Mirabegron (Oral route)
- Tablet, Extended Release
Uses of This Medicine:
Mirabegron is used to treat the symptoms of an overactive bladder. It will help control incontinence (loss of bladder control), the need to urinate right away, and the need to urinate often. Mirabegron works on the muscles of the bladder to prevent them from causing incontinence.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of mirabegron in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mirabegron in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
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.
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.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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. You may take this medicine with or without food.
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 oral dosage form (extended-release tablets):
- To treat bladder problems:
- Adults—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
- Children—Use and dose must be determined by your doctor.
- To treat bladder problems:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and 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.
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 of This Medicine:
- More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- pounding in the ears
- slow, fast, or irregular heartbeat
- decrease in vision
- eye pain
- lower abdominal or stomach pain
- nausea or vomiting
- pain in the groin or genitals
- tearing or eyes
- Incidence not known
- Blistering, peeling, or loosening of the skin
- decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- joint or muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
- Less common
- Abdominal or stomach pain
- back pain
- body aches or pain
- difficulty having a bowel movement (stool)
- difficulty with breathing
- difficulty with moving
- dry mouth
- ear congestion
- loss of voice
- muscle aches
- muscle stiffness
- stuffy or runny nose
- Acid or sour stomach
- burning feeling in the chest or stomach
- full or bloated feeling
- hives or welts
- 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
- shortness of breath or troubled breathing
- skin rash
- stomach discomfort or upset
- swelling of the lips
- tenderness in the stomach area
- thick, white vaginal discharge with mild or no odor
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:
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:
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.
Last Updated: 11/4/2014