Mirabegron

A beta-3 adrenergic receptor agonist.

Silodosin

An alpha-1 adrenergic receptor antagonist.

Note: This combination is not a standard FDA-approved fixed-dose combination. The use of Mirabegron and Silodosin together is typically off-label, meaning a doctor may prescribe them separately to manage specific symptoms in a patient with benign prostatic hyperplasia (BPH) and OAB.

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency in adults.

Mirabegron relaxes the bladder muscle, reducing the urge to urinate. Silodosin relaxes the muscles in the prostate gland, improving urine flow. The combined effect aims to manage both bladder overactivity and urinary outflow obstruction in men.

Store at room temperature (68-77°F or 20-25°C). Protect from moisture and light. Keep out of reach of children.

Dosage for both Mirabegron and Silodosin will be determined individually by the prescribing physician based on patient factors and response to therapy.

It's crucial to follow your doctor's prescribed dosage and schedule precisely. Do not alter the dosage without consulting your doctor.

Increased heart rate

High blood pressure

Dizziness

Headache

Dry mouth

Constipation

Nasal congestion

Retrograde ejaculation (in men)

Erectile dysfunction (in men)

Hypotension (low blood pressure)

Alcohol Consumption

May increase the risk of dizziness and hypotension. Avoid excessive alcohol consumption.



Driving or operating Machinery

May cause dizziness or drowsiness. Avoid driving or operating machinery until you know how this medication affects you.



Pregnant & Breastfeeding Women

Not recommended during pregnancy or breastfeeding. Consult your doctor immediately if you become pregnant or plan to breastfeed while taking these medications.



Children

Not approved for use in children.



Kidney

Dose adjustment may be necessary for patients with impaired kidney function.



Liver

Dose adjustment may be necessary for patients with impaired liver function.

Always consult your physician or pharmacist for the most accurate and up-to-date information regarding your prescribed medications.

Refer to the package insert provided with your medication for complete prescribing information.