Label: TRANSDERM SCOP- scopalamine patch, extended release

  • NDC Code(s): 10019-553-03, 10019-553-04, 10019-553-90
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 1, 2019

If you are a consumer or patient please visit this version.

  • 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)                                                      03/2019

    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: 3/2019

  • Table of Contents
  • 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.

    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 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 Drug Withdrawal/Post-Removal Symptoms

    Discontinuation 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. The onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. Instruct patients to seek medical attention if they experience severe symptoms.

    5.6 Blurred Vision

    Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.

    Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system [see Dosage and Administration (2.1)].

    5.7 Magnetic Resonance Imaging (MRI) Skin Burns

    Transderm Scōp contains an aluminized membrane. Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. Remove Transderm Scōp before undergoing an MRI.

  • 6 ADVERSE REACTIONS

    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)]
    Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.5)]
    Blurred Vision [see Warnings and Precautions (5.6)]
    MRI Skin Burns [see Warnings and Precautions (5.7)]

    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:hallucinations, disorientation, and paranoia

    Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness

    General disorders and administration site conditions: application site burning

    Eye disorders: dry eyes, eye pruritus, angle closure glaucoma, amblyopia, eyelid irritation

    Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema

    Renal and urinary disorders: dysuria

    Ear and labyrinth disorders: vertigo

  • 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-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:

    Scopolamine structural formula

    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 cm2 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:

    Cross section of transdermal 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 Interaction Studies

    An in vitro study using human hepatocytes examined the induction of CYP1A2 and CYP3A4 by scopolamine. Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymes at the concentrations up to 10 nM. In an in vitro study using human liver microsomes which evaluated the inhibition of CYP1A2, 2C8, 2C9, 2C19, 2D6 and 3A4, scopolamine did not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1 micromolar. No in vivo drug-drug interaction studies have been conducted.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term studies in animals have been conducted to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated.

    Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). However, fertility studies in male animals were not performed.

  • 14 CLINICAL STUDIES

    14.1 Prevention of Motion Sickness

    In 195 adult subjects of different racial origins who participated in clinical efficacy studies at sea or in a controlled motion environment, there was a 75% reduction in the incidence of motion-induced nausea and vomiting. Transderm Scōp was applied from 4 to 16 hours prior to the onset of motion in these studies.

    14.2 Prevention of Post-Operative Nausea and Vomiting

    A clinical efficacy study evaluated 168 adult female patients undergoing gynecological surgery with anesthesia and opiate analgesia. Patients received Transderm Scōp or placebo applied approximately 11 hours before anesthesia/opiate analgesia. No retching/vomiting during the 24-hour post-operative period was reported in 79% of those treated with Transderm Scōp compared to 72% of those receiving placebo. When the need for additional antiemetic medication was assessed during the same period, there was no need for medication in 89% of patients treated with Transderm Scōp as compared to 72% of placebo-treated patients.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Transderm Scōp (scopolamine transdermal system) 1 mg/3 days is available as the following:

    Cartons of 10 and 24 transdermal systems, packaged into individual foil pouches.

    Carton of 10 transdermal systems. NDC 10019-553-03
    Carton of 24 transdermal systems. NDC 10019-553-04

    Store at controlled room temperature between 68°F to 77°F (20°C to 25°C).

    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. 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 [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].

  • 17 PATIENT COUNSELING 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.
    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.

    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)].

    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)].


    Marketed by: Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    Manufactured by: ALZA Corporation, Vacaville, CA 95688 for
    GSK Consumer Healthcare, Warren, NJ 07059

    For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)

    Trademarks are owned by or licensed to the GSK group of companies.
    ©2019 GSK group of companies or its licensor

  • PATIENT PACKAGE INSERT

    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).
    Limit contact with water while swimming and bathing because Transderm Scōp may fall off. If Transderm Scōp falls off, throw it away and apply a new one on the hairless area behind your other ear.

    What are the possible side effects of Transderm Scōp?

    Transderm Scōp may cause serious side effects, including:

    angle closure glaucoma. If you have open angle glaucoma and use Transderm Scōp, remove Transderm Scōp and call a doctor right away if you feel pain or discomfort, have blurred vision, or see halos or colored images around lights and reddening of your eyes.
    worsening of seizures. Tell your doctor about any worsening of seizures while using Transderm Scōp.
    an unusual reaction called acute psychosis. Tell your doctor if you have any of these symptoms:
    confusion
    agitation
    rambling speech
    hallucinations (seeing or hearing things that are not there)
    paranoid behaviors and delusions (false belief in something)
    worsening of your preeclampsia during pregnancy. Some pregnant women with severe preeclampsia have had seizures after getting scopolamine by injection in the muscle (intramuscular) or injection in the vein (intravenous).
    difficulty urinating.
    difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting.
    withdrawal symptoms after removing Transderm Scōp after using it for several days. Some people may have certain symptoms such as difficulty with balance, dizziness, nausea, vomiting, stomach cramps, sweating, confusion, muscle weakness, low heart rate or low blood pressure that could start 24 hours or more after removing Transderm Scōp. Call your doctor right away if your symptoms become severe.
    temporary increase in the size of your pupil and blurry vision, especially if Transderm Scōp comes in contact with your eyes.
    skin burns at the site of Transderm Scōp. This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Transderm Scōp contains aluminum and should be removed from your skin before you have an MRI.

    The most common side effects of using Transderm Scōp include:

    dry mouth
    blurred vision or eye problems
    feeling sleepy or drowsy
    disorientation (confusion)
    dizziness
    feeling agitated or irritable
    pharyngitis (sore throat)

    Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Transderm Scōp.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    General information about the safe and effective use of Transderm Scōp.

    Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Transderm Scōp for a condition for which it was not prescribed. Do not give Transderm Scōp to other people, even if they have the same symptoms you have. It may harm them.

    You can ask your pharmacist or doctor for information about Transderm Scōp that is written for health professionals.

    What are the ingredients in Transderm Scōp?

    Active ingredient: scopolamine

    Inactive ingredients: light mineral oil, polyisobutylene, polypropylene and aluminized polyester film

    Marketed by: Baxter Healthcare Corporation,

    Deerfield, IL 60015 USA

    Manufactured by: ALZA Corporation, Vacaville, CA 95688 for

    GSK Consumer Healthcare, Warren, NJ 07059

    For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2019 GSK group of companies or its licensor.

    For more information, go to www.transdermscop.com or call GSK Consumer Healthcare at 1-800-398-5876.

    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).

    Figure 1
    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.
    2.
    Cut along the dashed line on the Transderm Scōp package to open (See Figure 2).
    Figure 2
    3.
    Remove the clear plastic backing from the tan-colored round Transderm Scōp (See Figure 3).
    Figure 3
    4.
    Do not touch the metallic adhesive (sticky) surface on Transderm Scōp with your hands (See Figure 4).
    Figure 4
    5.
    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.
    Figure 5

    How to remove Transderm Scōp:

    After removing Transderm Scōp, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Please note that the used Transderm Scōp will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children, pets or others, fold the used Transderm Scōp in half with the sticky side together. Throw away (dispose of) Transderm Scōp in the household trash out of the reach of children, pets or others.

    How should I store Transderm Scōp?

    Store Transderm Scōp at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it.
    Store Transderm Scōp in an upright position.
    Do not bend or roll Transderm Scōp.

    Keep Transderm Scōp and all medicines out of reach of children.

    The Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration                                                         Revised: March 2019

  • PRINCIPAL DISPLAY PANEL

    NDC 10019-553-03

    Transderm Scop

    (scopolamine)

    TRANSDERMAL SYSTEM, 1 mg/3 days

    Formulated delivery of approximately 1 mg over three days

    Rx ONLY

    10 Transdermal Systems Multipack

     
    ©20YY GSK or licensor. Rev. MM/20YY 07-03-00-0059 883366-10C
    883366-10C_TDS_Patch_10 ct_Front Carton.JPG
  • INGREDIENTS AND APPEARANCE
    TRANSDERM SCOP 
    scopalamine patch, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10019-553
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SCOPOLAMINE (UNII: DL48G20X8X) (SCOPOLAMINE - UNII:DL48G20X8X) SCOPOLAMINE1 mg  in 3 d
    Inactive Ingredients
    Ingredient NameStrength
    POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
    POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10019-553-0310 in 1 BOX12/01/2016
    11 in 1 POUCH
    13 d in 1 PATCH; Type 0: Not a Combination Product
    2NDC:10019-553-0424 in 1 BOX12/01/2016
    21 in 1 POUCH
    23 d in 1 PATCH; Type 0: Not a Combination Product
    3NDC:10019-553-901 in 1 POUCH12/01/2016
    33 d in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01787412/01/2016
    Labeler - Baxter Healthcare Corporation (005083209)