Mirabegron 50mg ER 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).
Drug Class
Urinary Antispasmodic
Pharmacologic Class
Beta-3 Adrenergic Agonist
Pregnancy Category
C
FDA Approved
Jun 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mirabegron is a medication used to treat overactive bladder (OAB) symptoms like urgency, frequent urination, and leaking urine. It works by relaxing the bladder muscle, allowing it to hold more urine and reducing the sudden urge to go.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you 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.
Administration Instructions
For all patients: swallow the tablets whole without chewing, breaking, or crushing them. Take each dose with a full glass of water.
Adults: you can take this medication with or without food.
Children: give this medication to children with food.
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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed 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 dose.
To ensure you 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.
Administration Instructions
For all patients: swallow the tablets whole without chewing, breaking, or crushing them. Take each dose with a full glass of water.
Adults: you can take this medication with or without food.
Children: give this medication to children with food.
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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed 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 dose.
Lifestyle & Tips
- Take the tablet whole with water; do not chew, crush, or divide it.
- Can be taken with or without food.
- Maintain adequate fluid intake.
- Avoid excessive caffeine and alcohol, which can irritate the bladder.
- Practice bladder training techniques (e.g., timed voiding, urge suppression strategies) as advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg orally once daily; may increase to 50 mg orally once daily after 8 weeks
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
overactive_bladder:
Initial dose 25 mg once daily, increase to 50 mg once daily based on efficacy and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl 60-89 mL/min)
Moderate:
No dose adjustment needed (CrCl 30-59 mL/min)
Severe:
Maximum dose 25 mg once daily (CrCl 15-29 mL/min)
Dialysis:
Not recommended (CrCl <15 mL/min or ESRD requiring hemodialysis or peritoneal dialysis)
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
Maximum dose 25 mg once daily (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
Mirabegron is a beta-3 adrenergic agonist. It activates beta-3 adrenergic receptors in the detrusor muscle of the bladder, leading to relaxation of the detrusor muscle during the storage phase of the urinary bladder fill-void cycle. This increases bladder capacity and reduces the frequency of abnormal bladder contractions, thereby alleviating symptoms of overactive bladder (OAB) such as urgency, frequency, and urge incontinence.
Pharmacokinetics
Absorption:
Bioavailability:
29% (25 mg dose), 35% (50 mg dose)
Tmax:
3.5 to 4 hours
FoodEffect:
Food decreases Cmax and AUC; however, it is not considered clinically significant and can be taken with or without food.
Distribution:
Vd:
129 L
ProteinBinding:
Approximately 71% (primarily to albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 50 hours
Clearance:
Not available
ExcretionRoute:
Urine (approximately 55%), Feces (approximately 34%)
Unchanged:
Approximately 25% (urine), 50% (feces)
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
Within 8 weeks
DurationOfAction:
24 hours (due to extended-release formulation and long half-life)
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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Trouble passing urine
Bladder irritation
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 may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Nose or throat irritation
Dry mouth
* Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Trouble passing urine
Bladder irritation
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 may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Nose or throat irritation
Dry mouth
* Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Sudden, significant increase in blood pressure
- Fast or irregular heartbeat (palpitations)
- Difficulty urinating or feeling like you can't empty your bladder completely
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Severe headache or dizziness
- Signs of a urinary tract infection (painful urination, fever, chills)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Certain health conditions, including:
+ Kidney disease
+ Liver disease
+ High blood pressure
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All health problems you are experiencing, as this medication may interact with other drugs or health conditions.
It is crucial to consult with your doctor and pharmacist to ensure it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Certain health conditions, including:
+ Kidney disease
+ Liver disease
+ High blood pressure
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All health problems you are experiencing, as this medication may interact with other drugs or health conditions.
It is crucial to consult with your doctor and pharmacist to ensure it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify 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. Please note that it may take several weeks for the full effects of the drug to become apparent.
As this medication can cause high blood pressure, it is crucial to have your blood pressure monitored as directed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This discussion will help you understand the benefits and risks associated with taking this medication during pregnancy or breastfeeding, allowing you to make an informed decision about your care and the well-being of your baby.
As this medication can cause high blood pressure, it is crucial to have your blood pressure monitored as directed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This discussion will help you understand the benefits and risks associated with taking this medication during pregnancy or breastfeeding, allowing you to make an informed decision about your care and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Palpitations
- Increased pulse rate
- Increased blood pressure
What to Do:
Treatment should be symptomatic and supportive. Monitor heart rate, blood pressure, and ECG. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Thioridazine (increased exposure of thioridazine)
- Flecainide (increased exposure of flecainide)
- Propafenone (increased exposure of propafenone)
- Digoxin (increased exposure of digoxin)
Moderate Interactions
- Metoprolol (increased exposure of metoprolol)
- Desipramine (increased exposure of desipramine)
- Warfarin (potential for increased INR, monitor)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: Mirabegron can increase blood pressure. Baseline assessment is crucial.
Timing: Before initiating therapy
Heart Rate (HR)
Rationale: Beta-3 agonists can affect heart rate.
Timing: Before initiating therapy
Routine Monitoring
Blood Pressure (BP)
Frequency: Periodically, especially in patients with hypertension
Target: Individualized, maintain within patient's target range
Action Threshold: Significant or sustained increase above baseline or target range; consider dose reduction or discontinuation.
Heart Rate (HR)
Frequency: Periodically
Target: Individualized
Action Threshold: Significant or sustained increase above baseline.
Symptoms of OAB (urgency, frequency, incontinence)
Frequency: Regularly
Target: Reduction in symptoms
Action Threshold: Lack of improvement after 8 weeks at 25 mg may warrant dose increase to 50 mg; persistent symptoms at 50 mg may require re-evaluation of therapy.
Symptoms of Urinary Retention
Frequency: Regularly, especially in patients with bladder outlet obstruction (BOO) or taking antimuscarinic medications
Target: Absence of symptoms
Action Threshold: Difficulty voiding, feeling of incomplete bladder emptying; consider discontinuation.
Symptom Monitoring
- Increased blood pressure
- Palpitations
- Tachycardia
- Headache
- Dizziness
- Urinary tract infection symptoms (dysuria, frequency, urgency)
- Symptoms of urinary retention (difficulty voiding, feeling of incomplete emptying)
- Angioedema (swelling of face, lips, tongue, throat)
Special Patient Groups
Pregnancy
Mirabegron is Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities based on animal data.
Second Trimester:
Limited human data, animal data suggest potential risks.
Third Trimester:
Limited human data, animal data suggest potential risks.
Lactation
Mirabegron is excreted in the milk of rats. It is unknown if it is excreted in human milk. 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 (Moderate concern) - Potential for adverse effects in breastfed infant; monitor for increased heart rate or other signs of beta-adrenergic stimulation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (65 years and over) and younger patients. No dose adjustment is needed based on age alone, but consider renal and hepatic function, which may be impaired in older adults.
Clinical Information
Clinical Pearls
- Mirabegron is a good alternative for patients who cannot tolerate antimuscarinic agents due to anticholinergic side effects (e.g., dry mouth, constipation, cognitive impairment).
- Monitor blood pressure regularly, especially in patients with pre-existing hypertension, as mirabegron can increase BP.
- Onset of full therapeutic effect may take up to 8 weeks.
- Caution should be exercised in patients with severe uncontrolled hypertension (systolic BP âĨ180 mmHg or diastolic BP âĨ110 mmHg) as mirabegron is not recommended in these patients.
- Use with caution in patients with bladder outlet obstruction (BOO) or those taking antimuscarinic medications for OAB, due to the risk of urinary retention.
Alternative Therapies
- Antimuscarinic agents (e.g., oxybutynin, tolterodine, solifenacin, darifenacin, fesoterodine)
- OnabotulinumtoxinA (Botox) intravesical injection
- Sacral neuromodulation
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises)
Cost & Coverage
Average Cost:
Varies, typically $300-$500 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.