Side Effects of Transderm Scop (scopolamine)

Transderm Scop (scopolamine) is an anticholinergic drug patch used to prevent motion sickness.

• Transderm Scop is 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 important for balance. When a person susceptible to motion sickness experiences motion, the vestibule sends a signal through nerves to the vomiting center in the brain, and vomiting occurs.
• Scientists believe that scopolamine prevents communication between the nerves of the vestibule and the vomiting center in the brain by blocking the action of the neurotransmitter 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. 

Common side effects of Transderm Scop include:

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

Serious side effects of Transderm Scop include:

• worsening of narrow-angle glaucoma,
• difficulty urinating,
• 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 a magnetic resonance imaging (MRI) scan.

Drug interactions of Transderm Scop include alcohol, tranquilizers, sedatives, and other drugs that cause drowsiness which may worsen the drowsiness caused by Transderm Scop.

Transderm Scop slows passage of materials including drugs through the stomach and intestines and may reduce the absorption of some drugs.

Drugs that have anticholinergic effects such as the following increase the anticholinergic side effects of Transderm Scop:

• belladonna alkaloids,
• antihistamines (including meclizine [Antivert, Bonine, Meni-D, Antrizine]),
• tricyclic antidepressants, and
• muscle relaxants.

Use of Transderm Scop in pregnant women has not been adequately evaluated. Transderm Scop passes into breast milk. Consult your doctor before breastfeeding.

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.

The following serious adverse reactions are described elsewhere in labeling:

• Acute Angle Closure Glaucoma
• Neuropsychiatric Adverse Reactions
• Eclamptic Seizures in Pregnant Women
• Gastrointestinal and Urinary Disorders
• Drug Withdrawal/Post-Removal Symptoms
• Blurred Vision
• MRI Skin Burns

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 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

Postmarketing 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: 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 pruritus, 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

Drugs Causing Central Nervous System (CNS) Adverse Reactions

The concurrent use of Transderm Scop 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 Transderm Scop.

Either Transderm Scop 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.

Anticholinergic Drugs

Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions, intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with Transderm Scop in patients receiving anticholinergic drugs.

Oral Drugs Absorbed In The Stomach

Transderm Scop, 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.

Interaction With Gastric Secretion Test

Scopolamine will interfere with the gastric secretion test. Discontinue Transderm Scop 10 days prior to testing.

Drug Abuse And Dependence

Controlled Substance

Transderm Scop contains scopolamine, which is not a controlled substance.

Dependence

Termination of Transderm Scop, 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.