Oxybutynin 5mg/5ml Syrup
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
Muscarinic receptor antagonist
Pregnancy Category
B
FDA Approved
Aug 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 leakage (incontinence). 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 benefit from 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.
When taking a liquid dose, measure it carefully using the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
However, if it is 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 benefit from 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.
When taking a liquid dose, measure it carefully using the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
However, if it is 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
- Avoid overheating and dehydration, especially in hot weather or during exercise, as this medication can reduce sweating and increase body temperature.
- Limit alcohol consumption, as it can increase dizziness and drowsiness.
- Maintain adequate fluid intake to help with dry mouth and prevent constipation.
- Increase fiber in your diet to help manage constipation.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg (1 teaspoon) 2 to 3 times daily
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
Maximum daily dose:
20 mg (4 teaspoons) per day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For neurogenic detrusor overactivity or overactive bladder (OAB) in children âĨ6 years: Initial 5 mg (1 teaspoon) twice daily. Maximum 5 mg (1 teaspoon) three times daily (15 mg/day). Max 20 mg/day for some indications.
Adolescent:
For neurogenic detrusor overactivity or overactive bladder (OAB) in adolescents âĨ6 years: Initial 5 mg (1 teaspoon) twice daily. Maximum 5 mg (1 teaspoon) three times daily (15 mg/day). Max 20 mg/day for some indications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
Use with caution. Consider lower initial doses (e.g., 2.5 mg BID) and titrate slowly.
Severe:
Use with caution. Consider lower initial doses (e.g., 2.5 mg BID) and titrate slowly. Monitor for anticholinergic side effects.
Dialysis:
Not well studied. Use with caution, consider lower doses.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
Use with caution. Consider lower initial doses (e.g., 2.5 mg BID) and titrate slowly.
Severe:
Use with caution. Consider lower initial doses (e.g., 2.5 mg BID) and titrate slowly. Monitor for anticholinergic side effects.
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 reduce bladder muscle spasms and increase bladder capacity, thereby reducing the frequency of uninhibited contractions of the detrusor muscle.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (due to extensive first-pass metabolism)
Tmax:
Approximately 0.5-1 hour
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Large (e.g., 193 L for 5 mg dose)
ProteinBinding:
Approximately 90% to plasma proteins
CnssPenetration:
Yes (contributes to CNS side effects)
Elimination:
HalfLife:
Oxybutynin: Approximately 2-3 hours; N-desethyloxybutynin: Approximately 7-8 hours
Clearance:
High systemic clearance
ExcretionRoute:
Primarily urine (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
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 urinate
+ Fever
+ Lower stomach pain or 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 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 for advice:
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 urinate
+ Fever
+ Lower stomach pain or 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 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 for advice:
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 dry mouth that interferes with speaking or swallowing
- Blurred vision or eye pain
- Confusion, hallucinations, or unusual thoughts/behavior (especially in elderly)
- Rapid or irregular heartbeat
- Signs of 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, inform your doctor and pharmacist about 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, discontinue, 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
Please note that this list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, inform your doctor and pharmacist about 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, discontinue, 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:
- Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, hot/dry skin, flushing)
- CNS excitation (e.g., restlessness, tremors, irritability, convulsions, delirium, hallucinations)
- Circulatory collapse
- Respiratory failure
- Paralysis
- Coma
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive, including gastric lavage, activated charcoal, and physostigmine for severe anticholinergic symptoms.
Drug Interactions
Contraindicated Interactions
- Not available
Major Interactions
- Potassium chloride (oral solid formulations) - increased risk of gastrointestinal lesions due to decreased GI motility.
- Other anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines, disopyramide) - increased risk of severe anticholinergic effects (e.g., dry mouth, constipation, blurred vision, urinary retention, CNS effects).
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - may increase plasma concentrations of oxybutynin and its active metabolite, leading to increased anticholinergic effects.
- CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive sedative effects.
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine) - oxybutynin may antagonize the effects of cholinesterase inhibitors, reducing their efficacy.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Bladder function assessment
Rationale: To establish baseline symptoms and severity of overactive bladder or neurogenic detrusor overactivity.
Timing: Prior to initiation of therapy
Renal and hepatic function tests
Rationale: To assess baseline organ function, especially in patients with pre-existing impairment, as dose adjustments may be necessary.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Efficacy (symptom improvement)
Frequency: Periodically (e.g., 2-4 weeks after initiation/dose change, then every 3-6 months)
Target: Reduction in urinary frequency, urgency, 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, dizziness, cognitive changes)
Frequency: Regularly, especially during dose titration and long-term therapy
Target: Minimal to tolerable side effects
Action Threshold: Intolerable side effects may require dose reduction, change in formulation (e.g., extended-release), 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 volume may indicate urinary retention and necessitate dose reduction or discontinuation.
Symptom Monitoring
- Urinary frequency
- Urinary urgency
- Urge incontinence episodes
- Nocturia
- Dry mouth
- Constipation
- Blurred vision
- Dizziness
- Headache
- Somnolence
- Confusion (especially in elderly)
- Heat intolerance
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 the potential benefits outweigh the potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data are limited.
Second Trimester:
Low risk based on animal data, but human data are limited.
Third Trimester:
Low risk based on animal data, but human data are limited.
Lactation
Oxybutynin is excreted into 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 to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately safe; possible adverse effects, but not probable. Weigh risk vs. benefit.)
Pediatric Use
Approved for children âĨ6 years for neurogenic detrusor overactivity and overactive bladder. Safety and efficacy in children younger than 6 years have not been established. Children are more susceptible to anticholinergic side effects.
Geriatric Use
Use with caution in elderly patients, as they are more susceptible to anticholinergic side effects such as dry mouth, constipation, blurred vision, and CNS effects (e.g., confusion, hallucinations, cognitive impairment). Start with lower doses and titrate slowly. Included in the Beers Criteria as a medication to avoid in older adults due to high anticholinergic burden.
Clinical Information
Clinical Pearls
- Oxybutynin syrup is often preferred for pediatric patients or those who have difficulty swallowing tablets.
- The most common side effects are anticholinergic in nature: dry mouth, constipation, and blurred vision. These are dose-related.
- Patients should be advised about the risk of heat prostration due to decreased sweating, especially in hot environments.
- Monitor for signs of urinary retention, particularly in patients with bladder outlet obstruction.
- Cognitive impairment is a significant concern in the elderly; consider alternative agents or lower doses if this occurs.
Alternative Therapies
- Other anticholinergics: Tolterodine, Solifenacin, Darifenacin, Fesoterodine
- Beta-3 adrenergic agonists: Mirabegron, Vibegron (less anticholinergic side effects)
- OnabotulinumtoxinA (Botox) injections into the bladder (for severe cases)
- Behavioral therapies: Bladder training, pelvic floor muscle exercises, fluid management
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 473 mL bottle (5mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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 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 happened.