Mirasol XR Tablet (Extended Release) Mirabegron 50 mg
Mirabegron, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency
During the urine storage phase, when urine accumulates in the bladder, sympathetic nerve stimulation predominates. Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature and hence bladder smooth muscle relaxation. During the urine voiding phase, the bladder is predominantly under parasympathetic nervous system control. Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction. The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP. Therefore beta 3-adrenoceptor stimulation should not interfere with the voiding process. This was confirmed in rats with partial urethral obstruction, where mirabegron decreased the frequency of non-voiding contractions without affecting the voided volume per micturition, voiding pressure or residual urine volume.
Dosage & Administration
Patients with Severe Renal Impairment or Patients with Moderate Hepatic Impairment: Maximum dose is 25 mg Mirabegron once daily
Patients with End Stage Renal Disease (ESRD) or Patients with Severe Hepatic Impairment: Not recommended
Clinically relevant drug interactions between mirabegron and medicinal products that inhibit, induce or are a substrate for one of the CYP isozymes or transporters are not expected, except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates.
Pregnancy & Lactation
Use in Lactation: Mirabegron is excreted in the milk of rodents and therefore, is predicted to be present in human milk. No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Mirabegron should not be administered during breast-feeding
Use in Special Populations
Gender: No dose adjustment is necessary according to gender.
Children: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.