All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. Avoid use of Transderm Scōp in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see Data). ![]() Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that Transderm Scōp does not affect them adversely.Īvailable 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. Concomitant use of other drugs that cause central nervous system (CNS) adverse reactions (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may increase this effect. Transderm Scōp may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery or participating in underwater sports. Transderm Scōp is not approved for use in pediatric patients. Consider more frequent monitoring during treatment with Transderm Scōp in elderly patients. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of Transderm Scōp. Discontinue Transderm Scōp if signs or symptoms of cognitive impairment develop. Scopolamine can cause drowsiness, disorientation, and confusion. Weigh this potential risk against the benefits before prescribing Transderm Scōp to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold. Seizures and seizure-like activity have been reported in patients receiving scopolamine. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects. ![]() Monitor patients for new or worsening psychiatric symptoms during treatment with Transderm Scōp. Other psychiatric reactions have also been reported, including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions. Scopolamine has been reported to exacerbate psychosis. ![]()
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