Scopolamine - Warnings and Precautions

5 WARNINGS 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.

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.

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.

Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system.

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.

5.1 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 [see Adverse Reactions ] .

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 [see Drug Interactions ] .

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 ] .