The following Structured Product Label (SPL) was submitted to the FDA by Zydus Pharmaceuticals Usa Inc. for the product Scopolamine (NDC 70710-1846). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 2.1 important application and removal instructions, 2.2 recommended adult dosage, 3 dosage forms and strengths, 4 contraindications, 5.1 acute angle closure glaucoma, 5.2 neuropsychiatric adverse reactions, 5.3 eclamptic seizures in pregnant women, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Scopolamine transdermal system is indicated in adults for the prevention of:
Motion Sickness
Apply one scopolamine 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 scopolamine transdermal system behind the other ear.
PONV
For surgeries other than cesarean section
Apply one scopolamine transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.
Scopolamine transdermal system is a tan colored round patch; having a tan colored backing film continuously imprinted with "Scopolamine 1 mg/ 3 days" on the outer surface and oversized transparent square shaped release liner with slit cut.
Scopolamine transdermal system is contraindicated in patients with:
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 scopolamine transdermal system 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).
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 scopolamine transdermal system. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects [see Drug Interactions (7.1)]. In cases of psychiatric reactions occurring scopolamine transdermal system should be removed at once. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention.
Seizures
Seizures and seizure-like activity have been reported in patients receiving scopolamine. Weigh this potential risk against the benefits before prescribing scopolamine transdermal system 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 scopolamine transdermal system if signs or symptoms of cognitive impairment develop. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of scopolamine transdermal system. Consider more frequent monitoring during treatment with scopolamine transdermal system in elderly patients [see Use in Specific Populations (8.5)]. Scopolamine transdermal system is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Hazardous Activities
Scopolamine transdermal system 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 scopolamine transdermal system 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 (8.1)]. Avoid use of scopolamine transdermal system 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 scopolamine transdermal system in patients suspected of having intestinal obstruction, patients with pyloric obstruction or patients with impeded flow of urine (e.g., in diseases of the prostate or urinary bladder neck obstruction and patients receiving other anticholinergic drugs [see Drug Interactions (7.2)]. Discontinue scopolamine transdermal system in patients who develop difficulty in urination.
Discontinuation of scopolamine transdermal system, 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, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see Dosage and Administration (2.1)].
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.
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.
*occurring in at least 3% of patients and at a rate higher than placebo | ||
| Scopolamine Transdermal System | Placebo | |
| % (N = 461) | % (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 |
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 reactions including burning, rash, pruritus and blistering
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 scopolamine transdermal system 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 scopolamine transdermal system [see Warnings and Precautions (5.2)]. Either scopolamine transdermal system 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 Drug Interactions (7.1)], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients receiving anticholinergic drugs [see Warnings and Precautions (5.2, 5.4)].
Scopolamine transdermal system, 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 scopolamine transdermal system 10 days prior to testing.
Risk Summary
Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of scopolamine transdermal system in patients with severe preeclampsia [see Warnings and Precautions (5.3) and Data]. Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage or adverse fetal outcomes.
In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively and developed eclamptic seizures soon after scopolamine administration [see Warnings and Precautions (5.3)].
Animal Data
In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by scopolamine transdermal system did not affect uterine contractions or increase the duration of labor.
Risk Summary
Scopolamine is present in human milk. There are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine 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 scopolamine transdermal system 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 scopolamine transdermal system in elderly patients [see Warnings and Precautions (5.2)].
Scopolamine transdermal system has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see Warnings and Precautions (5.2)].
Scopolamine transdermal system contains scopolamine, which is not a controlled substance.
Termination of scopolamine transdermal system, 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)].
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 scopolamine 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 the Poison Help line at 1-800-222-1222 for current information on the management of poisoning or overdosage.
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 1.237 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 molecular formula is C17H21NO4 and its structural formula is:
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 01)
Scopolamine has a molecular weight of 303.4 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 1.57 cm2 film 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 polyethylene/polyester film; (2) a drug layer of scopolamine, povidone and silicone adhesive; (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 scopolamine, povidone and silicone adhesive. A protective, oversized release liner of fluorosilicone-coated polyester, which covers the adhesive formulation layer, is removed before the system is used.
Scopolamine transdermal systems are packaged with an additional piece of protective film covering the system within each pouch. This piece of protective film is removed and discarded at the time of use.
Cross section of the system:
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 02)
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.
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.
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.
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. Scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system 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 scopolamine transdermal system as compared to 72% of placebo-treated patients.
Scopolamine transdermal system, 1 mg/3 days is available as the following:
Carton of 4 transdermal systems, packaged into individual foil pouches. NDC 70710-1846-4
Carton of 10 transdermal systems, packaged into individual foil pouches. NDC 70710-1846-2
Carton of 24 transdermal systems, packaged into individual foil pouches. NDC 70710-1846-7
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. Avoid touching the system during the treatment. Upon removal, fold the used transdermal system in half with the sticky side together and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others. Wash the hands and application site with soap and water after transdermal system removal [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].
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)]:
Patients with Open-Angle Glaucoma
Advise patients with open-angle glaucoma to remove the scopolamine 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
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 scopolamine transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing scopolamine transdermal system [see Warnings and Precautions (5.5)].
Blurred Vision
Inform patients that temporary dilation of the pupils and blurred vision may occur if scopolamine transdermal system comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system, do not touch the system while wearing it and wash hands and the application site with soap and water after transdermal system removal [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].
Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Rev: 03/24
INSTRUCTIONS FOR USE
Scopolamine (skoe pol' a meen) Transdermal System
Read this Instructions for Use before you start using scopolamine transdermal system 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 scopolamine transdermal system:
To help prevent nausea and vomiting from motion sickness:
To help prevent nausea and vomiting after surgery:
How to use scopolamine transdermal system:
Inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. An imprinted, tan backing membrane with a sticky surface is adhered to a clear, disposable release liner (See Figure 1).
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 03)
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. Tear along the notch and slit on the scopolamine transdermal system package to open (See Figure 2). Remove the contents of the pouch and discard the additional piece of clear protective film covering the transdermal system.
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 04)
3. Remove the larger half of clear plastic backing from the tan-colored round scopolamine transdermal system (See Figure 3).
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 05)
4. Do not touch the adhesive (sticky) surface on scopolamine transdermal system with your hands (See Figure 4).
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 06)
5. Apply the adhesive surface of scopolamine transdermal system firmly to the dry area of skin behind your ear. Remove the other half of the clear plastic and apply the entire patch to your skin. The imprinted, tan colored side of the transdermal system should be facing up and showing (See Figure 5). After placement of scopolamine transdermal system, avoid touching or applying pressure to the transdermal system while it is being worn because applying pressure may cause scopolamine to ooze out at the edge. Wash your hands with soap and water right away after applying scopolamine transdermal system, so that any medicine from scopolamine transdermal system that gets on your hands will not get into your eyes.
Image (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 07)
How to remove scopolamine transdermal system:
After removing scopolamine transdermal system, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Please note that the used scopolamine transdermal system will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children, pets or others, fold the used scopolamine transdermal system in half with the sticky side together. Throw away (dispose of) scopolamine transdermal system in the household trash out of the reach of children, pets or others.
How should I store scopolamine transdermal system?
Keep scopolamine transdermal system and all medicines out of reach of children.
The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Rev.: 03/24
| PATIENT INFORMATION Scopolamine (skoe pol' a meen) Transdermal System | |||
| Read this Patient Information before you start using scopolamine transdermal system 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 scopolamine transdermal system? Scopolamine transdermal system is a prescription medicine used for adults to help prevent:
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| Who should not use scopolamine transdermal system? Do not use scopolamine transdermal system if you:
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| What should I tell my doctor before using scopolamine transdermal system? Before you use scopolamine transdermal system, tell your doctor about all of your medical conditions, including if you:
Especially tell your doctor if you take: 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 scopolamine transdermal system?
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What should I avoid while using scopolamine transdermal system?
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| What are the possible side effects of scopolamine transdermal system? Scopolamine transdermal system may cause serious side effects, including:
o agitation o rambling speech o hallucinations (seeing or hearing things that are not there) o paranoid behaviors and delusions (false belief in something) If you experience any of the above symptoms, your doctor may stop your treatment with scopolamine transdermal system. If your symptoms continue and they are severe, get medical help. | |||
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| 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 scopolamine transdermal system. 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 scopolamine transdermal system. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use scopolamine transdermal system for a condition for which it was not prescribed. Do not give scopolamine transdermal system 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 scopolamine transdermal system that is written for health professionals. | |||
| What are the ingredients in scopolamine transdermal system? Active ingredient: scopolamine Inactive ingredients: tan-colored polyethylene/polyester film, polypropylene, povidone and silicone adhesive. For more information, go to [email protected] or Tel.: 1-877-993-8779. | |||
| Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 | |||
| Rev.: 03/24 | |||
Scopolamine transdermal system, 1 mg/3 days
Carton of 4 transdermal systems
NDC 70710-1846-4
Zydus
Rx only
Carton Labels (A673f990 Bfdf 4d84 B63f C1b2ba4c9e36 08)
* Please review the disclaimer below.
