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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.
In motion sickness clinical studies of Transderm Scop, 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 Scop 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
|Adverse Drug Reactions||303||65.7||259||56.7|
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 Scop, the following adverse drug reactions were reported by body system.
Psychiatric disorders: acute psychosis including: hallucinations disorientation, and paranoia.
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.
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 Scop. 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. 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.
Read the Transderm Scop (scopolamine) Side Effects Center for a complete guide to possible side effects
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]
Laboratory Test Interactions
Scopolamine will interfere with the gastric secretion test.
Drug Abuse And Dependence
Controlled Substance Class
Scopolamine is not a controlled substance.
Scopolamine is an antagonist at muscarinic receptors in the cholinergic system. Drugs in this class are not known to have significant abuse potential in humans.
Abrupt termination of Transderm Scop may result in withdrawal symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. [see ADVERSE REACTIONS and OVERDOSAGE] These withdrawal symptoms indicate that anticholinergic drugs, like scopolamine may produce physical dependence. These symptoms can be severe and may require medical intervention.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/25/2016
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