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

padagis israel pharmaceuticals ltd - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine 1 mg - 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 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 eclamptic seizures 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 scopolamine transdermal system 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. because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system in elderly patients [see warnings and precautions ( 5.2)] . scopolamine transdermal system has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with scopolamine transdermal system in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions ( 5.2)]. scopolamine transdermal system contains scopolamine, which is not a controlled substance. termination of scopolamine transdermal system, 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)] . instructions for use scopolamine (skoe pol’ a meen) transdermal system read this instructions for use before you start using scopolamine transdermal system and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. information about scopolamine transdermal system: to help prevent nausea and vomiting from motion sickness: to help prevent nausea and vomiting after surgery: how to use scopolamine transdermal system: inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. an imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (see figure 1). how to remove scopolamine transdermal system: after removing scopolamine transdermal system, be sure to wash your hands and the area behind your ear thoroughly with soap and water. please note that the used scopolamine transdermal system will still contain some of the active ingredient after use. to avoid accidental contact or ingestion by children, pets or others, fold the used scopolamine transdermal system in half with the sticky side together. throw away (dispose of) scopolamine transdermal system in the household trash out of the reach of children, pets or others. how should i store scopolamine transdermal system? keep scopolamine transdermal system and all medicines out of reach of children. the medication guide and instructions for use have been approved by the u.s. food and drug administration                                 revised: april 2019

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

e. fougera & co. 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. methscopolamine bromide 2.5 mg tablets/methscopolamine bromide 5 mg tablets are contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

breckenridge pharmaceutical, 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. methscopolamine bromide tablets, usp 2.5 mg and 5 mg, are contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

bayshore pharmaceuticals llc - 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. methscopolamine bromide tablets, usp 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

pd-rx 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. methscopolamine bromide tablets, usp 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

pd-rx pharmaceuticals, inc. - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - methscopolamine bromide 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. methscopolamine bromide tablets, usp 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

par pharmaceutical - 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. methscopolamine bromide tablets 2.5 mg and 5 mg are contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

mylan pharmaceuticals inc. - 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,

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

bryant ranch prepack - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for 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 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, 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 eclamptic seizures 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 scopolamine transdermal system 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. because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system in elderly patients [see warnings and precautions ( 5.2)] . scopolamine transdermal system has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with scopolamine transdermal system in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions ( 5.2)]. scopolamine transdermal system contains scopolamine, which is not a controlled substance. termination of scopolamine transdermal system, 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)] . instructions for use scopolamine (skoe pol’ a meen) transdermal system read this instructions for use before you start using scopolamine transdermal system and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. information about scopolamine transdermal system: - scopolamine transdermal system is a tan-colored, circle shaped transdermal system (patch) with “scop 1 mg/3 days” printed on it. - wear only one scopolamine transdermal system at any time. - do not cut scopolamine transdermal system. to help prevent nausea and vomiting from motion sickness: - apply one scopolamine transdermal system to your skin on a hairless area behind one ear at least 4 hours before the activity to prevent nausea and vomiting. - if the treatment is needed for longer than 3 days, remove scopolamine transdermal system from the hairless area behind your ear. get a new scopolamine transdermal system and place it on the hairless area behind your other ear. to help prevent nausea and vomiting after surgery: - follow your doctor’s instructions about when to apply scopolamine transdermal system before your scheduled surgery. - scopolamine transdermal system should be left in place for 24 hours after surgery. after 24 hours, scopolamine transdermal system should be removed and thrown away. how to use scopolamine transdermal system: inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. an imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (see figure 1). - select a hairless area of skin behind one of your ears. avoid areas on your skin that may have cuts, pain or tenderness. wipe the area of your skin with a clean, dry tissue. - cut along the dashed line on the scopolamine transdermal system package to open (see figure 2). - remove the clear plastic backing from the tan-colored round scopolamine transdermal system (see figure 3). - do not touch the metallic adhesive (sticky) surface on scopolamine transdermal system with your hands (see figure 4). - apply the metallic adhesive surface of scopolamine transdermal system firmly to the dry area of skin behind your ear. the imprinted, tan colored side of the transdermal system should be facing up and showing (see figure 5). wash your hands with soap and water right away after applying scopolamine transdermal system, so that any medicine from scopolamine transdermal system that gets on your hands will not get into your eyes. how to remove scopolamine transdermal system: after removing scopolamine transdermal system, be sure to wash your hands and the area behind your ear thoroughly with soap and water. please note that the used scopolamine transdermal system will still contain some of the active ingredient after use. to avoid accidental contact or ingestion by children, pets or others, fold the used scopolamine transdermal system in half with the sticky side together. throw away (dispose of) scopolamine transdermal system in the household trash out of the reach of children, pets or others. how should i store scopolamine transdermal system? - store scopolamine transdermal system at room temperature between 68°f and 77°f (20°c and 25°c) until you are ready to use it. - store scopolamine transdermal system in an upright position. - do not bend or roll scopolamine transdermal system. keep scopolamine transdermal system and all medicines out of reach of children. the medication guide and instructions for use have been approved by the u.s. food and drug administration                                 revised: april 2019

United States - English - 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 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 eclamptic seizures 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 scopolamine transdermal system 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. because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system in elderly patients [see warnings and precautions (5.2)] . scopolamine transdermal system has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with scopolamine transdermal system in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions (5.2)]. scopolamine transdermal system contains scopolamine, which is not a controlled substance. termination of scopolamine transdermal system, 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)] . instructions for use scopolamine (skoe pol’ a meen) transdermal system read this instructions for use before you start using scopolamine transdermal system and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. information about scopolamine transdermal system: to help prevent nausea and vomiting from motion sickness: to help prevent nausea and vomiting after surgery: how to use scopolamine transdermal system: inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. an imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (see figure 1). how to remove scopolamine transdermal system: after removing scopolamine transdermal system, be sure to wash your hands and the area behind your ear thoroughly with soap and water. please note that the used scopolamine transdermal system will still contain some of the active ingredient after use. to avoid accidental contact or ingestion by children, pets or others, fold the used scopolamine transdermal system in half with the sticky side together. throw away (dispose of) scopolamine transdermal system in the household trash out of the reach of children, pets or others. how should i store scopolamine transdermal system? keep scopolamine transdermal system and all medicines out of reach of children. the medication guide and instructions for use have been approved by the u.s. food and drug administration                                 revised: april 2019