Investigation of Pharmacokinetics of a New Sclerotherapeutic Drug OC-108 in Elderly Patients with Internal Hemorrhoids-Effect of Aging on the Pharmacokinetics of OC-108-

Accession number;04A0542889
Title;Investigation of Pharmacokinetics of a New Sclerotherapeutic Drug OC-108 in Elderly Patients with Internal Hemorrhoids-Effect of Aging on the Pharmacokinetics of OC-108-
Author; TAKAMURA HISAO (Kenseikai, Nara Daicho Komon Byo Senta) MIYOSHI SHINJI (Mitsubishi Pharma Corp., JPN) HASHIMOTO TOSHIO (Mitsubishi Pharma Corp., JPN)
Journal Title;Japanese Pharmacology & Therapeutics
Journal Code:Z0947A
ISSN:0386-3603
VOL.32;NO.6;PAGE.367-377(2004)
Figure&Table&Reference;FIG.6, TBL.6, REF.7
Pub. Country;Japan
Language;Japanese
Abstract;Sclerotherapy using OC-108 was used to treat 65-year or older patients with prolapsing internal hemorrhoids (Goligher's classification III degrees) at our hospital from June 2001 to March 2002. When six elderly patients (from 69 to 74 years old) were treated with OC-108, tmax of aluminum was 0.25.+-.0.00 h after dosing and Cmax was 2.09.+-.0.33 .MU.g/mL, showing rapid transfer of aluminum into the systemic circulation. Within 24 h after injection, the urinary excretion of aluminum reached 79% of the rate of excretion (48.7% of dose) within 96 h, showing that aluminum, after transfer into blood circulation, was excreted in urine relatively rapidly. These findings suggested that the pharmacokinetics of aluminum seem to be not influenced with aging. At 28 days after dosing, elimination of prolapse was achieved in 100%. From indices such as postdose complications, adverse reactions, abnormal changes in laboratory values, and abnormal changes in blood pressure, pulse rate and body temperature, there was no finding of particular clinical significance in the safety of OC-108. It was thus considered that OC-108 would be useful for the treatment of hemorrhoidal conditions in elderly people at the same dosage and administration as in non-elderly people. (author abst.)