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 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)].

The following serious adverse reactions are described elsewhere in labeling:

• Acute Angle Closure Glaucoma [see Warnings and Precautions (5.1)]
• Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.2)]
• Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (5.3)]
• Gastrointestinal and Urinary Disorders [see Warnings and Precautions (5.4)]
• Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.5)]
• Blurred Vision [see Warnings and Precautions (5.6)]
• MRI Skin Burns [see Warnings and Precautions (5.7)]

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 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:

Scopolamine has a molecular weight of 303.35 and a pKa of 7.55 to 7.81. The scopolamine transdermal system is a circular, 0.28 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, light mineral oil, isopropyl palmitate, crospovidone, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of mineral oil, polyisobutylene, isopropyl palmitate, crospovidone, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used.

Cross section of the system:

Scopolamine Transdermal System 1 mg/3 days is available as the following:

Carton of 4 transdermal systems, packaged into individual foil pouches.      NDC 42858-150-40

Carton of 10 transdermal systems, packaged into individual foil pouches.    NDC 42858-150-14

Carton of 24 transdermal systems, packaged into individual foil pouches.    NDC 42858-150-70

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Manufactured by:
LTS Lohmann Therapie-Systeme AG
Andernach, 56626, Germany

Marketed by:
Rhodes Pharmaceuticals
Wilson, NC 27893 USA

For more information, call Rhodes Pharmaceuticals at 1-888-827-0616

Revised: 4/2024

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 not use scopolamine transdermal system during a Magnetic Resonance Imaging scan (MRI). Remove scopolamine transdermal system before undergoing an MRI. It can cause your skin to burn.
• 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. If scopolamine transdermal system falls off, throw it away and apply a new one on the hairless area behind your other ear.

What are the possible side effects of scopolamine transdermal system?

Scopolamine transdermal system may cause serious side effects, including:

• angle closure glaucoma. If you have open angle glaucoma and use scopolamine transdermal system, remove scopolamine transdermal system and call a doctor right away if you feel pain or discomfort, have blurred vision, or see halos or colored images around lights and reddening of your eyes.
• worsening of seizures. Tell your doctor about any worsening of seizures while using scopolamine transdermal system.
• an unusual reaction called acute psychosis. Tell your doctor if you have any of these symptoms:
  • confusion
  • agitation
  • rambling speech
  • hallucinations (seeing or hearing things that are not there)
  • paranoid behaviors and delusions (false belief in something)

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. Some pregnant women with severe preeclampsia have had seizures after getting scopolamine by injection in the muscle (intramuscular) or injection in the vein (intravenous).
• difficulty urinating.
• difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea, or vomiting.
• withdrawal symptoms after removing scopolamine transdermal system after using it for several days. Some people may have certain symptoms such as difficulty with balance, dizziness, nausea, vomiting, stomach cramps, sweating, confusion, muscle weakness, low heart rate or low blood pressure that could start 24 hours or more after removing scopolamine transdermal system. Call your doctor right away if your symptoms become severe.
• temporary increase in the size of your pupil and blurry vision, especially if scopolamine transdermal system comes in contact with your eyes.
• skin burns at the site of scopolamine transdermal system. This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Scopolamine transdermal system contains aluminum and should be removed from your skin before you have an MRI.

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: crospovidone, isopropyl palmitate, light mineral oil, polyethylene polyisobutylene, polypropylene, siliconized PET film, and aluminized PET film. The brown printing ink contains ethyl acetate, methyl ethyl ketone, and acetone.

Manufactured by:
LTS Lohmann Therapie-Systeme AG
Andernach, 56626, Germany

Marketed by:
Rhodes Pharmaceuticals
Wilson, NC 27893, USA

For more information, call Rhodes Pharmaceuticals at 1-888-827-0616.

Rev: 4/2024

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, circle shaped 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. An imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (See Figure 1).

 

1.

Select a hairless area of skin behind one of your ears. Avoid areas on your skin that may have cuts, pain, or tenderness. Wipe the area of your skin with a clean, dry tissue.

2.

Cut along the dashed line on the scopolamine transdermal system package to open (See Figure 2).

3.

Remove the clear plastic backing from the tan-colored round scopolamine transdermal system (See Figure 3).

4.

Do not touch the metallic adhesive (sticky) surface on scopolamine transdermal system with your hands (See Figure 4).

5.

Apply the metallic adhesive surface of scopolamine transdermal system firmly to the dry area of skin behind your ear. The imprinted, tan-colored side of the transdermal system should be facing up and showing (See Figure 5). 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 approved by the U.S. Food and Drug Administration.

Revised: 4/2024

NDC 42858-150-40

Rx only

Scopolamine
Transdermal System

1 mg/3 days

Formulated delivery of approximately
1 mg over three days

4 Transdermal
Systems
Multipack