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Hepatic Impairment — Although the presence of hepatic impairment may be expected to reduce the clearance of olanzapine, a study of the effect of impaired liver function in subjects (n= 6) with clinically significant (Childs Pugh Classification A and B) cirrhosis revealed little effect on the pharmacokinetics of olanzapine. Age — In a study involving 24 healthy subjects, the mean elimination half-life of olanzapine was about 1.5 times greater in elderly (> 65 years) than in non-elderly subjects ( 65 years). Caution should be used in dosing the elderly, especially if there are other factors that might additively influence drug metabolism and/ or pharmacodynamic sensitivity (see DOSAGE AND ADMINISTRATION). Text Continues Below
Gender — Clearance of olanzapine is approximately 30% lower in women than in men. There were, however, no apparent differences between men and women in effectiveness or adverse effects. Dosage modifications based on gender should not be needed. Smoking Status — Olanzapine clearance is about 40% higher in smokers than in nonsmokers, although dosage modifications are not routinely recommended. Race — No specific pharmacokinetic study was conducted to investigate the effects of race. A cross-study comparison between data obtained in Japan and data obtained in the US suggests that exposure to olanzapine may be about 2-fold greater in the Japanese when equivalent doses are administered. Clinical trial safety and efficacy data, however, did not suggest clinically significant differences among Caucasian patients, patients of African descent, and a third pooled category including Asian and Hispanic patients. Dosage modifications for race are, therefore, not recommended. Combined Effects — The combined effects of age, smoking, and gender could lead to substantial pharmacokinetic differences in populations. The clearance in young smoking males, for example, may be 3 times higher than that in elderly nonsmoking females. Dosing modification may be necessary in patients who exhibit a combination of factors that may result in slower metabolism of olanzapine (see DOSAGE AND ADMINISTRATION). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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