Product Overview
[Drug Name]
Generic Name: Solifenacin Succinate Tablets
Trade Name: HaiSuoNing Solifenacin Succinate Tablets 5mg*10 Tablets
Pinyin Full Code: HaiSuoNing ZuoZuoSuanSuoLiNaXin Tablets 5mg*10 Tablets
[Main Ingredient]
Chemical Name: Solifenacin Succinate (3R)-1-Azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate Monosuccinate
Molecular Formula:C23H26N202·C4H6O4
Molecular Weight: 480.55
[Properties]
This product is a film-coated tablet that appears white after removal of the film coating.
[Indications/Main Functions]
For the treatment of urinary incontinence and/or urinary frequency and urgency in patients with overactive bladder.
[Specifications]
5mg*10 tablets
[Dosage and Administration]
The recommended dose of this product is 5 mg once daily, which can be increased to 10 mg once daily if necessary. This product must be taken whole with water and can be taken before or after meals. Patients with Renal Impairment: Patients with mild or moderate renal impairment (creatinine clearance >30 ml/min) do not require dosage adjustment. Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should use this product with caution, with a dose not exceeding 5 mg daily. Patients with Hepatic Impairment: Patients with mild hepatic impairment do not require dosage adjustment. Patients with moderate hepatic impairment (Child-Pugh score 7 to 9) should use this product with caution, with a dose not exceeding 5 mg once daily. The maximum dose of this product should not exceed 5 mg when used concomitantly with ketoconazole or therapeutic doses of other strong CYP3A4 inhibitors such as ritonavir, nelfinavir, and itraconazole.
[Adverse Reactions]
See package insert for details.
[Contraindications]
This product should not be used in patients with urinary retention, severe gastrointestinal disease (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, or in patients at risk for the following: patients with hypersensitivity to the active ingredient or excipients of this product; patients undergoing hemodialysis; patients with severe hepatic dysfunction; and patients with severe renal or moderate hepatic dysfunction who are taking strong CYP3A4 inhibitors such as ketoconazole.
[Precautions]
Before using this product, other causes of frequent urination (heart failure or renal disease) should be identified. If a urinary tract infection is present, appropriate antimicrobial therapy should be initiated. Caution should be exercised in the following patients: those with clinically significant lower urinary tract obstruction at risk of urinary retention; those with obstructive gastrointestinal disease; those at risk of decreased gastrointestinal motility; those with severe renal impairment (creatinine clearance ≤30 ml/min; see [Dosage and Administration] and [Pharmacokinetics]); in these patients, the dose should not exceed 5 mg once daily; those with moderate hepatic impairment (Child-Pugh score 7 to 9; see [Dosage and Administration] and [Pharmacokinetics]); in these patients, the dose should not exceed 5 mg once daily; those taking a potent cytochrome P450 3A4 inhibitor such as ketoconazole; see [Dosage and Administration] and [Drug Interactions]; those with hiatal hernia/gastroesophageal reflux and/or those taking medications that can cause or worsen esophagitis (e.g., bisphosphonates); and those with autonomic nervous system disorders. QT prolongation and torsades de pointes have been observed in patients with risk factors (e.g., preexisting long QT syndrome and hypokalemia). Safety and efficacy of this medication in patients with neurogenic detrusor overactivity have not been established. This medication should not be used in patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Angioedema with airway obstruction has been reported in some patients using this medication. If angioedema occurs, this medication should be discontinued and appropriate treatment and/or measures should be instituted. Hypersensitivity reactions have been reported in some patients using solifenacin succinate. In patients who experience hypersensitivity reactions, solifenacin succinate should be discontinued and appropriate treatment and/or measures should be instituted. The maximum efficacy of this medication can be determined as early as four weeks after administration. Effects on driving and operating machinery: Like other anticholinergic drugs, solifenacin may cause blurred vision, drowsiness, and (rarely) fatigue (see Adverse Reactions), which may negatively affect driving and operating machinery.
