Mirabegron 25mg 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
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, frequency, and incontinence. It works by relaxing the bladder muscle, allowing it to hold more urine.
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.
For all patients:
+ Swallow the tablets whole; do not chew, break, or crush them.
+ Take the medication with a full glass of water.
Adults: You can take the medication with or without food.
Children: Give the medication to children with food.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
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 pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
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 the missed dose.
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.
For all patients:
+ Swallow the tablets whole; do not chew, break, or crush them.
+ Take the medication with a full glass of water.
Adults: You can take the medication with or without food.
Children: Give the medication to children with food.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
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 pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
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 the missed dose.
Lifestyle & Tips
- Take the tablet whole with water; do not chew, crush, or divide it.
- Can be taken with or without food.
- Continue with bladder training exercises and fluid management as advised by your doctor.
- Report any significant increase in blood pressure or difficulty urinating to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg extended-release tablet orally once daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
Overactive Bladder (OAB):
Initial dose 25 mg ER once daily. May increase to 50 mg ER once daily after 8 weeks 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 required (CrCl 60-89 mL/min)
Moderate:
Maximum dose 25 mg ER once daily (CrCl 30-59 mL/min)
Severe:
Maximum dose 25 mg ER once daily (CrCl 15-29 mL/min). Not recommended for patients with ESRD (CrCl < 15 mL/min) or requiring hemodialysis.
Dialysis:
Not recommended for patients with ESRD (CrCl < 15 mL/min) or requiring hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment required (Child-Pugh A)
Moderate:
Maximum dose 25 mg ER 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 bladder, leading to relaxation of the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle. This increases bladder capacity without affecting voiding pressure or residual urine volume.
Pharmacokinetics
Absorption:
Bioavailability:
~29% (25 mg), ~35% (50 mg)
Tmax:
3.5-4 hours
FoodEffect:
Food decreases Cmax and AUC, but not considered clinically significant; can be taken with or without food.
Distribution:
Vd:
127 L
ProteinBinding:
~71%
CnssPenetration:
Limited
Elimination:
HalfLife:
~50 hours
Clearance:
Not available
ExcretionRoute:
Renal (55%), Fecal (34%)
Unchanged:
~25% (renal), ~50% (fecal)
Pharmacodynamics
OnsetOfAction:
Within hours, but full therapeutic effect may take weeks
PeakEffect:
Not precisely defined for OAB symptoms, but steady-state plasma concentrations are achieved within 7 days of once-daily dosing.
DurationOfAction:
24 hours (due to extended-release formulation and long half-life)
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 while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Fast heartbeat
Difficulty 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
Other Possible Side Effects
Most people taking this medication will not experience side effects, or they may be mild. However, if you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
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 immediate medical attention:
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
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Fast heartbeat
Difficulty 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
Other Possible Side Effects
Most people taking this medication will not experience side effects, or they may be mild. However, if you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
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, severe increase in blood pressure (e.g., severe headache, blurred vision)
- Difficulty urinating or feeling of incomplete bladder emptying
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Chest pain or irregular heartbeat
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:
+ Kidney disease
+ Liver disease
+ High blood pressure
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 dose 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:
+ Kidney disease
+ Liver disease
+ High blood pressure
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 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 currently breast-feeding, 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 breast-feeding, 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 currently breast-feeding, 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 breast-feeding, 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 Center) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Digoxin (increased digoxin levels, monitor)
- CYP2D6 substrates with narrow therapeutic index (e.g., flecainide, propafenone, thioridazine, desipramine, metoprolol - increased exposure of these drugs)
Moderate Interactions
- Warfarin (potential for increased INR, monitor)
- Other P-gp substrates (potential for increased exposure)
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: Mirabegron can increase blood pressure. Patients with severe uncontrolled hypertension (systolic blood pressure âĨ 180 mm Hg or diastolic blood pressure âĨ 110 mm Hg) should not take mirabegron.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure
Frequency: Periodically
Target: Maintain within patient's target range, typically <140/90 mmHg
Action Threshold: If significant increase or uncontrolled hypertension develops, consider dose reduction or discontinuation.
Symptoms of urinary retention
Frequency: Regularly
Target: Absence of symptoms
Action Threshold: If symptoms of bladder outlet obstruction or urinary retention develop, discontinue mirabegron and seek medical attention.
Symptom Monitoring
- Changes in blood pressure (headache, dizziness, blurred vision)
- Signs of urinary retention (difficulty urinating, weak stream, feeling of incomplete emptying)
- Symptoms of angioedema (swelling of face, lips, tongue, throat)
- Worsening of OAB symptoms
Special Patient Groups
Pregnancy
Mirabegron is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed adverse effects at high doses. Human data is limited.
Second Trimester:
Human data is limited.
Third Trimester:
Human data is limited.
Lactation
Mirabegron is excreted in the milk of rats. It is unknown whether mirabegron 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:
Risk to breastfed infant is unknown. Monitor for potential adverse effects if used.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in this population.
Geriatric Use
No dose adjustment is required based on age alone. However, elderly patients may have reduced renal or hepatic function, which may necessitate dose adjustment as per impairment guidelines. Higher incidence of hypertension observed in elderly patients in clinical trials.
Clinical Information
Clinical Pearls
- Mirabegron is an alternative to anticholinergic agents for OAB, particularly useful for patients who cannot tolerate anticholinergic side effects (e.g., dry mouth, constipation, cognitive impairment).
- Monitor blood pressure regularly, especially in patients with pre-existing hypertension.
- Patients with bladder outlet obstruction or those taking antimuscarinic medications for OAB should be monitored for signs of urinary retention.
- Full therapeutic effect may take several weeks (up to 8 weeks) to be observed, so patients should be advised to continue therapy as prescribed.
Alternative Therapies
- Anticholinergic 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:
$300 - $500 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.