istration and 70.4-fold with the gemfibrozil-itraconazole combination (seeCONTRAINDICATIONS,PRECAUTIONS,Drug-Drug Interactions).
Fenofibrate: Co-administration of 200 mg fenofibrate with a single dose of 0.25 mg repaglinide (after 5 days of once daily fenofibrate 200 mg) resulted in unchanged AUC and Cmax values for both drugs.
Ketoconazole: Co-administration of 200 mg ketoconazole and a single dose of 2 mg PRANDIN (after 4 days of once daily ketoconazole 200 mg) resulted in a 15% and 16% increase in repaglinide AUC and Cmax, respectively. The increases were from 20.2 ng/mL to 23.5 ng/mL for Cmax and from 38.9 ng/mL*hr to 44.9 ng/mL*hr for AUC.
Trimethoprim: Co-administration of 160 mg trimethoprim and a single dose of 0.25 mg PRANDIN (after 2 days of twice daily and one dose on the third day of trimethoprim 160 mg) resulted in a 61% and 41% increase in repaglinide AUC and Cmax, respectively. The increase in AUC was from 5.9 ng/mL*hr to 9.6 ng/mL*hr and the increase in Cmax was from 4.7 ng/mL to 6.6 ng/mL.
Cyclosporine:Co-administration of 100 mg cyclosporine with a single dose of 0.25 mg repaglinide (after two 100 mg doses of cyclosporine twelve hours apart) increased the repaglinide (0.25 mg) Cmax 1.8-fold and the AUC 2.5-fold in an interaction study with healthy volunteers (see PRECAUTIONS,Drug-Drug Interactions).
Rifampin:Co-administration of 600 mg rifampin and a single dose of 4 mg PRANDIN (after 6 days of once daily rifampin 600 mg) resulted in a 32% and 26% decrease in repaglinide AUC and Cmax, respectively. The decreases were from 40.4 ng/mL to 29.7 ng/mL for Cmax and from 56.8 ng/mL*hr to 38.7 ng/mL*hr for AUC.
In another study, co-administration of 600 mg rifampin and a single dose of 4 mg PRANDIN (after 6 days of once daily rifampin 600 mg) resulted in a 48% and 17% decrease in repaglinide median AUC and median Cmax respectively. The median decreases were from 54 ng/mL*hr to 28 ng/mL*hr for AUC and from 35 ng/mL to 29 ng/mL for Cmax. PRANDIN administered by itself (after 7 days of once daily rifampin 600 mg) resulted in an 80% and 79% decrease in repaglinide median AUC and Cmax respectively. The decreases were from 54 ng/mL*hr to 11 ng/mL*hr for AUC and from 35 ng/mL to 7.5 ng/mL for Cmax.
Levonorgestrel & Ethinyl Estradiol:Co-administration of a combination tablet of 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol administered once daily for 21 days with 2 mg PRANDIN administered three times daily (days 1-4) and a single dose on Day 5 resulted in 20% increases in repaglinide, levonorgestrel, and ethinyl estradiol Cmax. The increase in repaglinide Cmax was from 40.5 ng/mL to 47.4 ng/mL. Ethinyl estradiol AUC parameters were increased by 20%, while repaglinide and levonorgestrel AUC values remained unchanged.
Simvastatin:Co-administration of 20 mg simvastatin and a single dose of 2 mg PRANDIN (after 4 days of once daily simvastatin 20 mg and three times daily PRANDIN 2 mg) resulted in a 26% increase in repaglinide Cmax from 23.6 ng/mL to 29.7 ng/mL. AUC was unchanged.
Nifedipine:Co-administration of 10 mg nifedipine with a single dose of 2 mg PRANDIN (after 4 days of three times daily nifedipine 10 mg and three times daily PRANDIN 2 mg) resulted in unchanged AUC and Cmax values for both drugs.
Clarithromycin:Co-administration of 250 mg clarithromycin and a single dose of 0.25 mg PRANDIN (after 4 days of twice daily clarithromycin 250 mg) resulted in a 40% and 67% increase in repaglinide AUC and Cmax, respectively. The increase in AUC was from 5.3 ng/mL*hr to 7.5 ng/mL |
