Transderm Scop Drug Information

• 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. ( 1 )
• post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )

• Application and Removal ( 2.1 ):
• 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. ( 2.2 )
• PONV : For surgeries other than cesarean section, apply one transdermal system behind the ear the evening before surgery and remove 24 hours following surgery. ( 2.2 ) 2.1 Important Application and Removal Instructions
• Each TRANSDERM SCŌP transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days.
• Only wear one transdermal system at any time.
• Do not cut the transdermal system.
• Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear).
• After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands [see Warnings and Precautions ( 5.7 )] .
• 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 while it is being worn, 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 [see Warnings and Precautions ( 5.7 )] . 2.2 Recommended Adult Dosage Motion Sickness Apply one TRANSDERM SCŌP transdermal system to the hairless area behind one ear at least 4 hours before the antiemetic effect is required – for use up to 3 days. If therapy is required for longer than 3 days, remove the first transdermal system and apply a new TRANSDERM SCŌP transdermal system behind the other ear. PONV For surgeries other than cesarean section : Apply one TRANSDERM SCŌP transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.

• The following serious adverse reactions are described elsewhere in labeling:
• Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.1 )]
• Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.2 )]
• Eclamptic Seizures in Pregnant Women [see Warnings and Precautions ( 5.3 )]
• Gastrointestinal and Urinary Disorders [see Warnings and Precautions ( 5.4 )]
• Hyperthermia [see Warnings and Precautions ( 5.5 )]
• Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.6 )]
• Blurred Vision [see Warnings and Precautions ( 5.7 )]
• MRI Skin Burns [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are:
• Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. ( 6.1 )
• PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Motion Sickness The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils. PONV Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1 . Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV *occurring in at least 3% of patients and at a rate higher than placebo TRANSDERM SCŌP % (N = 461) Placebo % (N = 457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Psychiatric disorders : acute psychosis including: disorientation, hallucinations, and paranoia Nervous system disorders : amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions : application site reactions (including blistering, burning, pruritus, and rash) and hyperthermia Eye disorders : amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders : erythema, rash generalized, skin irritation Renal and urinary disorders : dysuria Ear and labyrinth disorders : vertigo

• 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 TRANSDERM SCŌP 10 days prior to testing. ( 7.4 ) 7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions The concurrent use of TRANSDERM SCŌP 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 TRANSDERM SCŌP [see Warnings and Precautions ( 5.2 )] . Either TRANSDERM SCŌP 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 [see Drug Interactions ( 7.1 )], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with TRANSDERM SCŌP in patients receiving anticholinergic drugs [see Warnings and Precautions ( 5.2 , 5.4 )] . 7.3 Oral Drugs Absorbed in the Stomach TRANSDERM SCŌP, 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 TRANSDERM SCŌP 10 days prior to testing.

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 . 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 . 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 SCŌP did not affect uterine contractions or increase the duration of labor.

Pediatric Use The safety and effectiveness of TRANSDERM SCŌP 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 .

• SCŌP 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 other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )

Anticholinergic toxicity includes both central and peripheral signs and symptoms: agitation, central nervous system effects (e.g., coma, confusion, hallucinations, lethargy, seizures, somnolence), decreased bowel sounds, dry flushed skin, dry mouth, hyperthermia, hypertension, supraventricular arrhythmias, tachycardia, urinary retention, visual disturbances (e.g., amblyopia, mydriasis). These symptoms can be severe and may require medical intervention. In cases of toxicity remove the TRANSDERM SCŌP transdermal system. Serious symptomatic cases of overdosage involving multiple transdermal system applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway and supporting respiration and circulation.

This should be rapidly followed by removal of all transdermal systems from the skin and the mouth. If there is evidence of transdermal system ingestion, endoscopic removal of swallowed transdermal systems, or administration of activated charcoal should be considered, as indicated by the clinical situation. In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.

The signs and symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal. Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal. If over-exposure occurs, call the Poison Help line at 1-800-222-1222 for current information on the management of poisoning or overdosage.