Ditropan XL 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; Anticholinergic
Pharmacologic Class
Antimuscarinic Agent
Pregnancy Category
Category B
FDA Approved
Jul 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ditropan XL 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 urine leakage.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated. Swallow the tablet whole with a full glass of water, without chewing, breaking, or crushing 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. 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
What to Do If You Miss 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated. Swallow the tablet whole with a full glass of water, without chewing, breaking, or crushing 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. 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
What to Do If You Miss 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
- Take the tablet whole with water; do not chew, crush, or divide it.
- You may take it with or without food.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Be aware of potential for heat prostration (fever and heat stroke due to decreased sweating) when in a hot environment, especially during exercise. Stay hydrated.
- Manage dry mouth by sipping water, chewing sugar-free gum, or using saliva substitutes.
- To prevent constipation, increase fiber intake, drink plenty of fluids, and engage in regular physical activity.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg once daily
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
Overactive Bladder:
Initial dose 5 or 10 mg once daily. May increase in 5 mg increments to a maximum of 30 mg 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 of age: Initial dose 5 mg once daily. May increase in 5 mg increments to a maximum of 20 mg once daily.
Adolescent:
For neurogenic detrusor overactivity: Adolescents âĨ6 years of age: 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 slower titration.
Severe:
Use with caution. Consider lower initial doses and slower titration. Not studied in patients with severe renal impairment (CrCl <30 mL/min).
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
Use with caution. Consider lower initial doses and slower titration. Not studied in patients with moderate to severe hepatic impairment.
Severe:
Use with caution. Consider lower initial doses and slower titration. Not studied in patients with moderate to severe hepatic impairment.
Pharmacology
Mechanism of Action
Oxybutynin is a competitive muscarinic receptor antagonist. It 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 reduce bladder muscle contractions and delay 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:
Approximately 4-6 hours (for oxybutynin and N-desethyloxybutynin)
FoodEffect:
Food does not significantly affect the extent of absorption (AUC) of oxybutynin or its active metabolite, but may delay Tmax by approximately 1-3 hours.
Distribution:
Vd:
Approximately 193 L
ProteinBinding:
Approximately 83-85%
CnssPenetration:
Yes, crosses the blood-brain barrier and can cause CNS effects.
Elimination:
HalfLife:
Oxybutynin: Approximately 13 hours; N-desethyloxybutynin: Approximately 15 hours
Clearance:
Not readily available for total body clearance, but renal clearance is minor.
ExcretionRoute:
Primarily urine (less than 0.1% as unchanged drug)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
Approximately 3-6 hours
DurationOfAction:
Up to 24 hours (due to extended-release formulation)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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 attention 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 help:
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 help 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 attention 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 help:
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 blurred vision or eye pain
- Signs of heat stroke (e.g., fever, hot/dry skin, confusion, rapid pulse)
- New or worsening confusion, hallucinations, or memory problems
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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 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 candies, 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 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, consult your doctor to discuss the potential benefits and risks to 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 candies, 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 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, consult your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth
- Blurred vision
- Flushing
- Urinary retention
- Constipation
- Dilated pupils
- Restlessness
- Excitement
- Psychotic behavior
- Fever
- Convulsions
- Coma
- Respiratory depression
- Paralysis
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may significantly increase oxybutynin exposure and risk of anticholinergic side effects.
- Other anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines) - 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, potentially reducing their efficacy.
- Drugs that slow gastrointestinal motility (e.g., opioids, loperamide) - may increase risk of severe constipation or paralytic ileus.
- Alcohol - may enhance the drowsiness and dizziness caused by oxybutynin.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Bladder diary/symptom assessment
Rationale: To establish baseline urinary frequency, urgency, and incontinence episodes.
Timing: Prior to initiation of therapy
Renal function (CrCl)
Rationale: To assess for potential need for dose adjustment or caution in patients with impairment.
Timing: Prior to initiation, especially in elderly or those with risk factors
Hepatic function (LFTs)
Rationale: To assess for potential need for dose adjustment or caution in patients with impairment.
Timing: Prior to initiation, especially in elderly or those with risk factors
Routine Monitoring
Efficacy (symptom improvement)
Frequency: Periodically, based on patient response (e.g., 2-4 weeks after dose adjustment, then every 3-6 months)
Target: Reduction in urinary frequency, urgency, and incontinence episodes.
Action Threshold: If symptoms persist or worsen, consider dose adjustment or alternative therapy.
Anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, CNS effects)
Frequency: Regularly, especially during dose titration and initial therapy.
Target: Tolerable level of side effects.
Action Threshold: If severe or intolerable, consider 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 (>200 mL) may indicate urinary retention and require intervention.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Drowsiness
- Headache
- Urinary retention
- Confusion or cognitive impairment (especially in elderly)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown no evidence of impaired fertility or harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show no teratogenicity.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Oxybutynin is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed 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:
Risk of anticholinergic effects (e.g., dry mouth, constipation, drowsiness, decreased milk production in mother).
Pediatric Use
Safety and effectiveness have been established for neurogenic detrusor overactivity in pediatric patients 6 years of age and older. Safety and effectiveness in pediatric patients younger than 6 years of age have not been established. Use with caution due to potential for increased sensitivity to anticholinergic effects.
Geriatric Use
Geriatric patients may be more sensitive to the anticholinergic effects of oxybutynin, particularly dry mouth, constipation, and CNS effects (e.g., confusion, hallucinations). Start with the lowest effective dose (e.g., 5 mg once daily) and titrate slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Ditropan XL is an extended-release formulation, designed for once-daily dosing, which may improve adherence and reduce the incidence of dry mouth compared to immediate-release oxybutynin.
- Tablets must be swallowed whole; do not chew, crush, or divide, as this will disrupt the extended-release mechanism and lead to rapid drug release.
- Patients may notice a ghost tablet (the empty shell) in their stool, which is normal and does not mean the medication was not absorbed.
- Counsel patients on non-pharmacological strategies for overactive bladder, such as bladder training, fluid management, and pelvic floor exercises.
- Monitor for signs of urinary retention, especially in men with benign prostatic hyperplasia (BPH).
Alternative Therapies
- Other anticholinergics (e.g., solifenacin, tolterodine, fesoterodine, darifenacin, trospium)
- Beta-3 adrenergic agonists (e.g., mirabegron, vibegron)
- OnabotulinumtoxinA (Botox) injections into the bladder
- Neuromodulation (e.g., sacral neuromodulation, percutaneous tibial nerve stimulation)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management)
Cost & Coverage
Average Cost:
$150 - $400 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 (for 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.