Myrbetriq 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, Beta-3 adrenergic agonist
Pharmacologic Class
Beta-3 adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Jun 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Myrbetriq is a medication used to treat overactive bladder (OAB) symptoms like urgency, frequency, and leakage. 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are 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 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 one.
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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are 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 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 one.
Lifestyle & Tips
- Take the tablet whole with water; do not chew, crush, or divide it.
- Can be taken with or without food.
- Take at approximately the same time each day.
- Continue to take as prescribed, even if symptoms improve, as it is a long-term treatment.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Monitor your blood pressure regularly, especially if you have high blood pressure.
- Limit caffeine and alcohol intake, as these can irritate the bladder and worsen OAB symptoms.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg orally once daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
initial_dose:
25 mg orally once daily, may increase to 50 mg once daily based on efficacy and tolerability after 8 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established for OAB in pediatric patients. Approved for neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older, but dosing differs and is weight-based for NDO.)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (eGFR 60-89 mL/min/1.73 m²)
Moderate:
No dose adjustment required (eGFR 30-59 mL/min/1.73 m²)
Severe:
Maximum dose 25 mg once daily (eGFR 15-29 mL/min/1.73 m²)
Dialysis:
Not recommended (eGFR <15 mL/min/1.73 m² or end-stage renal disease requiring hemodialysis or peritoneal dialysis)
Hepatic Impairment:
Mild:
No dose adjustment required (Child-Pugh A)
Moderate:
Maximum dose 25 mg once daily (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Confidence:
High
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 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 dose) to 35% (50 mg dose)
Tmax:
Approximately 3.5 to 4 hours
FoodEffect:
Food decreases Cmax and AUC; however, it is not considered clinically significant, and mirabegron can be taken with or without food.
Distribution:
Vd:
Approximately 129 L
ProteinBinding:
Approximately 71% (primarily to albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 50 hours
Clearance:
Approximately 13.4 L/hr
ExcretionRoute:
Renal (approximately 55% of dose, 25% as unchanged drug) and fecal (approximately 34% of dose)
Unchanged:
Approximately 25% (renal)
Pharmacodynamics
OnsetOfAction:
Within hours, but full therapeutic effect may take several weeks (up to 8 weeks for optimal response).
PeakEffect:
Clinical efficacy observed within 8 weeks.
DurationOfAction:
24 hours (due to extended-release formulation and long half-life)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter 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
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
If you experience any of these symptoms, seek medical attention immediately.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
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 individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter 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
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
If you experience any of these symptoms, seek medical attention immediately.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
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
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Difficulty urinating or painful urination (may indicate urinary retention or UTI)
- Swelling in the ankles or feet
- Fast or irregular heartbeat (palpitations, tachycardia)
- Vision changes
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 symptoms you experienced.
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
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.
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.
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
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.
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 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 currently 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:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment should be symptomatic and supportive. Monitor heart rate, blood pressure, and ECG.
Drug Interactions
Major Interactions
- Thioridazine (increased risk of QT prolongation and arrhythmias)
- Flecainide (increased flecainide exposure)
- Propafenone (increased propafenone exposure)
- Desipramine (increased desipramine exposure)
Moderate Interactions
- Digoxin (increased digoxin exposure, monitor digoxin levels)
- Metoprolol (increased metoprolol exposure, monitor blood pressure and heart rate)
- Warfarin (potential for increased INR, monitor INR)
- Dabigatran (potential for increased dabigatran exposure, monitor for bleeding)
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: Mirabegron can increase blood pressure. Baseline assessment is crucial, especially in patients with pre-existing hypertension.
Timing: Prior to initiation of therapy
Renal Function (eGFR)
Rationale: Dose adjustment is required for severe renal impairment.
Timing: Prior to initiation of therapy
Hepatic Function (Child-Pugh score)
Rationale: Dose adjustment is required for moderate hepatic impairment, and not recommended for severe impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure
Frequency: Periodically, especially in patients with hypertension
Target: Individualized, typically within normal limits or controlled range for hypertensive patients
Action Threshold: Significant or sustained increase in blood pressure; consider dose reduction or discontinuation if uncontrolled.
Symptoms of OAB (urgency, frequency, incontinence episodes)
Frequency: Regularly, especially during initial weeks of therapy
Target: Reduction in symptoms
Action Threshold: Lack of improvement after 8 weeks may warrant dose increase (from 25mg to 50mg) or alternative therapy.
Symptom Monitoring
- Increased blood pressure
- Headache
- Nasopharyngitis
- Urinary tract infection (UTI)
- Constipation
- Dry mouth
- Tachycardia
- Palpitations
- Dizziness
Special Patient Groups
Pregnancy
Mirabegron is Pregnancy Category C. Animal studies have shown adverse effects on fetal development at doses higher than clinical exposure. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at high doses.
Second Trimester:
Potential for developmental toxicity observed in animal studies at high doses.
Third Trimester:
Potential for developmental toxicity observed in animal studies at high doses.
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 unknown; potential for exposure and adverse effects in breastfed infant.
Pediatric Use
Safety and effectiveness in pediatric patients for OAB have not been established. Approved for neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older, with different weight-based dosing.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (65 years and over) and younger patients. No dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal or hepatic function, which may require dose adjustment.
Clinical Information
Clinical Pearls
- Mirabegron is a good alternative for patients who cannot tolerate anticholinergic side effects (e.g., dry mouth, constipation, cognitive impairment) commonly associated with other OAB medications.
- Monitor blood pressure, especially in patients with pre-existing hypertension, as mirabegron can increase blood pressure.
- Full therapeutic effect may take up to 8 weeks; patients should be advised to continue therapy even if immediate improvement is not seen.
- Consider starting with 25 mg in patients with moderate hepatic impairment or severe renal impairment.
- Avoid in patients with uncontrolled severe hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg).
Alternative Therapies
- Anticholinergics (e.g., oxybutynin, tolterodine, solifenacin, darifenacin, fesoterodine)
- OnabotulinumtoxinA (Botox) injections into the bladder
- Sacral neuromodulation
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management)
Cost & Coverage
Average Cost:
Not available (varies widely by pharmacy and location) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
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 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 occurred.