- 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
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **POSOLOGY AND METHOD OF ADMINISTRATION:**
_Adults, including the elderly:_
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.
_Children and adolescents:_
Solifenacin succinate is not indicated for treatment of OAB in the pediatric population.
**Special populations:**
_Patients with renal impairment:_
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.
_Patients with hepatic impairment:_
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).
_Co-medication:_
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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Method of administration:**
Solifenacin Succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS:**
Solifenacin Succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
- Contraindications
- **CONTRAINDICATIONS:**
**Solifenacin is contraindicated in**
- patients with urinary retention.
- patients with uncontrolled narrow-angle glaucoma.
- patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
- severe gastro-intestinal condition (including toxic megacolon and gastric retention).
- myasthenia gravis.
- patients undergoing haemodialysis.
- patients with severe hepatic impairment.
- patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.
- Atc Code
- G04BD08
- Atc Item Name
- solifenacin
- Pharma Manufacturer Name
- SYNERRV (S) PTE. LTD.
- Company Detail Path
- /organization/5e79491f079182d2/synerrv-s-pte-ltd
