ABD - İngilizce - 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)] .

Kanada - İngilizce - Health Canada

homeocan inc. - scopolamine hydrobromide - tablet - 6ch - scopolamine hydrobromide 6ch - homeopathic products

İsrail - İngilizce - Ministry of Health

teva pharmaceutical indust.ltd - scopolamine hydrobromide 0.25 mg/ml - solution for injection - scopolamine - scopolamine is used in cases where antimuscarinic action is desired, such as in premedication, where reduction of excitement and production of amnesia, in conjunction with morphine or pethidine, are desired.

Kanada - İngilizce - Health Canada

pfizer canada ulc - scopolamine hydrobromide - solution - 0.4mg - scopolamine hydrobromide 0.4mg - antimuscarinics antispasmodics

Kanada - İngilizce - Health Canada

pfizer canada ulc - scopolamine hydrobromide - solution - 0.6mg - scopolamine hydrobromide 0.6mg - antimuscarinics antispasmodics

Kanada - İngilizce - Health Canada

omega laboratories limited - scopolamine hydrobromide - liquid - 0.4mg - scopolamine hydrobromide 0.4mg - antimuscarinics antispasmodics

Kanada - İngilizce - Health Canada

omega laboratories limited - scopolamine hydrobromide - liquid - 0.6mg - scopolamine hydrobromide 0.6mg - antimuscarinics antispasmodics

ABD - İngilizce - NLM (National Library of Medicine)

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

ABD - İngilizce - 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.

ABD - İngilizce - NLM (National Library of Medicine)

aace pharmaceuticals, inc. - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - 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 is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.