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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP.
TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979 ------------------------- -- RECENT MAJOR CHANGES --------------------------- Warnings and Precautions (5.3) 03/ --------------------------- INDICATIONS AND USAGE ----------------------------- 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 after application.
- Upon removal, fold used transdermal system in half with sticky side together, and discard to prevent accidental contact or ingestion. 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) --------------------- DOSAGE FORMS AND STRENGTHS ----------------------- Transdermal system: 1 mg/3 days ( 3 ) ------------------------------ CONTRAINDICATIONS -------------------------------
- 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, urinary bladder neck obstruction or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. (5.4, 7.2) - Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. (5.5) - Blurred Vision: Avoid contact with the eyes. (2.1, 5.6) - Magnetic Resonance Imaging (MRI) Skin Burns: Remove Transderm Scōp prior to MRI scan. (5.7) ------------------------------ ADVERSE REACTIONS -------------------------------- 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 GlaxoSmithKline Consumer Healthcare at 1-800-398-5876 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch. ------------------------------ 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) ---------------------- 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 03/
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Application and Removal Instructions 2.2 Recommended Adult Dosage 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Acute Angle Closure Glaucoma 5.2 Neuropsychiatric Adverse Reactions 5.3 Eclamptic Seizures in Pregnant Women 5.4 Gastrointestinal and Urinary Disorders 5.5 Drug Withdrawal/Post-Removal Symptoms 5.6 Blurred Vision 5.7 Magnetic Resonance Imaging (MRI) Skin Burns 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions 7.2 Anticholinergic Drugs 7.3 Oral Drugs Absorbed in the Stomach 7.4 Interaction with Gastric Secretion Test
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal or Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.3 Dependence 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Prevention of Motion Sickness 14.2 Prevention of Post-Operative Nausea and Vomiting 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
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.
2 DOSAGE AND ADMINISTRATION
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 (5.6)].
- If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
- 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.
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.
3 DOSAGE FORMS AND STRENGTHS
Transdermal system: a circular, flat, tan-colored transdermal system imprinted with “Scopolamine 1 mg/3 days”
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)].
5 WARNINGS AND PRECAUTIONS
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)].
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. 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.
7 DRUG INTERACTIONS
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.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
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. Avoid use of Transderm Scōp in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see Data).
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 estimated 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
Eclamptic Seizures 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. Because there have been no consistent reports of adverse events in breastfed infants over decades of use, 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
Safety and effectiveness in pediatric patients have not been established. Pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported.
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 , 5.5 ) ]. Consider more frequent monitoring for CNS adverse reactions during treatment with Transderm Scōp in elderly patients [see Warnings and Precautions (5.2)].
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)].
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Transderm Scōp contains scopolamine, which is not a controlled substance.
9.3 Dependence
Termination of Transderm Scōp, 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_._ These withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. The onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see Warnings and Precautions (5.5)].
10 OVERDOSAGE
The signs and symptoms of anticholinergic toxicity include: lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. 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 (5.5)]. 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 your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
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 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy- phenylpropanoate. The empirical formula is C17H21NO 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, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of 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:
12 CLINICAL PHARMACOLOGY
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.
12.3 Pharmacokinetics
The system is formulated to deliver approximately 1 mg of scopolamine to the systemic circulation over 3 days.
Absorption Following application to the skin behind the ear, circulating plasma concentrations are detected within 4 hours with peak concentrations being obtained, on average, within 24 hours. The average plasma concentration produced is 87 pg/mL (0.28 nM) for free scopolamine and 354 pg/mL for total scopolamine (free + conjugates). Following removal of the used transdermal system, there is some degree of continued systemic absorption of scopolamine bound in the skin layers.
Distribution The distribution of scopolamine is not well characterized. It crosses the placenta and the blood brain barrier and may be reversibly bound to plasma proteins.
Elimination
Metabolism and Excretion Scopolamine is metabolized and conjugated with less than 5% of the total dose appearing unchanged in the urine. The enzymes responsible for metabolizing scopolamine are unknown. The exact elimination pattern of scopolamine has not been determined. Following transdermal system removal, plasma concentrations of scopolamine decline in a log linear fashion with an observed half-life of 9.5 hours. Less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours.
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 [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].
MRI Skin Burns Instruct patients to remove the Transderm Scōp transdermal system before undergoing an MRI [see Warnings and Precautions (5.7)].
Manufactured by: ALZA Corporation, Vacaville, CA 95688 for GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies. ©2019 GSK group of companies or its licensor.
MEDICATION GUIDE Transderm Scōp (trans-derm skōp) (scopolamine transdermal system)
Read this Patient Information before you start using Transderm Scōp and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is Transderm Scōp? Transderm Scōp is a prescription medicine used for adults to help prevent:
- nausea and vomiting from motion sickness
- nausea and vomiting from anesthesia or taking opioid pain medicines after surgery It is not known if Transderm Scōp is safe or effective in children. Who should not use Transderm Scōp? Do not use Transderm Scōp if you:
- have an eye problem called angle closure glaucoma.
- are allergic to scopolamine, belladonna alkaloids or any of the ingredients in Transderm Scōp. See the end of this leaflet for a list of the ingredients in Transderm Scōp. Ask your doctor if you are not sure. What should I tell my doctor before using Transderm Scōp? Before you use Transderm Scōp, tell your doctor about all of your medical conditions, including if you:
- have glaucoma (increased pressure in the eye).
- have a history of seizures or psychosis.
- have problems with your stomach or intestines.
- have trouble urinating.
- are scheduled to have a gastric secretion test.
- have liver or kidney problems.
- are pregnant or plan to become pregnant. It is not known if Transderm Scōp can harm your unborn baby.
- are breastfeeding or plan to breastfeed. Transderm Scōp can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you use Transderm Scōp. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Transderm Scōp may affect the way other medicines work, and other medicines may affect how Transderm Scōp works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scōp. Especially tell your doctor if you take:
- a sedative, hypnotic, opioid or anxiolytic (medicines that make you sleepy)
- an antidepressant medicine
- an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. How should I use Transderm Scōp?
- See the detailed Instructions for Use for information about how to use Transderm Scōp at the end of this Patient Information leaflet.
- It is important that you apply Transderm Scōp exactly as your doctor tells you to.
- Your doctor may change your Transderm Scōp dose. Do not change your Transderm Scōp dose without talking to your doctor.
- Wear only one Transderm Scōp at any time.
- If you use too much Transderm Scōp, call your doctor or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away. What should I avoid while using Transderm Scōp?
- You should not drink alcohol while using Transderm Scōp. It can increase your chances of having serious side effects.
- You should not drive, operate heavy machinery, or do other dangerous activities until you know how Transderm Scōp affects you.
- You should not use Transderm Scōp during a Magnetic Resonance Imaging scan (MRI). Remove Transderm Scōp before undergoing an MRI. It can cause your skin to burn.
- You should be careful if you use Transderm Scōp while you participate in watersports because you may feel lost or confused (disoriented).
INSTRUCTIONS FOR USE Transderm Scōp (trans-derm skōp) (scopolamine transdermal system)
Read this Instructions for Use before you start using Transderm Scōp and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Information about Transderm Scōp:
- Transderm Scōp is a tan-colored, circle shaped transdermal system (patch) with “Scopolamine 1 mg/3 days” printed on it.
- Wear only one Transderm Scōp at any time.
- Do not cut Transderm Scōp.
To help prevent nausea and vomiting from motion sickness:
- Apply one Transderm Scōp to your skin on a hairless area behind one ear at least 4 hours before the activity to prevent nausea and vomiting.
- If the treatment is needed for longer than 3 days, remove Transderm Scōp from the hairless area behind your ear. Get a new Transderm Scōp and place it on the hairless area behind your other ear.
To help prevent nausea and vomiting after surgery:
- Follow your doctor’s instructions about when to apply Transderm Scōp before your scheduled surgery.
- Transderm Scōp should be left in place for 24 hours after surgery. After 24 hours, Transderm Scōp should be removed and thrown away.
How to use Transderm Scōp:
Inside the Transderm Scōp package, you will find one Transderm Scōp. An imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (See Figure 1).
- Select a hairless area of skin behind one of your ears. Avoid areas on your skin that may have cuts, pain or tenderness. Wipe the area of your skin with a clean, dry tissue.
- Cut along the dashed line on the Transderm Scōp package to open (See Figure 2).
- Remove the clear plastic backing from the tan-colored round Transderm Scōp (See Figure 3).
- Do not touch the metallic adhesive (sticky) surface on Transderm Scōp with your hands (See Figure 4).
- Apply the metallic adhesive surface of Transderm Scōp firmly to the dry area of skin behind your ear. The imprinted, tan colored side of the transdermal system should be facing up and showing (See Figure 5). Wash your hands with soap and water right away after applying Transderm Scōp, so that any medicine from Transderm Scōp that gets on your hands will not get into your eyes.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP.
TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979 ------------------------- -- RECENT MAJOR CHANGES --------------------------- Warnings and Precautions (5.3) 03/ --------------------------- INDICATIONS AND USAGE ----------------------------- 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 after application.
- Upon removal, fold used transdermal system in half with sticky side together, and discard to prevent accidental contact or ingestion. 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) --------------------- DOSAGE FORMS AND STRENGTHS ----------------------- Transdermal system: 1 mg/3 days ( 3 ) ------------------------------ CONTRAINDICATIONS -------------------------------
- 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, urinary bladder neck obstruction or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. (5.4, 7.2) - Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. (5.5) - Blurred Vision: Avoid contact with the eyes. (2.1, 5.6) - Magnetic Resonance Imaging (MRI) Skin Burns: Remove Transderm Scōp prior to MRI scan. (5.7) ------------------------------ ADVERSE REACTIONS -------------------------------- 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 GlaxoSmithKline Consumer Healthcare at 1-800-398-5876 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch. ------------------------------ 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) ---------------------- 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 03/
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Application and Removal Instructions 2.2 Recommended Adult Dosage 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Acute Angle Closure Glaucoma 5.2 Neuropsychiatric Adverse Reactions 5.3 Eclamptic Seizures in Pregnant Women 5.4 Gastrointestinal and Urinary Disorders 5.5 Drug Withdrawal/Post-Removal Symptoms 5.6 Blurred Vision 5.7 Magnetic Resonance Imaging (MRI) Skin Burns 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions 7.2 Anticholinergic Drugs 7.3 Oral Drugs Absorbed in the Stomach 7.4 Interaction with Gastric Secretion Test
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal or Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.3 Dependence 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Prevention of Motion Sickness 14.2 Prevention of Post-Operative Nausea and Vomiting 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
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.
2 DOSAGE AND ADMINISTRATION
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 (5.6)].
- If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
- 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.
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.
3 DOSAGE FORMS AND STRENGTHS
Transdermal system: a circular, flat, tan-colored transdermal system imprinted with “Scopolamine 1 mg/3 days”
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)].
5 WARNINGS AND PRECAUTIONS
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)].
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. 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.
7 DRUG INTERACTIONS
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.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
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. Avoid use of Transderm Scōp in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see Data).
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 estimated 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
Eclamptic Seizures 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. Because there have been no consistent reports of adverse events in breastfed infants over decades of use, 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
Safety and effectiveness in pediatric patients have not been established. Pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported.
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 , 5.5 ) ]. Consider more frequent monitoring for CNS adverse reactions during treatment with Transderm Scōp in elderly patients [see Warnings and Precautions (5.2)].
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)].
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Transderm Scōp contains scopolamine, which is not a controlled substance.
9.3 Dependence
Termination of Transderm Scōp, 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_._ These withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. The onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see Warnings and Precautions (5.5)].
10 OVERDOSAGE
The signs and symptoms of anticholinergic toxicity include: lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. 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 (5.5)]. 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 your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
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 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy- phenylpropanoate. The empirical formula is C17H21NO 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, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of 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:
12 CLINICAL PHARMACOLOGY
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.
12.3 Pharmacokinetics
The system is formulated to deliver approximately 1 mg of scopolamine to the systemic circulation over 3 days.
Absorption Following application to the skin behind the ear, circulating plasma concentrations are detected within 4 hours with peak concentrations being obtained, on average, within 24 hours. The average plasma concentration produced is 87 pg/mL (0.28 nM) for free scopolamine and 354 pg/mL for total scopolamine (free + conjugates). Following removal of the used transdermal system, there is some degree of continued systemic absorption of scopolamine bound in the skin layers.
Distribution The distribution of scopolamine is not well characterized. It crosses the placenta and the blood brain barrier and may be reversibly bound to plasma proteins.
Elimination
Metabolism and Excretion Scopolamine is metabolized and conjugated with less than 5% of the total dose appearing unchanged in the urine. The enzymes responsible for metabolizing scopolamine are unknown. The exact elimination pattern of scopolamine has not been determined. Following transdermal system removal, plasma concentrations of scopolamine decline in a log linear fashion with an observed half-life of 9.5 hours. Less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours.
Drug Withdrawal/Post-Removal Symptoms Inform patients that if they remove the Transderm Scōp transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing Transderm Scōp [see Warnings and Precautions (5.5)].
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 [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].
MRI Skin Burns Instruct patients to remove the Transderm Scōp transdermal system before undergoing an MRI [see Warnings and Precautions (5.7)].
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MEDICATION GUIDE Transderm Scōp (trans-derm skōp) (scopolamine transdermal system)
Read this Patient Information before you start using Transderm Scōp and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is Transderm Scōp? Transderm Scōp is a prescription medicine used for adults to help prevent:
- nausea and vomiting from motion sickness
- nausea and vomiting from anesthesia or taking opioid pain medicines after surgery It is not known if Transderm Scōp is safe or effective in children. Who should not use Transderm Scōp? Do not use Transderm Scōp if you:
- have an eye problem called angle closure glaucoma.
- are allergic to scopolamine, belladonna alkaloids or any of the ingredients in Transderm Scōp. See the end of this leaflet for a list of the ingredients in Transderm Scōp. Ask your doctor if you are not sure. What should I tell my doctor before using Transderm Scōp? Before you use Transderm Scōp, tell your doctor about all of your medical conditions, including if you:
- have glaucoma (increased pressure in the eye).
- have a history of seizures or psychosis.
- have problems with your stomach or intestines.
- have trouble urinating.
- are scheduled to have a gastric secretion test.
- have liver or kidney problems.
- are pregnant or plan to become pregnant. It is not known if Transderm Scōp can harm your unborn baby.
- are breastfeeding or plan to breastfeed. Transderm Scōp can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you use Transderm Scōp. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Transderm Scōp may affect the way other medicines work, and other medicines may affect how Transderm Scōp works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scōp. Especially tell your doctor if you take:
- a sedative, hypnotic, opioid or anxiolytic (medicines that make you sleepy)
- an antidepressant medicine
- an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. How should I use Transderm Scōp?
- See the detailed Instructions for Use for information about how to use Transderm Scōp at the end of this Patient Information leaflet.
- It is important that you apply Transderm Scōp exactly as your doctor tells you to.
- Your doctor may change your Transderm Scōp dose. Do not change your Transderm Scōp dose without talking to your doctor.
- Wear only one Transderm Scōp at any time.
- If you use too much Transderm Scōp, call your doctor or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away. What should I avoid while using Transderm Scōp?
- You should not drink alcohol while using Transderm Scōp. It can increase your chances of having serious side effects.
- You should not drive, operate heavy machinery, or do other dangerous activities until you know how Transderm Scōp affects you.
- You should not use Transderm Scōp during a Magnetic Resonance Imaging scan (MRI). Remove Transderm Scōp before undergoing an MRI. It can cause your skin to burn.
- You should be careful if you use Transderm Scōp while you participate in watersports because you may feel lost or confused (disoriented).
