Ditropan 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
Category B
FDA Approved
Jun 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 leaking urine. It works by relaxing the bladder muscle, helping it hold more urine and reducing the urge to go.
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, consult with your pharmacist for guidance on proper disposal. You may also want to explore 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 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, consult with your pharmacist for guidance on proper disposal. You may also want to explore 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 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 requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Be aware of potential for heat intolerance; avoid strenuous exercise in hot environments and stay hydrated, as this medication can decrease sweating.
- Manage dry mouth by chewing sugar-free gum, sucking on hard candies, or using saliva substitutes.
- Increase fiber and fluid intake to help prevent constipation.
- Report any new or worsening vision problems, difficulty urinating, or confusion to your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg two to three times daily
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
initialDose:
5 mg two to three times daily
maximumDose:
5 mg four times daily (20 mg/day)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years of age and older: Initial dose 5 mg twice daily. Maximum dose 5 mg three times daily (15 mg/day). Not recommended for children under 6 years of age.
Adolescent:
Initial dose 5 mg two to three times daily. Maximum dose 5 mg four times daily (20 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Use with caution; consider lower initial doses.
Severe:
Use with caution; consider lower initial doses. Avoid if possible due to potential for accumulation of active metabolites.
Dialysis:
Not specifically studied; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Use with caution; consider lower initial doses.
Severe:
Use with caution; consider lower initial doses. Avoid if possible due to extensive hepatic metabolism.
Confidence:
Medium
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. It acts as a competitive antagonist of muscarinic acetylcholine receptors (M1, M2, M3), reducing bladder contractions and delaying the initial desire to void, thereby increasing bladder capacity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (due to extensive first-pass metabolism)
Tmax:
0.5 - 1.5 hours
FoodEffect:
Food can delay absorption but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 193 L
ProteinBinding:
Approximately 83-95%
CnssPenetration:
Limited, but can cause CNS side effects (e.g., dizziness, drowsiness, confusion), especially in susceptible individuals or at higher doses.
Elimination:
HalfLife:
Oxybutynin: Approximately 2-3 hours; N-desethyloxybutynin (DEO): Approximately 7-8 hours
Clearance:
Not available (highly variable due to first-pass metabolism)
ExcretionRoute:
Primarily renal (less than 0.1% as unchanged drug; metabolites excreted in urine)
Unchanged:
<0.1%
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes
PeakEffect:
Approximately 3-6 hours
DurationOfAction:
6-10 hours (for immediate-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 when 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 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 and excitability
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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 when 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 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 and excitability
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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
- Inability to urinate (urinary retention)
- Severe blurred vision or eye pain
- Confusion, hallucinations, or unusual thoughts/behavior
- Signs of heatstroke (e.g., fever, hot dry skin, rapid pulse, dizziness, fainting)
- 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
Please note that 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
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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
Please note that 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
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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 prior to 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, exercise caution and stay hydrated by drinking plenty of fluids to prevent dehydration.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing 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 use this medication with caution, 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 prior to 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, exercise caution and stay hydrated by drinking plenty of fluids to prevent dehydration.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing 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 use this medication with caution, 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:
- Severe anticholinergic effects: CNS excitation (restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, tachycardia, hypotension or hypertension, nausea, vomiting, urinary retention, dilated pupils, paralytic ileus, respiratory failure, coma.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including gastric lavage, activated charcoal, and physostigmine (for severe anticholinergic symptoms) under close medical supervision.
Drug Interactions
Major Interactions
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir) - 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, blurred vision, and CNS effects.
Moderate Interactions
- Drugs that slow gastrointestinal motility (e.g., opioid analgesics, phenothiazines) - may exacerbate constipation and increase risk of gastric retention.
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine) - oxybutynin may antagonize the effects of cholinesterase inhibitors, reducing their efficacy in Alzheimer's disease.
- Grapefruit juice - may inhibit CYP3A4 and increase oxybutynin levels.
Minor Interactions
- Digoxin - oxybutynin may increase digoxin levels due to reduced GI motility, requiring monitoring of digoxin levels.
Monitoring
Baseline Monitoring
Urinary symptoms assessment (frequency, urgency, incontinence episodes)
Rationale: To establish baseline severity and track treatment efficacy.
Timing: Prior to initiation of therapy
Post-void residual (PVR) volume
Rationale: To assess for baseline urinary retention, especially in patients with bladder outlet obstruction.
Timing: Prior to initiation of therapy (consider in at-risk patients)
Renal and hepatic function tests
Rationale: To assess baseline organ function, as dose adjustments may be needed in impairment.
Timing: Prior to initiation of therapy (consider in patients with known or suspected impairment)
Routine Monitoring
Urinary symptoms assessment
Frequency: Periodically (e.g., every 4-8 weeks initially, then every 3-6 months)
Target: Reduction in urgency, frequency, and incontinence episodes
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, CNS effects)
Frequency: At each follow-up visit, especially during dose titration
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 if symptoms of urinary retention develop or worsen
Target: <100-150 mL (generally)
Action Threshold: Significant increase in PVR or symptoms of urinary retention (e.g., difficulty voiding, sensation of incomplete emptying) warrants discontinuation or dose reduction.
Symptom Monitoring
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Drowsiness
- Headache
- Nausea
- Urinary retention (difficulty urinating, feeling of incomplete bladder emptying)
- Confusion or cognitive impairment (especially in elderly)
- Heat intolerance (reduced sweating)
Special Patient Groups
Pregnancy
Oxybutynin is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies; human data limited.
Second Trimester:
No specific increased risk identified in animal studies; human data limited.
Third Trimester:
No specific increased risk identified in animal studies; human data limited.
Lactation
Oxybutynin and its active metabolite are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., anticholinergic effects like dry mouth, constipation, drowsiness, or effects on milk production), 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:
L3 - Moderately safe. Potential for anticholinergic effects in infant; monitor for drowsiness, constipation, dry mouth. May decrease milk supply.
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 at lower initial doses, monitoring closely for adverse effects, especially CNS effects.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic side effects of oxybutynin, particularly CNS effects (e.g., confusion, hallucinations, drowsiness) and urinary retention. Start with lower doses and titrate slowly, monitoring closely for adverse effects. Consider alternative agents if anticholinergic burden is a concern.
Clinical Information
Clinical Pearls
- Immediate-release oxybutynin often causes more pronounced anticholinergic side effects (especially dry mouth) compared to extended-release formulations (Ditropan XL) or transdermal/topical formulations (Oxytrol, Gelnique) due to higher Cmax and different metabolic profiles.
- Patient adherence can be limited by anticholinergic side effects. Counseling on managing dry mouth and constipation is crucial.
- Consider alternative agents or formulations if side effects are intolerable, especially in the elderly or those with cognitive impairment.
- Always assess for bladder outlet obstruction before initiating oxybutynin, as it can precipitate urinary retention.
- Oxybutynin is effective for urge incontinence but less so for stress incontinence.
Alternative Therapies
- Other Antimuscarinics: Tolterodine (Detrol), Solifenacin (Vesicare), Darifenacin (Enablex), Fesoterodine (Toviaz), Trospium (Sanctura)
- Beta-3 Adrenergic Agonists: Mirabegron (Myrbetriq), Vibegron (Gemtesa)
- OnabotulinumtoxinA (Botox) intravesical injections
- Sacral Neuromodulation (InterStim, Axonics)
- 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 (5mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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'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 medication taken, the amount, and the time it happened.