WARNINGS AND PRECAUTIONS
Open Angle Glaucoma
Patients currently being treated for Open Angle Glaucoma
Glaucoma therapy in patients with open 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.
Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).
Temporary Dilation of the Pupil
Scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. [
see Adverse Reactions (6)
] In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.
[see How Supplied/ Storage and Handling]
Preexisting Gastrointestinal or Urinary Bladder Obstructions
Transderm Scōp® should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including Transderm Scōp®, to patients suspected of having intestinal obstruction.
Patients should be instructed to remove the patch if they develop any difficulties in urinating.
[see Adverse Reactions]
History of Seizures or Psychosis
Transderm Scōp® should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders.
Idiosyncratic Reactions
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, speech disorder, hallucinations, paranoia, and delusions.
[see Adverse Reactions]
Specific Populations
Pediatric
A safe and effective dose has not been established in the pediatric population
[see Use in Specific Populations]
. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied.
Elderly
Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. 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.
[see Use in Specific Populations]
Renal and Hepatic Impaired
Transderm Scōp® should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scōp® has not been studied in these populations.
[see Use in Specific Populations]
Safety Hazards
Drowsiness
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.
Disorienting Effects
Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine.
[see Patient Counseling Information]
MRI Skin Burns
Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp® contains aluminum, it is recommended to remove the system before undergoing an MRI.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
Based on data from one prospective study of Transderm Scōp® in cesarean delivery, the rate of newborn adverse events in both the Transderm Scōp® and placebo groups were the same. The rates were 10.5% (12 events in 114 newborns) in both treatment groups. None of these events were considered life threatening or drug related. Jaundice was the only adverse event occurring more frequently with Transderm Scōp® than placebo: 9 events (7.9%) versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and did not prolong the hospital stay.
There are no adequate and well-controlled studies of Transderm Scōp® use during pregnancy. 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. Transderm Scōp® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.
Labor and Delivery
During a clinical study among women undergoing cesarean section treated with Transderm Scōp® in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in newborns.
[see Clinical Studies]
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. Scopolamine does cross the placenta.
Nursing Mothers
Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scōp® is administered to a nursing woman.
Pediatric Use
A safe and effective dose has not been established in the pediatric population.
[see Warnings and Precautions]
Geriatric Use
Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion and dizziness. 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.
[see Warnings and Precautions]
Renal or Hepatic Impairment
Transderm Scōp® should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects.
[see Warnings and Precautions]
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