VIDEX EC (Page 6 of 8)

Drug Interactions

Tables 9 and 10 summarize the effects on AUC and Cmax , with a 90% confidence interval (CI) when available, following coadministration of VIDEX EC with a variety of drugs. For clinical recommendations based on drug interaction studies for drugs in bold font [see Dosage and Administration (2.3) and Drug Interactions (7.1)].

Table 9: Results of Drug Interaction Studies with VIDEX EC: Effects of Coadministered Drug on Didanosine Plasma AUC and Cmax Values
% Change of Didanosine Pharmacokinetic Parametersa
Drug Didanosine Dosage n AUC of Didanosine (90% CI) Cmax of Didanosine (90% CI)
↑ Indicates increase.↓ Indicates decrease.↔ Indicates no change, or mean increase or decrease of less than 10%.a The 90% confidence intervals for the percent change in the pharmacokinetic parameter are displayed.b All studies conducted in healthy volunteers at least 60 kg with creatinine clearance of at least 60 mL/min.c Tenofovir disoproxil fumarate.d 373 kilocalories, 8.2 grams fat.e Compared with VIDEX EC 250 mg administered alone under fasting conditions.f Compared with VIDEX EC 400 mg administered alone under fasting conditions.g Comparisons are made to historical controls (n=148, pooled from 5 studies) conducted in healthy subjects. The number of subjects evaluated for AUC and Cmax is 15 and 16, respectively.

tenofovir ,b,c 300 mg once daily with a light meald

400 mg single dose fasting2 hours before tenofovir

26

↑ 48%(31, 67%)

↑ 48%(25, 76%)

tenofovir ,b,c 300 mg once daily with a light meald

400 mg single dosewith tenofovir and a light meal

25

↑ 60%(44, 79%)

↑ 64%(41, 89%)

tenofovir ,b,c 300 mg once daily with a light meald

200 mg single dosewith tenofovir and a light meal

33

↑ 16%(6, 27%)e

↓ 12%(-25, 3%)e

250 mg single dosewith tenofovir and a light meal

33

↔ (-13, 5%)f

↓ 20%(-32, -7%)f

325 mg single dosewith tenofovir and a light meal

33

↑ 13%(3, 24%)f

↓ 11%(-24, 4%)f

methadone , chronic maintenance dose

400 mg single dose

15, 16g

↓ 17%(-29, -2%)

↓ 16%(-33, 4%)

Table 10: Results of Drug Interaction Studies with VIDEX EC: Effects of Didanosine on Coadministered Drug Plasma AUC and Cmax Values
% Change of Coadministered Drug Pharmacokinetic Parametersa,b
Drug Didanosine Dosage n AUC of Coadministered Drug (90% CI) Cmax of Coadministered Drug (90% CI)
↔ Indicates no change, or mean increase or decrease of less than 10%.a The 90% confidence intervals for the percent change in the pharmacokinetic parameter are displayed.b All studies conducted in healthy volunteers at least 60 kg with creatinine clearance of at least 60 mL/min.c Tenofovir disoproxil fumarate.d 373 kilocalories, 8.2 grams fat.

ciprofloxacin, 750 mg single dose

400 mg single dose

16

indinavir, 800 mg single dose

400 mg single dose

23

ketoconazole, 200 mg single dose

400 mg single dose

21

tenofovir,c 300 mg once daily with a light meald

400 mg single dosefasting 2 hours before tenofovir

25

tenofovir,c 300 mg once daily with a light meald

400 mg single dosewith tenofovir and a light meal

25

Didanosine Buffered Formulations: Tables 11 and 12 summarize the effects on AUC and Cmax , with a 90% or 95% CI when available, following coadministration of buffered formulations of didanosine with a variety of drugs. The results of these studies may be expected to apply to VIDEX EC. For most of the listed drugs, no clinically significant pharmacokinetic interactions were noted. For clinical recommendations based on drug interaction studies for drugs in bold font, [see Dosage and Administration (2.3) for Concomitant Therapy with Tenofovir Disoproxil Fumarate), Contraindications (4), and Drug Interactions (7.1)].

Table 11: Results of Drug Interaction Studies with Buffered Formulations of Didanosine: Effects of Coadministered Drug on Didanosine Plasma AUC and Cmax Values
% Change of Didanosine Pharmacokinetic Parametersa
Drug Didanosine Dosage n AUC of Didanosine (95% CI) Cmax of Didanosine (95% CI)
↑ Indicates increase.↓ Indicates decrease.↔ Indicates no change, or mean increase or decrease of less than 10%.a The 95% confidence intervals for the percent change in the pharmacokinetic parameter are displayed.b 90% CI.c HIV-infected patients.NA = Not available.

allopurinol ,renally impaired, 300 mg/day

200 mg single dose

2

↑ 312%

↑ 232%

healthy volunteer, 300 mg/dayfor 7 days

400 mg single dose

14

↑ 113%

↑ 69%

ganciclovir , 1000 mg every 8 hours,2 hours after didanosine

200 mg every 12 hours

12

↑ 111%

NA

ciprofloxacin, 750 mg every 12 hours for 3 days, 2 hours before didanosine

200 mg every 12 hoursfor 3 days

8c

↓ 16%

↓ 28%

indinavir, 800 mg single dose

simultaneous

200 mg single dose

16

1 hour before didanosine

200 mg single dose

16

↓ 17%(-27, -7%)b

↓ 13%(-28, 5%)b

ketoconazole, 200 mg/day for 4 days, 2 hours before didanosine

375 mg every 12 hoursfor 4 days

12c

↓ 12%

loperamide, 4 mg every 6 hours for 1 day

300 mg single dose

12c

↓ 23%

metoclopramide, 10 mg single dose

300 mg single dose

12c

↑ 13%

ranitidine, 150 mg single dose, 2 hours before didanosine

375 mg single dose

12c

↑ 14%

↑ 13%

rifabutin, 300 mg or 600 mg/day for 12 days

167 mg or 250 mg every 12 hoursfor 12 days

11

↑ 13%(-1, 27%)

↑ 17%(-4, 38%)

ritonavir, 600 mg every 12 hours for 4 days

200 mg every 12 hoursfor 4 days

12

↓ 13%(0, 23%)

↓ 16%(5, 26%)

stavudine, 40 mg every 12 hours for 4 days

100 mg every 12 hoursfor 4 days

10

sulfamethoxazole, 1000 mg single dose

200 mg single dose

8c

trimethoprim, 200 mg single dose

200 mg single dose

8c

↑ 17%(-23, 77%)

zidovudine, 200 mg every 8 hours for 3 days

200 mg every 12 hoursfor 3 days

6c

Table 12: Results of Drug Interaction Studies with Buffered Formulations of Didanosine: Effects of Didanosine on Coadministered Drug Plasma AUC and Cmax Values
% Change of Coadministered Drug Pharmacokinetic Parametersa
Drug Didanosine Dosage n AUC of Coadministered Drug (95% CI) Cmax of Coadministered Drug (95% CI)
↑ Indicates increase.↓ Indicates decrease.↔ Indicates no change, or mean increase or decrease of less than 10%.a The 95% confidence intervals for the percent change in the pharmacokinetic parameter are displayed. b HIV-infected patients.NA = Not available.

dapsone, 100 mg single dose

200 mg every 12 hours for 14 days

6b

ganciclovir, 1000 mg every 8 hours,2 hours after didanosine

200 mg every 12 hours

12b

↓ 21%

NA

nelfinavir , 750 mg single dose,1 hour after didanosine

200 mg single dose

10b

↑ 12%

ranitidine, 150 mg single dose,2 hours before didanosine

375 mg single dose

12b

↓ 16%

ritonavir, 600 mg every 12 hours for 4 days

200 mg every 12 hoursfor 4 days

12

stavudine, 40 mg every 12 hours for 4 days

100 mg every 12 hoursfor 4 days

10b

↑ 17%

sulfamethoxazole, 1000 mg single dose

200 mg single dose

8b

↓ 11%(-17, -4%)

↓ 12%(-28, 8%)

trimethoprim, 200 mg single dose

200 mg single dose

8b

↑ 10%(-9, 34%)

↓ 22%(-59, 49%)

zidovudine, 200 mg every 8 hours for 3 days

200 mg every 12 hoursfor 3 days

6b

↓ 10%(-27, 11%)

↓ 16.5%(-53, 47%)

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