Mirabegron Glenmark
Prolonged-release tablet for the treatment of overactive bladder (OAB) symptoms
Mirabegron Glenmark contains mirabegron, a beta-3 adrenergic agonist used to treat overactive bladder (OAB) in adults. It relieves symptoms of urgency, increased urination frequency, and urgency incontinence by relaxing the bladder muscle during filling. Available as 50 mg prolonged-release tablets, Mirabegron Glenmark is a prescription-only generic medicine manufactured by Glenmark Pharmaceuticals.
Quick Facts
Key Takeaways
- Mirabegron Glenmark is a beta-3 adrenergic agonist that treats overactive bladder symptoms including urgency, frequency, and urgency incontinence in adults.
- It works differently from anticholinergic bladder medications, avoiding common side effects such as dry mouth, constipation, and cognitive impairment.
- The standard dose is 50 mg taken once daily, swallowed whole with water, regardless of meals.
- Blood pressure should be monitored regularly during treatment as mirabegron can cause elevated blood pressure.
- It should not be used in patients with severe uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).
What Is Mirabegron Glenmark and What Is It Used For?
Mirabegron Glenmark belongs to a class of medications known as beta-3 adrenergic agonists. The active ingredient, mirabegron, was first developed and approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder. Glenmark Pharmaceuticals manufactures this generic version, which contains the same active substance and is bioequivalent to the original branded product.
Overactive bladder (OAB) is a common urological condition affecting an estimated 12–17% of the adult population worldwide, with prevalence increasing with age. The condition is characterised by a syndrome of urinary urgency, usually accompanied by increased daytime frequency and nocturia (waking at night to urinate), with or without urgency urinary incontinence. OAB significantly impacts quality of life, affecting sleep, work productivity, sexual function, and mental health.
Mirabegron works by activating beta-3 adrenergic receptors located on the detrusor smooth muscle of the urinary bladder. During the storage phase of the bladder fill-void cycle, this activation causes relaxation of the detrusor muscle, which increases the functional bladder capacity and reduces the frequency of involuntary bladder contractions. This mechanism is fundamentally different from anticholinergic drugs (such as oxybutynin, solifenacin, or tolterodine), which block muscarinic receptors to achieve a similar clinical effect.
The distinction in mechanism of action is clinically important. Anticholinergic medications commonly cause side effects such as dry mouth, constipation, blurred vision, and cognitive impairment—particularly concerning in elderly patients. Mirabegron’s beta-3 agonist mechanism largely avoids these anticholinergic side effects, making it a valuable treatment option for patients who are intolerant of or have contraindications to anticholinergic therapy. International guidelines from the European Association of Urology (EAU) and the American Urological Association (AUA) recommend mirabegron as a first-line pharmacological option alongside anticholinergics for OAB management.
Clinical trials, including large randomised controlled trials (RCTs) such as the SCORPIO, ARIES, and CAPRICORN studies, have demonstrated that mirabegron 50 mg significantly reduces the mean number of incontinence episodes per 24 hours and the mean number of micturitions per 24 hours compared to placebo. These benefits typically become apparent within the first four weeks of treatment and are sustained with long-term use.
What Should You Know Before Taking Mirabegron Glenmark?
Contraindications
Mirabegron Glenmark must not be used in certain situations where the risks outweigh the potential benefits. Understanding these contraindications is essential for safe use of this medication.
You should not take Mirabegron Glenmark if you are allergic to mirabegron or any of the other ingredients in the tablet. Signs of an allergic reaction may include skin rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing. If you experience any of these symptoms, stop taking the medication and seek immediate medical attention.
Mirabegron Glenmark is contraindicated in patients with severe uncontrolled hypertension, defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. This is because mirabegron can cause dose-related increases in blood pressure, and administering the drug to patients with already severely elevated blood pressure could lead to dangerous hypertensive crises.
Do not take Mirabegron Glenmark if you have severe uncontrolled high blood pressure (systolic ≥180 mmHg or diastolic ≥110 mmHg). Have your blood pressure checked before starting treatment and regularly during treatment.
Warnings and Precautions
Several clinical situations require special caution when using Mirabegron Glenmark. Your prescribing physician should be made aware of these conditions before initiating treatment.
Urinary retention and bladder outlet obstruction: Mirabegron should be used with caution in patients with bladder outlet obstruction (BOO) and in patients who are concurrently taking antimuscarinic medications for overactive bladder. Urinary retention has been reported in post-marketing experience in patients with BOO receiving mirabegron. If you have difficulty emptying your bladder or have a weak urine stream, discuss this with your doctor.
Hypertension: Mirabegron can increase blood pressure. Your blood pressure should be measured before starting treatment and periodically during treatment. In clinical trials, small increases in mean blood pressure of approximately 1 mmHg systolic and 0.5 mmHg diastolic were observed. However, individual patients may experience more significant increases. Patients with pre-existing hypertension should be monitored more frequently.
Renal impairment: In patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15–29 mL/min/1.73 m²), the recommended dose should not exceed 25 mg once daily (where available). Mirabegron is not recommended in patients with end-stage renal disease (eGFR <15 mL/min/1.73 m² or patients requiring haemodialysis).
Hepatic impairment: In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should not exceed 25 mg once daily (where available). Mirabegron is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Pregnancy and Breastfeeding
Pregnancy: There are no adequate and well-controlled studies of mirabegron in pregnant women. Animal reproduction studies have shown adverse effects at doses significantly higher than the maximum recommended human dose. Mirabegron Glenmark should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus. Women of childbearing potential are advised to use effective contraception during treatment.
Breastfeeding: Mirabegron is excreted into the milk of rats, but it is not known whether it is excreted in human breast milk. A risk to breastfed infants cannot be excluded. A decision should be made whether to discontinue breastfeeding or to discontinue mirabegron therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: The effect of mirabegron on human fertility has not been established. Animal studies did not show adverse effects on fertility at clinically relevant doses.
How Does Mirabegron Glenmark Interact with Other Drugs?
Drug interactions are an important consideration with mirabegron because of its effect on hepatic drug-metabolising enzymes. Mirabegron is a moderate inhibitor of the cytochrome P450 2D6 (CYP2D6) enzyme. This means that it can increase the plasma concentration of drugs that are substrates of CYP2D6 by slowing their metabolism. Understanding these interactions is crucial for safe prescribing and to avoid adverse effects from elevated drug levels.
When mirabegron is administered together with CYP2D6 substrates, the exposure of these substrates can increase significantly. In pharmacokinetic studies, co-administration of mirabegron 160 mg (a supratherapeutic dose) with metoprolol increased metoprolol AUC (area under the curve) by approximately 3.29-fold. At the therapeutic dose of 50 mg, the interaction is less pronounced but still clinically relevant, particularly for drugs with a narrow therapeutic index.
Major Interactions
| Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Digoxin | Increased digoxin plasma levels (AUC increased by 27%, Cmax by 29%) | Risk of digoxin toxicity (nausea, vomiting, arrhythmias) | Initiate digoxin at lowest dose; monitor digoxin levels |
| Thioridazine | Increased thioridazine exposure via CYP2D6 inhibition | Risk of QT prolongation and cardiac arrhythmias | Combination not recommended |
| Flecainide / Propafenone | Increased exposure of these antiarrhythmics via CYP2D6 | Risk of proarrhythmic effects | Use with caution; dose adjustment may be needed |
Minor Interactions
| Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Metoprolol | Increased metoprolol Cmax by 90% and AUC by 229% (at 160 mg mirabegron) | May enhance bradycardia and hypotension | Monitor heart rate and blood pressure; consider dose adjustment |
| Desipramine | Increased desipramine AUC by approximately 79% | Increased risk of tricyclic antidepressant side effects | Start desipramine at lower dose; titrate carefully |
| Warfarin | No clinically significant pharmacokinetic interaction observed | Low risk | No dose adjustment required; routine INR monitoring |
| Solifenacin | Modest increase in solifenacin exposure when co-administered | Potential for additive pharmacodynamic effects on bladder | Combination can be used; monitor for antimuscarinic side effects |
| Ketoconazole / Itraconazole | Strong CYP3A4 inhibitors increase mirabegron levels by ~45% | Increased risk of mirabegron side effects | No dose adjustment at 50 mg; caution with additional CYP2D6 poor metaboliser status |
Always inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. This list of interactions is not exhaustive. Your healthcare provider can assess whether Mirabegron Glenmark is safe to take with your other medications.
What Is the Correct Dosage of Mirabegron Glenmark?
Mirabegron Glenmark is formulated as a prolonged-release tablet, which means the active ingredient is released slowly over an extended period to maintain consistent blood levels throughout the day. This formulation is critical for the medication’s efficacy and safety profile, and therefore the tablets must not be crushed, chewed, or divided.
Adults
Standard Adult Dose
Dose: 50 mg once daily
Administration: Swallow the tablet whole with water. Do not crush, chew, or break the tablet.
Timing: Can be taken at any time of day, with or without food. For best results, take at approximately the same time each day.
Onset of effect: Symptom improvement is typically observed within 4–8 weeks. Continue treatment even if initial improvement seems gradual.
The therapeutic effect of mirabegron builds over time. While some patients may notice improvement within the first two weeks, the full benefit is generally achieved after approximately eight weeks of consistent daily use. It is important to continue taking the medication as prescribed, even if you do not notice immediate results.
Special Populations
| Patient Group | Recommended Dose | Notes |
|---|---|---|
| Adults (standard) | 50 mg once daily | No dose adjustment based on age, gender, or race |
| Elderly (≥65 years) | 50 mg once daily | No dose adjustment required; monitor blood pressure |
| Mild renal impairment | 50 mg once daily | No dose adjustment needed (eGFR 30–89) |
| Severe renal impairment | 25 mg once daily (where available) | eGFR 15–29; not recommended if eGFR <15 |
| Mild hepatic impairment | 50 mg once daily | Child-Pugh A; no adjustment needed |
| Moderate hepatic impairment | 25 mg once daily (where available) | Child-Pugh B; not recommended in Child-Pugh C |
Children and Adolescents
The safety and efficacy of mirabegron in children and adolescents under 18 years of age have not been established. Mirabegron Glenmark should not be used in this age group. Overactive bladder symptoms in children are typically managed with behavioural interventions, pelvic floor therapy, and, if pharmacotherapy is needed, anticholinergic medications such as oxybutynin under specialist supervision.
Elderly Patients
No dose adjustment is required for elderly patients. Clinical trials included a significant proportion of patients aged 65 years and older, and the efficacy and safety profile was consistent with that seen in younger adults. However, elderly patients are more likely to have comorbid conditions (such as hypertension) and to be taking multiple medications. Regular blood pressure monitoring and awareness of potential drug interactions are therefore especially important in this population.
Missed Dose
If you miss a dose of Mirabegron Glenmark, skip the missed dose and take the next dose at the usual scheduled time. Do not take a double dose to make up for a forgotten one. If you frequently forget doses, consider setting a daily alarm or using a pill organiser to help you remember.
Overdose
If you take more Mirabegron Glenmark than prescribed, or if someone accidentally takes your medication, contact your local poison control centre or seek emergency medical attention immediately.
Mirabegron has been administered to healthy volunteers in single doses of up to 400 mg. At these supratherapeutic doses, the most commonly reported adverse events were palpitations and increased heart rate. There is no specific antidote for mirabegron overdose. Treatment should be symptomatic and supportive, with monitoring of heart rate, blood pressure, and electrocardiogram (ECG) as clinically indicated. Haemodialysis is not expected to be effective in removing mirabegron due to its high protein binding.
What Are the Side Effects of Mirabegron Glenmark?
Like all medicines, Mirabegron Glenmark can cause side effects, although not everybody gets them. The side effects listed below are based on data from clinical trials involving over 10,000 patients treated with mirabegron, as well as post-marketing surveillance. Side effects are categorised by frequency according to international convention (MedDRA).
It is important to note that mirabegron was generally well tolerated in clinical trials. The overall incidence of adverse events was similar between mirabegron and placebo groups. Most adverse events were mild to moderate in severity and resolved without discontinuation of treatment. The rate of discontinuation due to adverse events was approximately 3–5% for mirabegron 50 mg compared to 2–4% for placebo.
Very Common
- Urinary tract infection (UTI)
Common
- Tachycardia (increased heart rate)
- Palpitations (awareness of heartbeat)
- Elevated blood pressure (hypertension)
- Nasopharyngitis (common cold symptoms)
- Headache
- Constipation
- Diarrhoea
- Nausea
- Dizziness
- Abdominal pain
- Vulvovaginal pruritus (genital itching)
Uncommon
- Cystitis (bladder inflammation)
- Dyspepsia (indigestion)
- Gastritis (stomach inflammation)
- Joint swelling
- Atrial fibrillation (irregular heartbeat)
- Dry mouth
- Urticaria (hives)
- Rash
- Leukocytoclastic vasculitis (blood vessel inflammation)
Rare
- Urinary retention (inability to empty the bladder)
- Angioedema (severe swelling of face, lips, tongue, or throat)
- Lip oedema (swelling of the lips)
- Eyelid oedema (swelling of the eyelids)
- Hypertensive crisis
- Purpura (purple spots on the skin)
Stop taking Mirabegron Glenmark and seek emergency medical help immediately if you experience: swelling of the face, lips, tongue, or throat (angioedema); difficulty breathing; a severe skin rash with blistering; or chest pain with severe palpitations. These may be signs of a serious allergic reaction or cardiac event.
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority (e.g., the MHRA Yellow Card scheme in the UK, FDA MedWatch in the US, or EMA EudraVigilance in the EU). Reporting side effects helps to provide more information on the safety of this medicine.
How Should You Store Mirabegron Glenmark?
Proper storage of Mirabegron Glenmark is essential to maintain the medication’s effectiveness and safety throughout its shelf life. The prolonged-release formulation is designed to release the active ingredient gradually, and exposure to adverse conditions (excessive heat, humidity, or light) can compromise this mechanism.
Temperature: Store at a temperature not exceeding 30°C (86°F). Do not freeze. Avoid storing in locations where temperature may fluctuate significantly, such as near windows, radiators, or in the car during hot weather.
Moisture protection: Keep the tablets in the original blister packaging until you are ready to take a dose. The prolonged-release coating is sensitive to moisture, and removing tablets in advance can compromise the formulation. Do not transfer tablets to pill organisers for more than one week at a time.
Children: Keep this medicine out of the sight and reach of children. Store in a secure location, ideally in a locked medicine cabinet. Accidental ingestion by a child requires immediate medical attention.
Expiry date: Do not use Mirabegron Glenmark after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month. Expired medications should not be used as the potency and safety cannot be guaranteed.
Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired medicines to your pharmacy for proper disposal. This helps protect the environment from pharmaceutical contamination.
What Does Mirabegron Glenmark Contain?
Understanding the composition of your medication is important, particularly if you have known allergies or intolerances to certain excipients. Each Mirabegron Glenmark 50 mg prolonged-release tablet contains the following components:
Active substance: Mirabegron 50 mg per tablet. Mirabegron is a synthetic beta-3 adrenergic agonist with the chemical name 2-(2-amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide. It has a molecular weight of 396.51 g/mol.
Excipients (inactive ingredients): The excipients used in prolonged-release tablet formulations typically include:
- Tablet core: Macrogol, hydroxypropyl cellulose, butylated hydroxytoluene (BHT), magnesium stearate
- Film coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) — these give the tablet its characteristic colour
Appearance: Mirabegron Glenmark 50 mg prolonged-release tablets are typically oval-shaped, film-coated tablets. The exact colour and markings may vary by manufacturer batch but are consistent within a batch for quality assurance purposes.
If you have known allergies to any of the above ingredients, discuss this with your doctor or pharmacist before taking this medication. In particular, patients with sensitivities to iron oxide dyes or butylated hydroxytoluene (BHT) should inform their healthcare provider.
Frequently Asked Questions
Mirabegron Glenmark is used to treat overactive bladder (OAB) symptoms in adults. These symptoms include urgency (a sudden, strong need to urinate), urinary frequency (needing to urinate more often than normal), and urgency incontinence (involuntary leakage of urine associated with a sudden urge to urinate). It works by relaxing the bladder muscle during filling, which increases bladder capacity and reduces the frequency of involuntary bladder contractions.
Mirabegron is a beta-3 adrenergic agonist, which is a different class of medication from the more traditional anticholinergic/antimuscarinic drugs (such as oxybutynin, solifenacin, or tolterodine). The key advantage is that mirabegron avoids the anticholinergic side effects that many patients find troublesome, including dry mouth, constipation, blurred vision, and cognitive impairment. This makes it particularly suitable for elderly patients, those with cognitive concerns, or patients who have tried anticholinergics but could not tolerate the side effects.
Some patients may begin to notice improvement in OAB symptoms within the first 2–4 weeks of treatment. However, the full therapeutic benefit of mirabegron is typically achieved after approximately 8 weeks of continuous daily use. It is important to take the medication every day as prescribed, even if you do not see immediate improvement. If after 8–12 weeks you feel the medication is not adequately controlling your symptoms, speak with your doctor about potentially adjusting your treatment plan.
Yes, Mirabegron Glenmark can be taken with or without food. Food does not significantly affect the absorption of mirabegron. The tablet should be swallowed whole with a glass of water and should not be crushed, chewed, or broken, as this would destroy the prolonged-release mechanism and could lead to an excessive initial release of the active ingredient.
Weight gain is not a commonly reported side effect of mirabegron. In clinical trials, there was no significant difference in weight changes between patients taking mirabegron and those taking placebo. If you experience unexplained weight changes while taking this medication, discuss it with your healthcare provider to rule out other potential causes.
Mirabegron Glenmark should not be used during pregnancy unless clearly necessary and only after careful assessment by a healthcare provider. There are no adequate studies of mirabegron in pregnant women, and animal studies have shown some reproductive effects at high doses. If you are pregnant, planning to become pregnant, or become pregnant while taking this medication, contact your doctor immediately to discuss the risks and benefits.
References
This article is based on the following peer-reviewed sources and international regulatory documents:
- European Medicines Agency (EMA). Mirabegron Summary of Product Characteristics (SmPC). EMA/CHMP, last updated 2024. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Myrbetriq (mirabegron) Prescribing Information. Reference ID: 5051372. Available at: www.accessdata.fda.gov
- Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial (SCORPIO). Eur Urol. 2013;63(2):283-295. doi:10.1016/j.eururo.2012.10.016
- Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder (ARIES). J Urol. 2013;189(4):1388-1395. doi:10.1016/j.juro.2012.10.017
- Herschorn S, Barkin J, Castro-Diaz D, et al. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder (CAPRICORN). Urology. 2013;82(2):313-320. doi:10.1016/j.urology.2013.02.077
- British National Formulary (BNF). Mirabegron. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- European Association of Urology (EAU). Guidelines on the Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. Updated 2024.
- Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β3-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013;63(2):296-305. doi:10.1016/j.eururo.2012.10.048
- Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202(3):558-563. doi:10.1097/JU.0000000000000309
Editorial Team
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