The mydriatic effect of scopolamine may cause an increase in intraocular pressure resulting in acute angle closure glaucoma. Monitor intraocular pressure in patients with open angle glaucoma and adjust glaucoma therapy during TRANSDERM SCŌP use, as needed. Advise patients to immediately remove the transdermal system and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).
Scopolamine has been reported to exacerbate psychosis. Other psychiatric reactions have also been reported, including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions [see Adverse Reactions (6.2)]. Monitor patients for new or worsening psychiatric symptoms during treatment with TRANSDERM SCŌP. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects [see Drug Interactions (7.1)]. In cases of psychiatric reactions occurring TRANSDERM SCŌP should be removed at once. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention.
Seizures
Seizures and seizure-like activity have been reported in patients receiving scopolamine. 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.
Cognitive Adverse Reactions
Scopolamine can cause drowsiness, disorientation, and confusion. Discontinue TRANSDERM SCŌP if signs or symptoms of cognitive impairment develop. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of TRANSDERM SCŌP. Consider more frequent monitoring during treatment with TRANSDERM SCŌP in elderly patients [see Use in Specific Populations (8.5)]. TRANSDERM SCŌP is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Hazardous Activities
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. 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 [see Drug Interactions (7.1)]. 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.