Transderm Scop
Scopolamine · Patch, Extended Release · Transdermal
Uses
1 INDICATIONS AND USAGE 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. ( 1 )
• post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )
Dosage and administration
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.
Dosage forms and strengths
Transdermal system: a circular, flat, tan-colored transdermal system imprinted with “SCOP 1 mg/3 days” Transdermal system: 1 mg/3 days ( 3 )
Contraindications
4 CONTRAINDICATIONS TRANSDERM 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 )
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. ( 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 TRANSDERM SCŌP 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 TRANSDERM SCŌP 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 ( 6.2 )] . Monitor patients for new or worsening psychiatric symptoms during treatment with TRANSDERM SCŌP. 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 ( 7.1 )] . In cases of psychiatric reactions occurring TRANSDERM SCŌP 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 SCŌP 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 SCŌP 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 SCŌP. Consider more frequent monitoring during treatment with TRANSDERM SCŌP in elderly patients [see Use in Specific Populations ( 8.5 )] . TRANSDERM SCŌP is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . Hazardous Activities TRANSDERM SCŌP 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 TRANSDERM SCŌP 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 [see Use in Specific Populations ( 8.1 )] . Avoid use of TRANSDERM SCŌP 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 TRANSDERM SCŌP 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 ( 7.2 )] . Discontinue TRANSDERM SCŌP 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.
Side effects
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
Drug 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 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.
Use in specific populations
• Geriatric Patients : Consider more frequent monitoring during treatment due to increased risk of CNS adverse reactions. ( 5.2 , 8.5 )
• Renal or Hepatic Impairment : Consider more frequent monitoring during treatment due to increased risk of CNS adverse reactions. ( 5.2 , 8.6 ) 8.1 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 ( 5.3 ) 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 ( 5.3 )] . 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. 8.2 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 SCŌP and any potential adverse effects on the breastfed child from TRANSDERM SCŌP or from the underlying maternal condition. 8.4 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 [see Warnings and Precautions ( 5.2 , 5.5 )] . 8.5 Geriatric Use Clinical trials of TRANSDERM SCŌP 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 ( 5.2 , 5.6 ) ]. Consider more frequent monitoring for CNS adverse reactions during treatment with TRANSDERM SCŌP in geriatric patients [see Warnings and Precautions ( 5.2 )] . 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 ( 5.5 )] . 8.6 Renal or Hepatic Impairment TRANSDERM SCŌP has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with TRANSDERM SCŌP in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see Warnings and Precautions ( 5.2 )].
Pregnancy
8.1 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 ( 5.3 ) 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 ( 5.3 )] . 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
8.4 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 [see Warnings and Precautions ( 5.2 , 5.5 )] .
Geriatric use
8.5 Geriatric Use Clinical trials of TRANSDERM SCŌP 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 ( 5.2 , 5.6 ) ]. Consider more frequent monitoring for CNS adverse reactions during treatment with TRANSDERM SCŌP in geriatric patients [see Warnings and Precautions ( 5.2 )] . 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 ( 5.5 )] .
Overdosage
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 [see Warnings and Precautions ( 5.6 )]. 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.
Description
11 DESCRIPTION TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌP transdermal system is a circular, 0.2 mm thick, 2.5 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system: Scopolamine structural formula Cross section of transdermal system
Mechanism of action
12.1 Mechanism of Action 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.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING TRANSDERM SCŌP (scopolamine transdermal system) 1 mg/3 days is available as the following: Cartons of 4, 10, and 24 transdermal systems, packaged into individual foil pouches.
• Carton of 4 transdermal systems. NDC 10019-008-04
• Carton of 10 transdermal systems. NDC 10019-008-10
• Carton of 24 transdermal systems. NDC 10019-008-24 Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Store pouch(es) in an upright position. Do not bend or roll pouch(es). Wash hands thoroughly with soap and water immediately after handling the transdermal system. Avoid touching the system during the treatment. 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 Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.7 )] .
Patient 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 ( 2.1 )] :
• 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 SCŌP 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 ( 5.1 )] . 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 SCŌP 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 SCŌP, 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 SCŌP does not affect them adversely [see Warnings and Precautions ( 5.2 )] . 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 ( 5.4 )] . Hyperthermia Inform patients that TRANSDERM SCŌP 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 ( 5.5 )] . Drug Withdrawal/Post-Removal Symptoms Inform patients that if they remove the TRANSDERM SCŌP 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 SCŌP [see Warnings and Precautions ( 5.6 )] . Blurred Vision Inform patients that temporary dilation of the pupils and blurred vision may occur if TRANSDERM SCŌP 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 ( 2.1 ), see Warnings and Precautions ( 5.7 )] . MRI Skin Burns Instruct patients to remove the TRANSDERM SCŌP transdermal system before undergoing an MRI [see Warnings and Precautions ( 5.8 )]. Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. 07-19-00-9783
Label text from the FDA structured product label by Baxter Healthcare Corporation (revised Jun 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Scopolamine in 1 product
Transderm Scop NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 10019-008 | Scopolamine 1 mg/3d Patch, Extended Release | Baxter Healthcare Corporation | NDA |
Transderm Scop recalls
- D-1083-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse
Frequently asked questions
What is Transderm Scop used for?
1 INDICATIONS AND USAGE 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. (…
What are the side effects of Transderm Scop?
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 the full label for the complete list.
Who makes Transderm Scop?
Transderm Scop is listed by 1 labeler in the FDA NDC directory, including Baxter Healthcare Corporation.
Has Transderm Scop been recalled?
The FDA enforcement database lists 1 recall for Transderm Scop, most recently D-1083-2022 (class ii): cGMP deviations: Temperature abuse