Oxybutynin ER 10mg Tablets
It is used to treat an overactive bladder.It is used in some children to treat a bladder problem called neurogenic detrusor overactivity (NDO).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Urinary Antispasmodic
Pharmacologic Class
Anticholinergic; Muscarinic Receptor Antagonist
Pregnancy Category
B
FDA Approved
Sep 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxybutynin ER is a medication used to treat overactive bladder (OAB) symptoms like frequent urination, urgent need to urinate, and incontinence (leaking urine). It works by relaxing the bladder muscles, which helps the bladder hold more urine and reduces the urge to go.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Swallow your medication whole, without chewing, breaking, or crushing it.
Take your medication with a full glass of water.
Note that you may see the tablet shell in your stool, but this is a normal occurrence and not a cause for concern.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store your medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also want to explore local drug take-back programs.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Swallow your medication whole, without chewing, breaking, or crushing it.
Take your medication with a full glass of water.
Note that you may see the tablet shell in your stool, but this is a normal occurrence and not a cause for concern.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store your medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also want to explore local drug take-back programs.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the tablet whole with water; do not chew, crush, or divide it.
- Can be taken with or without food.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Be cautious in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heat stroke.
- Maintain adequate fluid intake to help prevent constipation and dry mouth.
- Limit alcohol consumption, as it may increase drowsiness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
Overactive Bladder (OAB):
Initial dose 5 mg orally once daily; may increase in 5 mg increments to a maximum of 30 mg orally once daily to achieve a balance between efficacy and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For neurogenic detrusor overactivity: Children âĨ6 years: Initial dose 5 mg orally once daily; may increase in 5 mg increments to a maximum of 20 mg orally once daily.
Adolescent:
For neurogenic detrusor overactivity: Adolescents âĨ6 years: Initial dose 5 mg orally once daily; may increase in 5 mg increments to a maximum of 20 mg orally once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended, but use with caution.
Moderate:
No specific dosage adjustment recommended, but use with caution.
Severe:
Use with caution; consider lower initial doses and careful titration due to potential for increased plasma concentrations.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended, but use with caution.
Moderate:
Use with caution; consider lower initial doses and careful titration due to potential for increased plasma concentrations.
Severe:
Use with caution; consider lower initial doses and careful titration due to potential for increased plasma concentrations.
Pharmacology
Mechanism of Action
Oxybutynin acts as a competitive antagonist of muscarinic acetylcholine receptors. It exerts a direct antispasmodic effect on the smooth muscle of the detrusor muscle in the bladder, inhibiting the effects of acetylcholine on muscarinic receptors, thereby increasing bladder capacity and decreasing the frequency of uninhibited detrusor contractions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (due to extensive first-pass metabolism for immediate-release; ER formulation bypasses some first-pass metabolism, leading to higher systemic exposure of oxybutynin and lower exposure of the active metabolite N-desethyloxybutynin compared to IR)
Tmax:
Approximately 12-14 hours (for oxybutynin); 12-16 hours (for N-desethyloxybutynin)
FoodEffect:
Food does not significantly affect the absorption of oxybutynin ER.
Distribution:
Vd:
Approximately 193 L
ProteinBinding:
Approximately 97% (oxybutynin); 85% (N-desethyloxybutynin)
CnssPenetration:
Yes (can cross the blood-brain barrier, leading to CNS side effects)
Elimination:
HalfLife:
Approximately 13-17 hours (oxybutynin); 2-5 hours (N-desethyloxybutynin)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 0.1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for immediate-release; ER onset is slower due to extended release)
PeakEffect:
Not precisely defined for ER, but sustained over 24 hours
DurationOfAction:
24 hours (due to extended-release formulation)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Severe dizziness or fainting
Confusion
Hallucinations (seeing or hearing things that are not there)
Agitation
Mood changes
Fever
Inability to sweat during physical activity or in warm temperatures
Difficulty urinating
Severe stomach pain
Muscle weakness
Angioedema, a severe reaction that may be life-threatening, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
If you experience any of these symptoms, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Upset stomach
Diarrhea or constipation
Dry mouth
Trouble sleeping
Nervousness or excitability
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Severe dizziness or fainting
Confusion
Hallucinations (seeing or hearing things that are not there)
Agitation
Mood changes
Fever
Inability to sweat during physical activity or in warm temperatures
Difficulty urinating
Severe stomach pain
Muscle weakness
Angioedema, a severe reaction that may be life-threatening, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
If you experience any of these symptoms, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Upset stomach
Diarrhea or constipation
Dry mouth
Trouble sleeping
Nervousness or excitability
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe constipation or abdominal pain
- Difficulty urinating or inability to urinate (urinary retention)
- Severe dry mouth that interferes with speaking or swallowing
- Blurred vision or eye pain
- Signs of heat stroke (e.g., fever, hot/dry skin, confusion, rapid pulse)
- Confusion, hallucinations, or unusual thoughts/behavior
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Glaucoma
+ Slow movement of the gastrointestinal (GI) tract
+ Difficulty urinating
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Glaucoma
+ Slow movement of the gastrointestinal (GI) tract
+ Difficulty urinating
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration.
To manage dry mouth, practice good oral hygiene, suck on sugar-free hard candies, or chew sugar-free gum. Regular dental check-ups are also recommended.
If you have myasthenia gravis, monitor your condition closely, as this medication may exacerbate your symptoms. If your symptoms worsen, contact your doctor promptly.
Individuals 65 years of age or older should exercise caution when using this medication, as they may be more susceptible to side effects.
This medication is not recommended for children under the age of 6.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration.
To manage dry mouth, practice good oral hygiene, suck on sugar-free hard candies, or chew sugar-free gum. Regular dental check-ups are also recommended.
If you have myasthenia gravis, monitor your condition closely, as this medication may exacerbate your symptoms. If your symptoms worsen, contact your doctor promptly.
Individuals 65 years of age or older should exercise caution when using this medication, as they may be more susceptible to side effects.
This medication is not recommended for children under the age of 6.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth
- Dilated pupils
- Flushing
- Fever
- Tachycardia (fast heart rate)
- Arrhythmias
- Urinary retention
- Paralytic ileus
- CNS excitation (restlessness, tremor, irritability, convulsions, delirium, hallucinations)
- Respiratory depression
- Coma
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive, including gastric lavage, activated charcoal, and physostigmine for severe anticholinergic symptoms.
Drug Interactions
Major Interactions
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may significantly increase oxybutynin exposure and anticholinergic effects.
- Other anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines, amantadine) - additive anticholinergic effects, increasing risk of dry mouth, constipation, urinary retention, and CNS effects.
Moderate Interactions
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine) - oxybutynin may antagonize the effects of cholinesterase inhibitors, reducing their efficacy.
- Drugs that slow gastrointestinal motility (e.g., opioids, loperamide) - may exacerbate constipation and increase risk of paralytic ileus.
- Potassium chloride (wax matrix formulations) - increased risk of GI lesions due to slowed GI transit.
Minor Interactions
- Alcohol - may enhance drowsiness.
Monitoring
Baseline Monitoring
Urinary symptoms assessment (e.g., frequency, urgency, incontinence episodes)
Rationale: To establish baseline severity of OAB symptoms and monitor treatment efficacy.
Timing: Prior to initiation of therapy
Renal and hepatic function
Rationale: To assess baseline organ function, especially in patients with pre-existing impairment, as dosage adjustments or caution may be needed.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Efficacy (reduction in OAB symptoms)
Frequency: Periodically (e.g., 2-4 weeks after initiation/dose adjustment, then every 3-6 months)
Target: Patient-reported improvement in frequency, urgency, and incontinence episodes
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, CNS effects like dizziness, drowsiness, confusion)
Frequency: Regularly, especially during initial titration and dose changes
Target: Tolerable level of side effects
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Post-void residual (PVR) volume
Frequency: Periodically, especially in patients at risk for urinary retention (e.g., BPH, bladder outlet obstruction)
Target: <100-150 mL (generally)
Action Threshold: Significant increase in PVR or symptoms of urinary retention (e.g., difficulty voiding, sensation of incomplete emptying) requires immediate evaluation and potential discontinuation.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Drowsiness
- Headache
- Nausea
- Urinary retention
- Confusion (especially in elderly)
- Heat intolerance
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies.
Second Trimester:
No specific data, but generally considered low risk based on animal studies.
Third Trimester:
No specific data, but generally considered low risk based on animal studies.
Lactation
L3 (Moderately Safe). Oxybutynin and its active metabolite are excreted into breast milk. Potential for anticholinergic effects in the infant (e.g., drowsiness, constipation, dry mouth). Use with caution; monitor infant for side effects.
Infant Risk:
Low to moderate risk of adverse effects; monitor for drowsiness, constipation, and dry mouth.
Pediatric Use
Safety and efficacy of oxybutynin ER for OAB in children under 6 years of age have not been established. For neurogenic detrusor overactivity, it is approved for children âĨ6 years. Children may be more sensitive to anticholinergic side effects.
Geriatric Use
Use with caution in elderly patients (âĨ65 years) due to increased sensitivity to anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, cognitive impairment, dizziness, falls). Consider lower initial doses and slower titration. Avoid in frail elderly or those with cognitive impairment if possible.
Clinical Information
Clinical Pearls
- Oxybutynin ER is designed for once-daily dosing, providing sustained symptom control and potentially better adherence compared to immediate-release formulations.
- The ER formulation produces lower peak concentrations of the active metabolite N-desethyloxybutynin compared to IR, which may contribute to a lower incidence of dry mouth and other anticholinergic side effects for some patients.
- Patients should be advised to swallow the tablet whole and not to chew, crush, or divide it, as this would disrupt the extended-release mechanism.
- Ghost tablets (the insoluble shell) may be seen in the stool, which is normal and does not indicate that the medication was not absorbed.
- Counsel patients on non-pharmacological strategies for OAB, such as bladder training, fluid management, and pelvic floor exercises, as adjuncts to therapy.
Alternative Therapies
- Other anticholinergics (e.g., tolterodine ER, solifenacin, darifenacin, fesoterodine)
- Beta-3 adrenergic agonists (e.g., mirabegron, vibegron)
- OnabotulinumtoxinA (Botox) injections into the bladder
- Percutaneous tibial nerve stimulation (PTNS)
- Sacral neuromodulation (SNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises)
Cost & Coverage
Average Cost:
$50 - $200 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic); Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.