Warnings for Transderm Scop
Included as part of the "PRECAUTIONS" Section
Precautions for Transderm Scop
Acute Angle Closure Glaucoma
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 SCÖP 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).
Neuropsychiatric Adverse Reactions
Psychiatric Adverse Reactions
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]. Monitor patients for new or worsening psychiatric symptoms during treatment with TRANSDERM SCÖP. 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]. In cases of psychiatric reactions occurring TRANSDERM SCÖP 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 SCÖP 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 SCÖP 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 SCÖP. Consider more frequent monitoring during treatment with TRANSDERM SCÖP in elderly patients [see Use In Specific Populations]. TRANSDERM SCÖP is not approved for use in pediatric patients [see Use In Specific Populations].
Hazardous Activities
TRANSDERM SCÖP 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]. Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that TRANSDERM SCÖP does not affect them adversely.
Eclamptic Seizures In Pregnant Women
Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine [see Use In Specific Populations]. Avoid use of TRANSDERM SCÖP in patients with severe preeclampsia.
Gastrointestinal And Urinary Disorders
Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Consider more frequent monitoring during treatment with TRANSDERM SCÖP in patients suspected of having intestinal obstruction, patients with pyloric obstruction or patients with impeded flow of urine (e.g., in diseases of the prostate or urinary bladder neck obstruction) and patients receiving other anticholinergic drugs [see DRUG INTERACTIONS]. Discontinue TRANSDERM SCÖP in patients who develop difficulty in urination.
Hyperthermia
Serious adverse reactions of hyperthermia have been reported postmarketing in adult and pediatric patients receiving transdermal scopolamine, including fatal cases. Anticholinergic agents, including scopolamine, can increase core body temperature and reduce sweating, which may cause further increases in body temperature. Hyperthermia may be exacerbated by exposure to external heat sources or high environmental temperature. Pediatric and geriatric patients may be more susceptible to these anticholinergic effects on thermoregulation. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider. Symptoms may persist following removal of the used transdermal system as there may be continued systemic absorption of scopolamine through the skin. TRANSDERM SCÖP is not approved for use in pediatric patients [see Use In Specific Populations].
Drug Withdrawal/Post-Removal Symptoms
Discontinuation of TRANSDERM SCÖP, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. The onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. Instruct patients to seek medical attention if they experience severe symptoms.
Blurred Vision
Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.
Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see DOSAGE AND ADMINISTRATION].
Magnetic Resonance Imaging (MRI) Skin Burns
TRANSDERM SCÖP contains an aluminized membrane. Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. Remove TRANSDERM SCÖP before undergoing an MRI.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Administration Instructions
Counsel patients on how to apply and remove the transdermal system [see DOSAGE AND ADMINISTRATION]:
- Only wear one transdermal system at any time.
- Do not cut the transdermal system.
- Apply the transdermal system to the skin in the postauricular (hairless area behind one ear) area.
- After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands.
- If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
- Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system, since pressure exerted on it may cause scopolamine to ooze out at the edge.
- Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others.
- Wash the hands and application site with soap and water after transdermal system removal.
Patients With Open-Angle Glaucoma
Advise patients with open-angle glaucoma to remove the TRANSDERM SCÖP transdermal system immediately and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma, including pain and reddening of the eyes, accompanied by dilated pupils, blurred vision and/or seeing halos around lights [see WARNINGS AND PRECAUTIONS].
Neuropsychiatric Adverse Reactions
- Advise patients that psychiatric adverse reactions may occur, especially in patients with a past psychiatric history or in those receiving other drugs also associated with psychiatric effects, and to report to their healthcare provider any new or worsening psychiatric symptoms.
- Advise patients to discontinue TRANSDERM SCÖP and contact a healthcare provider immediately if they experience a seizure.
- Advise patients, especially elderly patients, that cognitive impairment may occur during treatment with TRANSDERM SCÖP, especially in those receiving other drugs also associated with CNS effects, and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment such as hallucinations, confusion or dizziness.
- Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that TRANSDERM SCÖP does not affect them adversely [see WARNINGS AND PRECAUTIONS].
Decreased Gastrointestinal Motility And Urinary Retention
Instruct patients to remove the transdermal system if they develop symptoms of intestinal obstruction (abdominal pain, nausea or vomiting) or any difficulties in urinating [see WARNINGS AND PRECAUTIONS].
Hyperthermia
Inform patients that TRANSDERM SCÖP can increase body temperature and reduce sweating, which may result in hyperthermia and be exacerbated by exposure to external heat sources or high environmental temperature. Geriatric patients may be more susceptible to these effects. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, remove the transdermal system, and contact their healthcare provider. Symptoms may persist after removal of the transdermal system [see WARNINGS AND PRECAUTIONS].
Drug Withdrawal/Post-Removal Symptoms
Inform patients that if they remove the TRANSDERM SCÖP transdermal system after several days of use, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing TRANSDERM SCÖP [see WARNINGS AND PRECAUTIONS].
Blurred Vision
Inform patients that temporary dilation of the pupils and blurred vision may occur if TRANSDERM SCÖP comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see DOSAGE AND ADMINISTRATION, see WARNINGS AND PRECAUTIONS].
MRI Skin Burns
Instruct patients to remove the TRANSDERM SCÖP transdermal system before undergoing an MRI [see WARNINGS AND PRECAUTIONS].
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No long-term studies in animals have been conducted to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated.
Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). However, fertility studies in male animals were not performed.
Use In Specific Populations
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 TRANSDERM SCOP in patients with severe preeclampsia [see WARNINGS AND PRECAUTIONS 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 in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see WARNINGS AND PRECAUTIONS].
Animal Data
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. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by TRANSDERM SCÖP did not affect uterine contractions or increase the duration of labor.
Lactation
Risk Summary
Scopolamine is present in human milk. There are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRANSDERM SCÖP and any potential adverse effects on the breastfed child from TRANSDERM SCÖP or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of TRANSDERM SCÖP have not been established in pediatric patients. Pediatric patients are particularly susceptible to the anticholinergic adverse reactions of scopolamine, including neurologic and psychiatric adverse reactions and drug withdrawal syndrome. Serious adverse reactions of acute psychosis (e.g., disorientation, hallucinations), amblyopia, hyperthermia (including a fatal case), and mydriasis have also been reported in pediatric patients [see WARNINGS AND PRECAUTIONS].
Geriatric Use
Clinical trials of TRANSDERM SCÖP did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. In other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see WARNINGS AND PRECAUTIONS]. Consider more frequent monitoring for CNS adverse reactions during treatment with TRANSDERM SCÖP in geriatric patients [see WARNINGS AND PRECAUTIONS].
Serious adverse reactions of hyperthermia have been reported postmarketing in geriatric patients receiving transdermal scopolamine, including a fatal case. Geriatric patients may be more susceptible to the anticholinergic effects of disruption in thermoregulation. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider [see WARNINGS AND PRECAUTIONS].
Renal Or Hepatic Impairment
TRANSDERM SCÖP has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with TRANSDERM SCÖP in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see WARNINGS AND PRECAUTIONS].