mirabegron

Mirabegron is a prescription medicine used to treat overactive bladder with symptoms of urgency (a strong need to urinate that is difficult to control), frequency (urinating often), and leakage (accidental urination due to a sudden or uncontrollable urge) in adults.

What brand names are available for mirabegron?

Myrbetriq

Is mirabegron available as a generic drug?

No

Do I need a prescription for mirabegron?

Yes

The most common side effects of mirabegron are:

• Headache
• Increased blood pressure
• Constipation
• Dizziness
• Diarrhea
• Back pain
• Dry mouth
• Joint pressure
• Common cold symptoms

Less commonly, some patients have experienced problems with emptying their bladder while taking mirabegron.

Possible serious side effects include:

• Heart problems
• Eye problems
• Stevens-Johnson syndrome
• Vaginal infections
• Cancer
• Urinary tract infection

• The recommended starting dose of mirabegron is 25 mg by mouth once daily. Mirabegron may be taken with or without food. If needed, the dose may be increased to 50 mg once daily based on individual patient response and tolerability.
• Mirabegron pills are designed to release active medication slowly over several hours. Mirabegron helps patients manage their symptoms throughout the day and until the next dose. Therefore, it's extremely important that patients do not crush or chew the tablets.
• Patients with severe kidney disease (creatinine clearance =30 ml/min) or patients with moderate liver disease (Child-Pugh Class B) should not take more than 25 mg of mirabegron per day.
• Use of mirabegron is not recommended in patients with end stage renal disease or in patients with severe liver disease (Child-Pugh Class C).

:

• Mirabegron is a moderate inhibitor of CYP2D6 liver enzymes. Taking mirabegron with medications that are metabolized or broken down by the CYP2D6 enzymes can result in an increase in their blood levels.
• Taking mirabegron with digoxin causes an increase in digoxin (Lanoxin) blood levels. Patients taking both medications should use the lowest possible dose of digoxin to decrease their risk of experiencing side effects.
• In clinical studies when mirabegron was administered with warfarin (Coumadin) blood levels of warfarin were increased. No effect on International Normalized Ratio (INR) and prothrombin time was observed. The true significance of this interaction is yet to be established.

:

• Use of mirabegron during pregnancy has not been adequately evaluated. Due to the lack of conclusive safety data, mirabegron should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Mirabegron is classified as FDA pregnancy risk category C.
• Although mirabegron was found in the milk of rats in animal studies, it is not known if mirabegron is excreted in human milk. As many drugs are excreted into human milk and have the potential of causing harm to the nursing infant, mirabegron should only be used during nursing if it is clearly needed.

What preparations of mirabegron are available?

Oral extended release tablets: 25 mg and 50 mg

How should I keep mirabegron stored?

Tablets should be stored at room temperature between 15 C to 30 C (59 F to 86 F).