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Drug Interactions between indinavir and tipranavir

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

indinavir tipranavir

Applies to: indinavir and tipranavir

GENERALLY AVOID: Coadministration with tipranavir plus low-dose ritonavir may significantly decrease the plasma concentrations of other protease inhibitors. The mechanism of interaction has not been described. Data are available for amprenavir, atazanavir, lopinavir, and saquinavir. In 16 HIV-positive subjects, administration of amprenavir (600 mg plus ritonavir 100 mg) in combination with tipranavir/ritonavir (500 mg/200 mg) twice a day for 14 days decreased the mean steady-state peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) of amprenavir by 39%, 44% and 55%, respectively, compared to administration without tipranavir/ritonavir. In 21 HIV-positive subjects, mean steady-state Cmax, AUC and Cmin of lopinavir (400 mg plus ritonavir 100 mg) decreased by 47%, 55% and 70%, respectively, while those of saquinavir (600 mg plus ritonavir 100 mg) decreased by 70%, 76% and 82%, respectively, during coadministration with tipranavir/ritonavir twice a day for 14 days. Likewise, mean steady-state Cmax, AUC and Cmin of atazanavir decreased by 57%, 68% and 81%, respectively, when atazanavir (300 mg plus ritonavir 100 mg once a day) was coadministered with tipranavir/ritonavir (500 mg/100 mg twice a day) for nine days in 13 subjects with unspecified HIV status. Atazanavir plus ritonavir increased tipranavir AUC by 20% and Cmin by 75%.

MANAGEMENT: Given the risk of reduced viral susceptibility and resistance development associated with subtherapeutic antiretroviral drug levels, use of other protease inhibitors in combination with tipranavir/ritonavir is not recommended.

References

  1. Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, DelGiudice P, Montagne N, Schapiro JM, Dellamonica P "Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypic-guided therapy: pharmacological data from the Viradapt Study." Aids 14 (2000): 1333-9
  2. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim (2005):

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Drug and food interactions

Moderate

indinavir food

Applies to: indinavir

ADJUST DOSING INTERVAL: According to the manufacturer, coadministration with a meal high in calories, fat, and protein reduces the absorption of indinavir. In ten patients given indinavir in this manner, the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of indinavir decreased by an average of 84% and 77%, respectively. In contrast, grapefruit juice may have only minor effects on the oral bioavailability of indinavir. The manufacturer's package labeling states that administration of a single 400 mg dose of indinavir with 8 oz. of grapefruit juice decreased indinavir AUC by an average of 26%. Likewise, a study consisting of 14 HIV-infected subjects found no uniform nor significant changes in steady-state indinavir AUC during administration with double-strength grapefruit juice compared to water. There was, however, a delay in absorption (Tmax) due to grapefruit juice that is unlikely to be of clinical significance.

MANAGEMENT: To ensure maximal oral absorption, indinavir should be administered without food but with water 1 hour before or 2 hours after a meal. Alternatively, indinavir may be administered with other liquids such as skim milk, juice, coffee, or tea, or with a light meal (e.g., dry toast with jelly, juice, and coffee with skim milk and sugar; corn flakes, skim milk and sugar).

References

  1. "Product Information. Crixivan (indinavir)." Merck & Co., Inc PROD (2001):
  2. Yeh KC, Deutsch PJ, Haddix H, Hesney M, Hoagland V, Ju WD, Justice SJ, Osborne B, Sterrett AT, Stone JA, Woolf E, Waldman S "Single-dose pharmacokinetics of indinavir and the effect of food." Antimicrob Agents Chemother 42 (1998): 332-8
  3. Shelton MJ, Wynn HE, Newitt RG, DiFrancesco R "Effects of grapefruit juice on pharmacokinetic exposure to indinavir in HIV-positive subjects." J Clin Pharmacol 41 (2001): 435-42

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Moderate

tipranavir food

Applies to: tipranavir

ADJUST DOSING INTERVAL: Food does not appear to substantially alter the pharmacokinetics of tipranavir. When tipranavir capsules or oral solution was coadministered with ritonavir capsules at steady-state, no clinically significant changes in tipranavir peak plasma concentration (Cmax) and systemic exposure (AUC) were observed under fed conditions (500 to 682 kcal, 23% to 25% calories from fat) relative to fasted conditions. The effect of food on tipranavir exposure during coadministration with ritonavir tablets has not been evaluated. High-fat foods may enhance the gastrointestinal absorption of tipranavir. In a multiple-dose study, administration of tipranavir capsules with a high-fat meal (868 kcal, 53% from fat, 31% from carbohydrates) increased the oral bioavailability of tipranavir by 31% compared to administration with toast and skimmed milk, but did not significantly affect tipranavir Cmax. Thus, tipranavir may be safely taken with standard or high-fat meals.

MANAGEMENT: Tipranavir coadministered with low-dose ritonavir should be taken with food to improve the gastrointestinal tolerability of ritonavir. According to the product labeling, tipranavir coadministered with ritonavir capsules or solution can be taken with or without meals, whereas tipranavir coadministered with ritonavir tablets must be taken with meals.

References

  1. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim (2005):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Canadian Pharmacists Association "e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink" (2006):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
View all 4 references

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Therapeutic duplication warnings

Therapeutic duplication is the use of more than one medicine from the same drug category or therapeutic class to treat the same condition. This can be intentional in cases where drugs with similar actions are used together for demonstrated therapeutic benefit. It can also be unintentional in cases where a patient has been treated by more than one doctor, or had prescriptions filled at more than one pharmacy, and can have potentially adverse consequences.

Duplication

Protease inhibitors

Therapeutic duplication

The recommended maximum number of medicines in the 'protease inhibitors' category to be taken concurrently is usually one. Your list includes two medicines belonging to the 'protease inhibitors' category:

  • indinavir
  • tipranavir

Note: In certain circumstances, the benefits of taking this combination of drugs may outweigh any risks. Always consult your healthcare provider before making changes to your medications or dosage.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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