- Approval Id
- b55c9be0c6ef20da
- Drug Name
- SOLICIN-5 FILM COATED TABLET 5 MG
- Product Name
- SOLICIN-5 FILM COATED TABLET 5 MG
- Approval Number
- SIN16510P
- Approval Date
- 2022-06-09
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>v. Recommended Dosage:</strong></p>
<p><em>Adults, including the elderly</em><br>
The recommended dose is 5 mg Solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg Solifenacin succinate 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 Tablet 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 Tablet 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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>iv. Therapeutic Indication:</strong></p>
<p>Solifenacin Succinate Tablet is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.</p>
- Contraindications
- <p><strong>vii. Contraindication:</strong></p>
<p>Solifenacin is contraindicated in</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
- ACCORD HEALTHCARE PRIVATE LIMITED
