Mirabegron

Mirabegron is used alone or in combination with solifenacin (Vesicare) to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. It is also used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 3 years of age and older. Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

Mirabegron comes as an extended-release (long-acting) tablet and as an extended-release suspension to take by mouth. The tablets are usually taken with or without food once a day in adults and with food once a day in children. The suspension is usually taken with food once a day. Take mirabegron at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mirabegron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extend-release tablets whole with water; do not split, chew, or crush them.

It is important to use the oral dosing device to accurately measure and take your dose of the extended-release suspension. Ask your pharmacist for a device if it was not provided. Shake the bottle vigorously for 1 minute, then let it stand for 1 to 2 minutes until the foam on top of the suspension is gone. If the granules have not mixed well, shake the bottle vigorously again for 1 minute and let it stand until the foam is gone. Use the oral dosing device to draw up the suspension and ignore any bubbles in your measurement. Do not save the dose in the dosing syringe for later; use within 1 hour after preparation. After each use, wash the oral dosing device with mild soap, then rinse with tap water and allow it to air dry. If the suspension is not used for 2 or more days, shake the bottle for 1 minute each day.

Your doctor may increase your dose, depending on how well your symptoms are controlled and the side effects you experience. Talk to your doctor about how you are feeling during your treatment with mirabegron.

Mirabegron controls the symptoms of overactive bladder or neurogenic detrusor overactivity, but does not cure these conditions. It may take 8 weeks or longer before you feel the full benefit of mirabegron. Continue to take mirabegron even if you feel well. Do not stop taking mirabegron without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking mirabegron,

• tell your doctor and pharmacist if you are allergic to mirabegron, any other medications, or any of the ingredients in mirabegron extended-release tablets and suspension. Ask your pharmacist or check the patient information for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking mirabegron. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had bladder outlet obstruction (a blockage at the base of the bladder that stops urine from flowing freely out of the bladder and causes difficulty emptying the bladder and/or a weak urine stream), high blood pressure, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking mirabegron, call your doctor.
• you should know that your blood pressure may increase during your treatment with mirabegron. Your doctor will check your blood pressure regularly during your treatment.

Unless your doctor tells you otherwise, continue your normal diet.

If it has been less than 12 hours since the missed dose, take it as soon as you remember it. If it has been more than 12 hours since the missed dose, skip it and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Mirabegron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• dry mouth
• constipation
• back pain
• joint pain
• difficulty emptying the bladder, or weak urine stream (especially when used with solifenacin)

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• swelling of face, lips, tongue or throat, difficulty breathing or swallowing, hives, rash, itching
• difficult, painful, urgent, or frequent urination

Mirabegron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature for up to 28 days after the date the pharmacist prepares the suspension.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• fast or pounding heartbeat

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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