TM Owner Astellas Pharma
Myrbetriq 50mg Tablet
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Indications & Clinical Uses
- Myrbetriq 50 mg (mirabegron) tablets are a beta-3 adrenergic agonist used mainly to treat overactive bladder (OAB) in adults with symptoms of urgency, frequent urination and urge urinary incontinence, taken alone or together with the antimuscarinic solifenacin.
- The 50 mg tablet is also approved for neurogenic detrusor overactivity (NDO) in children aged 3 years and older who weigh at least 35 kg; a separate granule formulation, Myrbetriq Granules, is used for lighter or younger children instead.
- Mirabegron works by relaxing the bladder muscle to increase storage capacity, unlike older antimuscarinic OAB drugs.
- It was originally developed and first approved by Astellas Pharma in Japan before wider global approval, including the US and Europe.
- Myrbetriq is taken once daily by mouth, with or without food, and swallowed whole with water; it is not for hospital-only use.
Side Effects
- Myrbetriq has no boxed warning.
- The most common side effects are increased blood pressure, a fast or pounding heartbeat, headache, nasal or throat irritation, urinary tract infection, constipation and dry mouth.
- A less common but serious reaction is angioedema of the face, lips, tongue or throat, which can occur after the first dose or later in treatment and needs immediate emergency care if breathing or swallowing is affected.
- Because Myrbetriq can raise blood pressure, patients should have it checked periodically, especially those with existing hypertension.
- Report difficulty passing urine, as this can indicate urinary retention.
- Seek prompt medical advice for a severe headache, chest tightness or palpitations, and stop the medicine and seek urgent care for any facial or throat swelling.
Precautions & Warnings
- Myrbetriq should not be used by anyone with a known hypersensitivity to mirabegron.
- It is not recommended in patients with severe uncontrolled high blood pressure (systolic 180 mmHg or above, or diastolic 110 mmHg or above), and blood pressure should be checked before starting and periodically during treatment.
- Use with caution in patients with bladder outlet obstruction or who are taking antimuscarinic medicines for OAB, because of a risk of urinary retention; this is particularly relevant in children with NDO who often use intermittent catheterisation.
- There is limited human data on use during pregnancy or breastfeeding, so this should be discussed individually with the prescriber.
- No specific driving restriction applies, but patients should judge their own ability if they feel dizzy.
- Dose caution is advised in significant hepatic or renal impairment.
Avoid Interactions
- Mirabegron moderately inhibits the CYP2D6 enzyme, so it can raise blood levels of drugs broken down by this pathway, including desipramine and metoprolol; dose adjustment of these medicines may be needed.
- Myrbetriq also increases digoxin exposure, so the lowest effective digoxin dose should be used and blood levels monitored when the two are combined.
- Strong CYP3A4 inhibitors can further raise mirabegron levels.
- There is a theoretical increased risk of arrhythmia when Myrbetriq is combined with other QT-prolonging or heart-rhythm medicines such as flecainide or propafenone, so these combinations should be used cautiously.
- Tell the prescriber about all other medicines, including antimuscarinic OAB drugs used together for combination therapy, and about any heart medicines, before starting Myrbetriq.
References
Frequently Asked Questions
Myrbetriq (mirabegron) 50 mg tablets treat overactive bladder in adults, easing urgency, frequent urination and leakage. The same tablet is also approved for neurogenic detrusor overactivity in children aged 3 and over who weigh at least 35 kg, unlike the separate Myrbetriq Granules.
Myrbetriq is one tablet swallowed whole, once daily, with or without food. It can be used alone or combined with another overactive bladder medicine called solifenacin. Do not crush or chew the tablet; take it at roughly the same time each day.
Common effects include raised blood pressure, fast heartbeat, headache, dry mouth, constipation and urinary tract infection. Rarely, Myrbetriq causes angioedema, swelling of the face, lips, tongue or throat. Get emergency help immediately if breathing or swallowing becomes difficult.
Avoid Myrbetriq if you have severe uncontrolled high blood pressure. Tell your prescriber if you take digoxin, metoprolol, desipramine or heart-rhythm drugs like flecainide, since mirabegron can raise their blood levels. Have your blood pressure checked regularly while taking it.
If you miss a dose, take it as soon as you remember that day, then continue your normal once-daily schedule; do not double up the next day. Store Myrbetriq tablets at room temperature, away from moisture and heat, and keep them in the original container.
Yes, Myrbetriq 50 mg tablets are approved for neurogenic detrusor overactivity in children aged 3 and older who weigh 35 kg or more; lighter children use Myrbetriq Granules instead. Blood pressure monitoring applies to children too, as it does in adults.
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