Rezok-DSR: Dosage And Administration

DOSAGE AND ADMINISTRATION:
One capsule once daily.
Special populations:
Geriatric: In 20 healthy elderly subjects administered 20 mg rabeprazole once daily for seven days, AUC values approximately doubled and the Cmax increased by 60% compared to values in a parallel younger control group. There was no evidence of drug accumulation after once daily administration.
Pediatric: The pharmacokinetics of rabeprazole was studied in 12 adolescent patients with GERD12 to 16 years of age, in a multicenter study. Patients received rabeprazole 20 mg once daily for five or seven days. An approximate 40% increase in exposure was noted following 5 to 7 days of dosing compared with the exposure after 1 day dosing. Pharmacokinetic parameters in adolescent patients with GERD 12 to 16 years of age were within the range observed in healthy adult volunteers.
Gender: In analyses adjusted for body mass and height, rabeprazole pharmacokinetics showed no clinically significant differences between male and female subjects.
Renal impairment: In 10 patients with stable end-stage renal disease requiring maintenance hemodialysis
(creatinine clearance ≤5 mL/min/1.73 m2), no clinically significant differences were
observed in the pharmacokinetics of rabeprazole after a single 20 mg oral dose when
compared to 10 healthy volunteers.
Hepatic impairment: In a single dose study of 10 patients with chronic mild to moderate compensated cirrhosis of the liver who were administered a 20 mg dose of rabeprazole, AUC0-24 was approximately doubled, the elimination half-life was 2- to 3-fold higher, and total body clearance was decreased to less than half compared to values in healthy men. In a multiple dose study of 12 patients with mild to moderate hepatic impairment administered 20 mg rabeprazole once daily for eight days, AUC 0-∞ and Cmax values increased approximately 20% compared to values in healthy age- and gender-matched subjects. These increases were not statistically significant.
No information exists on rabeprazole disposition in patients with severe hepatic

impairment.

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