Brief Summary of Prescribing Information

Transdermal Therapeutic System Programmed to deliver in vivo approximately 1.0 mg of scopolamine over 3 days.

INDICATIONS AND USAGE: Transderm Scop is indicated for prevention of nausea and vomiting associated with motion sickness in adults. The patch should be applied only to skin in the postauricular area.
CONTRAINDICATIONS: Transderm Scop is specifically contraindicated in persons who are hypersensitive to the drug scopolamine or to other belladonna alkaloids, or to any ingredient or component in the formulation or delivery system, or in patients with angle-closure (narrow angle) glaucoma.
WARNINGS: Transderm Scop should not be used in children and should be used with special caution in the elderly. See PRECAUTIONS. Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.Potentially alarming idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine.
PRECAUTIONS General: Scopolamine should be used with caution in patients with pyloric obstruction, or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or antimuscarinic drug to patients suspected of having intestinal obstruction. Transderm Scop should be used with special caution in the elderly or individuals with impaired metabolic, liver, or kidney functions, because of the increased likelihood of CNS effects. Caution should be exercised in patients with a history of seizure or psychosis, since scopolamine can potentially aggravate both disorders.
Information for Patients: 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. Patients should be advised to remove the patch immediately and contact a physician in the unlikely event that they experience symptoms of acute narrow-angle glaucoma (pain in and reddening of the eyes accompanied by dilated pupils). Patients should also be instructed to remove the patch if they develop any difficulties in urinating.Patients should be warned against driving a motor vehicle or operating dangerous machinery while wearing the patch. Patients who engage in these activities should also be aware of the possibility of withdrawal symptoms when the patch is removed. Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. A patient brochure is available.
Drug Interactions: Scopolamine should be used with care in patients taking drugs, including alcohol, capable of causing CNS effects. Special attention should be given to drugs having anticholinergic properties, e.g., belladonna alkaloids, antihistamines (including meclizine), and antidepressants.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals have been performed to evaluate carcinogenic potential. Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. In the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system), reduced maternal body weights were observed.
Pregnancy Category C: Teratogenic studies were performed in pregnant rats and rabbits with scopolamine hydrobromide administered by daily intravenous injection. No adverse effects were recorded in the rats. In the rabbits, the highest dose (plasma level approximately 100 times the level achieved in humans using a transdermal system) of drug administered had a marginal embryotoxic effect. Transderm Scop should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether scopolamine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Transderm Scop is administered to a nursing woman.
Pediatric Use: Children are particularly susceptible to the side effects of belladonna alkaloids. Transderm Scop should not be used in children because it is not known whether this system will release an amount of scopolamine that could produce serious adverse effects in children.
ADVERSE REACTIONS: The most frequent adverse reaction to Transderm Scop is dryness of the mouth. This occurs in about two thirds of the people. A less frequent adverse reaction is drowsiness, which occurs in less than one sixth of the people. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, is also observed. The following adverse reactions have also been reported on infrequent occasions during the use of Transderm Scop: disorientation; memory disturbances; dizziness; restlessness; hallucinations; confusion; difficulty urinating; rashes and erythema; acute narrow-angle glaucoma; and dry, itchy or red eyes. Drug Withdrawal: Symptoms including dizziness, nausea, vomiting, headache, and disturbances of equilibrium have been reported in a few patients following discontinuation of the use of the Transderm Scop system. These symptoms have occurred most often in patients who have used the system for more than three days.
OVERDOSAGE: Overdosage with scopolamine may cause disorientation, memory disturbances, dizziness, restlessness, hallucinations, confusion, psychosis, convulsions, bronchospasm and respiratory depression, and muscular weakness. Should these symptoms occur, the Transderm Scop patch should be removed immediately, adequate hydration should be maintained, and appropriate symptomatic treatment initiated.
CAUTION: Federal law prohibits dispensing without prescription.
Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054 ©2005