SCOPOLAMINE Drug Interactions: What You Need to Know

INTERACTIONS

• Drugs Causing Central Nervous System (CNS)

Adverse

Reactions : Monitor patients for CNS adverse reactions (drowsiness, dizziness or disorientations). ( 7.1 )

• Anticholinergic Drugs : Consider more frequent monitoring during treatment in patients receiving other anticholinergic drugs. ( 7.2 )
• Oral Drugs Absorbed in the Stomach : Monitor for increased or decreased therapeutic effect of the oral drug. ( 7.3 )
• Interaction with Gastric Secretion Test : Discontinue use of scopolamine transdermal system 10 days prior to testing. ( 7.4 )

7.1 Drugs Causing Central Nervous System (CNS)

Adverse Reactions

The concurrent use of scopolamine transdermal system with other drugs that cause CNS adverse reactions of drowsiness, dizziness or disorientation (e.g., sedatives, hypnotics, opiates, anxiolytics and alcohol) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may potentiate the effects of scopolamine transdermal system [see Warnings and Precautions ( 5.2 )] . Either scopolamine transdermal system or the interacting drug should be chosen, depending on the importance of the drug to the patient. If the interacting drug cannot be avoided, monitor patients for CNS adverse reactions.

7.2 Anticholinergic Drugs Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 )]</span>, intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients receiving anticholinergic drugs <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.2 , 5.4 )]</span> .

7.3 Oral Drugs Absorbed in the Stomach Scopolamine transdermal system, as an anticholinergic, may delay gastric and upper gastrointestinal motility and, therefore, the rate of absorption of other orally administered drugs. Monitor patients for modified therapeutic effect of concomitant orally administered drugs with a narrow therapeutic index.

7.4 Interaction with Gastric Secretion Test Scopolamine will interfere with the gastric secretion test. Discontinue scopolamine transdermal system 10 days prior to testing.

Scopolamine transdermal system is contraindicated in patients with:

• angle closure glaucoma. [see Warnings and Precautions ( 5.1 )]
• hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Reactions have included rash generalized and erythema [see Adverse Reactions ( 6.2 ), Description ( 11 )] .
• Angle closure glaucoma ( 4 , 6.2 )
• Hypersensitivity to scopolamine or to other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )

AND PRECAUTIONS

• Acute Angle Closure Glaucoma : Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 )
• Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 )
• Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia. ( 5.3 )
• Gastrointestinal and Urinary Disorders : Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, patients with impeded urine flow or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 )
• Hyperthermia : Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider. ( 5.5 )
• Drug Withdrawal/Post-Removal Symptoms : Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.6 )
• Blurred Vision : Avoid contact with the eyes. ( 2.1 , 5.7 )
• Magnetic Resonance Imaging (MRI)

Skin

Burns : Remove scopolamine transdermal system prior to MRI scan. ( 5.8 )

5.1 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 scopolamine transdermal system 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).

5.2 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 <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.2 )]</span> . Monitor patients for new or worsening psychiatric symptoms during treatment with scopolamine transdermal system. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 )]</span>. In cases of psychiatric reactions occurring scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system. Consider more frequent monitoring during treatment with scopolamine transdermal system in elderly patients [see Use in Specific Populations ( 8.5 )] . Scopolamine transdermal system is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .

Hazardous Activities

Scopolamine transdermal system 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 scopolamine transdermal system does not affect them adversely.

5.3 Eclamptic Seizures in Pregnant Women Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.1 )]</span>. Avoid use of scopolamine transdermal system in patients with severe preeclampsia.

5.4 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 scopolamine transdermal system 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 <span class="opacity-50 text-xs">[see Drug Interactions ( 7.2 )]</span> . Discontinue scopolamine transdermal system in patients who develop difficulty in urination.

5.5 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. Scopolamine transdermal system is not approved for use in pediatric patients <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.4 , 8.5 )]</span> .

5.6 Drug Withdrawal/Post-Removal Symptoms Discontinuation of scopolamine transdermal system, 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.

5.7 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 <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 )]</span> .

5.8 Magnetic Resonance Imaging (MRI)

Skin Burns

Scopolamine transdermal system 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 scopolamine transdermal system before undergoing an MRI.