [see warnings and precautions (5.3) and data] . available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data in published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see warnings and precautions (5.3)] . animal data in animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. an embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by transderm scŌp did not affect uterine contractions or increase the duration of labor. risk summary scopolamine is present in human milk. there are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for transderm scŌp and any potential adverse effects on the breastfed child from transderm scŌp or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported. clinical trials of transderm scŌp did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. in other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see warnings and precautions (5.2 ,5.5 )]. consider more frequent monitoring for cns adverse reactions during treatment with transderm scŌp in elderly patients [see warnings and precautions (5.2)] . transderm scŌp has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with transderm scŌp in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions (5.2)]. transderm scŌp contains scopolamine, which is not a controlled substance. termination of transderm scŌp, usually after several days of use, may result in withdrawal symptoms such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. these withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. the onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see warnings and precautions (5.5)] .