- Approval Id
- f9a93082bf295300
- Drug Name
- SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG
- Product Name
- SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG
- Approval Number
- SIN16335P
- Approval Date
- 2021-09-27
- Registrant
- SYNERRV (S) PTE. LTD.
- Licence Holder
- SYNERRV (S) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION:</strong><br>
<em>Adults, including the elderly:</em><br>
The recommended dose is 5 mg Solifenacin succinate film-coated tablet once daily. If needed, the dose may be increased to 10 mg Solifenacin succinate film-coated tablet once daily.</p>
<p><em>Children and adolescents:</em><br>
Solifenacin succinate is not indicated for treatment of OAB in the pediatric population.</p>
<p><strong>Special populations:</strong><br>
<em>Patients with renal impairment:</em><br>
No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should be treated with caution and receive no more than 5 mg once daily.</p>
<p><em>Patients with hepatic impairment:</em><br>
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. Solifenacin Succinate is not recommended for patients with severe hepatic impairment (Child-Pugh C).</p>
<p><em>Co-medication:</em><br>
The maximum dose of Solifenacin Succinate should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide antibiotics (see also INTERACTIONS WITH OTHER MEDICINAL PRODUCTS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of administration:</strong><br>
Solifenacin Succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS:</strong><br>
Solifenacin Succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong><br>
<strong>Solifenacin is contraindicated in</strong></p>
<ul class="dash">
<li>patients with urinary retention.</li>
<li>patients with uncontrolled narrow-angle glaucoma.</li>
<li>patients who have demonstrated hypersensitivity to the drug substance or other components of the product.</li>
<li>severe gastro-intestinal condition (including toxic megacolon and gastric retention).</li>
<li>myasthenia gravis.</li>
<li>patients undergoing haemodialysis.</li>
<li>patients with severe hepatic impairment.</li>
<li>patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.</li>
</ul>
- Atc Code
- G04BD08
- Atc Item Name
- solifenacin
- Pharma Manufacturer Name
- SYNERRV (S) PTE. LTD.
- Company Detail Path
- /organization/synerrv-s-pte-ltd
