Indication

Treatment of urinary incontinence, urgency and urinary frequency due to overactive bladder (OAB).


Dosage & Administration

Starting dose of Mirabegron is 25 mg once daily with or without food. Mirabegron 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily.
Mirabegron should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
Patients with severe Renal Impairment or Patients with Moderate Hepatic Impairment: Maximum dose of Mirabegron is 25 mg once daily.
Patients with End Stage Renal Disease (ESRD) or Patients with Severe Hepatic Impairment: Mirabegron not recommended.


Precautions

• Increased blood pressure: Mirabegron can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Mirabegron is not recommended for use in severe uncontrolled hypertensive patients.
Mirabegron
• Inability to empty your bladder (urinary retention): Mirabegron may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
• Patients taking drugs metabolized by CYP2D6: Mirabegron is a moderate inhibitor of CYP2D6. Appropriate monitoring is recommended and dose adjustment may be necessary for narrow therapeutic index CYP2D6 substrates.
Use in special group
Pregnancy Category C: There are no adequate and well-controlled studies using Mirabegron in pregnant women. Mirabegron should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Mirabegron treatment are encouraged to contact their physician.


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