سوفيناسين 10مجم 20 قرص

12.1 Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ( 1 ).

• 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily ( 2.1 ). • Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: • Severe renal impairment creatinine clearance <30 mL/min/1.73 m 2 ( 2.2 , 8.6 ). • Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child- Pugh C) ( 2.3 , 8.7 ). • Concomitant use of strong CYP3A4 inhibitors ( 2.4 , 7.1 ). 2.1 Dosing Information The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food. 2.2 Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) [ see (8.6) ]. 2.3 Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use of solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C) [ see (8.7) ]. 2.4 Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when solifenacin succinate tablets are administered with strong CYP3A4 inhibitors such as ketoconazole [ see ( 7.1 ) ].

The most common (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose ( 6.1 ). To report SUSPECTED , contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Solifenacin succinate has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 4) [see Clinical Studies ( 14 )] . Expected of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with solifenacin succinate was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the solifenacin succinate 10 mg group. Angioneurotic edema was reported in one patient taking solifenacin succinate 5 mg. Compared to 12 weeks of treatment with solifenacin succinate, the incidence and severity of were similar in patients who remained on drug for up to 12 months in Study 5 [ see Clinical Studies ( 14 ) ]. The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified , in the four randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with solifenacin succinate 5 or 10 mg once daily for up to 12 weeks. Table 1: Reported by ≥ 1% of Patients and Exceeding Placebo in Studies 1, 2, 3 and 4 Placebo (%) Solifenacin Succinate 5 mg (%) Solifenacin Succinate 10 mg (%) Number of Patients 1216 578 1233 GASTROINTESTINAL DISORDERS Dry Mouth 4.2 10.9 27.6 Constipation 2.9 5.4 13.4 Nausea 2 1.7 3.3 Dyspepsia 1 1.4 3.9 Abdominal Pain Upper 1 1.9 1.2 Vomiting NOS 0.9 0.2 1.1 INFECTIONS AND INFESTATIONS Urinary Tract Infection NOS 2.8 2.8 4.8 Influenza 1.3 2.2 0.9 Pharyngitis NOS 1 0.3 1.1 NERVOUS SYSTEM DISORDERS Dizziness 1.8 1.9 1....

Solifenacin succinate tablets are contraindicated in patients: • With urinary retention [ see ( 5.2 ) ], • With gastric retention [ see ( 5.3 ) ], • With uncontrolled narrow-angle glaucoma [ see ( 5.5 ) ], and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported have included anaphylaxis and angioedema [ see ( 6.2 ) ]. • Urinary retention ( 4 , 5.2 ). • Gastric retention ( 4 , 5.3 ). • Uncontrolled narrow-angle glaucoma ( 4 , 5.5 ). • Hypersensitivity to this product or any of its components ( 4 , 5.1 , 6.2 ).