Scopolamine

The most common side effects are:

• drowsiness,
• dry mouth,
• blurred vision, and
• dilation of the pupils.

Scopolamine may worsen narrow angle glaucoma, cause difficulty urinating and lead to dry, itchy eyes. Some patients may experience disorientation and confusion. If used more than 3 days some patients may experience withdrawal symptoms such as nausea, vomiting, headache, and dizziness. Some patches may cause burns of the skin if worn during an MRI (magnetic resonance imaging) scan. Patients should tell their health care professional that they are using a medication patch prior to receiving an MRI scan, and the patch should be removed.

Do not touch dropper tip to any surface, as this may contaminate the solution. For topical use only-not for injection. In infants and small children, use with extreme caution.

Common Side Effects of Scopolamine

• Dry mouth or dry skin
• Sleepiness
• Dizziness
• Restlessness
• Blurred vision
• Dilated pupils
• Dry or itchy eyes
• Constipation
• Decreased sweating

Discuss these side effects with your doctor.

Serious Side Effects

• Itching or hives, swelling in your face and hands, or swelling or tingling in your mouth or throat, chest tightness, difficulty breathing -- these could be signs of an allergic reaction
• Blurred vision or difficulty speaking (eye pain or redness, seeing halos around lights, blurred vision, increased sensitivity to light, hallucinations, unusual thoughts or behaviors)
• Flushing or redness in your face, neck, arms or upper chest
• Rapid heartbeats
• Confusion, or behavior changes
• Difficulty urinating
• Dilated pupils, accompanied by pain and redness of the eyes

Call your doctor immediately if you have any of the above symptoms, and stop using scopolamine. Be aware that nausea, vomiting, dizziness, headaches, and clumsiness can occur if you've taken scopolamine for more than a few days and then stop taking it.

Dosage Forms And Strengths

The Transderm Scop® system is a tan-colored circular flat patch which contains 1.5 mg of scopolamine base and is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days.

Storage And Handling

The Transderm Scop® system is a tan-colored circular patch, 2.5 cm², on a clear, oversized, hexagonal peel strip, which is removed prior to use.

Each Transderm Scop system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately 1 mg of scopolamine over 3 days. Transderm Scop® is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included. [see PATIENT INFORMATION]

1 Package (4 patches) NDC 0067-4345-04

The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F).

Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets. [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION]

Manufactured by: ALZA Corporation, Vacaville, CA 95688. Distributed by: Novartis Cons umer Health, Inc., Parsippany, NJ 07054-0622. Revised: Dec 2014

Because strategies for the management of drug overdose continually evolve, it is strongly recommended that a poison control center be contacted to obtain up-to-date information regarding the management of Transderm Scop® patch overdose. The prescriber should be mindful that antidotes used routinely in the past may no longer be considered optimal treatment. For example, physostigmine, used more or less routinely in the past, is seldom recommended for the routine management of anticholinergic syndromes.

Until up-to-date authoritative advice is obtained, routine supportive measures should be directed to maintaining adequate respiratory and cardiac function. 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 patch. Serious symptomatic cases of overdosage involving multiple patch 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 patches from the skin and the mouth. If there is evidence of patch ingestion, gastric lavage, endoscopic removal of swallowed patches, 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 symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal. [see ADVERSE REACTIONS] 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. Obtaining a careful history is crucial to making the correct diagnosis.

Transderm Scop®
pronounced tran(t)s-derm skop
(scopolamine) transdermal system patch

Read this Patient Information before you start using Transderm Scop® 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 Transderm Scop®?

The Transderm Scop® patch is a prescription medicine used for adults to:

• help prevent nausea and vomiting from motion sickness
• help prevent nausea and vomiting from anesthesia or taking opioid pain medicines after surgery

It is not known if Transderm Scop® is safe or effective in children.

Who should not use Transderm Scop®?

Do not use Transderm Scop® if you:

• have an eye problem called angle closure glaucoma
• if you are allergic to any of the ingredients in Transderm Scop® or other medicines called belladonna alkaloids. See the end of this leaflet for a list of the ingredients in Transderm Scop®. Ask your doctor if you are not sure.

What should I tell my doctor before using Trans derm Scop®?

Before you use Transderm Scop®, tell your doctor if you:

• are scheduled to have a gastric secretion test
• have glaucoma (increased pressure in the eye)
• have liver or kidney problems
• have problems with your stomach or intestines
• have trouble urinating
• have a history of seizures or psychosis
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Transderm Scop® can harm your unborn baby.
• are breast-feeding or plan to breast-feed. Transderm Scop® can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you use Transderm Scop®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Transderm Scop® may affect the way other medicines work, and other medicines may affect how Transderm Scop® works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scop®.

Especially tell your doctor if you take:

• a sedative or tranquilizer (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 Transderm Scop®?

Use Transderm Scop® exactly as your doctor tells you to use it.

Transderm Scop® is a tan-colored circle shaped patch.

Wear only one patch at any time.

Do not cut the patch.

To help prevent nausea and vomiting from motion sickness:

• Apply one Transderm Scop® patch 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 the patch from the hairless area behind your ear. Get a new Transderm Scop® patch 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 Transderm Scop® before your scheduled surgery.
• The Transderm Scop® patch should be left in place for 24 hours after surgery. After 24 hours the patch should be removed and thrown away.

Apply Transderm Scop® as follows:

Inside the Transderm Scop® package, you will find one Transderm Scop® patch. A tan colored patch with a metallic (silver) sticky surface is adhered to a clear disposable backing (See Figure 1).

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 dotted line on the Transderm Scop® package to open (See Figure 2).

Figure 2

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

Figure 3

4. Avoid touching the metallic adhesive (sticky) surface on the patch with your hands (See Figure 4).

Figure 4

5. Apply the metallic adhesive surface of the patch firmly to the dry area of skin behind your ear. The tan-colored side of the patch should be facing up and showing (See Figure 5). Wash your hands with soap and water right away after applying the patch, so that any medicine from the patch that gets on your hands will not get into your eyes.

Figure 5

After removing the patch, be sure to wash your hands andtransscop the area behind your ear thoroughly with soap and water. Note that the used patch will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children or pets, fold the used patch in half with the sticky side together. Dispose in the trash out of the reach of children and pets.

If you use too much Transderm Scop®, call your doctor or local poison control center, or go to the nearest hospital emergency room right away.

What should I avoid while using Transderm Scop®?

• You should not drink alcohol while using Transderm Scop®. 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 Transderm Scop® affects you.
• You should not use Transderm Scop® during a Magnetic Resonance Imaging scan (MRI). Remove Transderm Scop® patch before undergoing an MRI; it can cause your skin to burn.
• You should be careful if you use Transderm Scop® while you participate in watersports because you may feel lost or confused (disoriented).
• Limit contact with water while swimming and bathing because the Transderm Scop® patch may fall off. If the patch 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 Transderm Scop®?

Transderm Scop® may cause serious side effects, including:

• angle closure glaucoma. If you have open angle glaucoma and use Transderm Scop®, remove the patch and call a doctor right away if you get pain and reddening of your eyes with an increase in the size of your pupil (the small dark circle in the eye).
• temporary increase in the size of your pupil and blurry vision, especially if Transderm Scop® comes in contact with your eyes
• difficulties in urinating
• difficulties in food passing from the stomach to the small intestines , which may cause abdominal pain, nausea or vomiting.
• worsening of seizures. Tell your doctor about any worsening of seizures while using Transderm Scop®.
• 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)
• skin burns at the site of the patch. This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Transderm Scop® contains aluminum and should be removed from your skin before you have an MRI.

The most common side effects of using Transderm Scop® include:

• dry mouth
• drowsiness
• disorientation (confusion)
• blurred vision
• pharyngitis
• memory trouble
• dizziness
• restlessness
• agitation
• problems urinating
• skin rashes or redness, application site burning
• dry itchy, or reddened whites of the eyes, and eye pain

Symptoms when removing Transderm Scop®. Some people may have certain symptoms 24 hours or more after removing Transderm Scop®. These symptoms may include:

• dizziness
• nausea
• vomiting
• headache
• problems with balance and walking
• decrease in blood pressure
• muscle weakness
• decrease in heart rate

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 Transderm Scop®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may reports side effects to FDA at 1-800- FDA-1088.

How should I store Transderm Scop®?

• Store Transderm Scop® at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it.
• Keep Transderm Scop® and all medicines out of reach of children.

General Information about Trans derm Scop®

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Transderm Scop® for a condition for which it was not prescribed. Do not give Transderm Scop® to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Transderm Scop®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor forinformation about Transderm Scop® that is written for the health professionals.

For more information, go to www. transdermscop.com or call 1-800-452-0051.

What are the ingredients in the Transderm Scop® patch?

Active ingredient: Scopolamine

Inactive ingredients : light mineral oil and polyisobutylene and aluminized polyester film

Scopolamine ophthalmic causes the muscles in your eye to become relaxed. This widens your pupil. Your pupil will remain wide and will not respond to light.

Scopolamine ophthalmic is used to dilate (widen) your pupil when you have an inflammatory condition or in diagnostic or postsurgery situations in which this effect may be helpful.

Scopolamine ophthalmic may also be used for purposes other than those listed in this medication guide.

Clinical 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 clinical practice.

In motion sickness clinical studies of Transderm Scop, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed.

In a total of five clinical studies in which Transderm Scop was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥ 3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1).

Table 6.1 PONV: Adverse Drug Reactions in ≥ 3% of Patients

Postmarketing Experience

The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.

In worldwide marketing with Transderm Scop, the following adverse drug reactions were reported by body system.

Psychiatric disorders: acute psychosis including: hallucinations disorientation, and paranoia.

Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness.

General disorders and administration site conditions: application site burning.

Eye disorders: dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation.

Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema.

Renal and urinary disorders: dysuria.

Ear and Labyrinth Disorders: vertigo.

Drug Withdrawal/Post-Removal Symptoms

Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scop. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scop system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.

These symptoms can be severe and may require medical intervention.

Read the entire FDA prescribing information for Transderm Scop (Scopolamine)

Serious side effects have been reported with scopolamine. See the “Scopolamine Precautions” section.

Common side effects of scopolamine include the following:

• dry mouth
• blurry vision
• drowsiness
• dizziness
• disorientation
• memory disturbances
• restlessness
• hallucinations
• confusion
• difficulty urinating
• skin rashes or redness
• temporary changes in heart rate such as palpitations

This is not a complete list of scopolamine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you take too much scopolamine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of scopolamine can be fatal, especially to a child.

Overdose symptoms may include fever, warmth, vomiting, feeling restless or excited, confusion, hallucinations, weak or shallow breathing, or seizure (convulsions).

Other drugs may interact with scopolamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Contraindications

• Angle-closure glaucoma.119 a b d

• Prostatic hypertrophy and obstructive uropathy (urinary bladder neck obstruction caused by prostatic hypertrophy).119 a d (See GU Effects under Cautions.)

• Obstructive GI disease (e.g., pyloroduodenal stenosis, achalasia).119 a d (See GI Effects under Cautions.)

• Repeated administration in those with chronic lung disease.b (See Respiratory Effects under Cautions.)

• Paralytic ileus.a

• Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.a d

• Known idiosyncratic reaction to anticholinergic drugs.119

• Known hypersensitivity to scopolamine, other belladonna alkaloid, barbiturates,e or any ingredient or component in the formulation or administration system.a b d

Warnings/Precautions

Warnings

Possible adverse CNS effects, including CNS depression, manifested as drowsiness, euphoria, amnesia, fatigue, and dreamless sleep; disorientation; confusion; memory disturbances; and dizziness.a Excitement, restlessness, hallucinations, or delirium may paradoxically occur, especially when scopolamine is used in the presence of severe pain.a May result in impairment of performance of activities requiring mental alertness, physical coordination, or visual acuity (e.g., operating machinery, driving a motor vehicle).b d

Use caution with underwater sports participation; warn patients about possible disorientation.b

Use with caution in patients with autonomic neuropathy.d

Possible increased intraocular pressure; monitor open-angle glaucoma therapy and adjust as necessary.b

Excessive susceptibility to the effects of scopolamine occurs rarely.a b Toxic symptoms may occur with therapeutic doses.a b

Most serious idiosyncratic reaction is acute toxic psychosis (e.g., confusion, agitation, rambling speech, hallucinations, paranoid behavior, delusions).b Other manifestations may include marked CNS disturbances (e.g., complete disorientation, active delirium), somnolence, dilated pupils, accelerated pulse rate, and dryness of the mouth with a husky quality of the voice.a b

Idiosyncratic reaction usually is reversed by physostigmine.a

Possible drug withdrawal symptoms (e.g., nausea, vomiting, headache, dizziness, disturbances of equilibrium) following discontinuance of the transdermal system; usually do not appear until ≥24 hours after system removal.a d

Withdrawal symptoms must be distingushed from overdosage signs and symptoms.a d Mental confusion and dizziness may be observed with both withdrawal and acute toxicity.a d Scopolamine withdrawal is suggested by bradycardia, headache, nausea, abdominal cramps, and sweating, while tachyarrhythmias, dry skin, and decreased bowel sounds occur with acute toxicity.a d

General Precautions

Possible tachycardia; use with caution in patients with tachyarrhythmias, CHF, CAD, or hyperthyroidism.119 d

Possible decreased GI motility.b Use with caution if pyloric or intestinal obstruction is suspected.b

Possible increased sensitivity to antimuscarinic effects (e.g., mydriasis, positive chronotropic effect).d

Systemically administered antimuscarinics may reduce bronchial secretions and may lead to inspissation and formation of bronchial plugs in debilitated patients with chronic pulmonary disease; use with caution in such patients.d

Antimuscarinics decrease the tone and amplitude of contractions of the ureters and bladder.d In patients with uninhibited or reflex neurogenic bladder, the amplitude and frequency of uninhibited contractions are reduced and bladder capacity is increased.d

Possible urinary retention in patients with urinary obstruction.d Use with caution in patients with partial obstructive uropathy.d Use contraindicated in patients with obstructive uropathy (urinary bladder neck obstruction caused by prostatic hypertrophy).119 a d

Scopolamine may aggravate seizures or psychosis; use with caution in patients with a history of these conditions.b

Specific Populations

Category C.119 b

Distributed into milk.110 113 Caution if used in nursing women.110 113 119 b

Safety and efficacy of scopolamine hydrobromide tablets or scopolamine transdermal system not established.119 a b

Generally use antimuscarinics with caution; children are particularly susceptible to adverse effects of belladonna alkaloids.b d

Do not use scopolamine transdermal system in children since it is not known if the system will release an amount of drug that could cause serious adverse effects.a b

Use with caution; possible increased incidence of mental confusion and other adverse CNS effects compared with younger adults.a d (See CNS Effects under Cautions.)

Use with caution; possible increased incidence of adverse CNS effects.a d (See CNS Effects under Cautions.) Tablets contraindicated.119

Use with caution; possible increased incidence of adverse CNS effects.a d (See CNS Effects under Cautions.) Tablets contraindicated.119

Common Adverse Effects

With transdermal therapy, dry mouth, drowsiness, dizziness, blurred vision, mydriasis.a b

With oral therapy, dry mouth, dry skin, drowsiness, flushing, tachycardia, urinary retention, mydriasis.119

With parenteral therapy, dry mouth, dry skin, anhidrosis, tachycardia, urinary retention, mydriasis.e

• Competitively inhibits acetylcholine or other cholinergic stimuli at autonomic effectors innervated by postganglionic cholinergic nerves and, to a lesser extent, on smooth muscles that lack cholinergic innervation.d

• At usual doses, principally antagonizes cholinergic stimuli at muscarinic receptors and has little or no effect on cholinergic stimuli at nicotinic receptors.d

• Generally more potent than atropine in its antimuscarinic action on the iris, ciliary body, and certain secretory (salivary, bronchial, sweat) glands, and less potent than atropine in its antimuscarinic action on the heart and on bronchial and intestinal smooth muscle.a

• Apparently corrects some central imbalance of acetylcholine and norepinephrine that may occur in patients with motion sickness.a Antimuscarinics may block the transmission of cholinergic impulses from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center; these effects result in prevention of motion-induced nausea and vomiting.a

• Antimuscarinics also have been referred to as anticholinergics (cholinergic blocking agents), but this term is appropriate only when it describes the antagonism of cholinergic stimuli at any cholinergic receptor, whether muscarinic or nicotinic.d

• Also have been referred to as parasympatholytics since the antagonized functions principally are under the parasympathetic division of the nervous system.d

• Receptors at various sites are not equally sensitive to inhibitory effects of antimuscarinics, and degree of inhibition at each site is dose dependent.d Relative sensitivity of physiologic functions (proceeding from the most sensitive) is as follows: secretions of the salivary, bronchial, and sweat glands; pupillary dilation, ocular accommodation, and heart rate; contraction of the detrusor muscle of the bladder and smooth muscle of the GI tract; and gastric secretion and motility.d Doses used to decrease gastric secretions are likely to cause dryness of the mouth (xerostomia) and interfere with visual accommodation, and possibly cause difficulty in urinating.d

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name