mirabegron

What is the most important information I should know about mirabegron?

What is mirabegron?

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.

What should I discuss with my healthcare provider before taking mirabegron?

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.

How should I take mirabegron?

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.

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

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

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking mirabegron?

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

What are the possible side effects of mirabegron?

• pain or burning when you urinate; or
• dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears.

Common side effects 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.

What other drugs will affect mirabegron?

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.

Where can I get more information?

Your pharmacist can provide more information about mirabegron.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 4.01. Revision date: 4/5/2021.