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Juluca 50 mg/25 mg film-coated tablets(七)
2019-04-16 22:48:43 来源: 作者: 【 】 浏览:10382次 评论:0
No dose adjustment is required.
Herbal products
St. John's wort/ Dolutegravir
St. John's wort/ Rilpivirine
Dolutegravir ↓
Not studied. Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected.
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected
(induction of CYP3A enzymes).
Co-administration may cause significant decreases in rilpivirine plasma concentrations. This may result in loss of therapeutic effect of Juluca. Co-administration of Juluca with St. John's wort is contraindicated (see section 4.3).
Proton pump inhibitors
Omeprazole
Lansoprazole
Rabeprazole
Pantoprazole
Esomeprazole/ Dolutegravir
Omeprazole/ Rilpivirine1,2
 
 
 
 
 
 
 
 
 
Lansoprazole
Rabeprazole
Pantoprazole
Esomeprazole/
Rilpivirine
Dolutegravir ↔
(Not studied)
 
 
 
 
Rilpivirine
AUC ↓ 40%
Cmin ↓ 33%
Cmax ↓ 40%
(reduced absorption due to gastric pH increase).
Omeprazole
AUC ↓ 14%
Cmin NA
Cmax ↓ 14%
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected
(reduced absorption due to gastric pH increase).
Co-administration may significantly decrease rilpivirine plasma concentration. This may result in loss of therapeutic effect of Juluca. Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
H2-recepter antagonists
Famotidine Cimetidine
Nizatidine
Ranitidine/ Dolutegravir
Famotidine/ Rilpivirine1,2
40 mg single dose taken 12 hours before rilpivirine
Famotidine/ Rilpivirine1,2
40 mg single dose taken 2 hours before rilpivirine
Famotidine/ Rilpivirine1,2
40 mg single dose taken 4 hours after rilpivirine
Cimetidine
Nizatidine
Ranitidine/ Rilpivirine
Dolutegravir ↔
(Not studied)
Rilpivirine
AUC ↓ 9%
Cmin NA
Cmax ↔
Rilpivirine
AUC ↓ 76%
Cmin NA
Cmax ↓ 85%
(reduced absorption due to gastric pH increase).
Rilpivirine
AUC ↑ 13%
Cmin NA
Cmax ↑ 21%
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption due to gastric pH increase).
The combination of Juluca and H2-receptor antagonists should be used with particular caution. Only H2-receptor antagonists that can be dosed once daily should be used.
H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Antacids and supplements
Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Dolutegravir1
Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Rilpivirine
Dolutegravir ↓
AUC ↓ 74%
Cmax ↓ 72%
C24 ↓ 74%
(Complex binding to polyvalent ions).
Rilpivirine ↓
Not studied. Significant decreases in rilpivirine plasma concentrations are expected
(reduced absorption due to gastric pH increase).
The combination of Juluca and antacids should be used with particular caution. Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Calcium supple
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