SCOPOLAMINE- scopolamine_patch

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.
CLINICAL PHARMACOLOGY
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. 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. Less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours. An in vitro in vitro in vivo.
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.

Scopolamine transdermal system is indicated in adults for the prevention of: Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: 1 1.

DOSAGE AND ADMINISTRATION
Application and Removal 2. 1 Recommended Dosage Motion Sickness 2. 2 PONV 2. 2 in vivo Do not cut the transdermal system. [see Warnings and Precautions (5. 7) ] [see Warnings and Precautions (5. 7) ] Apply one scopolamine transdermal system to the hairless area behind one ear at least 4 hours before the antiemetic effect is required en dash 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. Apply one scopolamine transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.
For surgeries other than cesarean section
Apply one scopolamine transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.
Instructions for Use
Scopolamine 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: Do not 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, peach backing membrane with a sticky surface is adhered to a clear, disposable release liner (See Figure 1). 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. Food and Drug Administration Manufactured for: Mylan Pharmaceuticals Inc. Revised: 5/2025 SCOP:R10/PL:SCOP:R5 Instructions for Use Figure 1 Instructions for Use Figure 2 Instructions for Use Figure 3 Instructions for Use Figure 4 Instructions for Use Figure 5.

The following serious adverse reactions are described elsewhere in labeling: [see Warnings and Precautions (5. 1) [see Warnings and Precautions (5. 2) [see Warnings and Precautions (5. 3) [see Warnings and Precautions (5. 4) [see Warnings and Precautions (5. 5) [see Warnings and Precautions (5. 6) ] [see Warnings and Precautions (5. 7) Most common adverse reactions are: Motion Sickness 6. 1 PONV 6. 1 To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www. gov/medwatch. 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 occurring in at least 3% of patients and at a rate higher than placebo Scopolamine Transdermal System % (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 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: Nervous system disorders: General disorders and administration site conditions: Eye disorders: Skin and subcutaneous tissue disorders: Renal and urinary disorders: Ear and labyrinth disorders:.

Scopolamine transdermal system is contraindicated in patients with: [see Warnings and Precautions (5. 1) [see Adverse Reactions (6. 2) Description (11) 4 6. 2 4 7.

Geriatric Patients 5. 5 Renal or Hepatic Impairment 5. 6 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) 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 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. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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) 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. 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. The safety and effectiveness of scopolamine transdermal system has not been established in pediatric patients. Pediatric patients are particularly susceptible to the anticholinergic adverse reactions of scopolamine, including neurologic and psychiatric adverse reactions and drug withdrawal syndrome. Serious adverse reactions of acute psychosis (e. , disorientation, hallucinations), amblyopia, hyperthermia (including a fatal case), and mydriasis have been reported in pediatric patients [see Warnings and Precautions (5. 5) 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. 6) [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) 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.

Drugs Causing Central Nervous System (CNS) Adverse Reactions 7. 1 Anticholinergic Drugs 7. 2 Oral Drugs Absorbed in the Stomach 7. 3 Interaction with Gastric Secretion Test 7. 4 The concurrent use of scopolamine transdermal system with other drugs that cause CNS adverse reactions of drowsiness, dizziness or disorientation (e. , sedatives, hypnotics, opiates, anxiolytics and alcohol) or have anticholinergic properties (e. , 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) Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions [see Drug Interactions (7. 1) [see Warnings and Precautions (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.

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)
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) If over-exposure occurs, call the Poison Help line at 1-800-222-1222 for current information on the management of poisoning or overdosage.
NONCLINICAL TOXICOLOGY
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.
CLINICAL STUDIES
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.
Patient Information
Scopolamine 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: 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: 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: Tell your doctor about all the medicines you take, 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 scopolamine transdermal system? Instructions for Use Do not What should I avoid while using scopolamine transdermal system? What are the possible side effects of scopolamine transdermal system? Scopolamine transdermal system may cause serious side effects, including: angle closure glaucoma. worsening of seizures. an unusual reaction called acute psychosis. o o o o o 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. worsening of your preeclampsia during pregnancy. difficulty urinating. difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting. increased body temperature (hyperthermia) and a decrease in sweating. withdrawal symptoms after removing scopolamine transdermal system after using it for several days. temporary increase in the size of your pupil and blurry vision, The most common side effects of using scopolamine transdermal system 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 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: peach-colored polyethylene/polyester film, polypropylene, povidone and silicone adhesive. The brown imprinting ink contains acrylic polymers, carbon black, iron oxides (red and yellow), polydimethylsiloxane, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and triethanolamine. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

Mylan Pharmaceuticals Inc.

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