Mirabegron

Mirabegron is used in adults to treat overactive bladder, which includes symptoms like frequent or urgent urination and urinary incontinence. Mirabegron can sometimes be taken with another medicine called solifenacin (Vesicare).

In children, mirabegron is used to treat neurogenic detrusor overactivity (NDO). Urinary incontinence from NDO happens due to permanent nerve damage from conditions like multiple sclerosis or spinal injury.

Mirabegron tablets can be given to children who are at least 3 years old. Mirabegron granules are for children who are at least 3 years old and weigh at least 77 pounds (35 kilograms).

Mirabegron may also be used for other reasons not mentioned in this medication guide.

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 have uncontrolled hypertension (high blood pressure).

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.

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

Mirabegron may cause serious side effects. Call your doctor right away 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.

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

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

Tell your doctor about all the other medicines you are taking, 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.