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Drug Interactions between Astagraf XL and Mi-Acid Double Strength

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

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Interactions between your drugs

Moderate

magnesium hydroxide tacrolimus

Applies to: Mi-Acid Double Strength (calcium carbonate / magnesium hydroxide) and Astagraf XL (tacrolimus)

MONITOR: Coadministration with aluminum-magnesium hydroxide may increase tacrolimus blood concentrations in vivo. The mechanism of interaction is unknown. In a single-dose study, administration of tacrolimus with aluminum-magnesium hydroxide in healthy volunteers resulted in a 10% and 21% increase in tacrolimus peak concentration (Cmax) and systemic exposure (AUC), respectively, compared to administration without aluminum-magnesium hydroxide. This finding contradicts the results from an in vitro study, which showed that tacrolimus incubated in 100 mL simulated gastric fluid with the equivalent of 500 mg of various antacids resulted in loss of tacrolimus, due presumably to a pH-mediated degradation of tacrolimus. Specifically, Mylanta caused a 14% loss of tacrolimus in 24 hours, magnesium oxide caused a 98% loss in 12 hours, and calcium carbonate caused a 30% loss in 24 hours. In contrast, aluminum hydroxide gel caused an immediate 35% loss of tacrolimus (within 2 minutes) and no further loss for 24 hours, suggesting adsorption of tacrolimus.

MANAGEMENT: Given the narrow therapeutic index and the large interindividual variability in the pharmacokinetics of tacrolimus, caution is advised if the drug is used in combination with aluminum and/or magnesium hydroxide. Pharmacologic response and tacrolimus blood levels should be monitored more closely whenever aluminum/magnesium hydroxide is added to or discontinued from therapy, and the immunosuppressant dosage adjusted as necessary. Patients should be advised to contact their doctor if they experience potential signs and symptoms of tacrolimus toxicity such as fever, infection, diarrhea, tremor, headache, fatigue, lethargy, and changes in motor function, mental status, or sensory function.

References

  1. Steeves M, Abdallah HY, Venkataramanan R, et al. "In-vitro activation of a novel immunosuppressant, FK 506, and antacids." J Pharm Pharmacol 43 (1991): 574-7
  2. "Product Information. Prograf (tacrolimus)." Fujisawa PROD (2001):

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Minor

calcium carbonate tacrolimus

Applies to: Mi-Acid Double Strength (calcium carbonate / magnesium hydroxide) and Astagraf XL (tacrolimus)

In vitro data suggest that the presence of antacids may reduce the bioavailability of tacrolimus. An in vitro study showed that tacrolimus incubated in 100 mL simulated gastric fluid with the equivalent of 500 mg of various antacids resulted in loss of tacrolimus, due presumably to a pH-mediated degradation of tacrolimus. Specifically, aluminum-magnesium hydroxide caused a 14% loss of tacrolimus in 24 hours, magnesium oxide caused a 98% loss in 12 hours, and calcium carbonate caused a 30% loss in 24 hours. In contrast, aluminum hydroxide gel caused an immediate 35% loss of tacrolimus (within 2 minutes) and no further loss for 24 hours, suggesting adsorption of tacrolimus. Whether these effects occur in vivo, and to what extent, are unknown. Sodium bicarbonate has been reported to cause widely variable trough plasma levels and reduced blood concentrations of tacrolimus when given close to the time of administration of tacrolimus. No other details were available in the report. However, in a single-dose study, administration of tacrolimus with aluminum-magnesium hydroxide in healthy volunteers resulted in a 10% and 21% increase (not decrease) in tacrolimus peak concentration (Cmax) and systemic exposure (AUC), respectively, compared to administration without aluminum-magnesium hydroxide.

References

  1. Steeves M, Abdallah HY, Venkataramanan R, et al. "In-vitro activation of a novel immunosuppressant, FK 506, and antacids." J Pharm Pharmacol 43 (1991): 574-7

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Drug and food interactions

Moderate

calcium carbonate food

Applies to: Mi-Acid Double Strength (calcium carbonate / magnesium hydroxide)

ADJUST DOSING INTERVAL: Administration with food may increase the absorption of calcium. However, foods high in oxalic acid (spinach or rhubarb), or phytic acid (bran and whole grains) may decrease calcium absorption.

MANAGEMENT: Calcium may be administered with food to increase absorption. Consider withholding calcium administration for at least 2 hours before or after consuming foods high in oxalic acid or phytic acid.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Canadian Pharmacists Association "e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink" (2006):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Agencia Española de Medicamentos y Productos Sanitarios Healthcare "Centro de información online de medicamentos de la AEMPS - CIMA. https://cima.aemps.es/cima/publico/home.html" (2008):
  5. Mangels AR "Bone nutrients for vegetarians." Am J Clin Nutr 100 (2014): epub
  6. Davies NT "Anti-nutrient factors affecting mineral utilization." Proc Nutr Soc 38 (1979): 121-8
View all 6 references

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Moderate

tacrolimus food

Applies to: Astagraf XL (tacrolimus)

ADJUST DOSING INTERVAL: Consumption of food has led to a 27% decrease in the bioavailability of orally administered tacrolimus.

MANAGEMENT: Tacrolimus should be administered at least one hour before or two hours after meals.

GENERALLY AVOID: Grapefruit juice has been reported to increase tacrolimus trough concentrations. Data are limited, but inhibition of the CYP450 enzyme system appears to be involved.

MANAGEMENT: The clinician may want to recommend that the patient avoid ingesting large amounts of grapefruit juice while taking tacrolimus.

References

  1. "Product Information. Prograf (tacrolimus)." Fujisawa PROD (2001):
  2. Hooks MA "Tacrolimus, a new immunosuppressant--a review of the literature." Ann Pharmacother 28 (1994): 501-11

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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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