Scopolamine (Page 2 of 6)

5.5 Drug Withdrawal/Post-Removal Symptoms

Discontinuation of scopolamine transdermal system, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. The onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. Instruct patients to seek medical attention if they experience severe symptoms.

5.6 Blurred Vision

Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.

Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system [see Dosage and Administration (2.1)].

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in labeling:

Acute Angle Closure Glaucoma [see Warnings and Precautions (5.1)]
Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.2)]
Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (5.3)]
Gastrointestinal and Urinary Disorders [see Warnings and Precautions (5.4)]
Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.5)]
Blurred Vision [see Warnings and Precautions (5.6)]

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.

Table 1: Common Adverse Reactions * in Surgical Patients for the Prevention of PONV
*
occurring in at least 3% of patients and at a rate higher than placebo

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

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.