Scopolamine

TRANSDERM SCŌP is indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. TRANSDERM SCŌP is an anticholinergic indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.

Scopolamine, a belladonna alkaloid, is an anticholinergic. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

Application and Removal: • Each TRANSDERM SCŌP transdermal system delivers 1 mg of scopolamine over 3 days. • Only wear one transdermal system at a time. • Do not cut the transdermal system. • Wash hands thoroughly with soap and water after application. • Avoid touching or applying pressure to the transdermal system once applied. • Upon removal, fold used transdermal system in half with sticky side together, discard to prevent accidental contact or ingestion, and wash the hands and application site with soap and water. Recommended Dosage: • Motion Sickness: Apply one transdermal system to the hairless area behind one ear at least 4 hours before antiemetic effect is required for use up to 3 days. If therapy for more than 3 days is required, remove the first transdermal system and apply a new transdermal system behind the other ear.

TRANSDERM SCŌP is contraindicated in patients with: • angle closure glaucoma. • 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. • Angle closure glaucoma. • Hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component of the formulation or delivery system.

• 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. • 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.

The following serious adverse reactions are described elsewhere in labeling: • Acute Angle Closure Glaucoma • Neuropsychiatric Adverse Reactions • Eclamptic Seizures in Pregnant Women • Gastrointestinal and Urinary Disorders • Hyperthermia • Drug Withdrawal/Post-Removal Symptoms • Blurred Vision • MRI Skin Burns Most common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. • PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis.

• Drugs Causing Central Nervous System (CNS) Adverse Reactions: Monitor patients for CNS adverse reactions (drowsiness, dizziness or disorientations). • Anticholinergic Drugs: Consider more frequent monitoring during treatment in patients receiving other anticholinergic drugs. • Oral Drugs Absorbed in the Stomach: Monitor for increased or decreased therapeutic effect of the oral drug. • Interaction with Gastric Secretion Test: Discontinue use of TRANSDERM SCŌP 10 days prior to testing.

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Store pouch(es) in an upright position.