Reference

Pharmacological and clinical profile of solifenacin succinate (Vesicare) developed as a new therapeutic agent for overactive bladder

All Rights Reserved. Pharmacological and clinical profile of solifenacin succinate (Vesicare) developed as a new therapeutic agent for overactive bladder. 242478-38-2 are also occured in this study. Ohtake, Akiyoshi; Sato, Shuichi; Ikeda, Ken; Sasamata, Masao; Miyata, Keiji (Pharmacol. Res. Lab., Astellas Pharma Inc., Tsukuba 305-8585, Japan). Nippon Yakurigaku Zasshi, 128(6), 425-432 (Japanese) 2006 Nippon Yakuri Gakkai. CODEN: NYKZAU. ISSN: 0015-5691. DOCUMENT TYPE: Journal; General Review CA Section: 1 (Pharmacology) A review on pharmacol. profile of new therapeutic agent for overactive bladder, solifenacin succinate (Vesicare) focusing on effect on muscarine receptor, effect on urination function and bladder tissue selectivity as muscarinic receptor antagonist, and on clin. test results in Japan of phase I, phase III, and long-term administration test. .

Open-label study of the safety and pharmacokinetics of solifenacin in subjects with hepatic impairment

All Rights Reserved. Open-label study of the safety and pharmacokinetics of solifenacin in subjects with hepatic impairment. Kuipers, Mirjam; Smulders, Ronald; Krauwinkel, Walter; Hoon, Timothy (Astellas Pharma Europe BV, Liederdorp, Neth.). Journal of Pharmacological Sciences (Tokyo, Japan), 102(4), 405-412 (English) 2006 Japanese Pharmacological Society. CODEN: JPSTGJ. ISSN: 1347-8613. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Detg.There are some reagents with their cas registry numbers 242478-37-1 and 242478-38-2 are used in this study. the pharmacokinetics and safety of solifenacin succinate, a once-daily, oral antimuscarinic agent indicated for treatment of overactive bladder, in subjects with hepatic impairment. In this open-label study, 16 subjects (eight with moderate hepatic impairment [defined as a Child-Pugh score of 7-9], eight healthy) received a single oral 10 mg solifenacin dose. Blood and urine were collected for pharmacokinetic assessments. Pharmacokinetic parameters (primary: area under the plasma concn.-time curve from time 0 to infinity [AUC0-￥] and max. plasma concn. [Cmax]) and safety were evaluated for solifenacin and its metabolites. There were no clin. relevant differences in safety. Moderate hepatic impairment increased AUC0-￥ by 60%, and the mean elimination half-life of solifenacin and several of its metabolites was longer vs. healthy subjects. Mean Cmax values were comparable between the groups. A single oral dose of solifenacin was well tolerated in hepatically impaired and healthy subjects; however, moderate hepatic impairment influenced solifenacin pharmacokinetics. In patients with mild hepatic impairment, solifenacin may be used without special caution; however, in patients with moderate hepatic impairment, doses greater than 5 mg are not recommended and the 5 mg dose should be used with caution. .