oxytrol
Pharmaranks rates Oxytrol 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Oxytrol (Oxybutynin) is a cholinergic muscarinic antagonist used to treat Neurogenic Urinary Bladder, Urinary Incontinence, Dysuria.
Oxybutynin · by Allergan
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Oxybutynin
- Drug class
- Cholinergic Muscarinic Antagonist
- Form
- Patch
- Strength
- Oxybutynin 3.9MG/24HR
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Allergan
- Half-life
- about 2 to 3 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.42 for 30 — not your price
- FDA application
- NDA021351
What is Oxytrol?
From the FDA label:OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39 cm 2 transdermal system containing 36 mg of oxybutynin. OXYTROL has a nominal in vivo delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (inter-individual variation in skin permeability is approximately 20%). Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C 22 H 31 NO 3 . Its structural formula is: Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water. OXYTROL is a matrix-type transdermal system composed of three layers as illustrated in Figure 1. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix transdermal system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a cast film of acrylic adhesive containing oxybutynin and triacetin, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix transdermal system. Figure…
How to use
OXYTROL 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days). A new application site should be selected with each new transdermal system to avoid re-application to the same site within 7 days. Do not divide or cut the transdermal system into pieces. Do not use if the transdermal system is damaged. Apply OXYTROL transdermal system twice weekly (every 3 to 4 days) to dry, intact skin on the abdomen, hip, or buttocks. ( 2 ) Select a new application site with each new transdermal system to avoid re-application to the same site within 7 days. ( 2 ) Do not divide or cut the transdermal system into pieces. Do not use if the transdermal system is damaged.
Side effects
The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. ( 6.1 ) 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…
Warnings
Important safety information
Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1 ) Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. ( 5.2 ) Central Nervous System Effects: Somnolence has been reported with products containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. ( 5.3 ) Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue OXYTROL and initiate appropriate therapy. ( 5.4 ) Skin Hypersensitivity: Discontinue OXYTROL in patients with skin hypersensitivity. ( 5.5 ) Myasthenia gravis: Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ( 5.6 ) 5.1 Urinary Retention Administer OXYTROL with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4) ] . 5.2 Risks in Patients with Gastrointestinal Disorders Administer OXYTROL with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4) ] . 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 hiatus hernia/gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. 5.3 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, somnolence, confusion and hallucinations [see Adverse Events (6.2) ] . 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. 5.4 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. 5.5 Skin Hypersensitivity Patients who develop skin hypersensitivity to OXYTROL should discontinue drug treatment. 5.6 Exacerbation of Symptoms of Myasthenia Gravis 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.
Who should not take Oxytrol
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 [ see Warnings and Precautions (5.5) ] . Urinary retention ( 4 ) Gastric retention ( 4 ) Uncontrolled narrow-angle glaucoma ( 4 ) Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL ( 4 )
Overdose — what happens if you take too much
The plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients recovered fully with treatment directed at their symptoms.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No specific drug-drug interaction studies have been performed with OXYTROL. Other Anticholinergics (muscarinic antagonists): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects. ( 7.1 ) 7.1 Other Anticholinergics The concomitant use of OXYTROL with other anticholinergic drugs, or with other agents that produce dry mouth, constipation, somnolence, and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 Cytochrome P450 Inhibitors Pharmacokinetic studies have not been performed with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g., ketoconazole, itraconazole, and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin).
How long does Oxybutynin stay in your body?
The elimination half-life of oxybutynin is about 2 to 3 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the immediate-release oral figure: the label states oxybutynin is rapidly absorbed, reaching peak levels within an hour, after which plasma levels fall with an effective half-life of about 2 to 3 hours. The same label notes that in the frail elderly the elimination half-life is prolonged to about 5 hours and a lower starting dose is recommended — the group most often prescribed this drug clears it more slowly. Extended-release tablets do not clear faster or slower: the apparent half-life after a single 10 mg ER dose is about 12 to 13 hours, which reflects slow release, not slower elimination. The active metabolite N-desethyloxybutynin outlasts the parent and reaches far higher levels after a swallowed dose (metabolite-to-parent AUC ratio 11.9 to 1 after a single 5 mg oral dose, versus 1.3 to 1 with the transdermal patch, which skips first-pass metabolism). Oxybutynin is cleared almost entirely by liver CYP3A4 (under 0.1% of the dose leaves unchanged in urine), so CYP3A4 inhibitors can raise exposure. No studies were conducted in kidney or liver impairment.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Oxybutynin Chloride Tablets USP — FDA prescribing information, Clinical Pharmacology (DailyMed).
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Oxytrol ranks — best-rated cholinergic muscarinic antagonist for:
Dosage forms
Patch
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Oxytrol treat?
- Oxytrol (Oxybutynin) may be used to treat neurogenic urinary bladder, urinary incontinence, dysuria, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Oxytrol work?
- Oxytrol is a cholinergic muscarinic antagonist. These drugs block muscarinic receptors, the docking sites for the nerve signal acetylcholine. By preventing acetylcholine from acting, they calm the 'rest-and-digest' nervous system, which can dry secretions, relax airway and bladder muscles, and speed up the heart, depending on the drug.
- How is Oxytrol rated?
- pharmaranks gives Oxytrol a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Oxytrol cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.42 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Oxytrol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Oxytrol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Oxytrol?
- Oxytrol is marketed by Allergan. You can see Allergan's full profile, rating, and other products on pharmaranks.
- Is Oxytrol a brand-name or generic drug?
- Oxytrol is a brand-name product with the active ingredient Oxybutynin.
- Is Oxytrol available over the counter?
- No. Oxytrol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Oxytrol come in?
- Oxytrol is currently marketed as patch, per the FDA's National Drug Code Directory.
- What class of drug is Oxytrol?
- Oxytrol is classified as cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Oxytrol FDA-registered?
- Oxytrol is on record with the U.S. FDA under application number NDA021351. You can verify this on its official FDA label.
- Has Oxytrol been recalled by the FDA?
- Oxytrol has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Oxytrol safe?
- There's no single safe-or-not verdict. pharmaranks gives Oxytrol a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Oxytrol?
- Oxytrol's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. ( 6.1 ) 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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