title: Effect of renal impairment on the pharmacokinetics of memantine.
abstract: The effect of renal impairment on the pharmacokinetics of a single oral dose of memantine (10 mg) was determined in Japanese subjects. Subjects were assigned to four groups based on baseline creatinine clearance (CL(CR)): normal renal function (> 80 mL/min, n = 6), and mild (50 to ≤ 80 mL/min, n = 6), moderate (30 to < 50 mL/min, n = 6), and severe renal impairment (5 to < 30 mL/min, n = 7). Mean memantine maximum plasma concentration (C(max)) was similar in the groups (12.66, 17.25, 15.75, and 15.83 ng/mL, respectively), as was mean time to C(max) (6.2, 5.2, 4.3, and 5.4 h, respectively). However, exposure to memantine determined from mean area under the plasma concentration-time curve was 1.62-, 1.97-, and 2.33-times higher in subjects with mild, moderate, and severe renal impairment, respectively, as compared to controls with normal renal function. Mean memantine plasma elimination half-life increased according to increasing renal impairment (61.15, 83.00, 100.13, and 124.31 h, respectively), while mean cumulative urinary recovery of unchanged memantine in 72 h after dosing decreased according to increasing renal impairment (33.68%, 33.47%, 23.60%, and 16.17%, respectively). These results are the same as those in the previous study on caucasian individuals, when compared per body weight. It is suggested that the dose of memantine should be halved in patients with renal impairment.
authors.affiliation: ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group.
authors.forename: Takashi
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authors.lastname: Moritoyo
authors.forename: Tomoko
authors.initials: T
authors.lastname: Hasunuma
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Harada
authors.forename: Tomonori
authors.initials: T
authors.lastname: Tateishi
authors.forename: Makoto
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authors.lastname: Watanabe
authors.forename: Tsutomu
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authors.lastname: Kotegawa
authors.forename: Masahiro
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authors.lastname: Nagai
authors.forename: Yuji
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authors.lastname: Kumagai
authors.forename: Tomomichi
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authors.lastname: Fujitani
authors.forename: Takahumi
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authors.lastname: Okura
authors.forename: Tomikazu
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authors.lastname: Fukuoka
authors.forename: Kenichi
authors.initials: K
authors.lastname: Miyoshi
authors.forename: Bunzo
authors.initials: B
authors.lastname: Matsuura
authors.forename: Shinya
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authors.lastname: Furukawa
authors.forename: Tomoe
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authors.lastname: Kobori
authors.forename: Hiroyoko
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authors.lastname: Moritoyo
authors.forename: Noriko
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authors.lastname: Nishikawa
authors.forename: Tomoaki
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authors.lastname: Tsujii
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Iwaki
authors.forename: Masahiko
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authors.lastname: Nakamura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Makino
authors.forename: Kei
authors.initials: K
authors.lastname: Ohnuma
authors.forename: Koichiro
authors.initials: K
authors.lastname: Yuji
authors.forename: Megumi
authors.initials: M
authors.lastname: Hashimoto
authors.forename: Masaru
authors.initials: M
authors.lastname: Takasu
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Hashizume
authors.forename: Koji
authors.initials: K
authors.lastname: You
authors.forename: Tomoko
authors.initials: T
authors.lastname: Matsumura
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Nahoko
authors.initials: N
authors.lastname: Matsumoto
authors.forename: Junichi
authors.initials: J
authors.lastname: Nakamura
authors.forename: Jun
authors.initials: J
authors.lastname: Miura
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
authors.forename: Kozo
authors.initials: K
authors.lastname: Kitazawa
authors.forename: Takanori
authors.initials: T
authors.lastname: Shibata
authors.forename: Aki
authors.initials: A
authors.lastname: Kuroki
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Honda
authors.forename: Masanori
authors.initials: M
authors.lastname: Mukai
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Ohashi
authors.forename: Takuya
authors.initials: T
authors.lastname: Morimoto
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Imai
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Okudaira
authors.forename: Fuminori
authors.initials: F
authors.lastname: Sato
authors.forename: Junko
authors.initials: J
authors.lastname: Imanaga
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Tanaka
authors.forename: Masahiro
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authors.lastname: Nomoto
mesh_terms: D000368:Aged; D019540:Area Under Curve; D044466:Asian People; D018691:Excitatory Amino Acid Antagonists / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D008559:Memantine / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D008875:Middle Aged; D051437:Renal Insufficiency / Q000378:metabolism*; D044465:White People
chemical_list: D018691:Excitatory Amino Acid Antagonists; D008559:Memantine