Mirabegron

Overactive Urinary Bladder, Urge Urinary Incontinence

Drug Status

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

NO

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Known Teratogen

No

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Pharmaceutical Class

Beta3-Adrenergic Agonist

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Controlled Drug Substance

No

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Drug Ingredient

Mirabegron

Summary

  • Mirabegron is primarily used to treat overactive bladder (OAB), a condition characterized by symptoms such as urinary urgency, frequency, and incontinence. It is also used to treat urge incontinence and increased urinary frequency associated with OAB in adults.

  • Mirabegron works by stimulating beta-3 adrenergic receptors in the bladder. This leads to relaxation of the bladder muscle, which increases bladder capacity and reduces the frequency of urination. This helps to alleviate the symptoms of OAB and improve bladder control.

  • Mirabegron is typically taken orally once daily. The usual starting dose is 25 mg, which may be increased to 50 mg after 8 weeks if needed. It can be taken with or without food.

  • The most common side effects of Mirabegron include high blood pressure, headache, dry mouth, constipation, and urinary tract infection. Serious heart-related issues such as increased heart rate, hypertension, and rare cases of heart failure may also occur.

  • Mirabegron can increase blood pressure, so it should be used with caution in patients with high blood pressure. It is contraindicated in patients with severe renal or hepatic impairment, bladder outlet obstruction, or severe urinary retention. It should be used with caution in pregnant women and during breastfeeding. Patients with a history of heart disease should also use Mirabegron cautiously.

Indications and Purpose

How does Mirabegron work?

Mirabegron works by stimulating beta-3 adrenergic receptors in the bladder. This action leads to the relaxation of the bladder muscle (detrusor muscle), which increases the bladder's capacity and reduces the frequency of involuntary contractions. As a result, it helps to improve symptoms of overactive bladder (OAB), such as urinary urgency, frequency, and incontinence. Unlike anticholinergic drugs, Mirabegron does not affect the central nervous system and has a more targeted action in the bladder.

Is Mirabegron effective?

Studies have shown that Mirabegron is effective in treating overactive bladder (OAB). In clinical trials, it has been found to significantly reduce symptoms like urinary urgency, frequency, and incontinence. A study published in the New England Journal of Medicine demonstrated that Mirabegron improved bladder control and quality of life compared to a placebo, with a similar effectiveness to anticholinergic medications, but with a better side-effect profile. Additionally, Mirabegron has been shown to have a long-lasting effect on symptoms with a once-daily dosage.

What is Mirabegron?

Mirabegron is commonly used to treat overactive bladder (OAB) symptoms, such as urinary frequency, urgency, and incontinence. It works by stimulating beta-3 adrenergic receptors in the bladder, leading to relaxation of the bladder muscle, which increases bladder capacity and reduces the frequency of urination. This helps to alleviate the symptoms of OAB and improve bladder control.

Directions for Use

For how long do I take Mirabegron?

You typically take Mirabegron for as long as your doctor advises to manage symptoms of overactive bladder. It’s a long-term treatment that is often continued as long as it is effective and well-tolerated.

How do I dispose of Mirabegron?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How do I take Mirabegron?

Mirabegron can be taken with or without food. There are no specific food restrictions while using this medication. It is important to swallow the tablet whole, without chewing or crushing it. If you miss a dose, take it as soon as you remember, unless it's almost time for the next dose. In that case, skip the missed dose and resume your regular schedule.

How long does it take for Mirabegron to start working?

Mirabegron typically starts to work within 1 to 2 weeks of starting treatment, but it may take up to 4 to 8 weeks to experience the full benefit, especially for symptoms like frequent urination or urgency. It may vary depending on the individual and their response to the medication.

How should I store Mirabegron?

Mirabegron should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It should be kept in its original packaging, tightly closed, and protected from moisture and light. Keep the medication out of reach of children and avoid storing it in areas with excessive heat or humidity, such as bathrooms.

What is the usual dose of Mirabegron?

For adults and children over 3 who weigh at least 35 kg, this medicine starts at 25 mg once a day. After 4 to 8 weeks, the doctor might increase it to 50 mg if needed. People with kidney or liver problems may need a different dose.

Warnings and Precautions

Can I take Mirabegron with other prescription drugs?

Beta-Blockers (e.g., Metoprolol, Propranolol): Mirabegron can increase blood pressure and heart rate. Beta-blockers may reduce these effects, so combining them may lessen the effectiveness of Mirabegron.

CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir, Itraconazole): These drugs can increase Mirabegron levels in the blood, increasing the risk of side effects such as high blood pressure and urinary retention. Dose adjustment of Mirabegron may be required.

CYP3A4 Inducers (e.g., Rifampin, Carbamazepine): These drugs can lower the effectiveness of Mirabegron by increasing its metabolism. Higher doses of Mirabegron might be needed to achieve the desired effect.

Anticholinergic Drugs (e.g., Tolterodine, Oxybutynin): Combining Mirabegron with other anticholinergics can increase the risk of side effects such as dry mouth, constipation, and blurred vision.

Can Mirabegron be taken safely while breastfeeding?

Mirabegron is excreted in animal milk, but it is not known whether it is excreted in human milk. Due to the potential risk of adverse effects on the nursing infant, caution is recommended when using Mirabegron during breastfeeding. It is advisable to consult with a healthcare provider to weigh the potential benefits and risks before using this medication while breastfeeding.

Can Mirabegron be taken safely while pregnant?

Mirabegron is classified as pregnancy category C by the FDA, which means that its safety during pregnancy has not been well established. Animal studies have shown some potential for harm to the fetus, but there are no adequate, well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnant women should consult their healthcare provider before using Mirabegron.

Does Mirabegron have adverse effects?

Adverse effects, which are unwanted or harmful reactions to a medicine, can occur with any medication. For this medicine, common adverse effects might include nausea, headache, dizziness, fatigue, and dry mouth. These effects can vary in frequency, with some people experiencing them more often than others. There are also serious adverse effects that, although rare, require immediate medical attention. These might include severe allergic reactions, which can cause difficulty breathing or swelling, or signs of liver damage, such as yellowing of the skin or eyes. It's important to report any new or worsening symptoms to your healthcare provider. Never stop taking a medicine without first consulting your doctor, as they can provide guidance on how to manage side effects or adjust your treatment safely.

Does Mirabegron have any safety warnings?

This medicine, which is called ibuprofen, has several safety warnings. One major warning is the risk of stomach bleeding, which can occur because ibuprofen can irritate the stomach lining. This is especially a concern for people who take high doses or use it long-term. Symptoms to watch for include stomach pain, black or bloody stools, and vomiting blood. Another warning is the risk of heart attack or stroke, which can happen because ibuprofen may increase blood pressure and affect heart function. This risk is higher for people with existing heart conditions. Signs to monitor include chest pain, shortness of breath, and sudden weakness or numbness. Lastly, ibuprofen can cause kidney problems, which occur because it can reduce blood flow to the kidneys. Symptoms to be aware of include changes in urination, swelling in the legs or feet, and fatigue. Always consult a healthcare provider before using ibuprofen, especially if you have existing health issues.

Is it safe to drink alcohol while taking Mirabegron?

Alcohol is generally safe in moderation while taking Mirabegron. However, alcohol can irritate the bladder and may worsen overactive bladder symptoms.

Is it safe to exercise while taking Mirabegron?

Yes, it is safe to exercise while taking Mirabegron. Regular physical activity can even benefit bladder health. Just stay hydrated and avoid overexertion if you experience side effects.

Is it safe to stop Mirabegron?

To determine if it's safe to stop a medicine, first identify its purpose. If it's for managing a chronic condition like hypertension or diabetes, stopping it may lead to uncontrolled symptoms or complications. For medicines providing symptomatic relief, stopping might cause symptoms to return. If it's for a temporary condition like an infection, stopping early could result in incomplete treatment and resistance. Some medicines can cause withdrawal symptoms or rebound effects, where symptoms return worse than before. Abruptly stopping certain medicines can be life-threatening, especially those affecting the heart or brain. Always consult a doctor before stopping any medicine to ensure it's safe and to discuss a proper discontinuation plan if needed.

Is Mirabegron addictive?

This medicine has no known potential for dependence or addiction. It is considered safe in terms of habit-forming properties. Therefore, there is no need to worry about developing a physical or psychological dependence on this medication. However, it is always important to use any medicine as directed by a healthcare professional to ensure safety and effectiveness. If you have any concerns or questions about your medication, it is best to discuss them with your doctor or pharmacist.

Is Mirabegron safe for the elderly?

Mirabegron can raise blood pressure, so doctors will want to check it regularly, especially if you already have high blood pressure. It shouldn't be used if your blood pressure is very high. It can also cause trouble emptying your bladder, especially if you already have problems with that or take certain other medicines. In rare cases, it can cause a serious allergic reaction called angioedema.

What are the most common side effects of Mirabegron?

A side effect is an unwanted or unexpected symptom caused by a medicine. For this medicine, common side effects may include nausea, which is feeling sick to your stomach, dizziness, which is feeling lightheaded or unsteady, headache, which is pain in the head, fatigue, which is feeling very tired, and dry mouth, which is a lack of saliva. The frequency of these side effects can vary, but they are generally considered common. It's important to note that when starting a new medicine, people might experience new symptoms that could be coincidental, unrelated, or temporary. These symptoms might also be due to another health issue. Always talk to a healthcare provider before stopping any medicine, as they can provide guidance on managing side effects and ensure your treatment is safe and effective.

Who should avoid taking Mirabegron?

Hypertension: Mirabegron can increase blood pressure, so it should be used with caution in patients with high blood pressure, and blood pressure should be monitored regularly during treatment.

Severe Renal or Hepatic Impairment: The medication is contraindicated in patients with severe renal or hepatic impairment, as it may affect the metabolism and clearance of the drug.

Bladder Outlet Obstruction: Patients with bladder outlet obstruction or severe urinary retention should avoid Mirabegron, as it may worsen these conditions.

Pregnancy and Lactation: It should be used with caution in pregnant women and only if the benefits outweigh the risks. It's not known whether it passes into breast milk, so caution is advised during breastfeeding.

Cardiac Conditions: Patients with a history of arrhythmia or heart disease should use Mirabegron cautiously due to potential effects on heart rate and blood pressure.