Description
Mirabegron is used alone or together with other medicines (eg, solifenacin succinate) to treat the symptoms of an overactive bladder (OAB), such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. It is also used to treat neurogenic detrusor overactivity (NDO). Mirabegron works on the muscles of the bladder to increase the amount of urine your bladder can hold and prevent them from causing incontinence.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension, Extended Release
- Tablet, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mirabegron oral liquid to treat NDO in children 3 years of age and older and the extended-release tablet to treat NDO in children 3 years of age and older and weighing 35 kilograms (kg) or more. Safety and efficacy have not been established to treat NDO in children younger than 3 years of age or to treat OAB in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mirabegron in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Colchicine
- Thioridazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amphetamine
- Benzphetamine
- Clozapine
- Codeine
- Cyclosporine
- Dabigatran Etexilate
- Dextroamphetamine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Eliglustat
- Ensartinib
- Hydroxyamphetamine
- Lefamulin
- Lisdexamfetamine
- Mavorixafor
- Methamphetamine
- Morphine
- Morphine Sulfate Liposome
- Oxycodone
- Posaconazole
- Propafenone
- Relugolix
- Repotrectinib
- Sirolimus
- Tenofovir Alafenamide
- Venetoclax
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Desipramine
- Digoxin
- Metoprolol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bladder blockage (hard to urinate) or
- Hypertension (high blood pressure), or history of—Use with caution. May make these conditions worse.
- End-stage kidney disease or
- Hypertension (high blood pressure), severe uncontrolled or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Kidney disease, severe or
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the extended-release tablet whole and with water. Do not crush, break, or chew it. Adults may take this medicine with or without food. Children should take it with food.
To use the oral liquid:
- It is best to take this medicine within 1 hour with food.
- Shake the bottle well just before taking each dose.
- Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For symptoms of an overactive bladder:
- For oral dosage form (extended-release tablets alone):
- Adults—At first, 25 milligrams (mg) once a day. Your doctor may increase the dose to 50 mg once a day after 4 to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets together with solifenacin succinate):
- Adults—At first, 25 milligrams (mg) mirabegron and 5 mg solifenacin succinate once a day. Your doctor may increase the dose of mirabegron to 50 mg once a day after 4 to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets alone):
- For neurogenic detrusor overactivity:
- For oral dosage form (extended-release tablets):
- Children 3 years of age and older weighing 35 kilograms (kg) or more—At first, 25 milligrams (mg) once a day. Your doctor may increase the dose to 50 mg once a day after 4 to 8 weeks.
- Children 3 years of age and older weighing less than 35 kg—Use the oral liquid for these patients.
- Children younger than 3 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release suspension):
- Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor:
- Weighing 35 kilograms (kg) or more—At first, 6 milliliters (mL) once a day. Your doctor may increase the dose to 10 mL once a day after 4 to 8 weeks.
- Weighing 22 to less than 35 kg—At first, 4 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 8 mL per day.
- Weighing 11 to less than 22 kg—At first, 3 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mL per day.
- Children younger than 3 years of age or weighing less than 11 kg—Use and dose must be determined by your doctor.
- Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor:
- For oral dosage form (extended-release tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 12 hours from your regular schedule, take the dose as soon as you can. If you miss a dose and it is more than 12 hours, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away unused oral liquid 28 days after first opening the bottle.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase your blood pressure. You will need to have your blood pressure measured while you are using this medicine. If you notice any change in your blood pressure, call your doctor right away.
This medicine may increase your risk of having urinary retention (trouble passing urine or not fully emptying the bladder), especially when using another medicine (eg, solifenacin succinate). Check with your doctor if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.
This medicine may cause a serious allergic reaction, called angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, rouble breathing, or trouble swallowing after using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- difficult, burning, or painful urination
- dizziness
- frequent urge to urinate
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- slow, fast, or irregular heartbeat
Rare
- Blindness
- decrease in vision
- eye pain
- lower abdominal or stomach pain
- nausea
- pain in the groin or genitals
- tearing or eyes
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- confusion
- cough
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficulty in passing urine (dribbling)
- itching
- joint or muscle pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- red skin lesions, often with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- trouble sleeping
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Back pain
- body aches or pain
- constipation
- difficulty having a bowel movement
- difficulty with breathing
- difficulty with moving
- dry mouth
- ear congestion
- fever
- general feeling of discomfort or illness
- loss of voice
- muscle ache or stiffness
- shivering
- sneezing
- stomach pain
- stuffy or runny nose
- sweating
Rare
- Belching
- burning feeling in the chest or stomach
- full or bloated feeling
- heartburn
- hives or welts, skin rash
- indigestion
- itching or pain of the vagina or genital area
- pain or tenderness around the eyes and cheekbones
- pressure in the stomach
- redness of the skin
- stomach discomfort, upset, or tenderness
- swelling of the lips
- thick, white vaginal discharge with mild or no odor
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
