Myrbetriq 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?
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.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow your doctor's instructions and read all the information provided. Here are some key guidelines to keep in mind:
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 this medication with or without food.
Children: Give this medication to children with food.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it 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 local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it has been 12 hours or more since the missed dose, skip it 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 out of your medication, follow your doctor's instructions and read all the information provided. Here are some key guidelines to keep in mind:
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 this medication with or without food.
Children: Give this medication to children with food.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it 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 local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it has been 12 hours or more since the missed dose, skip it 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.
- Continue to practice bladder training techniques (e.g., timed voiding, urge suppression) as advised by your doctor.
- Limit caffeine and alcohol intake, as these can irritate the bladder.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg extended-release tablet orally once daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
initial_dose:
25 mg once daily
maintenance_dose:
May increase to 50 mg once daily based on efficacy and tolerability after 8 weeks
Pediatric Dosing
Neonatal:
Not established for Overactive Bladder (OAB)
Infant:
Not established for OAB
Child:
Not established for OAB (Approved for neurogenic detrusor overactivity (NDO) in patients 3 years and older)
Adolescent:
Not established for OAB (Approved for neurogenic detrusor overactivity (NDO) in patients 3 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment for 25 mg. For 50 mg dose, maximum 25 mg once daily.
Moderate:
No dose adjustment for 25 mg. For 50 mg dose, maximum 25 mg once daily.
Severe:
Maximum 25 mg once daily.
Dialysis:
Not recommended for patients with end-stage renal disease (CrCl <15 mL/min) or on hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment (Child-Pugh A).
Moderate:
Maximum 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 bladder, leading to relaxation of the detrusor smooth muscle during the urine storage phase. This increases bladder capacity without affecting voiding pressure or residual urine volume.
Pharmacokinetics
Absorption:
Bioavailability:
29-35%
Tmax:
3.5-4 hours
FoodEffect:
A high-fat meal decreases Cmax by 45% and AUC by 17%. Can be taken with or without food.
Distribution:
Vd:
Approximately 1600 L
ProteinBinding:
Approximately 71% (primarily to albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 50 hours
Clearance:
Not available
ExcretionRoute:
Renal (approximately 25% unchanged), Fecal (approximately 55%)
Unchanged:
Approximately 25% (renal)
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief
PeakEffect:
Full therapeutic effect may take several weeks (e.g., 8 weeks for maximal benefit)
DurationOfAction:
24 hours (due to extended-release formulation)
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
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 experience any of the following side effects or any other symptoms that 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, 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
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 experience any of the following side effects or any other symptoms that 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, 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:
- Significant increase in blood pressure (e.g., severe headache, blurred vision, pounding in ears, anxiety)
- Difficulty urinating or feeling of incomplete bladder emptying (signs of urinary retention)
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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 adjust 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 adjust 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 regularly, as advised by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby.
As this medication can cause high blood pressure, it is crucial to have your blood pressure monitored regularly, as advised by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Palpitations
- Increased pulse rate
- Increased blood pressure
What to Do:
Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Supportive treatment and monitoring of vital signs are recommended.
Drug Interactions
Major Interactions
- Strong CYP2D6 inhibitors (e.g., quinidine, propafenone, flecainide, thioridazine): May increase mirabegron exposure. Max mirabegron dose 25 mg.
- Drugs metabolized by CYP2D6 with narrow therapeutic index (e.g., thioridazine, propafenone, flecainide, desipramine): Mirabegron is a moderate CYP2D6 inhibitor and may increase their exposure. Dose reduction may be needed.
Moderate Interactions
- Digoxin: Mirabegron increases digoxin Cmax and AUC. Initiate digoxin at lowest dose and monitor serum digoxin levels.
- Metoprolol: Mirabegron increases metoprolol Cmax and AUC. Dose adjustment of metoprolol may be needed.
- Warfarin: No clinically significant interaction observed, but monitor INR if co-administered.
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure (BP)
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 (CrCl)
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.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially in patients with hypertension
Target: Individualized, typically within normal limits or controlled range for hypertensive patients
Action Threshold: Significant or sustained increase in BP; consider dose reduction or discontinuation if uncontrolled.
Overactive Bladder (OAB) Symptoms
Frequency: Periodically (e.g., at follow-up visits)
Target: Reduction in urinary frequency, urgency, and incontinence episodes
Action Threshold: Lack of efficacy after 8 weeks at 50 mg; consider alternative therapies.
Digoxin levels (if co-administered)
Frequency: As clinically indicated, especially after mirabegron initiation or dose change
Target: Therapeutic range for digoxin
Action Threshold: Elevated digoxin levels; consider digoxin dose reduction.
Symptom Monitoring
- Urinary frequency
- Urinary urgency
- Urge incontinence episodes
- Blood pressure changes (e.g., headache, dizziness, palpitations)
- Signs of urinary retention (e.g., difficulty voiding, feeling of incomplete bladder emptying)
Special Patient Groups
Pregnancy
Mirabegron is Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies showed adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; human data lacking.
Second Trimester:
Potential risk based on animal data; human data lacking.
Third Trimester:
Potential risk based on animal data; human data lacking.
Lactation
It is unknown if mirabegron is excreted in human milk. Mirabegron and its metabolites are excreted in the milk of rats. 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:
Unknown; potential for adverse effects based on animal data.
Pediatric Use
Safety and effectiveness for the treatment of OAB in pediatric patients have not been established. Approved for neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older.
Geriatric Use
No dose adjustment is required based on age alone. However, geriatric patients may have reduced renal or hepatic function, which necessitates dose adjustment as per impairment guidelines. Monitor blood pressure regularly.
Clinical Information
Clinical Pearls
- Mirabegron is a good alternative for patients with OAB who cannot tolerate anticholinergic medications due to side effects like dry mouth, constipation, or cognitive impairment.
- It can be used in combination with the anticholinergic solifenacin (Vesicare) for patients who do not achieve adequate symptom control with monotherapy.
- Patients should be advised that it may take up to 8 weeks to achieve the full therapeutic effect.
- Monitor blood pressure, especially in patients with pre-existing hypertension, as mirabegron can increase BP.
Alternative Therapies
- Anticholinergics (e.g., Oxybutynin, Tolterodine, Solifenacin, Darifenacin, Fesoterodine)
- OnabotulinumtoxinA (Botox) injections into the detrusor muscle
- Sacral neuromodulation (SNS)
- Percutaneous tibial nerve stimulation (PTNS)
- Behavioral therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management)
Cost & Coverage
Average Cost:
Typically high for brand-name medication per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug)
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, including the amount taken and the time it happened, to ensure you receive the best possible care.