스코폴라민브롬화수소산염수화물

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 an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. ( 1 ) post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )

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 )] . Angle closure glaucoma. ( 4 , 6.2 ) Hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )

Acute Angle Closure Glaucoma: Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 ) Neuropsychiatric Adverse Reactions: May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 ) Eclamptic Seizures in Pregnant Women: Avoid use in patients with severe preeclampsia. ( 5.3 ) Gastrointestinal and Urinary Disorders: Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, patients with impeded urine flow or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 ) Hyperthermia: Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider. ( 5.5 ) Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.6 ) Blurred Vision: Avoid contact with the eyes. ( 2.1 , 5.7 ) Magnetic Resonance Imaging (MRI) Skin Burns: Remove scopolamine transdermal system prior to MRI …

8.1 Pregnancy Risk Summary Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of scopolamine transdermal system 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 …