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Mirabegron Extended-Release is available in the following:

• Extended-release tablets: 25 mg and 50 mg.
• For extended-release oral suspension: 8 mg/mL of mirabegron after reconstitution

Mirabegron Extended-Release is a beta-3 agonist that is used to treat:

• Overactive bladder in adults
• Neurogenic detrusor overactivity (NDO) in children ages 3 years and older

Mirabegron Extended-Release is a beta agonist that activates (wakes up) certain proteins in your bladder that cause your bladder muscles to relax. This makes the bladder to hold on to more urine, allowing you to go to the bathroom less often.

Mirabegron Extended-Release is dosed as follows:

Overactive bladder (OAB)

• Adults (Mirabegron Extended-Release tablets): The typical starting dose is 25 mg by mouth once a day. It can be taken alone or together with 5 mg of solifenacin (Vesicare). If needed, your healthcare provider might raise your dose to 50 mg once a day after 1 to 2 months

Neurogenic detrusor overactivity (NDO)

Children 77 pounds (35 kg) or less:

• Mirabegron Extended-Release granules: Your child’s provider will determine the dose based on your child’s body weight. The dose typically ranges from 24 mg to 64 mg by mouth once daily.

Children 77 pounds (35 kg) or more:

• Mirabegron Extended-Release tablets: The typical starting dose is 25 mg by mouth once a day. If needed, your healthcare provider might raise your dose to 50 mg once a day after 1 to 2 months
• Mirabegron Extended-Release granules: The typical starting dose is 48 mg by mouth once a day. If needed, your child’s provider might raise the dose to 80 mg once a day after 1 to 2 months

Your dose might differ if you have kidney or liver problems.

Mirabegron Extended-Release is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Mirabegron Extended-Release:

• Overactive bladder
• High blood pressure
• Common cold symptoms
• Urinary tract infection
• Headache
• Constipation
• Upper respiratory tract infection

Neurogenic detrusor overactivity

• Urinary tract infection
• Common cold symptoms
• Constipation
• Headache
• Nausea

Serious side effects are rare with Mirabegron Extended-Release. Contact your healthcare provider immediately if you experience any of the following.

• Angioedema: swelling of your face, lips, tongue and/or throat
  High blood pressure: headache, vision changes, dizziness

The following medications may interact with Mirabegron Extended-Release:

• Drugs Metabolized by CYP2D6: Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6
• especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary
• Digoxin: When initiating a combination of mirabegron and digoxin with or without solifenacin succinate, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect

Various FDA-approved generic manufacturers

It is not known if Mirabegron Extended-Release tablets or Mirabegron Extended-Release GRANULES will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

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