Oxybutynin 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
Pharmacologic Class
Anticholinergic, Muscarinic Receptor Antagonist
Pregnancy Category
Category B
FDA Approved
Jun 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxybutynin is a medication used to treat overactive bladder. It helps to relax the bladder muscles, which can reduce the urge to urinate, the frequency of urination, and episodes of incontinence (leaking urine).
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, at the same time every day. It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal or participate in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, at the same time every day. It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal or participate in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it 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 one.
Lifestyle & Tips
- Avoid activities that may lead to overheating (e.g., strenuous exercise in hot weather) as this medication can decrease sweating and increase the risk of heatstroke.
- Avoid or limit alcohol consumption as it can increase drowsiness and dizziness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
- To help with dry mouth, chew sugar-free gum, suck on sugar-free hard candies, or use saliva substitutes.
- To help with constipation, increase fiber intake, drink plenty of fluids, and engage in regular physical activity.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg two to three times daily
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
initialDose:
2.5 mg two to three times daily
maximumDose:
20 mg per day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For neurogenic bladder in children âĨ6 years: 5 mg two to three times daily. Max 20 mg/day. Not recommended for children <6 years for overactive bladder.
Adolescent:
For neurogenic bladder in adolescents âĨ6 years: 5 mg two to three times daily. Max 20 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
Consider starting with a lower dose (e.g., 2.5 mg two times daily) and titrate carefully.
Severe:
Use with caution; consider lower doses and close monitoring due to potential for increased plasma concentrations.
Dialysis:
Not well studied; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
Consider starting with a lower dose (e.g., 2.5 mg two times daily) and titrate carefully.
Severe:
Use with caution; consider lower doses and close monitoring due to potential for increased plasma concentrations.
Pharmacology
Mechanism of Action
Oxybutynin exerts a direct antispasmodic effect on the smooth muscle of the detrusor muscle in the bladder and inhibits the muscarinic action of acetylcholine on smooth muscle. These actions increase bladder capacity and diminish the frequency of uninhibited contractions of the detrusor muscle.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (due to extensive first-pass metabolism)
Tmax:
Approximately 1 hour
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 193 L
ProteinBinding:
Approximately 83-85%
CnssPenetration:
Limited (parent drug), active metabolite (N-desethyloxybutynin) can cross the blood-brain barrier.
Elimination:
HalfLife:
Approximately 2-3 hours (oxybutynin), 7-8 hours (N-desethyloxybutynin)
Clearance:
Approximately 28 L/hr (oxybutynin)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<0.1% (urine)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Approximately 3-6 hours
DurationOfAction:
Approximately 6-10 hours
Safety & Warnings
Side Effects
Urgent 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
+ 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
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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
+ 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
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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 heatstroke (e.g., fever, hot/dry skin, confusion, rapid pulse)
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 and its symptoms.
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 drugs 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 allergic reaction and its symptoms.
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 drugs 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 candy, or chew sugar-free gum. Regular dental check-ups are also recommended.
If you have myasthenia gravis, be aware that your condition may worsen while taking this medication. If your symptoms deteriorate, contact your doctor promptly.
Individuals aged 65 and older should exercise caution when using this medication, as they 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, be aware that your condition may worsen while taking this medication. If your symptoms deteriorate, contact your doctor promptly.
Individuals aged 65 and older should exercise caution when using this medication, as they 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:
- Intensification of central anticholinergic effects (e.g., restlessness, excitement, psychotic behavior, hallucinations, delirium, convulsions)
- Severe anticholinergic peripheral effects (e.g., flushing, fever, tachycardia, urinary retention, paralytic ileus, mydriasis)
- Circulatory collapse
- Respiratory failure
- Paralysis
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. Gastric lavage may be indicated. Physostigmine may be considered for severe anticholinergic symptoms. Catheterization for urinary retention. Respiratory support if needed.
Drug Interactions
Major Interactions
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may significantly increase oxybutynin exposure and adverse effects.
- Other anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines) - additive anticholinergic effects, increasing risk of dry mouth, constipation, urinary retention, blurred vision, and CNS effects.
Moderate Interactions
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine) - oxybutynin may antagonize the effects of cholinesterase inhibitors, potentially reducing their efficacy.
- Drugs that slow gastrointestinal motility (e.g., opioids, loperamide) - increased risk of severe constipation or paralytic ileus.
- Alcohol and other CNS depressants - additive sedative effects.
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 increased monitoring.
Timing: Prior to initiation, especially in elderly or those with known impairment.
Routine Monitoring
Urinary symptoms
Frequency: Periodically (e.g., every 4-8 weeks initially, then as needed)
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, urinary retention, CNS effects like dizziness, confusion)
Frequency: Regularly, especially during dose titration and initiation.
Target: Minimal to tolerable side effects.
Action Threshold: Severe or 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
Action Threshold: Significantly increased PVR (>200 mL) may indicate urinary retention and necessitate discontinuation.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Drowsiness
- Confusion (especially in elderly)
- Urinary retention
- Headache
- Nausea
Special Patient Groups
Pregnancy
Oxybutynin is 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 major birth defects observed in animal studies. Human data limited.
Second Trimester:
No specific risks identified beyond general pregnancy considerations.
Third Trimester:
No specific risks identified beyond general pregnancy considerations.
Lactation
Oxybutynin and its active metabolite are excreted into breast milk. Due to potential for anticholinergic effects in the infant (e.g., sedation, constipation, dry mouth) and potential for decreased milk production, use with caution. Monitor infant for adverse effects.
Infant Risk:
L3 (Moderately Safe - Limited controlled studies show no increase in adverse effects, or only non-life-threatening adverse effects. Risk of adverse effects is possible. Weigh benefits vs. risks.)
Pediatric Use
Not recommended for children under 6 years for overactive bladder. For neurogenic bladder in children âĨ6 years, dosing is established, but close monitoring for anticholinergic side effects is crucial, especially CNS effects.
Geriatric Use
Elderly patients are more susceptible to anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, blurred vision, and CNS effects like confusion, dizziness, hallucinations). Start with lower doses (e.g., 2.5 mg two times daily) and titrate slowly. Avoid in frail elderly or those with cognitive impairment due to increased risk of delirium.
Clinical Information
Clinical Pearls
- Oxybutynin is a first-generation anticholinergic for OAB and is associated with higher rates of dry mouth and constipation compared to newer agents.
- The active metabolite, N-desethyloxybutynin, contributes significantly to the anticholinergic activity and side effect profile.
- Extended-release formulations (Oxybutynin XL) and transdermal patches (Oxytrol) are available and may have a lower incidence of dry mouth due to different pharmacokinetic profiles.
- Counsel patients on strategies to manage dry mouth and constipation.
- Warn patients about potential for heat intolerance due to decreased sweating.
Alternative Therapies
- Other anticholinergics/antimuscarinics: Tolterodine, Solifenacin, Darifenacin, Fesoterodine, Trospium
- Beta-3 adrenergic agonists: Mirabegron, Vibegron
- OnabotulinumtoxinA (Botox) injections into the bladder
- Sacral neuromodulation
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management)
Cost & Coverage
Average Cost:
Varies, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.