Oxybutynin ER 15mg 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
Muscarinic Receptor Antagonist
Pregnancy Category
Category B
FDA Approved
Jul 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 leaking urine. It works by relaxing the bladder muscles, helping your bladder hold more urine and reducing the sudden urges to go.
How to Use This Medicine
Taking Your Medication
To 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 ensure your medication remains effective and safe:
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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it is 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 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 ensure your medication remains effective and safe:
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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it is 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 crush, chew, or break it.
- It can be taken with or without food.
- Maintain adequate fluid intake to prevent constipation and dry mouth.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Avoid alcohol, as it can increase drowsiness.
- Be aware of potential heat prostration (fever and heat stroke due to decreased sweating) in hot environments or during strenuous exercise, especially in the elderly or those with chronic illness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg to 15 mg once daily
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
initialDose:
Start with 5 mg or 10 mg once daily
maintenanceDose:
Adjust in 5 mg increments to achieve optimal response with tolerable side effects, up to a maximum of 30 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children âĨ6 years: Initial 5 mg once daily; maximum 20 mg once daily. Not recommended for children <6 years.
Adolescent:
For adolescents âĨ6 years: Initial 5 mg once daily; maximum 20 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Use with caution; consider lower initial doses and slower titration.
Severe:
Use with caution; consider lower initial doses and slower titration. Avoid if possible.
Dialysis:
Not available
Hepatic Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Use with caution; consider lower initial doses and slower titration.
Severe:
Use with caution; consider lower initial doses and slower titration. Avoid if possible.
Pharmacology
Mechanism of Action
Oxybutynin is a competitive antagonist of muscarinic acetylcholine receptors. It exerts a direct antispasmodic effect on the smooth muscle of the detrusor muscle in the bladder, reducing involuntary contractions. This action increases bladder capacity and decreases the frequency of uninhibited detrusor contractions, thereby reducing symptoms of overactive bladder such as urinary urgency, frequency, and urge incontinence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (oral IR), higher for ER due to bypass of first-pass metabolism saturation. N-desethyloxybutynin bioavailability is higher.
Tmax:
4-6 hours (for oxybutynin ER)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
193 L (oxybutynin)
ProteinBinding:
Approximately 97% to plasma proteins
CnssPenetration:
Yes, can cross the blood-brain barrier and cause CNS effects.
Elimination:
HalfLife:
Approximately 13 hours (oxybutynin), 15 hours (N-desethyloxybutynin)
Clearance:
Not available
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<0.1% (oxybutynin) in urine
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for IR, ER is slower and more sustained)
PeakEffect:
Approximately 4-6 hours (for ER)
DurationOfAction:
24 hours (for ER formulation)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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
+ 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 symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Upset stomach
Diarrhea or constipation
Dry mouth
Trouble sleeping
Nervousness and 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 medical attention right away:
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
+ 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 symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Upset stomach
Diarrhea or constipation
Dry mouth
Trouble sleeping
Nervousness and 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 blurred vision or eye pain
- Confusion, hallucinations, or unusual thoughts/behavior
- Rapid or irregular heartbeat
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 allergic reaction you experienced, including any symptoms that occurred.
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 the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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 allergic reaction you experienced, including any symptoms that occurred.
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 the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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, wait until you understand how this drug 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 candy, or chew sugar-free gum. Regular dental check-ups are also recommended.
If you have myasthenia gravis, this medication may exacerbate your condition. If your symptoms worsen, contact your doctor promptly.
Adults 65 years and older should exercise caution when using this medication, as they may be more susceptible to side effects.
This drug 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 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, wait until you understand how this drug 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 candy, or chew sugar-free gum. Regular dental check-ups are also recommended.
If you have myasthenia gravis, this medication may exacerbate your condition. If your symptoms worsen, contact your doctor promptly.
Adults 65 years and older should exercise caution when using this medication, as they may be more susceptible to side effects.
This drug 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 with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, hot/dry skin, flushing)
- CNS excitation (e.g., restlessness, tremors, irritability, convulsions, delirium, hallucinations)
- Circulatory disturbances (e.g., tachycardia, hypertension, hypotension, circulatory failure)
- Respiratory failure
- Paralysis
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and physostigmine for severe anticholinergic symptoms.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may significantly increase oxybutynin exposure and risk of adverse effects.
- Other anticholinergic agents (e.g., tricyclic antidepressants, phenothiazines, antihistamines, amantadine) - may potentiate anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention, CNS effects).
Moderate Interactions
- Drugs that slow gastric motility (e.g., prokinetic agents like metoclopramide) - may affect the release rate of the ER formulation.
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine) - oxybutynin may antagonize the effects of these drugs, reducing their efficacy.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Urinary symptoms (frequency, urgency, incontinence episodes)
Rationale: To establish baseline severity and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Renal and hepatic function
Rationale: To identify potential impairment that may necessitate dose adjustment or caution.
Timing: Prior to initiation, especially in patients with known or suspected impairment.
Routine Monitoring
Efficacy (reduction in OAB symptoms)
Frequency: Periodically, typically within 2-4 weeks of initiation or dose adjustment, then every 3-6 months.
Target: Patient-reported improvement in symptoms.
Action Threshold: If symptoms persist or worsen, consider dose adjustment or alternative therapy.
Anticholinergic side effects (dry mouth, constipation, blurred vision, urinary retention, CNS effects)
Frequency: Regularly, especially during dose titration and initial weeks of therapy.
Target: Tolerable level of side effects.
Action Threshold: If severe or intolerable, consider dose reduction, switching to an alternative formulation (e.g., transdermal patch), or discontinuing therapy.
Post-void residual (PVR) volume
Frequency: Periodically, especially in patients at risk for urinary retention (e.g., BPH).
Target: <100-150 mL (generally)
Action Threshold: Significant increase in PVR volume may indicate urinary retention and necessitate discontinuation.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Dizziness
- Drowsiness
- Headache
- Nausea
- Abdominal pain
- Confusion (especially in elderly)
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:
Limited data, generally considered low risk based on animal studies.
Second Trimester:
Limited data, generally considered low risk.
Third Trimester:
Limited data, generally considered low risk.
Lactation
Oxybutynin is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., anticholinergic effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately Safe) - Use with caution. Monitor infant for anticholinergic effects (e.g., dry mouth, constipation, drowsiness, decreased feeding).
Pediatric Use
Not recommended for children under 6 years of age due to lack of established safety and efficacy. For children 6 years and older, use with caution and follow specific dosing guidelines, starting with the lowest effective dose.
Geriatric Use
Use with caution due to increased sensitivity to anticholinergic effects (e.g., dry mouth, constipation, urinary retention, cognitive impairment, dizziness, falls). Start with the lowest effective dose (e.g., 5 mg once daily) and titrate slowly. Avoid in patients with severe cognitive impairment.
Clinical Information
Clinical Pearls
- Oxybutynin ER is designed for once-daily dosing, providing sustained symptom control.
- Instruct patients to swallow the tablet whole; crushing or chewing will release the drug too quickly, leading to increased side effects and reduced efficacy.
- The ghost tablet (empty shell) may be visible in the stool, which is normal and does not mean the medication was not absorbed.
- Dry mouth is a very common side effect; advise patients on strategies like sugar-free candies, chewing gum, or artificial saliva.
- Constipation is also common; encourage adequate fluid and fiber intake.
- Monitor for signs of urinary retention, especially in men with benign prostatic hyperplasia (BPH).
- Cognitive side effects (confusion, memory impairment) are a concern, particularly in the elderly. Consider alternative agents if these occur.
Alternative Therapies
- Other anticholinergics (e.g., tolterodine ER, solifenacin, fesoterodine, trospium)
- Beta-3 adrenergic agonists (e.g., mirabegron, vibegron)
- OnabotulinumtoxinA (Botox) bladder injections
- Sacral neuromodulation
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management)
Cost & Coverage
Average Cost:
$50 - $200 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.