Mirabegron is used in adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. Mirabegron is sometimes used together with another medicine called solifenacin (Vesicare).

Mirabegron is used in children to treat neurogenic detrusor overactivity (NDO). Urinary incontinence caused by NDO is related to permanent nerve damage from conditions such as multiple sclerosis or spinal injury.

Mirabegron tablets may be used in children at least 3 years old. Mirabegron granules are for use in children at least 3 years old who also weigh at least 77 pounds (35 kilograms).

Mirabegron may also be used for purposes not listed in this medication guide.

You should not use mirabegron if you have uncontrolled hypertension (high blood pressure).

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you take mirabegron with solifenacin, take both medicines at the same time each day.

Take the mirabegron tablet with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

An adult may take a mirabegron tablet with or without food. However, a child should take the tablet with food.

Both adults and children should take mirabegron granules with food.

A pharmacist will mix mirabegron granules into a suspension (liquid) before you receive the medicine.

Shake the suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If the suspension will not be used for 2 days or longer, shake the bottle vigorously for 1 minute each day to keep the granules thoroughly mixed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch from using mirabegron tablets to using the suspension. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Throw away any unused mirabegron suspension after the expiration date on the medicine label has passed.

You should not use mirabegron if you are allergic to it.

Tell your doctor if you have ever had:

• high blood pressure;

• a bladder obstruction;

• trouble emptying your bladder (very little urine or a weak stream of urine);

• kidney disease; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Mirabegron should not be given to a child younger than 3 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose may cause pounding heartbeats or fluttering in your chest.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Stop using mirabegron and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mirabegron may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

Common side effects of mirabegron may include:

• painful urination;

• increased blood pressure;

• sinus pain, sore throat;

• constipation;

• headache; or

• dry mouth or fast heartbeats (when taken with solifenacin).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• digoxin;

• flecainide;

• propafenone;

• solifenacin; or

• thioridazine.

This list is not complete. Other drugs may affect mirabegron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.