Scopolamine Trandermal System (Page 2 of 5)

5.7 Magnetic Resonance Imaging (MRI) Skin Burns

Scopolamine transdermal system contains an aluminized membrane. Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. Remove scopolamine transdermal system before undergoing an MRI.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in labeling:

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Acute Angle Closure Glaucoma [see Warnings and Precautions (5.1)]

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Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.2)]

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Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (5.3)]

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Gastrointestinal and Urinary Disorders [see Warnings and Precautions (5.4)]

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Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.5)]

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Blurred Vision [see Warnings and Precautions (5.6)]

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MRI Skin Burns [see Warnings and Precautions (5.7)]

6.1 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.

	Scopolamine Transdermal System % (N = 461)	Placebo % (N = 457)
Dry mouth	29	16
Dizziness	12	7
Somnolence	8	4
Agitation	6	4
Visual Impairment	5	3
Confusion	4	3
Mydriasis	4	0
Pharyngitis	3	2

*occurring in at least 3% of patients and at a rate higher than placebo

6.2 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

7 DRUG INTERACTIONS

7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions

The concurrent use of scopolamine transdermal system 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 scopolamine transdermal system [see Warnings and Precautions (5.2)]. Either scopolamine transdermal system 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.

7.2 Anticholinergic Drugs

Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions [see Drug Interactions (7.1)], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients receiving anticholinergic drugs [see Warnings and Precautions (5.2, 5.4)].

7.3 Oral Drugs Absorbed in the Stomach

Scopolamine transdermal system, 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.

7.4 Interaction with Gastric Secretion Test

Scopolamine will interfere with the gastric secretion test. Discontinue scopolamine transdermal system 10 days prior to testing.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. Avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see Data).

In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

Eclamptic Seizures
In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see Warnings and Precautions (5.3)].

Animal Data

In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by scopolamine transdermal system did not affect uterine contractions or increase the duration of labor.