Transderm Scop (Page 2 of 4)

5.8 MRI Skin Burns

Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp contains aluminum, it is recommended to remove the system before undergoing an MRI.

6 ADVERSE REACTIONS

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 clinical practice.

Motion Sickness

In motion sickness clinical studies of Transderm Scōp, the most frequent adverse reaction was dry 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 Scōp was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1).

Table 6.1 PONV: Adverse Drug Reactions in ≥3% of Patients

Transderm Scōp

(N=461)

Placebo

(N=457)

n

%

n

%

Adverse Drug Reactions

303

65.7

259

56.7

Dry mouth

133

28.9

72

15.8

Dizziness

57

12.4

33

7.2

Somnolence

36

7.8

16

3.5

Urinary Retention

33

7.2

30

6.6

Agitation

28

6.1

20

4.4

Visual Impairment

23

5.0

12

2.6

Confusion

18

3.9

14

3.1

Mydriasis

16

3.5

2

0.4

Pharyngitis

15

3.3

10

2.2

6.2 Postmarketing Experience

The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.

In worldwide marketing with Transderm Scōp, the following adverse drug reactions were reported by body system.

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 pruritis, 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.

6.3 Drug Withdrawal/Post-Removal Symptoms

Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scōp. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.

These symptoms can be severe and may require medical intervention.

7 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. [ see Warnings and Precautions (5.3)]

Scopolamine should be used with caution 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.

In vitro studies indicated that the potential for scopolamine to alter the pharmacokinetics of other concomitant

medications through inhibition of CYP 1A2, 2C8, 2C9, 2C19, 2D6 and 3A4 or induction of CYP 1A2 and 3A4 is

low; however, in vivo studies have not been conducted. [ see Clinical Pharmacology (12.3)]

7.1 Laboratory Test Interactions

Scopolamine will interfere with the gastric secretion test.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C
Based on data from one prospective study of Transderm Scōp in cesarean delivery, the rate of newborn adverse

events in both the Transderm Scōp and placebo groups were the same. The rates were 10.5% (12 events in 114

newborns) in both treatment groups. None of these events were considered life threatening or drug related.

Jaundice was the only adverse event occurring more frequently with Transderm Scōp than placebo: 9 events (7.9%)

versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and

did not prolong the hospital stay.

There are no adequate and well-controlled studies of Transderm Scōp use during pregnancy. 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. Transderm Scōp should

be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.

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