Scopolamine 1 mg/3d Patch, Extended Release — NDC 69238-1662-2 (Billing 69238-1662-02)
This is a package of Scopolamine 1 mg/3d Patch, Extended Release from Amneal Pharmaceuticals NY LLC, marketed since Jun 2025 and currently FDA-listed; retail pharmacies pay about $4.34 per unit (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004704
- GCN: 18160
- GPI-14 (Medi-Span): 50200060008610
- HICL (First Databank): 012306
- AHFS class code: 12:08.08.00
- RxCUI (RxNorm): 226552
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Apply it to the hairless skin directly behind one ear — that flat area just behind the earlobe. Either side works fine. The key is that the skin is clean, dry, and hair-free so the...
- Where exactly do I put the patch, and does it matter which side?
- Put it on at least 4 hours before you need it to be working — so if you're boarding a cruise ship in the morning, apply it the night before. The patch takes several hours to build...
- How soon before a trip should I put the patch on?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Scopolamine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.336 | $43.36 / 10 patch |
| Medicaid paysCMS SDUD · 12 mo | $5.85 | $58.47 / 10 patch |
| Medicare drug plans payPart D · Q2 2026 | $8.13 | $81.31 / 10 patch |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 69238-1662-02 You're viewing this Main listing | 10 PATCH in 1 CARTON / 3 d in 1 PATCH | $4.34 / ea | $43.36 | 2025-06-11 | — | Active |
| 69238-1662-04 69238-1662-4 | 24 PATCH in 1 CARTON / 3 d in 1 PATCH | $4.34 / ea | $104.06 | 2025-06-11 | — | Active |
| 69238-1662-09 69238-1662-9 | 4 PATCH in 1 CARTON / 3 d in 1 PATCH | $4.34 / ea | $17.34 | 2025-06-11 | — | Active |
This pack has the lowest per-ea cost of the 3 priced pack sizes ($4.34 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Scopolamine 1 mg/3d Patch, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Scopolamine 1 mg/3d 00378-6470-44 | Mylan | 24 patches | $4.336 | AB | Availability likely | — |
| scopolamine 1 mg/3d 00591-2258-04 | Actavis | 4 patches | $4.336 | AB | Availability likely | — |
| Scopolamine 1 mg/3d 42858-0150-14 | Rhodes | 10 patches | $4.336 | AB | Availability likely | — |
| Scopolamine Transdermal System 1 mg 45802-0580-01 | Padagis | 1 patch | $4.336 | AB | Discontinued | — |
| Scopolamine 1.5 mg 50742-0505-04 | Ingenus | 1 patch | $4.336 | AB | Availability likely | — |
| Scopolamine 1 mg/3dthis 69238-1662-02 | Amneal | 10 patches | $4.336 | AB | Availability likely | — |
| Scopolamine 1 mg/3d 70710-1846-02 | Zydus | 10 patches | $4.336 | AB | Availability likely | — |
| Transderm Scop 1 mg/3d 10019-0008-01 | Baxter | 1 patch | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 50090-5349-00 | A-S | 4 pouches | — | AB | FDA listed | — |
| scopolamine 1 mg/3d 50090-7188-00 | A-S | 1 d | — | AB | FDA listed | — |
| Scopolamine Trandermal System 1 mg 63629-8450-01 | Bryant | 1 patch | — | AB | FDA listed | — |
| Scopolamine Trandermal System 1 mg 63629-8451-01 | Bryant | 1 patch | — | AB | FDA listed | — |
| Scopolamine Trandermal System 1 mg 63629-8452-01 | Bryant | 1 patch | — | AB | FDA listed | — |
| Scopolamine 1.5 mg 68071-3994-04 | NuCare | 1 patch | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 70771-1787-02 | Zydus | 10 patches | — | AB | FDA listed | — |
| Scopolamine Transdermal System 1 mg 71335-2718-01 | Bryant | 1 patch | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 71335-3013-01 | Bryant | 4 patches | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 71335-3014-01 | Bryant | 10 patches | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 71335-3015-01 | Bryant | 24 patches | — | AB | FDA listed | — |
| Scopolamine Trandermal System 1 mg 72162-1419-02 | Bryant | 1 patch | — | AB | FDA listed | — |
| Scopolamine 1 mg/3d 72162-2453-02 | Bryant | 4 patches | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII UG00KM4WR7
A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
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UNII 212N9O2MMZ
A synthetic polymer used as a film-coating agent and emulsifier. It helps form a smooth protective layer around tablets or capsules and improves how oil and water-based ingredients mix together in the formulation.
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UNII T71QXI2O62
Polypropylene is a plastic polymer derived from petroleum. In medicines, this high-molecular-weight form provides structure and rigidity, commonly used in capsule shells, tablet coatings, or packaging components to protect the active ingredient and control how the medicine breaks down in your body.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 9N5G1G3D3H
A silicone-based polymer blend used as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during tablet or capsule manufacturing.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Scopolamine transdermal system 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. Scopolamine transdermal system 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 ▾
2 DOSAGE AND ADMINISTRATION Application and Removal (2.1) : Each scopolamine transdermal system delivers 1 mg of scopolamine over 3 days. Only wear one transdermal system at a time. Do not cut the transdermal system.
Wash hands thoroughly with soap and water after application. Avoid touching or applying pressure to the transdermal system once applied. Upon removal, fold used transdermal system in half with sticky side together, discard to prevent accidental contact or ingestion, and wash the hands and application site with soap and water.
Recommended Dosage: Motion Sickness: Apply one transdermal system to the hairless area behind one ear at least 4 hours before antiemetic effect is required for use up to 3 days. If therapy for more than 3 days is required, remove the first transdermal system and apply a new transdermal system behind the other ear. (2.2) PONV: For surgeries other than cesarean section, apply one transdermal system behind the ear the evening before surgery and remove 24 hours following surgery.
(2.2)
2.1Important Application and Removal Instructions Each scopolamine transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days. Only wear one transdermal system at any time. Do not cut the transdermal system.
Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear). After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands [see Warnings and Precautions (5.7) ] . If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system while it is being worn, since pressure exerted on it may cause scopolamine to ooze out at the edge. Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others. Wash the hands and application site with soap and water after transdermal system removal [see Warnings and Precautions (5.7) ] .
2.2Recommended Adult Dosage 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Transdermal system: a round patch, consisting of a tan backing film flood printed with “Scopolamine 1 mg/3 days” Transdermal system: 1 mg/3 days (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Scopolamine transdermal system is contraindicated in patients with: angle closure glaucoma [see Warnings and Precautions (5.1) ] . hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Reactions have included rash generalized and erythema [see Adverse Reactions (6.2) , Description (11) ] . Angle closure glaucoma.
(4 , 6.2) Hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. (4 , 7)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Acute Angle Closure Glaucoma: Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. (5.1) Neuropsychiatric Adverse Reactions: May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities.
Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. (5.2 , 7.1) Eclamptic Seizures in Pregnant Women: Avoid use in patients with severe preeclampsia. (5.3) Gastrointestinal and Urinary Disorders: Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, patients with impeded urine flow or receiving other anticholinergic drugs.
Discontinue if patient develops difficulty in urination. (5.4 , 7.2) Hyperthermia: Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider.
(5.5) Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. (5.6) Blurred Vision: Avoid contact with the eyes. (2.1 , 5.7)
5.1Acute 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 scopolamine 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).
5.2Neuropsychiatric 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 scopolamine.
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 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 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 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.
Consider more frequent monitoring during treatment with scopolamine in elderly patients [see Use in Specific Populations (8.5) ] . Scopolamine is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . Hazardous Activities Scopolamine 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… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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) ] Hyperthermia [see Warnings and Precautions (5.5) ] Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.6) ] Blurred Vision [see Warnings and Precautions (5.7) ] 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
6.1Clinical 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 Scopolamine % (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
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Psychiatric disorders: acute psychosis including: disorientation, hallucinations, and paranoia Nervous system disorders: amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions: application site reactions (including blistering, burning, pruritus, and rash) and hyperthermia Eye disorders: amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders: erythema, rash generalized, skin irritation Renal and urinary disorders: dysuria Ear and labyrinth disorders: vertigo
🔄 Drug Interactions ▾
7 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 scopolamine 10 days prior to testing. (7.4)
7.1Drugs Causing Central Nervous System (CNS) Adverse Reactions The concurrent use of scopolamine 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 [see Warnings and Precautions (5.2) ] . Either scopolamine 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.
7.2Anticholinergic 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 scopolamine in patients receiving anticholinergic drugs [see Warnings and Precautions (5.2 , 5.4) ] .
7.3Oral Drugs Absorbed in the Stomach Scopolamine, 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.
7.4Interaction with Gastric Secretion Test Scopolamine will interfere with the gastric secretion test. Discontinue scopolamine 10 days prior to testing.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric Patients: Consider more frequent monitoring during treatment due to increased risk of CNS adverse reactions. (5.2 , 8.5) Renal or Hepatic Impairment: Consider more frequent monitoring during treatment due to increased risk of CNS adverse reactions. (5.2 , 8.6)
8.1Pregnancy 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 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 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 scopolamine did not affect uterine contractions or increase the duration of labor.
8.2Lactation 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 and any potential adverse effects on the breastfed child from scopolamine or from the underlying maternal condition.
8.4Pediatric Use Clinical trials of scopolamine did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. In other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see Warnings and Precautions (5.2 , 5.6) ] . Consider more frequent monitoring for CNS adverse reactions during treatment with scopolamine in geriatric patients [see Warnings and Precautions (5.2) ] .
Serious adverse reactions of hyperthermia have been reported postmarketing in geriatric patients receiving transdermal scopolamine, including a fatal case. Geriatric patients may be more susceptible to the anticholinergic effects of disruption in thermoregulation. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider [see Warnings and Precautions (5.5) ] .
8.5Geriatric Use Clinical trials of scopolamine 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… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 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 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 scopolamine did not affect uterine contractions or increase the duration of labor.
🧒 Pediatric Use ▾
8.4Pediatric Use Clinical trials of scopolamine did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. In other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see Warnings and Precautions (5.2 , 5.6) ] . Consider more frequent monitoring for CNS adverse reactions during treatment with scopolamine in geriatric patients [see Warnings and Precautions (5.2) ] .
Serious adverse reactions of hyperthermia have been reported postmarketing in geriatric patients receiving transdermal scopolamine, including a fatal case. Geriatric patients may be more susceptible to the anticholinergic effects of disruption in thermoregulation. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider [see Warnings and Precautions (5.5) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of scopolamine 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 in elderly patients [see Warnings and Precautions (5.2) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Anticholinergic toxicity includes both central and peripheral signs and symptoms: agitation, central nervous system effects (e.g., coma, confusion, hallucinations, lethargy, seizures, somnolence), decreased bowel sounds, dry flushed skin, dry mouth, hyperthermia, hypertension, supraventricular arrhythmias, tachycardia, urinary retention, visual disturbances (e.g., amblyopia, mydriasis). These symptoms can be severe and may require medical intervention. In cases of toxicity remove the 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 (5.6) ] . Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal.
If over-exposure occurs, call the Poison Help line at 1-800-222-1222 for current information on the management of poisoning or overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Scopolamine, a belladonna alkaloid, is an anticholinergic. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center.
Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Scopolamine transdermal system, 1 mg/3 days is available as the following: Cartons of 4, 10 and 24 transdermal systems, packaged into individual foil pouches. Carton of 4 transdermal systems. NDC 69238-1662-9 Carton of 10 transdermal systems.
NDC 69238-1662-2 Carton of 24 transdermal systems. NDC 69238-1662-4 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store pouch(es) in an upright position.
Do not bend or roll pouch(es). Wash hands thoroughly with soap and water immediately after handling the transdermal system. Avoid touching the system during the treatment.
Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others. Wash the hands and application site with soap and water after transdermal system removal [see Dosage and Administration (2.1) , Warnings and Precautions (5.7) ] .
📋 Description ▾
11 DESCRIPTION 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 1.16 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate.
The empirical formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.35 and a pKa of 7.55 to 7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 1.55 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, pigmented polyethylene/polyester film printed with brown ink; (2) a solid matrix drug reservoir layer of silicone adhesive, scopolamine, povidone and dimethicone; (3) a microporous monolayer polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of silicone adhesive, povidone, dimethicone and scopolamine.
A protective, oversized release liner of fluoropolymer-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. Cross section of the system: Structural Formula Patch System
💬 Information for Patients ▾
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.
Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system, since pressure exerted on it may cause scopolamine to ooze out at the edge. Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others. Wash the hands and application site with soap and water after transdermal system removal.
Patients with Open-Angle Glaucoma Advise patients with open-angle glaucoma to remove the 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 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 scopolamine and contact a healthcare provider immediately if they experience a seizure. Advise patients, especially elderly patients, that cognitive impairment may occur during treatment with scopolamine, 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 scopolamine does not affect them adversely [see Warnings and Precautions (5.2) ] .
Decreased Gastrointestinal Motility and Urinary Retention Instruct patients to remove the transdermal system if they develop symptoms of intestinal obstruction (abdominal pain, nausea or vomiting) or any difficulties in urinating [see Warnings and Precautions (5.4) ] . Hyperthermia Inform patients that scopolamine can increase body temperature and reduce sweating, which may result in hyperthermia and be exacerbated by exposure to external heat sources or high environmental temperature. Geriatric patients may be more susceptible to these effects.
Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, remove the transdermal system, and contact their healthcare provider. Symptoms may persist after removal of the transdermal system [see Warnings and Precautions (5.5) ] . Drug Withdrawal/Post-Removal Symptoms Inform patients that if they remove the scopolamine transdermal system after several days of use, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing scopolamine [see Warnings and Precautions (5.6) ] .
Blurred Vision Inform patients that temporary dilation of the pupils and blurred vision may occur if scopolamine comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the t… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Prevention 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. Scopolamine was applied from 4 to 16 hours prior to the onset of motion in these studies.
14.2Prevention 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 scopolamine 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 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 as compared to 72% of placebo-treated patients.
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE
9.1Controlled Substance Scopolamine transdermal system contains scopolamine, which is not a controlled substance.
9.3Dependence Termination of scopolamine, 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) ] .
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, 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.
📄 Patient Package Insert ▾
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: nausea and vomiting from motion sickness nausea and vomiting from anesthesia or taking opioid pain medicines after surgery It is not known if scopolamine transdermal system is safe and effective in children. Who should not use scopolamine transdermal system?
Do not use scopolamine transdermal system if you: have an eye problem called angle closure glaucoma. are allergic to scopolamine, belladonna alkaloids or any of the ingredients in scopolamine transdermal system. See the end of this Patient Information leaflet for a list of the ingredients in scopolamine transdermal system. Ask your doctor if you are not sure.
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: 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 scopolamine transdermal system can harm your unborn baby. are breastfeeding or plan to breastfeed.
Scopolamine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you use scopolamine transdermal system. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Scopolamine transdermal system may affect the way other medicines work, and other medicines may affect how scopolamine transdermal system works. Medicines that you take by mouth may not be absorbed well while you use scopolamine transdermal system. 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 scopolamine transdermal system?
See the detailed Instructions for Use for information about how to use scopolamine transdermal system at the end of this Patient Information leaflet. It is important that you apply scopolamine transdermal system exactly as your doctor tells you to. Your doctor may change your scopolamine transdermal system dose.
Do not change your scopolamine transdermal system dose without talking to your doctor. Wear only one scopolamine transdermal system at any time. If you use too much scopolamine transdermal system, call your doctor or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What should I avoid while using scopolamine transdermal system? You should not drink alcohol while using scopolamine transdermal system. 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 scopolamine transdermal system affects you. You should be careful if you use scopolamine transdermal system while you participate in watersports because you may feel lost or confused (disoriented). Limit contact with water while swimming and bathing because scopolamine transdermal system may fall off.… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
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: Scopolamine transdermal system is a tan-colored, round transdermal system (patch) with “Scopolamine 1 mg/3 days” printed on it. Wear only one scopolamine transdermal system at any time. Do not cut scopolamine transdermal system.
To help prevent nausea and vomiting from motion sickness: Apply one scopolamine transdermal system 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 scopolamine transdermal system from the hairless area behind your ear. Get a new scopolamine transdermal system 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 scopolamine transdermal system before your scheduled surgery. Scopolamine transdermal system should be left in place for 24 hours after surgery. After 24 hours, scopolamine transdermal system should be removed and thrown away.
How to use scopolamine transdermal system: Inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. A round patch, consisting of a tan backing film flood printed with “Scopolamine 1 mg/3 days”, a layer of white to off-white adhesive, a white to off-white polypropylene membrane, and a layer of white to off-white adhesive protected with removable, transparent, dimpled and oversized release liner (See Figure 1). Select a hairless area of skin behind one of your ears.
Avoid areas on your skin that may have cuts, pain or tenderness. Wipe the area of your skin with a clean, dry tissue. Cut along the dashed line on the scopolamine transdermal system package to open (See Figure 2).
Open and remove the tan-colored round scopolamine transdermal system from the pouch (See Figure 3). Do not touch the white to off-white adhesive (sticky) surface on scopolamine transdermal system with your hands (See Figure 4). Apply the white to off-white adhesive surface of scopolamine transdermal system firmly to the dry area of skin behind your ear.
The flood printed, 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.
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? Store scopolamine transdermal system at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it.
Store scopolamine transdermal system in an upright position. Do not bend or roll scopolamine transdermal system. Keep scopolamine transdermal system and all medicines out of reach of children.
The Patient Information and Instructions for Use have been app… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
RECENT MAJOR CHANGES Warnings and Precautions, Hyperthermia ( 5.5 ) 4/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Pouch Carton