Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Hyperthermia
New subsection added:
Serious adverse reactions of hyperthermia have been
reported postmarketing in adult and pediatric patients receiving transdermal
scopolamine, including fatal cases. Anticholinergic agents, including
scopolamine, can increase core body temperature and reduce sweating, which may cause
further increases in body temperature. Hyperthermia may be exacerbated by
exposure to external heat sources or high environmental temperature. Pediatric
and geriatric patients may be more susceptible to these anticholinergic effects
on thermoregulation. Advise patients if body temperature increases, or they are
not sweating in warm environmental conditions, to remove the transdermal system
and contact their healthcare provider. Symptoms may persist following removal
of the used transdermal system as there may be continued systemic absorption of
scopolamine through the skin. TRANSDERM SC?P is not approved for use in
pediatric patients [see Use in Specific Populations (8.4, 8.5)].
6
Adverse Reactions
6.2 Postmarketing Experience
Additions
and/or revisions underlined:
…
General disorders and
administration site conditions: application site reactions (including blistering,
burning, pruritus, and rash) and hyperthermia
…
8
Use in Specific Populations
8.4 Pediatric Use
Additions
and/or revisions underlined:
The safety and effectiveness
of TRANSDERM SC?P have not been established in pediatric patients. Pediatric
patients are particularly susceptible to the anticholinergic adverse
reactions of scopolamine, including neurologic and psychiatric adverse reactions
and drug withdrawal syndrome. Serious adverse reactions of acute psychosis (e.g.,
disorientation, hallucinations), amblyopia, hyperthermia (including a
fatal case), and mydriasis have also been reported in pediatric patients
[see Warnings and Precautions (5.2, 5.5)].
8.5
Geriatric Use
Additions
and/or revisions underlined:
…
Serious
adverse reactions of hyperthermia have been reported postmarketing in geriatric
patients receiving transdermal scopolamine, including a fatal case. Geriatric patients
may be more susceptible to the anticholinergic effects of disruption in
thermoregulation. Advise patients if body temperature increases, or they are not
sweating in warm environmental conditions, to remove the transdermal system and
contact their healthcare provider [see
Warnings and Precautions (5.5)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
…
Hyperthermia
Inform patients that TRANSDERM SC?P can increase
body temperature and reduce sweating, which may result in hyperthermia and be
exacerbated by exposure to external heat sources or high environmental temperature.
Geriatric patients may be more susceptible to these effects. Advise patients if
body temperature increases, or they are not sweating in warm environmental
conditions, remove the transdermal system, and contact their healthcare
provider. Symptoms may persist after removal of the transdermal system [see Warnings and Precautions (5.5)].
Drug Withdrawal/Post-Removal Symptoms
Inform patients that if they remove the TRANSDERM SC?P
transdermal system after several days of use, withdrawal symptoms may occur
and to seek immediate medical care if they develop severe symptoms after
removing TRANSDERM SC?P [see Warnings and
Precautions (5.6)].
…
PATIENT
INFORMATION
Additions
and/or revisions underlined:
…
What are the possible side effects of TRANSDERM SC?P?
TRANSDERM SC?P may
cause serious side effects, including:
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Neuropsychiatric Adverse Reactions
Additions and/or
revisions underlined:
Psychiatric Adverse Reactions
… In cases
of psychiatric reactions occurring TRANSDERM SC?P should be removed at once.
If, despite this, the symptoms persist in a severe form, instruct patients to
seek medical attention.
…
Cognitive
Adverse Reactions
…
If,
despite this, the symptoms persist in a severe form, instruct patients to seek
medical attention.
…
5.4 Gastrointestinal and Urinary Disorders
Additions
and/or revisions underlined:
![]()
Scopolamine, due to its
anticholinergic properties, can decrease gastrointestinal motility and cause
urinary retention. Consider more frequent monitoring during treatment with
TRANSDERM SC?P in patients suspected of having intestinal obstruction, patients
with pyloric obstruction or patients with impeded flow of urine (e.g., in
diseases of the prostate or urinary bladder neck obstruction) and patients
receiving other anticholinergic drugs [see Drug
Interactions (7.2)]. Discontinue
TRANSDERM SC?P in patients who develop difficulty in urination.
5.6 Blurred Vision
Additions and/or revisions underlined:
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, do not touch the system
while wearing it, and wash hands and the application site with soap and water
after transdermal system removal [see Dosage and
Administration (2.1)].
6
Adverse Reactions
6.2 Postmarketing Experience
Additions and/or revisions underlined:
…
General disorders and administration site conditions: application site reactions including burning, rash, pruritus,
and blistering
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Administration
Instructions
Counsel
patients on how to apply and remove the transdermal system [see Dosage and
Administration (2.1)]:
…
…
…
Blurred
Vision
Inform
patients that temporary dilation of the pupils and blurred vision may occur if
TRANSDERM SC?P comes in contact with the eyes. Instruct patients to wash their
hands thoroughly with soap and water immediately after handling the transdermal
system, do not touch the system while wearing it, and wash hands and the
application site with soap and water after transdermal system removal [see Dosage and Administration
(2.1), see Warnings and
Precautions (5.6)].
PATIENT
INFORMATION
Additions and/or revisions underlined:
…
What are the
possible side effects of TRANSDERM SC?P?
TRANSDERM SC?P may
cause serious side effects, including:
…
Approved Drug Label (PDF)
4
Contraindications
Addition of the following to the 2nd bullet concerning
belladonna alkaloids:
Reactions
have included rash generalized and erythema.
5
Warnings and Precautions
Extensive changes to this
section; please refer to label for complete information. Below are the updated subsection titles:
5.1 Acute Angle Closure
Glaucoma
5.2 Neuropsychiatric
Adverse Reactions
5.3 Eclamptic Seizures in
Pregnant Women
5.4 Gastrointestinal and
Urinary Disorders
5.5 Drug
Withdrawal/Post-Removal Symptoms
5.6 Blurred Vision
5.7 Magnetic Resonance
Imaging (MRI) Skin Burns
6
Adverse Reactions
Newly created bulleted
line listing:
Acute Angle Closure
Glaucoma
Neuropsychiatric Adverse
Reactions
Eclamptic Seizures in
Pregnant Women
Gastrointestinal and
Urinary Disorders
Drug
Withdrawal/Post-Removal Symptoms
Blurred Vision
MRI Skin Burns
6.1 Clinical
Trials Experience
Revised as below:
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
7
Drug Interactions
Newly created subsections; please
refer to label for complete information.
7.1 Drugs Causing
Central Nervous System (CNS) Adverse Reactions
7.2
Anticholinergic Drugs
7.3 Oral Drugs
Absorbed in the Stomach
7.4 Interaction
with Gastric Secretion Test
8
Use in Specific Populations
8.1 Pregnancy
8.2 Lactation
PLLR conversion; extensive
changes. Please refer to label for
complete information.
8.4 Pediatric Use
Additions and/or revisions
underlined:
Safety and effectiveness in pediatric patients have not been
established. Pediatric patients are particularly susceptible to the adverse
reactions of scopolamine; including mydriasis, hallucinations, amblyopia and
drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as
hallucinations, amblyopia and mydriasis have also been reported.
8.5 Geriatric Use
Additions and/or revisions
underlined:
In other clinical experience, elderly patients had an increased risk of
neurologic and psychiatric adverse reactions, such as hallucinations,
confusion, dizziness and drug withdrawal syndrome. Consider more frequent monitoring for CNS adverse reactions during
treatment with Transderm Sc?p in elderly patients.
8.6 Renal or
Hepatic Impairment
Additions and/or revisions
underlined:
Transderm Sc?p has not been studied in patients with renal or
hepatic impairment. Consider more frequent monitoring during treatment with
Transderm Sc?p in patients with renal or hepatic impairment because of the
increased risk of CNS adverse reactions.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Newly created from
information contained in the prior Patient Information document.
PATIENT COUNSELING INFORMATION
Extensive changes; please
refer to label for complete information.
Approved Drug Label (PDF)
4
Contraindications
Addition of the following to the 2nd bullet concerning
belladonna alkaloids:
Reactions
have included rash generalized and erythema.
5
Warnings and Precautions
Extensive changes to this
section; please refer to label for complete information. Below are the updated subsection titles:
5.1 Acute Angle Closure
Glaucoma
5.2 Neuropsychiatric
Adverse Reactions
5.3 Eclamptic Seizures in
Pregnant Women
5.4 Gastrointestinal and
Urinary Disorders
5.5 Drug
Withdrawal/Post-Removal Symptoms
5.6 Blurred Vision
5.7 Magnetic Resonance
Imaging (MRI) Skin Burns
6
Adverse Reactions
Newly created bulleted
line listing:
Acute Angle Closure
Glaucoma
Neuropsychiatric Adverse
Reactions
Eclamptic Seizures in
Pregnant Women
Gastrointestinal and
Urinary Disorders
Drug
Withdrawal/Post-Removal Symptoms
Blurred Vision
MRI Skin Burns
6.1 Clinical
Trials Experience
Revised as below:
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
7
Drug Interactions
Newly created subsections; please
refer to label for complete information.
7.1 Drugs Causing
Central Nervous System (CNS) Adverse Reactions
7.2
Anticholinergic Drugs
7.3 Oral Drugs
Absorbed in the Stomach
7.4 Interaction
with Gastric Secretion Test
8
Use in Specific Populations
8.1 Pregnancy
8.2 Lactation
PLLR conversion; extensive
changes. Please refer to label for
complete information.
8.4 Pediatric Use
Additions and/or revisions
underlined:
Safety and effectiveness in pediatric patients have not been
established. Pediatric patients are particularly susceptible to the adverse
reactions of scopolamine; including mydriasis, hallucinations, amblyopia and
drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as
hallucinations, amblyopia and mydriasis have also been reported.
8.5 Geriatric Use
Additions and/or revisions
underlined:
In other clinical experience, elderly patients had an increased risk of
neurologic and psychiatric adverse reactions, such as hallucinations,
confusion, dizziness and drug withdrawal syndrome. Consider more frequent monitoring for CNS adverse reactions during
treatment with Transderm Sc?p in elderly patients.
8.6 Renal or
Hepatic Impairment
Additions and/or revisions
underlined:
Transderm Sc?p has not been studied in patients with renal or
hepatic impairment. Consider more frequent monitoring during treatment with
Transderm Sc?p in patients with renal or hepatic impairment because of the
increased risk of CNS adverse reactions.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Newly created from
information contained in the prior Patient Information document.
PATIENT COUNSELING INFORMATION
Extensive changes; please
refer to label for complete information.
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