Naratriptan use in specific populations: Difference between revisions
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==Special Populations== | |||
====Age==== | |||
A small decrease in clearance (approximately 26%) was observed in healthy elderly subjects (65 to 77 years) compared to younger patients, resulting in slightly higher exposure (see PRECAUTIONS). | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NARATRIPTAN TABLET, COATED [SANDOZ INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39c658d3-5bc8-4f81-9837-1c4edcf1b6c2 | publisher = | date = | accessdate = }}</ref> | |||
====Race==== | |||
The effect of race on the pharmacokinetics of naratriptan has not been examined. | |||
====Renal Impairment==== | |||
Clearance of naratriptan was reduced by 50% in patients with moderate renal impairment (creatinine clearance, 18 to 39 mL/min) compared to the normal group. Decrease in clearances resulted in an increase of mean half-life from 6 hours (healthy) to 11 hours (range: 7 to 20 hours). The mean Cmax increased by approximately 40%. The effects of severe renal impairment (creatinine clearance: ≤15 mL/min) on the pharmacokinetics of naratriptan has not been assessed (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION). | |||
====Hepatic Impairment==== | |||
Clearance of naratriptan was decreased by 30% in patients with moderate hepatic impairment (Child-Pugh grade A or B). This resulted in an approximately 40% increase in the half-life (range: 8 to 16 hours). The effects of severe hepatic impairment (Child-Pugh grade C) on the pharmacokinetics of naratriptan have not been assessed (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NARATRIPTAN TABLET, COATED [SANDOZ INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39c658d3-5bc8-4f81-9837-1c4edcf1b6c2 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 20:16, 3 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Special Populations
Age
A small decrease in clearance (approximately 26%) was observed in healthy elderly subjects (65 to 77 years) compared to younger patients, resulting in slightly higher exposure (see PRECAUTIONS).
Race
The effect of race on the pharmacokinetics of naratriptan has not been examined.
Renal Impairment
Clearance of naratriptan was reduced by 50% in patients with moderate renal impairment (creatinine clearance, 18 to 39 mL/min) compared to the normal group. Decrease in clearances resulted in an increase of mean half-life from 6 hours (healthy) to 11 hours (range: 7 to 20 hours). The mean Cmax increased by approximately 40%. The effects of severe renal impairment (creatinine clearance: ≤15 mL/min) on the pharmacokinetics of naratriptan has not been assessed (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).
Hepatic Impairment
Clearance of naratriptan was decreased by 30% in patients with moderate hepatic impairment (Child-Pugh grade A or B). This resulted in an approximately 40% increase in the half-life (range: 8 to 16 hours). The effects of severe hepatic impairment (Child-Pugh grade C) on the pharmacokinetics of naratriptan have not been assessed (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).[1]
References
Adapted from the FDA Package Insert.