Oxybutynin ER 5mg Tablets

Oxybutynin is a competitive antagonist of muscarinic acetylcholine receptors. It exerts a direct antispasmodic effect on the smooth muscle of the detrusor muscle in the bladder, inhibiting the action of acetylcholine at these receptors. This action reduces bladder muscle contractions, increases bladder capacity, and delays the initial desire to void, thereby alleviating symptoms of overactive bladder (urinary urgency, frequency, and urge incontinence).

Urgent Side Effects: Seek Medical Help Right Away

While 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 pass urine
+ 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 passing urine
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

Most people experience few or no side effects when taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Upset stomach
Diarrhea or constipation
Dry mouth
Trouble sleeping
Nervousness or excitability

Reporting Side Effects

This is not an exhaustive list of possible 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.

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 symptoms you experienced as a result of the allergy.
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 in combination with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid operating a vehicle or engaging in activities that require alertness and clear vision until you understand how it affects you.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that can cause drowsiness, consult with your doctor to discuss potential interactions.

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, 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, monitor your condition closely, as this medication may exacerbate your symptoms. 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 the age of 6.

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.

• Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May significantly increase oxybutynin plasma concentrations, leading to increased anticholinergic side effects. Co-administration should be avoided or used with extreme caution with dose reduction.
• Other anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): May potentiate anticholinergic effects (dry mouth, constipation, blurred vision, CNS effects) and increase risk of heat prostration.

• Drugs that slow gastrointestinal motility (e.g., opioids, metoclopramide, prokinetic agents): May reduce the absorption of other orally administered drugs due to prolonged GI transit time. Oxybutynin itself can slow GI motility.
• Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine): Oxybutynin may antagonize the effects of cholinesterase inhibitors, potentially reducing their efficacy in Alzheimer's disease.

• Alcohol: May enhance the sedative effects of oxybutynin.

• Dry mouth
• Constipation
• Blurred vision
• Dizziness
• Somnolence
• Headache
• Nausea
• Urinary retention
• Signs of heat prostration (e.g., fever, hot/dry skin, confusion, rapid pulse) in hot environments.

Oxybutynin is Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Oxybutynin and its active metabolite are excreted into breast milk. The amount is small, but potential for anticholinergic effects in the infant exists (e.g., sedation, constipation). Use with caution; monitor infant for adverse effects. L3 (Moderately safe).

Approved for neurogenic detrusor overactivity in children ≥6 years. Safety and efficacy for overactive bladder (OAB) in children <18 years have not been established. Children may be more susceptible to anticholinergic side effects.

Elderly patients may be more sensitive to the anticholinergic effects of oxybutynin, particularly CNS effects (e.g., confusion, hallucinations, dizziness, somnolence). Lower initial doses and careful titration are recommended. Increased risk of falls due to dizziness/blurred vision.

• The extended-release (ER) formulation of oxybutynin is generally associated with a lower incidence of dry mouth compared to the immediate-release (IR) formulation, due to lower peak plasma concentrations.
• Patients should be advised that the tablet shell may be visible in their stool, which is a normal occurrence and does not mean the medication was not absorbed.
• Oxybutynin ER should be swallowed whole and not chewed, crushed, or divided, as this would disrupt the extended-release mechanism and could lead to rapid absorption and increased side effects.
• Consider alternative agents (e.g., beta-3 agonists like mirabegron) for patients who cannot tolerate anticholinergic side effects or have contraindications to anticholinergics (e.g., uncontrolled narrow-angle glaucoma, urinary retention).

• Other antimuscarinics: Tolterodine (Detrol, Detrol LA), Solifenacin (Vesicare), Fesoterodine (Toviaz), Darifenacin (Enablex), Trospium (Sanctura, Sanctura XR)
• Beta-3 adrenergic agonists: Mirabegron (Myrbetriq), Vibegron (Gemtesa)
• OnabotulinumtoxinA (Botox) intravesical injection
• Percutaneous tibial nerve stimulation (PTNS)
• Sacral neuromodulation (SNS)
• Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.