Ditropan XL 5mg 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; Anticholinergic
Pharmacologic Class
Muscarinic receptor antagonist
Pregnancy Category
Category B
FDA Approved
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ditropan XL is a medication used to treat overactive bladder. It helps relax the bladder muscles, which can reduce the sudden urge to urinate, frequent urination, and leakage (incontinence). It's an extended-release tablet, meaning it releases the medicine slowly over the day.
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. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. Swallow the tablet whole with a full glass of water; do not chew, break, or crush it. It's normal to see the tablet shell in your stool, and this is not a cause for concern.
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. 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the 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. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. Swallow the tablet whole with a full glass of water; do not chew, break, or crush it. It's normal to see the tablet shell in your stool, and this is not a cause for concern.
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. 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the tablet whole with water; do not chew, crush, or divide it.
- Take at approximately the same time each day.
- Stay hydrated to help manage dry mouth, but avoid excessive fluid intake if it worsens bladder symptoms.
- Manage constipation by increasing fiber intake and fluids, or with laxatives if needed.
- Be aware of potential for reduced sweating and increased body temperature, especially in hot weather or during exercise. Avoid overheating.
- Avoid alcohol or other CNS depressants as they can increase dizziness or drowsiness.
- Avoid driving or operating machinery until you know how the medication affects you, due to potential for dizziness or blurred vision.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg once daily
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
initialDose:
Start with 5 mg once daily. May increase in 5 mg increments to a maximum of 30 mg once daily to achieve a balance of efficacy and tolerability.
maximumDose:
30 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years of age and older with neurogenic detrusor overactivity: Initial dose 5 mg once daily. May increase in 5 mg increments to a maximum of 20 mg once daily.
Adolescent:
For adolescents 6 years of age and older with neurogenic detrusor overactivity: Initial dose 5 mg once daily. May increase in 5 mg increments to a maximum of 20 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
Use with caution. Consider lower initial doses and careful titration.
Severe:
Use with caution. Consider lower initial doses and careful titration. Not studied in severe renal impairment.
Dialysis:
Not studied in patients on dialysis. Use with caution.
Hepatic Impairment:
Mild:
Use with caution. Consider lower initial doses and careful titration.
Moderate:
Use with caution. Consider lower initial doses and careful titration.
Severe:
Not studied in severe hepatic impairment. Use with caution, consider lower initial doses and careful titration.
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 reduce 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% (due to extensive first-pass metabolism)
Tmax:
4-6 hours (for extended-release formulation)
FoodEffect:
Food does not significantly affect the absorption of oxybutynin from Ditropan XL.
Distribution:
Vd:
193 L
ProteinBinding:
Approximately 83-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours (oxybutynin); Approximately 15 hours (N-desethyloxybutynin)
Clearance:
Not readily available for extended-release, but high due to first-pass metabolism.
ExcretionRoute:
Urine (less than 0.1% as unchanged drug)
Unchanged:
Less than 0.1%
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for immediate release, extended release is slower)
PeakEffect:
3-6 hours
DurationOfAction:
24 hours (for extended-release formulation)
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 medical attention immediately:
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 medical attention immediately:
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 inability to have a bowel movement
- Inability to urinate (urinary retention)
- Severe stomach pain
- Eye pain, redness, or sudden vision changes (especially blurred vision or seeing halos around lights)
- Confusion, hallucinations, or unusual thoughts/behavior (especially in older adults)
- Rapid or irregular heartbeat
- Signs of an 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 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 whether 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 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 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 whether 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 activities that require alertness and clear vision, wait until 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, this medication may exacerbate your condition. If your symptoms worsen, contact your doctor immediately.
Adults 65 years and older should use this medication with caution, as they may be more susceptible to side effects.
This medication is not recommended for children under 6 years of age.
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 activities that require alertness and clear vision, wait until 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, this medication may exacerbate your condition. If your symptoms worsen, contact your doctor immediately.
Adults 65 years and older should use this medication with caution, as they may be more susceptible to side effects.
This medication is not recommended for children under 6 years of age.
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., intense dry mouth, dilated pupils, blurred vision, hot and dry skin, fever)
- CNS excitation (e.g., restlessness, agitation, delirium, hallucinations, seizures)
- Circulatory disturbances (e.g., tachycardia, arrhythmias, flushing)
- Respiratory depression
- Paralysis
- Coma
What to Do:
Seek immediate medical attention or call a poison control center (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, erythromycin, ritonavir): May significantly increase oxybutynin exposure, leading to increased anticholinergic side effects. Co-administration should be avoided or dose reduction of oxybutynin considered.
- Other anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): May potentiate anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention, CNS effects).
Moderate Interactions
- CNS depressants (e.g., alcohol, sedatives, hypnotics, opioid analgesics): May enhance the sedative effects of oxybutynin.
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine): May antagonize the effects of cholinesterase inhibitors, reducing their efficacy in Alzheimer's disease.
- Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though not well-established for oxybutynin.
Minor Interactions
- Drugs that affect gastrointestinal motility (e.g., prokinetic agents like metoclopramide): Oxybutynin may antagonize their effects.
Monitoring
Baseline Monitoring
Bladder diary
Rationale: To assess baseline urinary frequency, urgency, and incontinence episodes.
Timing: Prior to initiation of therapy
Renal and hepatic function
Rationale: To identify potential impairment that may necessitate dose adjustment or increased monitoring, especially in elderly or those with known dysfunction.
Timing: Prior to initiation, if clinically indicated
Routine Monitoring
Efficacy (symptom improvement)
Frequency: Periodically (e.g., 2-4 weeks after dose adjustment, then every 3-6 months)
Target: Reduction in urinary 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
Frequency: Regularly, especially after dose adjustments
Target: Minimizing dry mouth, constipation, blurred vision, and CNS effects (dizziness, confusion).
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)
Target: <100 mL (generally)
Action Threshold: Significant increase in PVR volume (e.g., >200 mL) may indicate urinary retention and necessitate discontinuation.
Symptom Monitoring
- Urinary frequency
- Urinary urgency
- Urge incontinence episodes
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Headache
- Somnolence
- Confusion or cognitive changes (especially in elderly)
- Difficulty urinating or signs of urinary retention
- Eye pain or vision changes (signs of narrow-angle glaucoma)
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 and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but generally avoided if alternatives exist.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified.
Lactation
Oxybutynin is excreted in 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 discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk of anticholinergic effects (e.g., sedation, constipation, dry mouth, urinary retention) in the infant. Monitor infant for these effects.
Pediatric Use
Approved for children 6 years of age and older with neurogenic detrusor overactivity. Safety and efficacy in children younger than 6 years have not been established. Children may be more susceptible to anticholinergic side effects.
Geriatric Use
Use with caution in elderly patients (âĨ65 years) due to increased risk of anticholinergic side effects, particularly cognitive impairment, constipation, and dry mouth. Start with lower doses and titrate slowly. Avoid in frail elderly or those with pre-existing cognitive impairment if possible.
Clinical Information
Clinical Pearls
- Ditropan XL is an extended-release formulation designed to reduce the incidence of dry mouth compared to immediate-release oxybutynin.
- Tablets must be swallowed whole; chewing, crushing, or dividing can lead to rapid release of the drug and increased side effects.
- Patients may notice a 'ghost tablet' in their stool, which is the empty shell of the extended-release tablet and is normal.
- Advise patients about the risk of heat prostration due to decreased sweating, especially during physical activity or in hot environments.
- Monitor for signs of urinary retention, especially in men with benign prostatic hyperplasia (BPH).
Alternative Therapies
- Other anticholinergics (e.g., solifenacin, tolterodine, fesoterodine, darifenacin)
- Beta-3 adrenergic agonists (e.g., mirabegron, vibegron)
- OnabotulinumtoxinA (Botox) injections into the detrusor muscle
- Sacral neuromodulation
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand, Tier 1 for generic. Coverage varies by insurance plan.
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.