Transderm-Scop

Scopolamine is an oral, intravenous, ophthalmic or topical drug with many uses including the prevention of motion sickness. Transderm Scop is scopolamine administered topically (through the skin or transdermally) via a special delivery system that gradually releases scopolamine onto the skin over a period of three days. Scopolamine is absorbed into the body through the skin. It is not clear how scopolamine prevents nausea and vomiting due to motion sickness. The vestibular part of the ear is very important for balance. When a person who is susceptible to motion sickness experiences motion, the vestibule sends a signal through nerves to the vomiting center in the brain, and vomiting occurs. Acetylcholine is a chemical that nerves use to transmit messages to each other (a neurotransmitter). Scientists believe that scopolamine prevents communication between the nerves of the vestibule and the vomiting center in the brain by blocking the action of acetylcholine (anticholinergic effect). Scopolamine also may work directly on the vomiting center. Scopolamine must be taken before the onset of motion sickness to be effective. The FDA approved Transderm Scop in December 1979.

Scopolamine most commonly comes in a 0.4 milligram (mg) tablet, or as a transdermal skin patch applied behind the ear that delivers 1 mg of scopolamine over three days.

Only one patch should be worn at a time, and it should be applied four hours ahead of time to prevent motion sickness. Avoid contact with the adhesive layer of the patch when removing it from the package to prevent contamination.

Take the tablet as directed by your doctor, which is usually 0.4 to 0.8 mg every eight hours as needed, with a full glass of water.

For children ages 12 and younger, the maximum dose is 0.3 mg. Children and the elderly are much more vulnerable to the drug's side effects.

Scopolamine Overdose

Seek medical help immediately, or call the poison control help line if you think you or someone else has overdosed on scopolamine.

Symptoms of overdose include drowsiness, dizziness, agitation, fever, excitability, seizures, and hallucinations.

Missed Dose of Scopolamine

Take your missed dose of scopolamine as soon as you remember. But if it's close to the time for your next dose, wait and take the next scheduled dose.

Do not take an extra dose to make up for the one you missed.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of scopolamine, there are no specific foods that you must exclude from your diet when receiving this medication.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of scopolamine transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of scopolamine transdermal in geriatric patients. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution in patients receiving scopolamine transdermal.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil
• Tiotropium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma, narrow-angle—Should not be used in patients with this condition.

• Glaucoma, open-angle (wide-angle) or
• Intestinal or stomach blockage or
• Psychosis, history of or
• Seizures, history of or
• Urinating problems (e.g., urinary tract blockage or trouble urinating)—Use with caution. May make these conditions worse.

• Liver disease or
• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Transderm Scop by mouth. Use on your skin only. Keep out of your mouth and eyes (may burn).
• Do not use patches that are cut or do not look right.
• Wash your hands before and after use.
• Use skin patch behind the ear. If using for motion sickness, put on 4 hours before travel starts.
• Wear only one patch at a time.
• Be careful to not knock loose the patch while bathing or showering.
• If the patch falls off, put a new one on.
• If using for motion sickness and this medicine is needed for more than 3 days, throw away the old patch. Put a new one on behind the other ear.
• When patch is taken off, wash site with soap and water.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on more than 1 patch at a time.
• Many times Transderm Scop is used on an as needed basis. Do not use more often than told by the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Transderm Scop, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Transderm Scop. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Transderm Scop.

Review Date: October 4, 2017

The Transderm Scōp® (scopolamine) transdermal system is a circular flat patch designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is α -(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.0 2,4] non-7-yl ester. The empirical formula is C17H21NO4 and its structural formula is:

Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp® system is a film 0.2 mm thick and 2.5 cm2, with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir of scopolamine, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system.

Cross section of the system:

You should not use this medicine if you are allergic to scopolamine or similar medicines such as methscopolamine, hyoscyamine, or atropine, or if you have:

• narrow-angle glaucoma.

To make sure scopolamine is safe for you, tell your doctor if you have ever had:

• glaucoma;

• liver or kidney disease;

• epilepsy or other seizure disorder;

• urination problems; or

• a blockage in your digestive tract (stomach or intestines).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Scopolamine transdermal can pass into breast milk and may affect the nursing baby. Tell your doctor if you are breast-feeding.

Older adults may be more sensitive to the side effects of scopolamine transdermal.

Scopolamine transdermal is not approved for use by anyone younger than 18 years old.

Since scopolamine transdermal is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor for instructions if you forget to apply the patch as directed before surgery.

Scopolamine slows the digestive tract, which can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor if any of your oral medications do not seem to work as well while you are using scopolamine transdermal.

Using scopolamine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• atropine;

• cold or allergy medicine that contains an antihistamine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or

• bronchodilators--aclidinium, ipratropium, or tiotropium.

This list is not complete. Other drugs may interact with scopolamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to scopolamine: compounding powder, injectable solution, oral tablet, transdermal film extended release

Cardiovascular

Cardiovascular side effects are limited when scopolamine (the active ingredient contained in Transderm-Scop) is delivered transdermally. Occasionally, there may be some clinically insignificant reductions in heart rate or blood pressure.[Ref]

Dermatologic

Dermatologic side effects have included rash, dryness of the skin, and erythema. Dermatitis may occur at the site of application, in some cases due to the scopolamine (the active ingredient contained in Transderm-Scop) itself.[Ref]

Gastrointestinal

Gastrointestinal side effects reported have included dry mouth, which occurred in approximately two-thirds of the patients using the transdermal patch.[Ref]

General

Most adverse effects of scopolamine (the active ingredient contained in Transderm-Scop) are extensions of its pharmacologic activity and are anticholinergic in nature. Scopolamine delivered transdermally is associated with considerably less side effects than when administered by other routes.[Ref]

Genitourinary

Genitourinary side effects have included retention. Urinary retention has been reported infrequently with the transdermal patch.[Ref]

Nervous system

Nervous system side effects including drowsiness occurs quite frequently and is reported by about 17% of patients administered the scopolamine (the active ingredient contained in Transderm-Scop) transdermal patch. Other nervous system side effects are sporadic, including dizziness, restlessness, insomnia, disorientation, memory disturbances, hallucinations, paranoia, and confusion. Most reports of scopolamine-induced psychosis and delirium have involved the elderly, although some behavioral and mental irregularities may also be seen in young children. Concomitant use of antihistamines and other anticholinergics may be predisposing factors.

Recurrent migraine attacks have been described in one individual following an apparent scopolamine intoxication characterized by weakness, blurred vision, drowsiness, confusion, motor incoordination, and a stuporous state lasting 2 hours.[Ref]

Recurrent classic migraine attacks developed in a 20-year-old naval crew member who had been treated continuously with transdermal scopolamine for 5 months. The initial attack occurred within 24 hours of diagnosis of scopolamine intoxication. The patient had no self or family history of migraines. The attacks, presenting with prodrome and aura, followed by severe throbbing left headache, nausea, photophobia and sonophobia lasting 6 to 8 hours, recurred every 10 to 14 days for more than a year. Common triggers of migraines and other precipitating factors could not be identified in this case.[Ref]

Ocular

Ocular side effects have included transient mydriasis and cycloplegia, resulting in blurred vision. Symptoms generally resolve within 2 days following removal of the patch but may take longer depending on the cumulative dose received. Unilateral dilation of the pupil and anisocoria have been reported, suggesting that some ocular events may be due to inadvertent contamination of the eye when there is failure to wash the hands after drug application. Narrow angle glaucoma resulting from bilateral mydriasis has been reported rarely but, in one case, required surgery. Esotropia has also occurred in a pediatric patient with neurodevelopmental disabilities but resolved several days after removal of the patch.[Ref]

Other

Withdrawal symptoms may seldomly develop within 2 or 3 days following removal of the patch, usually in patients who have used it for more than 3 days. These symptoms are consistent with rebound cholinesterase activity and include dizziness, nausea, vomiting, paresthesias of the hands and feet, dysphoria, and hypotension.[Ref]

Some side effects of Transderm-Scop may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.