February 11, 2016
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Transderm Scop

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Transderm Scop




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Open Angle Glaucoma

Patients Currently Being Treated for Open Angle Glaucoma

Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during Transderm Scop use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.

Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).

Temporary Dilation Of The Pupil

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

Patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. [see ADVERSE REACTIONS] In addition, it is important that used patches be disposed of properly to avoid contact with children or pets. [see HOW SUPPLIED/ Storage and Handling]

Preexisting Gastrointestinal Or Urinary Bladder Obstructions

Transderm Scop should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including

Transderm Scop, to patients suspected of having intestinal obstruction.

Patients should be instructed to remove the patch if they develop any difficulties in urinating. [see ADVERSE REACTIONS]

History Of Seizures Or Psychosis

Transderm Scop should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders.

Idiosyncratic Reactions

Idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, speech disorder, hallucinations, paranoia, and delusions. [see ADVERSE REACTIONS]

Specific Populations

Pediatric

A safe and effective dose has not been established in the pediatric population [see Use in Specific Populations]. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied.

Elderly

Transderm Scop should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. Clinical trials of Transderm Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. [see Use in Specific Populations]

Renal and Hepatic Impaired

Transderm Scop should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scop has not been studied in these populations. [see Use in Specific Populations]

Safety Hazards

Drowsiness

Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.

Disorienting Effects

Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. [see PATIENT INFORMATION]

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 Scop contains aluminum, it is recommended to remove the system before undergoing an MRI.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION)

Please read this instruction sheet carefully before opening the system package.

Transderm Scop® Transdermal System

Generic Name: scopolamine, pronounced skoe-POL-a-meen

  • Elderly patients should be informed that Transderm Scop may cause a greater likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome and to seek immediate medical care if they become confused, disoriented or dizzy while wearing the patch or after removing.
  • Patients should be informed that since Transderm Scop may cause drowsiness, disorientation and confusion they should avoid engaging in activities that require mental alertness such as driving a motor vehicle or operating dangerous machinery.
  • Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of Transderm Scop.
  • Because of the possibility of drowsiness, disorientation and confusion, patients should be informed that they should avoid drinking alcohol. In addition, patients should be informed that the following medications should be used with caution when taking Transderm Scop:
  • Patients with the following conditions should be informed about the chance of developing serious reactions with Transderm Scop®:
    • patients with open angle glaucoma (may cause an increase in intraocular pressure)
    • patients with impaired kidney or liver function (increased likelihood of CNS effects)
    • patients with a history of seizures or psychosis (can potentially worsen both disorders)
    • patients with obstruction at the level of the pylorus, which is the outlet of the stomach, or urinary
    • bladder neck obstruction (may cause difficulties in urinating)
    • patients suspected of having intestinal obstruction
    • pregnant or nursing mothers
  • Patients should be informed that if they remove the Transderm Scop patch suddenly before treatment is complete, the following withdrawal symptoms may occur: dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, slow heart rate and low blood pressure. Patients should be instructed to seek immediate medical care if they develop any of these symptoms after removing Transderm Scop.
  • Patients should be informed that Transderm Scop can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Patients should be informed to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, patients should be informed that used patches must be disposed of properly to avoid contact with children or pets.
  • Patients should be informed that 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 Scop contains aluminum, patients should be advised to remove the system before undergoing an MRI.
  • Patients should be advised to use only one patch at a time.
  • Patients should be advised not to cut the patch.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Based on data from one prospective study of Transderm Scop in cesarean delivery, the rate of newborn adverse events in both the Transderm Scop 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 Scop 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 Scop 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 Scop should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.

Labor And Delivery

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 newborns. [see Clinical Studies] Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by

Transderm Scop did not affect uterine contractions or increase the duration of labor. Scopolamine does cross the placenta.

Nursing Mothers

Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scop is administered to a nursing woman.

Pediatric Use

A safe and effective dose has not been established in the pediatric population. [see WARNINGS AND PRECAUTIONS]

Geriatric Use

Transderm Scop should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion and dizziness. Clinical trials of Transderm Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. [see WARNINGS AND PRECAUTIONS]

Renal Or Hepatic Impairment

Transderm Scop should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. [see WARNINGS AND PRECAUTIONS]

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/25/2016

Warnings
Precautions

Transderm Scop - User Reviews

Transderm Scop User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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