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 who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine.  A patient brochure is available.

Drug Interactions

The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying.

Scopolamine should be used with care in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.

Laboratory Test Interactions
Scopolamine will interfere with the gastric secretion test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been completed to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated. 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. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system).

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 rats. Scopolamine hydrobromide has been shown to have a marginal embryotoxic effect in rabbits when administered by daily intravenous injection at doses producing plasma levels approximately 100 times the level achieved in humans using a transdermal system. During a clinical study among women undergoing cesarean section treated with Transderm Scop in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in the newborns. There are no other adequate and well-controlled studies in pregnant women. Other than in the adjunctive use for delivery by cesarean section, Transderm Scop should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because scopolamine is excreted in human milk, caution should be exercised when Transderm Scop is administered to a nursing woman.

Labor and Delivery
Scopolamine administered parenterally at higher doses than the dose delivered by Transderm Scop does not increase the duration of labor, nor does it affect uterine contractions. Scopolamine does cross the placenta.

Pediatric Use

The safety and effectiveness of Transderm Scop in children has not been established. 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 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 drug⁷.

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.

Continued above...

OVERDOSAGE

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.

Most cases of toxicity involving the use of the product will resolve with simple removal of 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 Drug Withdrawal/Post Removal Symptoms). 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.

Physostigmine salicylate:

In Adults:  Administered intravenously in doses of 0.5 to 2mg at a rate not to exceed 1mg per minute.  If symptoms recur, doses of 0.5 to 2mg may be repeated up to a total dose of 5mg.

   In Children:  0.02 mg/kg administered intramuscularly or intravenously every 5 to 10 minutes, until a therapeutic effect is seen or a total dose of 2mg is achieved.  Infusion rate should not exceed 0.5 mg per minute.

OR

Neostigmine methylsulfate:

In Adults:  Administered intramuscularly in doses of 0.5 to 1 mg, repeated every 2 to 3 hours; OR intravenously in doses of 0.5 to 2 mg, repeated as needed.

   Small doses of a short-acting barbiturate (e.g., 100 mg thiopental sodium) or benzodiazepine, or a rectal infusion of 2% solution of chloral hydrate may control agitation or delirium.  Intravenous norepinephrine bitartrate or metaraminol bitartrate may be given cautiously to restore blood pressure.  To treat respiratory depression, administer artificial respiration with oxygen.

DOSAGE AND ADMINISTRATION

Initiation of Therapy: To prevent the nausea and vomiting associated with motion sickness, one Transderm Scop patch (programmed to deliver approximately 1.0 mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required. To prevent post operative nausea and vomiting, the patch should be applied the evening before scheduled surgery. To minimize exposure of the newborn baby to the drug, apply the patch one hour prior to cesarean section. Only one patch should be worn at any time. Do not cut the patch.

Handling: After the patch is applied on dry skin behind the ear, the hands should be washed thoroughly with soap and water and dried. Upon removal, the patch should be discarded. To prevent any traces of scopolamine from coming into direct contact with the eyes, the hands and the application site should be washed thoroughly with soap and water and dried. (A patient brochure is available).

Continuation of Therapy: Should the patch become displaced, it should be discarded, and a fresh one placed on the hairless area behind the other ear. For motion sickness, if therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear. For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.

HOW SUPPLIED

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 programmed to deliver in-vivo approximately 1.0 mg of scopolamine over 3 days. Transderm Scop is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included. 1 Package (4 patches) NDC 0067-4345-04. The system should be stored at controlled room temperature between 20^o C and 25^o C (68^o F and 77^o F).

CAUTION

Federal law prohibits dispensing without prescription.

REFERENCES

1. McEvoy, G.K. (ed.); AHSF Drug Information; American Society of Hospital Pharmacists, Bethesda, MD, pp. 608-611 (1990).
2. Gilman, A.G. et al (ed.); The Pharmacological Basis of Therapeutics (8th Ed.); Pergamon Press, New York, NY, pp. 150-165 (1990).
3. Clissold, S.P. et al; "Transdermal Hyoscine (Scopolamine), A Preliminary Review of its Pharmacodynamic Properties and Therapeutic Efficacy", Drugs, 29: 189-207 (1985).
4. Pharmacokinetic clinical data on file.
5. Kotelko, D.M. et al; "Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine", Anesthesiology 71(5): 675-678 (1989).
6. Bailey, P.L. et al; "Transdermal scopolamine reduces nausea and vomiting after outpatient laparoscopy", Anesthesiology 72(6): 977-980 (1990).
7. Clinical safety data on file.

Mfd by:  ALZA Corporation

Palo Alto, CA  94303-0802

Distributed by:

Novartis Consumer Health, Inc.

Summit, NJ  07901-1312

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