- Approval Id
- de356dc9e1596d03
- Drug Name
- BETMIGA ® PROLONGED-RELEASE TABLETS 50MG
- Product Name
- BETMIGA ® PROLONGED-RELEASE TABLETS 50MG
- Approval Number
- SIN14623P
- Approval Date
- 2014-09-15
- Registrant
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Licence Holder
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Adults (including elderly patients)</em><br>
The recommended starting dose of Betmiga is 25 mg once daily. Based on individual patient efficacy and tolerability the dose may be increased to 50mg once daily.</p>
<p>Betmiga can be taken with or without food.</p>
<p><em>Special populations</em></p>
<p><em>Renal and hepatic impairment</em><br>
No dose adjustment is necessary in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m<sup>2</sup> as estimated by MDRD). In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m<sup>2</sup>), the recommended dose is 25 mg dose once daily with or without food. Betmiga has not been studied in patients with End Stage Renal Disease (eGFR < 15 mL/min/1.73 m<sup>2</sup> or patients requiring haemodialysis) (see sections 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). In patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dose is 25 mg once daily with or without food. Betmiga has not be studied in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Gender</em><br>
No dose adjustment is necessary according to gender.</p>
<p><em>Paediatric population</em></p>
<p>The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.</p>
<p><u>Method of administration</u><br>
The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Mirabegron is contraindicated in patients with</p>
<ul class="dash">
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.</li>
</ul>
- Atc Code
- G04BD12
- Atc Item Name
- mirabegron
- Pharma Manufacturer Name
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
