Oxybutynin 2.5mg Tablets
It is used to treat an overactive bladder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Urinary Antispasmodic; Anticholinergic
Pharmacologic Class
Muscarinic Receptor Antagonist
Pregnancy Category
B
FDA Approved
Jul 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxybutynin is a medication used to treat overactive bladder 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 out of 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.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
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 the missed one.
To ensure you get the most out of 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.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
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 the missed one.
Lifestyle & Tips
- Maintain adequate hydration to prevent dry mouth and constipation, but avoid excessive fluid intake that could worsen bladder symptoms.
- Increase fiber intake and use stool softeners if constipation occurs.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, due to potential dizziness or drowsiness.
- Be cautious in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heat stroke.
- Report any new or worsening vision problems, confusion, or difficulty urinating to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mg orally 2-3 times daily
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
overactive_bladder:
Initial: 2.5 mg orally 2-3 times daily. Max: 5 mg orally 4 times daily (20 mg/day).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Neurogenic detrusor overactivity (âĨ6 years): Initial: 5 mg orally twice daily. Max: 5 mg orally 3 times daily (15 mg/day).
Adolescent:
Neurogenic detrusor overactivity (âĨ6 years): Initial: 5 mg orally twice daily. Max: 5 mg orally 3 times daily (15 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for side effects.
Moderate:
Use with caution, consider lower initial doses (e.g., 2.5 mg twice daily) and titrate slowly. Monitor for anticholinergic side effects.
Severe:
Use with caution, consider lower initial doses (e.g., 2.5 mg twice daily) and titrate slowly. Monitor for anticholinergic side effects. Avoid if possible.
Dialysis:
Not well studied, use with caution and monitor closely. Likely not dialyzable due to high protein binding and metabolism.
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor for side effects.
Moderate:
Use with caution, consider lower initial doses (e.g., 2.5 mg twice daily) and titrate slowly. Monitor for anticholinergic side effects.
Severe:
Use with caution, consider lower initial doses (e.g., 2.5 mg twice daily) and titrate slowly. Monitor for anticholinergic side effects. Avoid if possible.
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, as well as inhibiting the muscarinic actions of acetylcholine on smooth muscle. This action reduces bladder contractions and delays the initial desire to void, thereby increasing bladder capacity and decreasing the frequency of involuntary detrusor contractions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (due to extensive first-pass metabolism)
Tmax:
0.5-1.5 hours
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
193 L
ProteinBinding:
Approximately 97%
CnssPenetration:
Yes (can cause CNS side effects like dizziness, confusion)
Elimination:
HalfLife:
2-3 hours (oxybutynin); 7-8 hours (N-desethyloxybutynin)
Clearance:
Not available (highly variable due to first-pass)
ExcretionRoute:
Renal (less than 0.1% as unchanged drug)
Unchanged:
Less than 0.1%
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes
PeakEffect:
3-6 hours
DurationOfAction:
6-10 hours (for immediate-release)
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 pass urine
+ 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 passing urine
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 notice 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 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 pass urine
+ 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 passing urine
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 notice 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
- Severe blurred vision or eye pain
- Confusion, hallucinations, or memory problems (especially in older adults)
- Rapid or irregular heartbeat
- Signs of heat stroke (e.g., fever, hot dry skin, dizziness, confusion, muscle cramps)
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. Do not initiate, stop, or modify 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. Do not initiate, stop, or modify 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, 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 candy, 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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
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 candy, 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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
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:
- Intensified anticholinergic effects (e.g., severe dry mouth, dilated pupils, flushing, fever, tachycardia, urinary retention, paralytic ileus)
- CNS excitation (e.g., restlessness, tremors, irritability, convulsions, delirium, hallucinations)
- Severe drowsiness or stupor leading to coma
- Respiratory depression
- Circulatory collapse
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is 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 and N-desethyloxybutynin exposure, leading to increased anticholinergic side effects. Avoid concomitant use or reduce oxybutynin dose.
- Other anticholinergic agents (e.g., tricyclic antidepressants, phenothiazines, antihistamines, amantadine, disopyramide): May potentiate anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention, CNS effects).
Moderate Interactions
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine): Oxybutynin may antagonize the effects of cholinesterase inhibitors, potentially reducing their efficacy in Alzheimer's disease.
- Drugs that slow gastrointestinal motility (e.g., opioids, loperamide): May increase risk of severe constipation or paralytic ileus.
- Alcohol: May enhance drowsiness and dizziness.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Urinary symptoms assessment (frequency, urgency, incontinence episodes)
Rationale: To establish baseline severity of overactive bladder symptoms and track treatment efficacy.
Timing: Prior to initiation of therapy
Renal function (SCr, eGFR)
Rationale: To assess baseline kidney function, especially in elderly or those with pre-existing renal impairment, as dose adjustments may be considered.
Timing: Prior to initiation of therapy
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess baseline liver function, especially in elderly or those with pre-existing hepatic impairment, as dose adjustments may be considered.
Timing: Prior to initiation of therapy
Intraocular pressure (in patients with glaucoma)
Rationale: Oxybutynin can exacerbate narrow-angle glaucoma. Ensure angle-closure glaucoma is controlled or ruled out.
Timing: Prior to initiation of therapy (if risk factors present)
Routine Monitoring
Urinary symptoms assessment
Frequency: Periodically (e.g., 2-4 weeks after initiation, then every 3-6 months or as clinically indicated)
Target: Reduction in frequency, urgency, and incontinence episodes
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for dose adjustment or alternative therapy.
Anticholinergic side effects (dry mouth, constipation, blurred vision, dizziness, cognitive changes)
Frequency: Regularly, especially during dose titration and initial weeks of therapy
Target: Tolerable level of side effects
Action Threshold: Intolerable side effects may require dose reduction, change to extended-release formulation, 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 (>200-250 mL) may indicate urinary retention and require discontinuation.
Cognitive function (especially in elderly)
Frequency: Periodically
Target: Stable cognitive status
Action Threshold: New or worsening confusion, memory impairment, or delirium may necessitate discontinuation.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Drowsiness
- Headache
- Nausea
- Urinary retention
- Confusion
- Hallucinations
- Heat intolerance (decreased sweating)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm, but human studies are limited. Use only if clearly needed and potential benefits outweigh risks.
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
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). Monitor infant for side effects.
Infant Risk:
Moderate risk; monitor for drowsiness, constipation, dry mouth, or decreased feeding.
Pediatric Use
Approved for neurogenic detrusor overactivity in children âĨ6 years. Use with caution due to potential for CNS side effects and heat intolerance. Not recommended for children <6 years for overactive bladder due to lack of established safety and efficacy.
Geriatric Use
Increased sensitivity to anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, urinary retention, and especially cognitive impairment like confusion, memory loss, hallucinations). Start with lower doses (e.g., 2.5 mg once or twice daily) and titrate slowly. Avoid if possible in frail elderly or those with cognitive impairment.
Clinical Information
Clinical Pearls
- Oxybutynin immediate-release has a high incidence of anticholinergic side effects, particularly dry mouth, due to its rapid absorption and significant first-pass metabolism to the active metabolite N-desethyloxybutynin.
- Consider extended-release formulations (e.g., Ditropan XL) or transdermal patch (Oxytrol) for better tolerability due to more stable plasma levels and reduced peak concentrations of the active metabolite.
- Counsel patients on managing dry mouth (sugar-free candies/gum, sips of water) and constipation (fiber, fluids, stool softeners).
- Warn patients about potential for heat intolerance due to decreased sweating, especially during exercise or in hot environments.
- Monitor elderly patients closely for cognitive side effects; consider alternative agents if cognitive impairment is a concern.
Alternative Therapies
- Other antimuscarinics: Tolterodine, Solifenacin, Darifenacin, Fesoterodine, Trospium
- Beta-3 adrenergic agonists: Mirabegron, Vibegron (less anticholinergic side effects)
- OnabotulinumtoxinA (Botox) injections into the bladder (for refractory cases)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (2.5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for 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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.