openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma should be monitored and may need to be adjusted during Transderm Scōp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure. Transderm Scōp should not be used in children and should be used with caution in the elderly. See PRECAUTIONS. Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery. Rarely, idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, rambling speech, hallucinations, paranoid behaviors, and delusions.
ADVERSE DRUG EXPERIENCES The adverse reactions for Transderm Scōp are provided separately for patients with motion sickness and with post-operative nausea and vomiting. Motion Sickness: In motion sickness clinical studies of Transderm Scōp, the most frequent adverse reaction was dryness of the mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed. Post-operative Nausea and Vomiting: In a total of five clinical studies in which Transderm Scōp was administered perioperatively to a total of 461 patients and safety was assessed, dry mouth was the most frequently reported adverse drug experience, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug 6 . Postmarketing and Other Experience: In addition to the adverse experiences reported during clinical testing of Transderm Scōp, the following are spontaneously reported adverse events from postmarketing experience. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of Transderm Scōp in their causation cannot be reliably determined: acute angle-closure (narrow-angle) glaucoma; confusion; difficulty urinating; dry, itchy, or conjunctival injection of eyes; restlessness; hallucinations; memory disturbances; rashes and erythema; and transient changes in heart rate. Drug Withdrawal/Post-Removal Symptoms: Symptoms such as dizziness, nausea, vomiting, and headache occur following abrupt discontinuation of antimuscarinics. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. Some symptoms may be related to adaptation from a motion environment to a motion-free environment. More serious symptoms including muscle weakness, bradycardia and hypotension may occur following discontinuation of Transderm Scōp.