How Should This Medicine Be Used
Mirabegron comes as an extended-release 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.
What Are Reasons I Shouldnt Take Myrbetriq
There are a few reasons why your healthcare provider may not choose Myrbetriq as part of your treatment, including:
A person should not take Myrbetriq if they are allergic to the ingredients.
Myrbetriq may cause harm to the fetus. It is best to talk to your provider if you are pregnant or plan to become pregnant so that they can decide the best option for you.
It isnât known if Myrbetriq passes into human milk, but it can potentially cause serious harm to a breastfed child. Talk with your provider if you are breastfeeding to discuss the best treatment plan.
A person aged 65 years or older often processes drugs more slowly. A lower dose or different schedule may be required.
Other Health Conditions
In specific individuals, the body may handle Myrbetriq differently. Inform your healthcare provider if you have:
- High blood pressure
Clinical Efficacy & Safety
Phase II Trials
Phase III Trials
Table 1 Primary Endpoints for Phase III Trials Evaluating Mirabegron in Patients with OAB
The adrenoceptors are expressed in the cardiovascular system and, as a consequence, the effects of mirabegron on cardiovascular safety have been closely monitored in the key registration trials.54 Over 1/3 of patients with OAB in these trials had hypertension at baseline, however, CV safety profile of mirabegron has been found to be acceptable at therapeutic doses and comparable with that of anitmuscarinic agents.54 That notwithstanding, mirabegron should not be given to those patients with severe uncontrolled hypertension, in line with both FDA and EMA directions.
Recently, the efficacy of mirabegron compared to solifenacin has been examined in a randomised non-inferiority phase IIIb trial of patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy.55 Patients were randomised to receive mirabegron or solifenacin for 12 weeks. The mean difference in mean number of micturitions/24h between the two groups was 0.18 therefore, the non-inferiority of mirabegron was not demonstrated since the lower limit of the 95% CI was not > 0.20. Nervertheless, improvements in OAB symptoms were observed but there was no significant difference between the two treatments. Both therapies were well tolerated, but with a numerically lower incidence of dry mouth with mirabegron.
Phase IV Trials
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Does Myrbetriq Cause Weight Gain Or Weight Loss
Its not known to. Changes in weight or appetite werent reported in clinical studies of Myrbetriq.
But Myrbetriq can sometimes cause urinary retention . This could lead to temporary weight gain. See Myrbetriq side effects above to learn more about urinary retention.
If youre concerned about changes in your weight while taking Myrbetriq, talk with your doctor. They can try to determine the cause and suggest ways to manage this.
What Are The Precautions I Should Take
Your doctor will have taken all of these necessary factors into account when prescribing Myrbetriq and have decided that the benefits outweigh the risks or adverse effects. However, you can still be aware of the main precautions to avoid accidentally causing some change.
- Tell your doctor or pharmacist about any other bladder problems , high blood pressure, kidney or liver problems.
- Limit your intake of alcohol and talk to your doctor if you are using cannabis
- Tell the surgeon or dentist before having surgery that you are being treated with Myrbetriq.
- During pregnancy, your prescribing doctor will only have decided on this treatment because it is needed. If you fall pregnant when already on Myrbetriq, discuss this with both the prescribing physicians and your obstetrician.
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Does Myrbetriq Cause Dementia Hair Loss Or Kidney Problems
No, Myrbetriq likely doesnt cause dementia or hair loss. These conditions werent reported as side effects in clinical studies of Myrbetriq.
Other drugs prescribed to treat overactive bladder may increase the risk of dementia. These include:
Myrbetriq isnt known to directly cause kidney problems. This also wasnt reported in clinical studies of the drug. But other side effects of Myrbetriq can lead to kidney problems if theyre severe or left untreated. This includes conditions such as:
- urinary tract infection , which may cause burning or pain during urination
- urinary retention
If youre concerned about having dementia or hair loss with Myrbetriq, talk with your doctor. They can advise on your risk of these side effects with Myrbetriq.
Also, if youre concerned about your risk of kidney problems while taking Myrbetriq, tell your doctor. If you have symptoms of a UTI or urinary retention, let your doctor know right away. They may recommend treatment to help lower your risk of kidney problems.
Mechanism Of Action Of Myrbetriq
Myrbetriq belongs to a class of drugs called 3-adrenoreceptor agonists, which activate a receptor on the detrusor muscle causing its relaxation. It is an antispasmodic, meaning that it suppresses muscle spasms and relaxes the bladder muscles. This increases the capacity of the bladder to hold more urine for a longer period of time, preventing urgent, frequent or uncontrolled urination.
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Are Hair Loss Dementia And Kidney Problems Possible Side Effects Of Myrbetriq
No, neither hair loss nor dementia were reported as side effects in Myrbetriqs studies.
Other drugs prescribed to treat OAB, such as oxybutynin, may make dementia worse in people who already have it. But this isnt expected with Myrbetriq.
Myrbetriq also isnt known to directly cause kidney problems. But it can cause urinary tract infections and urinary retention. In rare cases, these side effects can cause kidney problems, especially if theyre left untreated.
Be sure to call your doctor right away if you think you may have a UTI or urinary retention while taking Myrbetriq. If you have a UTI, your doctor will likely prescribe an antibiotic to treat the infection. Treating a UTI as soon as possible can help lower the risk that it spreads to your kidneys.
No Generic Alternative To Myrbetriq Is Available
Myrbetriq is a brand-name prescription drug and there is no generic alternative currently available.
A generic drug is an FDA-approved medication that contains the same active ingredients as the brand-name drug and is therapeutically equivalent. Generic drugs are typically much less expensive than brand-name drugs.
The earliest date that a generic for Myrbetriq could become available is 2025 when Mirabegrons patents expire.
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Approved For Combination Use
For adults with overactive bladder symptoms of urgency, frequency and leakage, Myrbetriq is FDAapproved for use in combination with solifenacin succinate. Ask your doctor if this combination treatment may be right for you.
What is MYRBETRIQ? MYRBETRIQ is a prescription medicine for adults that can be used alone or with solifenacin succinate to treat the following symptoms due to a condition called overactive bladder:
- Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
- Urgency: a strong need to urinate right away
- Frequency: urinating often
How should I take MYRBETRIQ
- If your doctor prescribes MYRBETRIQ and solifenacin succinate together, you should take 1 MYRBETRIQ tablet and 1 solifenacin tablet at the same time, 1 time a day.
- You should take MYRBETRIQ with water and swallow the tablet whole.
- Do not chew, break, or crush the tablet.
- You can take MYRBETRIQ with or without food.
- You can take MYRBETRIQ and solifenacin succinate together with or without food.
- If you miss a dose of MYRBETRIQ tablets, take it as soon as possible. If it has been more than 12 hours since taking the last dose of MYRBETRIQ tablets, skip that dose and take the next dose at the usual time.
- If you take too much MYRBETRIQ tablets, call your doctor or go to the nearest hospital emergency room right away.
The most common side effects of MYRBETRIQ, when used with solifenacin succinate, include:
Myrbetriqs Side Effects Explained
Below, you can find detailed information about one of Myrbetriqs side effects. To learn more about other side effects of this medication, talk with your doctor.
Diarrhea is one of the more common side effects of Myrbetriq, but it doesnt happen often. To learn more about how often this side effect occurred in clinical studies, see the drugs prescribing information.
In some cases, diarrhea can lead to dehydration. If you have diarrhea with Myrbetriq, its important to stay hydrated by drinking plenty of water.
If you have bothersome or long lasting diarrhea with Myrbetriq, talk with your doctor. They can suggest ways to ease your symptoms.
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Drug Dosage And Side Effects
Myrbetriq is given orally in a tablet form for extended release . The recommended starting dose for the treatment of OAB is 25 mg once daily, which could be increased to 50 mg depending on the patient response. It is advised to swallow the whole tablet without crushing or chewing. If a dose is missed, the usual dose schedule should be followed without making up for the missed dose. These recommendations are not specific to MS and the drug should only be taken following doctors prescription and after discussing its risks and benefits.
Myrbetriq should not be taken if the patient has certain allergies, high blood pressure, kidney disease, liver disease, or bladder blockage . The safety information is inadequate for use in children, and pregnant and breastfeeding women.
Doctors advice is needed to take other medications in combination with Myrbetriq. Several medications that are not recommended to take together with Myrbetriq include thioridazine, amphetamine, digoxin, flecainidine, metoprolol, desipramine, and warfarin.
Side effects of mirabegron include raised blood pressure, allergic reaction , painful urination, fever, constipation, irregular heartbeat, headache, back or side pain, dizziness, bladder pain, bloody or cloudy urine, and blurred vision.
Physicians advice is needed for disposal of unused medication.
Who Can And Cannot Take Mirabegron
Mirabegron can be taken by adults .
It is not suitable for everyone. To make sure it’s safe for you, tell your doctor or pharmacist before starting mirabegron if you:
- have had an allergic reaction to mirabegron or any other medicines in the past
- have liver or kidney problems
- have high blood pressure
- are not able to pee or empty your bladder completely
- have a blockage in your bladder
- have a heart problem called QT prolongation
- are pregnant, trying to get pregnant or breastfeeding
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Using Myrbetriq For Overactive Bladder
The FDA has approved Myrbetriq to treat overactive bladder . OAB is a condition that causes sudden, intense, and frequent urges to urinate.
Specifically, Myrbetriq is used prescribed to treat OAB in adults with urinary:
OAB is often caused by other conditions, such as diabetes, prostate problems, or Parkinsons disease.
What Does Myrbetriq Cost
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use. Keep in mind that the drugs cost with insurance may vary.
You may be wondering if Myrbetriq is available as a generic, and about the generic cost. Myrbetriq isnt available as a generic at this time.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Myrbetriq manufacturers website to see if they have support options.
You can also check out this article to learn more about saving money on prescriptions.
Some important things to discuss with your doctor when considering Myrbetriq treatment include:
- your overall health
- any medical conditions you may have
- all medications you take
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Why Is Myrbetriq So Expensive
Myrbetriq is commonly used to treat overactive bladder in adults. It relaxes the muscles in the bladder to help decrease problems with urination. Myrbetriq is an expensive prescription drug with no generic alternative currently available.
There are several reasons why Myrbetriq is so expensive including patent laws that prohibit the sale of a generic alternative and unregulated pricing.
Using Myrbetriq For Neurogenic Detrusor Overactivity
The FDA has approved Myrbetriq to treat neurogenic detrusor overactivity in children ages 3 years and older.
NDO is a type of overactive bladder. Its often caused by a nerve problem, which can happen with conditions such as multiple sclerosis and stroke. Symptoms of NDO overlap with those of overactive bladder and include urinary urgency, frequency, and incontinence.
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Some Side Effects Can Be Serious If You Experience Any Of These Symptoms Call Your Doctor Immediately Or Get Emergency Medical Treatment:
- swelling of face, lips, tongue or throat, difficulty breathing or swallowing, hives, rash, itching
- difficult, painful, urgent, or frequent urination
Mirabegron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .
What Are The Symptoms Of Overactive Bladder
Symptoms of OAB and neurogenic detrusor overactivity may include frequent urination, involuntary loss of urine , or sudden strong urges to urinate that are hard to control. OAB can affect your lifestyle by making your movements dependent on the availability of toilets wherever you go, restricting travel and socialization, and disturbing your rest at night.
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How To Use Myrbetriq 8 Mg/ml Oral Suspensionextended Release Overactive Bladder Agents
Read the Patient Information Leaflet if available from your pharmacist before you start taking mirabegron and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food as directed by your doctor, usually once daily. You will receive this medication from the pharmacy as a suspension that has been prepared by your pharmacist. Shake the bottle well for 1 minute before use. Then let it stand until the foam on top of the suspension is gone . If the granules have not mixed well, shake the bottle well again for 1 minute and let it stand until the foam is gone. Carefully measure the dose using a special measuring device/spoon. Disregard any bubbles when measuring. Do not use a household spoon because you may not get the correct dose. Take within 1 hour after you have measured out the dose. Wash the special measuring device/spoon after each use and let it air dry.
If the suspension will not be used for 2 or more days, shake the bottle well for 1 minute each day.
The dosage is based on your medical condition, weight, and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Tell your doctor if your condition does not get better or if it gets worse.
How To Take Myrbetriq
Myrbetriq is available as an oral tablet or liquid suspension. A healthcare provider will select which form and dose you should take based on your condition and body weight.
Your provider will prescribe the right dose for you. The prescribed dose is usually taken once a day. This medication is meant to be taken by mouth.
If you are prescribed the tablets, you can take your dose with or without food. Swallow the tablet whole and take it with water. Children who are prescribed the tablets should take their dose with food.
If you are taking the suspension , you should take your dose within one hour of eating food. The pharmacist will dispense Myrbetriq Granules as a suspension and provide an oral dosing device for use. If you will not be using the suspension for two or more days, shake the bottle vigorously for one minute each day to ensure the granules are mixed well.
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Is Myrbetriq Safe To Take
Myrbetriq is generally considered safe to take. But the drug can cause mild or serious side effects for some people. For details about possible side effects, see the Myrbetriq: Side effects section above.
If youre concerned about the safety of Myrbetriq, talk with your doctor or pharmacist. They can discuss your risk of side effects with the drug.