TRANSDERM SCOP

The adverse reactions for Transderm Scop are provided separately for patients with motion sickness and with post-operative nausea and vomiting.

Motion Sickness: In motion sickness clinical studies of Transderm Scop, the most frequent adverse reaction was dryness of the 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.

Post-operative Nausea and Vomiting: In a total of five clinical studies in which Transderm Scop was administered perioperatively to a total of 461 patients and safety was assessed, dry mouth was the most frequently reported adverse drug experience, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug6.

Postmarketing and Other Experience: In addition to the adverse experiences reported during clinical testing of Transderm Scop, the following are spontaneously reported adverse events from postmarketing experience. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of Transderm Scop in their causation cannot be reliably determined: acute angle-closure (narrow-angle) glaucoma; confusion; difficulty urinating; dry, itchy, or conjunctival injection of eyes; restlessness; hallucinations; memory disturbances; rashes and erythema; and transient changes in heart rate.

Drug Withdrawal/Post-Removal Symptoms: Symptoms such as dizziness, nausea, vomiting, and headache occur following abrupt discontinuation of antimuscarinics. 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. Some symptoms may be related to adaptation from a motion environment to a motion-free environment. More serious symptoms including muscle weakness, bradycardia and hypotension may occur following discontinuation of Transderm Scop.

Before using Transderm Scop Patch:
Some medical conditions may interact with Transderm Scop Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, difficulty urinating, irregular heartbeat, heart failure, hernia, glaucoma, or a predisposition to glaucoma
• if you will be having a magnetic resonance imaging (MRI) scan

Some MEDICINES MAY INTERACT with Transderm Scop Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-adrenergic blockers (eg, propranolol) or digoxin because the risk of their side effects may be increased by Transderm Scop Patch
• Phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by Transderm Scop Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if Transderm Scop Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Cardiovascular
Cardiovascular side effects are limited when scopolamine is delivered transdermally. Occasionally, there may be some clinically insignificant reductions in heart rate or blood pressure.

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 itself.

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

General
Most adverse effects of scopolamine 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.

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

Nervous system
Nervous system side effects including drowsiness occurs quite frequently and is reported by about 17% of patients administered the scopolamine 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.

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.

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.

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.