Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Risks in Patients with Gastrointestinal Disorders
(Additions
and/or revisions are underlined)
OXYTROL
should be used with caution in patients who have hiatus hernia/gastroesophageal
reflux and/or who are concurrently taking drugs (such as bisphosphonates) that
can cause or exacerbate esophagitis.
5.6 Exacerbation of Symptoms of Myasthenia Gravis
(Additions and/or revisions are underlined)
Avoid
use of OXYTROL
in patients with myasthenia gravis, a disease characterized by decreased
cholinergic activity at the neuromuscular junction. If experiencing
exacerbation of symptoms of myasthenia gravis, oxybutynin-containing product
should be discontinued and appropriate therapy promptly provided.
6
Adverse Reactions
6.1 Clinical Trials Experience
(Additions
and/or revisions are underlined)
Table
1: Number (%) of adverse reactions occurring in greater than or equal to 2% of OXYTROL-treated patients and
greater in the OXYTROL group than in the placebo group (Study 1).
Table
2: Number (%) of adverse reactions occurring in greater
than or equal to 2% of
OXYTROL-treated patients and greater in the OXYTROL group than in the placebo
group (Study 2).
6.2 Postmarketing Experience
(Additions
and/or revisions are underlined)
Nervous
System Disorders: Memory impairment, dizziness, somnolence, confusion
Psychiatric Disorders: Delirium, hallucinations
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and
Lactation Labeling Rule Conversion-Additions and/or revisions are underlined)
Risk
Summary
There
are no studies with topical or oral oxybutynin use in pregnant women to
inform a drug associated risk for birth defects or miscarriage.
No adverse developmental outcomes were observed in animal reproduction
studies when oxybutynin chloride was administered to pregnant rats and rabbits
during organogenesis at approximately 50 and 1 times, respectively, the maximum
human dose based on body surface area.
In
the U.S. general population, the estimated background risk of major
birth defects and miscarriage in clinically recognized pregnancies is 2-4% and
15-20% respectively.
Data
Animal Data
Subcutaneous
administration
of oxybutynin chloride to rats at doses up to 25 mg/kg (approximately 50
times the human exposure based on surface area) and to rabbits at doses
up to0.4 mg/kg (approximately 1 times the human exposure based on body
surface area) throughout the period of organogenesis revealed no evidence of
harm to the fetus.
8.2 Lactation
(Pregnancy and
Lactation Labeling Rule Conversion-Additions and/or revisions are underlined)
Risk
Summary
There
is no information on the presence of oxybutynin in human milk, the effects on
the breastfed child, or the effects on milk production. The developmental and
health benefits of breastfeeding should be considered along with the mother’s
clinical need for OXYTROL and any potential adverse effects on the breastfed
child from OXYTROL or from the underlying maternal condition.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Inform
patients that OXYTROL should be applied to dry, intact skin on the abdomen,
hip, or buttock and not be applied to areas that have been treated with
oils, lotions or powders. The patch should not be exposed to sunlight. Contact with water while bathing, swimming,
showering or exercising will not change the effect of OXYTROL. A new
application site should be selected with each new system to avoid
re-application to the same site within 7 days. Inform patients to try to
change the patch on the same 2 days each week and that the package of OXYTROL
has a calendar checklist printed on the back to remind patients of their
schedule. Inform patients to avoid rubbing the patch area during bathing,
swimming, showering or exercising. Inform patients that details on use of
the system are explained in the Patient Information Leaflet.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Risks in Patients with Gastrointestinal Disorders
(Additions
and/or revisions are underlined)
OXYTROL
should be used with caution in patients who have hiatus hernia/gastroesophageal
reflux and/or who are concurrently taking drugs (such as bisphosphonates) that
can cause or exacerbate esophagitis.
5.7 Exacerbation of Symptoms of Myasthenia Gravis
(Additions and/or revisions are underlined)
Avoid
use of OXYTROL
in patients with myasthenia gravis, a disease characterized by decreased
cholinergic activity at the neuromuscular junction. If experiencing
exacerbation of symptoms of myasthenia gravis, oxybutynin-containing product
should be discontinued and appropriate therapy promptly provided.
6
Adverse Reactions
6.1 Clinical Trials Experience
(Additions
and/or revisions are underlined)
Table
1: Number (%) of adverse reactions occurring in greater than or equal to 2% of OXYTROL-treated patients and
greater in the OXYTROL group than in the placebo group (Study 1).
Table
2: Number (%) of adverse reactions occurring in greater
than or equal to 2% of
OXYTROL-treated patients and greater in the OXYTROL group than in the placebo
group (Study 2).
6.2 Postmarketing Experience
(Additions
and/or revisions are underlined)
Nervous
System Disorders: Memory impairment, dizziness, somnolence, confusion
Psychiatric Disorders: Delirium, hallucinations
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and
Lactation Labeling Rule Conversion-Additions and/or revisions are underlined)
Risk
Summary
There
are no studies with topical or oral oxybutynin use in pregnant women to
inform a drug associated risk for birth defects or miscarriage.
No adverse developmental outcomes were observed in animal reproduction
studies when oxybutynin chloride was administered to pregnant rats and rabbits
during organogenesis at approximately 50 and 1 times, respectively, the maximum
human dose based on body surface area.
In
the U.S. general population, the estimated background risk of major
birth defects and miscarriage in clinically recognized pregnancies is 2-4% and
15-20% respectively.
Data
Animal Data
Subcutaneous
administration
of oxybutynin chloride to rats at doses up to 25 mg/kg (approximately 50
times the human exposure based on surface area) and to rabbits at doses
up to0.4 mg/kg (approximately 1 times the human exposure based on body
surface area) throughout the period of organogenesis revealed no evidence of
harm to the fetus.
8.2 Lactation
(Pregnancy and
Lactation Labeling Rule Conversion-Additions and/or revisions are underlined)
Risk
Summary
There
is no information on the presence of oxybutynin in human milk, the effects on
the breastfed child, or the effects on milk production. The developmental and
health benefits of breastfeeding should be considered along with the mother’s
clinical need for OXYTROL and any potential adverse effects on the breastfed
child from OXYTROL or from the underlying maternal condition.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
Instructions
for Use
(Additions and/or revisions are underlined)
Inform
patients that OXYTROL should be applied to dry, intact skin on the abdomen,
hip, or buttock and not be applied to areas that have been treated with
oils, lotions or powders. The patch should not be exposed to sunlight. Contact with water while bathing, swimming,
showering or exercising will not change the effect of OXYTROL. A new
application site should be selected with each new system to avoid
re-application to the same site within 7 days. Inform patients to try to
change the patch on the same 2 days each week and that the package of OXYTROL
has a calendar checklist printed on the back to remind patients of their
schedule. Inform patients to avoid rubbing the patch area during bathing,
swimming, showering or exercising. Inform patients that details on use of
the system are explained in the Patient Information Leaflet.
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