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Transderm Scop®
(scopolamine) Transdermal System
The Transderm Scop® (scopolamine) transdermal system is a circular flat patch 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 α -(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4 ] non-7-yl ester. The empirical formula is C17H21NO4 and its structural formula is:
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Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scop system is a film 0.2 mm thick and 2.5 cm², with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir 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) an adhesive formulation of mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system.
Cross section of the system:
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Transderm Scop is indicated in adults for the prevention of:
Apply one Transderm Scop 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 Scop transdermal system behind the other ear.
For surgeries other than cesarean section:
Apply one Transderm Scop transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.
Transdermal system: a circular, flat, tan-colored transdermal system imprinted with “Scopolamine 1 mg/3 days”
Transderm Scop (scopolamine transdermal system) 1 mg/3 days is available as the following:
Carton of 4 transdermal systems, packaged into individual foil pouches. NDC 0067-4346-04
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, WARNINGS AND PRECAUTIONS].
Manufactured by: ALZA Corporation, Vacaville, CA 95688. Revised: Feb 2019
The following serious adverse reactions are described elsewhere in labeling:
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.
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.
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
| Transderm Scop % (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 |
| *occurring in at least 3% of patients and at a rate higher than placebo | ||
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
The concurrent use of Transderm Scop 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 Scop [see WARNINGS AND PRECAUTIONS]. Either Transderm Scop 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.
Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions [see Drugs Causing Central Nervous System (CNS) Adverse Reactions], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with Transderm Scop in patients receiving anticholinergic drugs [see WARNINGS AND PRECAUTIONS].
Transderm Scop, 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.
Scopolamine will interfere with the gastric secretion test. Discontinue Transderm Scop 10 days prior to testing.
Transderm Scop contains scopolamine, which is not a controlled substance.
Termination of Transderm Scop, 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].
Included as part of the "PRECAUTIONS" Section
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 Scop 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).
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]. Monitor patients for new or worsening psychiatric symptoms during treatment with Transderm Scop. 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].
Seizures and seizure-like activity have been reported in patients receiving scopolamine. Weigh this potential risk against the benefits before prescribing Transderm Scop to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold.
Scopolamine can cause drowsiness, disorientation, and confusion. Discontinue Transderm Scop if signs or symptoms of cognitive impairment develop. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of Transderm Scop. Consider more frequent monitoring during treatment with Transderm Scop in elderly patients [see Use In Specific Populations]. Transderm Scop is not approved for use in pediatric patients [see Use In Specific Populations].
Transderm Scop 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]. Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that Transderm Scop does not affect them adversely.
Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine [see Use In Specific Populations]. Avoid use of Transderm Scop in patients with severe preeclampsia.
Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Consider more frequent monitoring during treatment with Transderm Scop 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]. Discontinue Transderm Scop in patients who develop difficulty in urination.
Discontinuation of Transderm Scop, 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.
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].
Transderm Scop 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 Scop before undergoing an MRI.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Counsel patients on how to apply and remove the transdermal system [see DOSAGE AND ADMINISTRATION]:
Advise patients with open-angle glaucoma to remove the Transderm Scop 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].
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].
Inform patients that if they remove the Transderm Scop transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing Transderm Scop [see WARNINGS AND PRECAUTIONS].
Inform patients that temporary dilation of the pupils and blurred vision may occur if Transderm Scop 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, WARNINGS AND PRECAUTIONS].
Instruct patients to remove the Transderm Scop transdermal system before undergoing an MRI [see WARNINGS AND PRECAUTIONS].
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.
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 Scop 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.
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].
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 Scop did not affect uterine contractions or increase the duration of labor.
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 Scop and any potential adverse effects on the breastfed child from Transderm Scop or from the underlying maternal condition.
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.
Clinical trials of Transderm Scop 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]. Consider more frequent monitoring for CNS adverse reactions during treatment with Transderm Scop in elderly patients [see WARNINGS AND PRECAUTIONS].
Transderm Scop has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with Transderm Scop in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see WARNINGS AND PRECAUTIONS].
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 Scop 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]. 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.
Transderm Scop is contraindicated in patients with:
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.
The system is formulated to deliver approximately 1 mg of scopolamine to the systemic circulation over 3 days.
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.
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.
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.
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.
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 Scop was applied from 4 to 16 hours prior to the onset of motion in these studies.
A clinical efficacy study evaluated 168 adult female patients undergoing gynecological surgery with anesthesia and opiate analgesia. Patients received Transderm Scop 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 Scop 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 Scop as compared to 72% of placebo-treated patients.
Transderm Scop
(trans-derm skop)
(scopolamine) transdermal system
Read this Patient Information before you start using Transderm Scop 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 Scop?
Transderm Scop is a prescription medicine used for adults to help prevent:
It is not known if Transderm Scop is safe or effective in children.
Who should not use Transderm Scop?
Do not use Transderm Scop if you:
What should I tell my doctor before using Transderm Scop?
Before you use Transderm Scop, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Transderm Scop may affect the way other medicines work, and other medicines may affect how Transderm Scop works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scop. Especially tell your doctor if you take:
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 Scop?
What should I avoid while using Transderm Scop?
What are the possible side effects of Transderm Scop?
Transderm Scop may cause serious side effects, including:
The most common side effects of using Transderm Scop include:
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 Scop.
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 Scop.
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Transderm Scop for a condition for which it was not prescribed. Do not give Transderm Scop 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 Scop that is written for health professionals.
What are the ingredients in Transderm Scop?
Active ingredient: scopolamine
Inactive ingredients: light mineral oil, polyisobutylene, polypropylene and aluminized polyester film
INSTRUCTIONS FOR USE
Transderm Scop
(trans-derm skop)
(scopolamine transdermal system)
Read this Instructions for Use before you start using Transderm Scop 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 Scop:
To help prevent nausea and vomiting from motion sickness:
To help prevent nausea and vomiting after surgery:
How to use Transderm Scop:
Inside the Transderm Scop package, you will find one Transderm Scop. An imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (See Figure 1).
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How to remove Transderm Scop:
After removing Transderm Scop, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Please note that the used Transderm Scop 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 Scop in half with the sticky side together. Throw away (dispose of) Transderm Scop in the household trash out of the reach of children, pets or others.
How should I store Transderm Scop?
Keep Transderm Scop 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.
