ruit juice and ATOZET is not recommended.
Diltiazem 240 mg OD, 28 days
40 mg SD
↑ 51%
After initiation or following dose adjustments of diltiazem, appropriate clinical monitoring of these patients is recommended.
Erythromycin 500 mg QID, 7 days
10 mg SD
↑ 33%^
Lower maximum dose and clinical monitoring of these patients is recommended.
Amlodipine 10 mg, single dose
80 mg SD
↑ 18%
No specific recommendation.
Cimetidine 300 mg QID, 2 weeks
10 mg OD for 4 weeks
↓ less than 1%^
No specific recommendation.
Antacid suspension of magnesium and aluminium hydroxides, 30 mL QID, 2 weeks
10 mg OD for 4 weeks
↓ 35%^
No specific recommendation.
Efavirenz 600 mg OD, 14 days
10 mg for 3 days
↓ 41%
No specific recommendation.
Rifampicin 600 mg OD, 7 days (coadministered)
40 mg SD
↑ 30%
If coadministration cannot be avoided, simultaneous coadministration of ATOZET with rifampicin is recommended, with clinical monitoring.
Rifampicin 600 mg OD, 5 days (doses separated)
40 mg SD
↓ 80%
Gemfibrozil 600 mg BID, 7 days
40 mg SD
↑ 35%
Not recommended.
Fenofibrate 160 mg OD, 7 days
40 mg SD
↑ 3%
Not recommended.
Boceprevir 800 mg TID, 7 days
40 mg SD
↑ 2.3 fold
Lower starting dose and clinical monitoring of these patients is recommended. The dose of ATOZET should not exceed a daily dose of 10/20 mg during coadministration with boceprevir.
& Data given as x-fold change represent a simple ratio between co-administration and atorvastatin alone (i.e., 1-fold = no change). Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change).
# See sections 4.4 and 4.5 for clinical significance.
* Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4. Intake of one 240 ml glass of grapefruit juice also resulted in a decreased AUC of 20.4% for the active orthohydroxy metabolite. Large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites).
^ Total atorvastatin equivalent activity
Increase is indicated as “↑”, decrease as “↓”
OD = once daily; SD = single dose; BID = twice daily; TID = three times daily; QID = four times daily
Table 2
Effect of Atorvastatin on the Pharmacokinetics of Coadministered Medicinal Products
Atorvastatin and Dosing Regimen
Coadministered Medicinal Product
ATOZET
Medicinal Product/Dose (mg)
Change in AUC&
Clinical Recommendation
80 mg OD for 10 days
Digoxin 0.25 mg OD, 20 days
↑ 15%
Patients taking digoxin should be monitored appropriately.
40 mg OD for 22 days
Oral contraceptive OD, 2 months
-norethisterone 1 mg
-ethinyl estradiol 35 μg
↑ 28%
↑ 19%
No specific recommendation.
80 mg OD for 15 days
* Phenazone, 600 mg SD
↑ 3%
No specific recommendation
10 mg, OD for 4 days
Fosamprenavir 1400 mg |
