Mirabegron 25 mg + Solifenacin 5 mg (ER)

Category- Allopathy

Medicine Highlights

Mirabegron + Solifenacin Uses

Mirabegron 25 mg + Solifenacil (5 mg) (ER) is an oral combination medicine belonging to the category of muscarinic receptor antagonists and beta-3 agonists is used for the following indications:

1. Overactive bladder 
2. Bladder leakage 
3. Unable to hold urine 

Mirabegron + Solifenacin side effects 

More Common  

1. Blurred vision 
2. Dry mouth, dry eyes 
3. Painful urination 
4. Constipation 
5. Heat stroke, increased sweating, dry skin, dizziness, tiredness, nausea, feeling hot 

Less Common 

1. Severe stomach pain, or constipation for 3 days or longer; 
2. Pain or burning when you urinate; 
3. Headache, confusion, drowsiness, hallucinations; 
4. Vision changes, eye pain, or seeing halos around lights; 
5. Little or no urination, pain or burning when you urinate; 
6. Dehydration symptoms—dizziness, tiredness, feeling very thirsty or hot, decreased sweating, or hot and dry skin; or 
7. High potassium level—nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. 
8. Back pain 
9. Body aches or pain 
10. Constipation 
11. Difficulty having a bowel movement 
12. Difficulty with breathing 
13. Difficulty with moving 
14. Dry mouth 
15. Ear congestion 
16. Fever 
17. General feeling of discomfort or illness 
18. Loss of voice 
19. Muscle ache or stiffness 
20. Shivering 
21. Sneezing 
22. Stomach pain 
23. Stuffy or runny nose 
24. Sweating 

How Mirabegron + Solifenacin works 

This medicine treats overactive bladder, a condition where the bladder contracts too often causing urgency and leakage. Mirabegron activates β3‑adrenergic receptors in the bladder muscle to increase storage capacity, while solifenacin blocks muscarinic receptors to reduce involuntary contractions. Together they improve bladder control, lessen frequency, and reduce nighttime urination.

Safety Measures and Warning

Allergies 

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicine. Also tell your health care professional if you have any other types of allergies, such as foods, dyes, preservatives, or animals.  

Pregnancy

This combination is not recommended in pregnancy due to lack of safety data and animal studies show risks such as poor development and low birth weight. Always consult a doctor before using it.

Kidney and Liver Problems

Patients with previous liver and kidney damage are not recommended to take the medicine, as it can cause liver and kidney toxicity while being removed from the body.

Breastfeeding

Long-term use of solifenacin and mirabegron might reduce milk production. It is not known whether solifenacin is passed into breast milk. Since it remains in the body for a long time, there are chances that it may be passed on to your infant. As there is no adequate data to prove its safety and efficacy in humans while breastfeeding, it is best to consult your doctor before taking this medicine.

Heart Problems

Solifenacin in combination with mirabegron may affect the heart and blood pressure. It is not recommended for patients with arrhythmia or heart disease, and medical advice should be sought before use.

Mirabegron + Solifenacin Interaction with Food Product 

The use of drinks that contain alcohol raises your risk of low blood pressure from mirabegron. If you drink alcohol, talk to your doctor. You may need to have your blood pressure monitored while you take this drug.

Mirabegron + Solifenacin Interaction with Other Medicines  

Avoid taking Mirabegron 25 mg with the following medicines, as it may increase or decrease the desired effect, or in worse cases, it could be fatal:

Mirabegron + Solifenacin Chemical Structure

IUPAC (International Union of Pure and Applied Chemistry)/ Chemical name

Mirabegron-(3R)-1-azabicyclo [2.2.2] octan-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate

Solifenacin-2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl] amino} ethyl) phenyl] acetamide 

Intake routine/cycle

Daily dose

Take mirabegron and solifenacin exactly as your doctor recommends. The dose may change based on your condition and how well you respond. Do not take more than prescribed without consulting your doctor.

Missed Dose

If you forget to take your medicine, take the medication as soon as you remember. If it’s nearly time for your next dose, skip the missed one and continue with your regular schedule. Always consult the doctor before making any changes to your dosage.

Overdose

It is not recommended to take more than 300 mg of solifenacin per day, as it may cause severe overdosing effects like kidney and liver damage, fatigue, blurred vision, mental changes, and dizziness. If you face any of the severe effects, meet the doctor.

Storage

1. Store the medicine at room temperature 
2. Keep away from sunlight and moisture 
3. Keep out of reach of children 

Directions for use 

1. Take Mirabegron + Solifenacin exactly as prescribed by your doctor, at the same time each day. 
2. Do not stop taking Mirabegron + Solifenacin without your doctor’s approval, even if you feel better. 
3. If you forget to take Mirabegron + Solifenacin, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose. 

Mirabegron + Solifenacin Summary 

Mirabegron and solifenacin are two medicines often used. to treat overactive bladder, a condition where you feel a sudden urge to pee and sometimes can’t control it. Mirabegron helps the bladder hold more urine by relaxing its muscles, while solifenacin calms down the nerves that make your bladder squeeze too often. This combination reduces the urge to urinate and leaks and helps with nighttime bathroom trips. Common side effects include dry mouth, constipation, dizziness, and sometimes blurry vision or urinary infections. Extra care is needed in older adults, pregnant or breastfeeding women, children, and those with heart disease, as side effects may be stronger. Taking more than the usual daily limits of mirabegron (25–50 mg) or solifenacin (5–10 mg) can cause serious problems like fast heartbeat, high blood pressure, confusion, or dizziness, so doses must not be exceeded.

FAQ’s

What are the uses of Mirabegron + Solifenacin tablets?

Solifenacin is a muscarinic receptor antagonist medicine used to treat overactive bladder, a condition where you feel the sudden need to pee often or can’t hold it in. It works by calming down bladder nerves to reduce urgency and leaks.

What are the side effects of Mirabegron + Solifenacin ?

Common side effects of this medicine use include dry mouth, constipation, and blurred vision. Avoid it if you have trouble passing urine, stomach issues like severe constipation, or certain eye problems like glaucoma.

What is the mechanism of action of Mirabegron + Solifenacin ?

This medicine treats overactive bladder by relaxing the bladder muscle through β3‑adrenergic activation (mirabegron) and blocking muscarinic receptors (solifenacin), improving control and reducing urgency, frequency, and nighttime urination.

What is the recommended solifenacin dose range per day?

It is recommended to take up to 30 mg of solifenacin per day without getting any side effects, and doses above 30 mg can cause severe side effects and may lead to mental health changes, confusion, dizziness, etc.

Reference 

1. Yamaguchi O, Marui E, Kakizaki H, et al. Solifenacin as a treatment for overactive bladder: results of a Japanese phase 3 trial. Int J Urol. 2007;14(6):483–489. Availablr from. 
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Siva Krishna Adithya Bhumireddy

Siva Krishna Adithya Bhumireddy completed a Bachelor of Pharmacy from GIET School of Pharmacy, affiliated with Andhra University, and from his 3rd year of graduation, he was working as a freelance medical and publication writer. Having expertise in systematic reviews and clinical research. With his keen interest and skills in research and documentation practices, he also reviewed more than 150 manuscripts from international journals like Elsevier, Springer Nature, and Sage Journals, and all the manuscripts were indexed and appeared in PubMed, Scopus, and Web of Science databases, and he received honorary recognition letters and certificates from all of them. Siva Krishna Adithya also published a few systematic, narrative reviews and a few chapters of international expertise.