WARNINGS AND PRECAUTIONS
Urinary Retention
Administer OXYTROL with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Risks in Patients with Gastrointestinal Disorders
Administer OXYTROL with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
OXYTROL, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony.
OXYTROL should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
Central Nervous System Effects
Products containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered.
Angioedema
Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, OXYTROL should be discontinued and appropriate therapy promptly provided.
Skin Hypersensitivity
Patients who develop skin hypersensitivity to OXYTROL should discontinue drug treatment.
Exacerbation of Symptoms of Myasthenia Gravis
Administer OXYTROL with caution to patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category B
There are no adequate and well-controlled studies using OXYTROL in pregnant women. OXYTROL should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during OXYTROL treatment are encouraged to contact their physician.
Risk Summary
Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk.
Animal Data
In a rat embryo/fetal developmental toxicity study, pregnant rats received up to 25 mg/kg subcutaneously of oxybutynin chloride. Maternal systemic exposure was estimated to be 50 times that of women treated at the maximum recommended human dose (MRHD) of 36 mg, based on body surface area. No embryo/fetal toxicity was observed in rats under the conditions of this study.
In a rabbit embryo/fetal developmental toxicity study, pregnant rabbits received oxybutynin chloride at up to 0.4 mg/kg subcutaneously. Maternal systemic exposure was estimated to be about equal that of women treated at the MRHD of 36 mg, based on body surface area. No embryo/fetal toxicity was observed in rabbits under the conditions of this study.
In mouse and hamster embryo/fetal development studies, no embryo/fetal toxicity was observed.
Nursing Mothers
It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OXYTROL is administered to a nursing woman.
Pediatric Use
The safety and efficacy of OXYTROL in pediatric patients have not been established.
Geriatric Use
Forty-nine percent of OXYTROL-treated patients in the clinical studies were at least 65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see
Clinical Pharmacology (
12.3
)].
Renal Impairment
The safety and efficacy of OXYTROL have not been established in patients with renal impairment.
Hepatic Impairment
The safety and efficacy of OXYTROL have not been established in patients with hepatic impairment.
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