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Drug Interactions between lamivudine / raltegravir and Uni-Lan II

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

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Interactions between your drugs

Major

aluminum hydroxide raltegravir

Applies to: Uni-Lan II (aluminum hydroxide / magnesium hydroxide / simethicone) and lamivudine / raltegravir

GENERALLY AVOID: Coadministration with aluminum-, magnesium-, and/or calcium-containing antacids may reduce the oral bioavailability of raltegravir. The proposed mechanism is chelation of raltegravir by polyvalent cations, but changes in solubility and lipophilicity of raltegravir related to pH increases may also contribute. In drug interaction studies, raltegravir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) decreased by 44%, 49% and 63%, respectively, when a single 20 mL dose of aluminum and magnesium hydroxide antacid was administered simultaneously with raltegravir (400 mg twice daily). The Cmax, AUC and Cmin of raltegravir decreased by 51%, 51% and 56%, respectively, when the antacid was given 2 hours before raltegravir, and by 22%, 30% and 57%, respectively, when the antacid was given 2 hours after raltegravir. When given 4 hours apart, raltegravir Cmax, AUC and Cmin decreased by 22%, 19% and 60% with antacid administered first, and by 30%, 32% and 62% with raltegravir administered first. Minimal changes in raltegravir Cmax and AUC were observed when administration was staggered by 6 hours; however, Cmin was still diminished by approximately 50% regardless of whether antacid was administered before or after raltegravir. When raltegravir 400 mg twice daily was given with a single dose of antacid containing calcium carbonate 3000 mg, raltegravir Cmax, AUC and Cmin decreased by 52%, 55% and 32%, respectively. These changes are not considered clinically significant by the manufacturer. However, when a single 1200 mg dose of raltegravir was coadministered with the calcium carbonate antacid, raltegravir Cmax, AUC and Cmin decreased by 74%, 72% and 58%, respectively. Staggering the doses by administering the calcium carbonate antacid 12 hours after raltegravir resulted in minimal changes in raltegravir Cmax and AUC, but Cmin was still reduced by 57%.

MANAGEMENT: Concomitant use of raltegravir with aluminum- and/or magnesium-containing antacids should generally be avoided, even if administration is staggered. Antacids containing calcium carbonate should not be used with once-daily raltegravir (HD formulation), but may be used without dose adjustment for other raltegravir products.

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. "Product Information. Isentress (raltegravir)." Merck & Co., Inc (2007):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Kiser JJ, Bumpass JB, Meditz AL, et al. "Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus seronegative volunteers." Antimicrob Agents Chemother 54 (2010): 4999-5003
  6. Roberts JL, Kiser JJ, Hindman JT, Meditz AL "Virologic failure with a raltegravir-containing antiretroviral regimen and concomitant calcium administration." Pharmacotherapy 31 (2011): 298e-302e
  7. Moss DM, Siccardi M, Murphy M, et al. "Divalent metals and pH alter raltegravir disposition in vitro." Antimicrob Agents Chemother 56 (2012): 3020-6
View all 7 references

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Major

magnesium hydroxide raltegravir

Applies to: Uni-Lan II (aluminum hydroxide / magnesium hydroxide / simethicone) and lamivudine / raltegravir

GENERALLY AVOID: Coadministration with aluminum-, magnesium-, and/or calcium-containing antacids may reduce the oral bioavailability of raltegravir. The proposed mechanism is chelation of raltegravir by polyvalent cations, but changes in solubility and lipophilicity of raltegravir related to pH increases may also contribute. In drug interaction studies, raltegravir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) decreased by 44%, 49% and 63%, respectively, when a single 20 mL dose of aluminum and magnesium hydroxide antacid was administered simultaneously with raltegravir (400 mg twice daily). The Cmax, AUC and Cmin of raltegravir decreased by 51%, 51% and 56%, respectively, when the antacid was given 2 hours before raltegravir, and by 22%, 30% and 57%, respectively, when the antacid was given 2 hours after raltegravir. When given 4 hours apart, raltegravir Cmax, AUC and Cmin decreased by 22%, 19% and 60% with antacid administered first, and by 30%, 32% and 62% with raltegravir administered first. Minimal changes in raltegravir Cmax and AUC were observed when administration was staggered by 6 hours; however, Cmin was still diminished by approximately 50% regardless of whether antacid was administered before or after raltegravir. When raltegravir 400 mg twice daily was given with a single dose of antacid containing calcium carbonate 3000 mg, raltegravir Cmax, AUC and Cmin decreased by 52%, 55% and 32%, respectively. These changes are not considered clinically significant by the manufacturer. However, when a single 1200 mg dose of raltegravir was coadministered with the calcium carbonate antacid, raltegravir Cmax, AUC and Cmin decreased by 74%, 72% and 58%, respectively. Staggering the doses by administering the calcium carbonate antacid 12 hours after raltegravir resulted in minimal changes in raltegravir Cmax and AUC, but Cmin was still reduced by 57%.

MANAGEMENT: Concomitant use of raltegravir with aluminum- and/or magnesium-containing antacids should generally be avoided, even if administration is staggered. Antacids containing calcium carbonate should not be used with once-daily raltegravir (HD formulation), but may be used without dose adjustment for other raltegravir products.

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. "Product Information. Isentress (raltegravir)." Merck & Co., Inc (2007):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Kiser JJ, Bumpass JB, Meditz AL, et al. "Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus seronegative volunteers." Antimicrob Agents Chemother 54 (2010): 4999-5003
  6. Roberts JL, Kiser JJ, Hindman JT, Meditz AL "Virologic failure with a raltegravir-containing antiretroviral regimen and concomitant calcium administration." Pharmacotherapy 31 (2011): 298e-302e
  7. Moss DM, Siccardi M, Murphy M, et al. "Divalent metals and pH alter raltegravir disposition in vitro." Antimicrob Agents Chemother 56 (2012): 3020-6
View all 7 references

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Drug and food interactions

Major

aluminum hydroxide food

Applies to: Uni-Lan II (aluminum hydroxide / magnesium hydroxide / simethicone)

GENERALLY AVOID: The concomitant administration of aluminum-containing products (e.g., antacids and phosphate binders) and citrates may significantly increase serum aluminum concentrations, resulting in toxicity. Citrates or citric acid are contained in numerous soft drinks, citrus fruits, juices, and effervescent and dispersible drug formulations. Citrates enhance the gastrointestinal absorption of aluminum by an unknown mechanism, which may involve the formation of a soluble aluminum-citrate complex. Various studies have reported that citrate increases aluminum absorption by 4.6- to 50-fold in healthy subjects. Patients with renal insufficiency are particularly at risk of developing hyperaluminemia and encephalopathy. Fatalities have been reported. Patients with renal failure or on hemodialysis may also be at risk from soft drinks and effervescent and dispersible drug formulations that contain citrates or citric acid. It is unknown what effect citrus fruits or juices would have on aluminum absorption in healthy patients.

MANAGEMENT: The concomitant use of aluminum- and citrate-containing products and foods should be avoided by renally impaired patients. Hemodialysis patients should especially be cautioned about effervescent and dispersible over-the-counter remedies and soft drinks. Some experts also recommend that healthy patients should separate doses of aluminum-containing antacids and citrates by 2 to 3 hours.

ADJUST DOSING INTERVAL: The administration of aluminum-containing antacids with enteral nutrition may result in precipitation, formation of bezoars, and obstruction of feeding tubes. The proposed mechanism is the formation of an insoluble complex between the aluminum and the protein in the enteral feeding. Several cases of esophageal plugs and nasogastric tube obstructions have been reported in patients receiving high-protein liquids and an aluminum hydroxide-magnesium hydroxide antacid or an aluminum hydroxide antacid.

MANAGEMENT: Some experts recommend that antacids should not be mixed with or given after high protein formulations, that the antacid dose should be separated from the feeding by as much as possible, and that the tube should be thoroughly flushed before administration.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Wohlt PD, Zheng L, Gunderson S, Balzar SA, Johnson BD, Fish JT "Recommendations for the use of medications with continuous enteral nutrition." Am J Health Syst Pharm 66 (2009): 1438-67

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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.

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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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