Oxybutyninside effects
84 HR oxybutynin 0.162 MG/HR Transdermal System [Oxytrol]
Adverse reactions
The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-678-1605 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 clinical practice. The safety of OXYTROL was evaluated in a total of 417 patients who participated in two clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in earlier phase trials. In the two pivotal studies, a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively. No deaths were reported during treatment. No serious adverse events related to treatment were reported. Adverse reactions reported in the pivotal trials are summarized in Tables 1 and 2 below.
Table 1: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 1). Adverse Reaction Placebo (N = 132) OXYTROL (3.9 mg/day) (N = 125) N % N % Application site pruritus 8 6.1% 21 16.8% Dry mouth 11 8.3% 12 9.6% Application site erythema 3 2.3% 7 5.6% Application site vesicles 0 0.0% 4 3.2% Diarrhea 3 2.3% 4 3.2% Dysuria 0 0.0% 3 2.4% Table 2: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 2). Adverse Reaction Placebo (N = 117) OXYTROL (3.9 mg/day) (N = 121) N % N % Application site pruritus 5 4.3% 17 14.0% Application site erythema 2 1.7% 10 8.3% Dry mouth 2 1.7% 5 4.1% Constipation 0 0.0% 4 3.3% Application site rash 1 0.9% 4 3.3% Application site macules 0 0.0% 3 2.5% Abnormal vision 0 0.0% 3 2.5% Most adverse reactions were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2. Adverse reactions that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these discontinuations were due to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth. In the open-label extension, the most common treatment-related adverse reactions were: application site pruritus, application site erythema, and dry mouth.
6.2 Postmarketing
Experience The following adverse reactions have been identified during post approval use of OXYTROL. 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.
Nervous System Disorders: Memory impairment, dizziness, somnolence, confusion Psychiatric Disorders: Delirium, hallucinations
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 29, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Warnings
For external use only Frequent urination can also be caused by: urinary tract infections (UTI) diabetes early pregnancy other more serious conditions If you think you might have one of these conditions, it is important to see your doctor before use. Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you. Do not use if you have any of these symptoms, which could be the sign of a UTI or other serious condition. See your doctor as soon as possible if you have: ○ pain or burning when urinating. These symptoms may also be accompanied by a fever or chills. ○ blood in your urine ○ unexplained lower back or side pain ○ urine that is cloudy, or foul-smelling ○ are male. Your symptoms may be due to a more serious condition. ○ are under the age of 18. It is not known if it works or is safe in children. ○ only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition. ○ have been told by a doctor you have urinary retention (are not able to empty your bladder) ○ have been told by a doctor you have gastric retention (your stomach empties slowly after a meal) ○ have glaucoma ○ are allergic to oxybutynin Ask a doctor before use if you have symptoms of diabetes, such as: ○ excessive thirst ○ extreme hunger unexplained weight loss liver or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription medication for overactive bladder taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example, ketoconazole, itraconazole) When using this product you may have itching, rash or redness where the patch was placed drinking alcohol may increase sleepiness Stop use and ask a doctor if you are not able to empty your bladder (urinary retention) condition worsens, or if new symptoms appear condition does not improve after 2 weeks of use you have an allergic reaction to this product you have severe redness, itchiness or blistering at the site of application If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 29, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
The use of OXYTROL is contraindicated in the following conditions: Urinary retention Gastric retention Uncontrolled narrow-angle glaucoma Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL. Urinary retention Gastric retention Uncontrolled narrow-angle glaucoma Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 29, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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