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Drug Interactions between Acid Controller Complete and Juluca

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

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Interactions between your drugs

Major

famotidine rilpivirine

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Juluca (dolutegravir / rilpivirine)

ADJUST DOSING INTERVAL: Coadministration with H2-receptor antagonists may significantly decrease the oral bioavailability of rilpivirine. The proposed mechanism involves a pH-dependent reduction in dissolution and absorption of rilpivirine, which is poorly soluble over a wide pH range. When a single 40 mg dose of famotidine was administered 2 hours before a single 150 mg dose of rilpivirine to 23 study subjects, mean rilpivirine peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 85% and 76%, respectively, compared to rilpivirine administered alone. By contrast, when the dose of famotidine was administered either 12 hours before or 4 hours after the rilpivirine dose, no clinically significant changes in rilpivirine Cmax and AUC were observed.

MANAGEMENT: To minimize the risk of reduced viral susceptibility and resistance development associated with subtherapeutic levels of rilpivirine, H2-receptor antagonists should be administered at least 12 hours before or 4 hours after the rilpivirine dose.

References

  1. (2011) "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals

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Major

calcium carbonate dolutegravir

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Juluca (dolutegravir / rilpivirine)

ADJUST DOSING INTERVAL: Coadministration with medications containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of dolutegravir. The mechanism of interaction has not been established. In 16 study subjects, administration of a single 50 mg dose of dolutegravir simultaneously with an antacid (Maalox) decreased dolutegravir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin; 24 hours post-dose) by 72%, 74% and 74%, respectively, compared to administration without the antacid. When the antacid was administered 2 hours after dolutegravir, the Cmax, AUC and Cmin of dolutegravir decreased by just 18%, 26% and 30%, respectively. Administration of single-dose dolutegravir simultaneously with a multivitamin (One-A-Day) decreased the Cmax, AUC and Cmin of dolutegravir by 35%, 33% and 32%, respectively.

MANAGEMENT: Dolutegravir should be administered 2 hours before or 6 hours after medications containing polyvalent cations such as antacids, laxatives, or mineral supplements.

References

  1. (2013) "Product Information. Tivicay (dolutegravir)." ViiV Healthcare

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Major

magnesium hydroxide dolutegravir

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Juluca (dolutegravir / rilpivirine)

ADJUST DOSING INTERVAL: Coadministration with medications containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of dolutegravir. The mechanism of interaction has not been established. In 16 study subjects, administration of a single 50 mg dose of dolutegravir simultaneously with an antacid (Maalox) decreased dolutegravir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin; 24 hours post-dose) by 72%, 74% and 74%, respectively, compared to administration without the antacid. When the antacid was administered 2 hours after dolutegravir, the Cmax, AUC and Cmin of dolutegravir decreased by just 18%, 26% and 30%, respectively. Administration of single-dose dolutegravir simultaneously with a multivitamin (One-A-Day) decreased the Cmax, AUC and Cmin of dolutegravir by 35%, 33% and 32%, respectively.

MANAGEMENT: Dolutegravir should be administered 2 hours before or 6 hours after medications containing polyvalent cations such as antacids, laxatives, or mineral supplements.

References

  1. (2013) "Product Information. Tivicay (dolutegravir)." ViiV Healthcare

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Moderate

calcium carbonate rilpivirine

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Juluca (dolutegravir / rilpivirine)

ADJUST DOSING INTERVAL: Coadministration with antacids may decrease the oral bioavailability of rilpivirine. The proposed mechanism involves a pH-dependent reduction in dissolution and absorption of rilpivirine, which is poorly soluble over a wide pH range. The interaction has not been studied specifically with antacids, but has been reported for H2-receptor antagonists and proton pump inhibitors.

MANAGEMENT: To minimize the risk of reduced viral susceptibility and resistance development associated with subtherapeutic levels of rilpivirine, antacids or other medications that contain antacids (e.g., didanosine buffered tablets or pediatric oral solution) should be administered at least 2 hours before or 4 hours after the rilpivirine dose.

References

  1. (2011) "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals

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Moderate

magnesium hydroxide rilpivirine

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Juluca (dolutegravir / rilpivirine)

ADJUST DOSING INTERVAL: Coadministration with antacids may decrease the oral bioavailability of rilpivirine. The proposed mechanism involves a pH-dependent reduction in dissolution and absorption of rilpivirine, which is poorly soluble over a wide pH range. The interaction has not been studied specifically with antacids, but has been reported for H2-receptor antagonists and proton pump inhibitors.

MANAGEMENT: To minimize the risk of reduced viral susceptibility and resistance development associated with subtherapeutic levels of rilpivirine, antacids or other medications that contain antacids (e.g., didanosine buffered tablets or pediatric oral solution) should be administered at least 2 hours before or 4 hours after the rilpivirine dose.

References

  1. (2011) "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals

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Minor

famotidine calcium carbonate

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide)

Antacids and some aluminum, calcium, and magnesium salts may decrease the plasma concentrations of H2-receptor antagonists during oral coadministration. The mechanism of interaction is unknown, but may involve reduced oral absorption due to increased gastric pH. Study data vary, with no changes to nearly 60% reductions in systemic exposures (AUCs) reported for cimetidine, famotidine, and ranitidine. The clinical significance has not been established. As a precaution, patients may consider taking H2-receptor antagonists one to two hours before antacids.

References

  1. Donn KH, Eshelman FN, Plachetka JR, et al. (1984) "The effects of antacid and propantheline on the absorption of oral ranitidine." Pharmacotherapy, 4, p. 89-92
  2. Albin H, Vincon G, Demotes-Mainard F, et al. (1984) "Effect of aluminium phosphate on the bioavailability of cimetidine and prednisolone." Eur J Clin Pharmacol, 26, p. 271-3
  3. Lin JH, Chremos AN, Kanovsky SM, Schwartz S, Yeh KC, Kann J (1987) "Effects of antacids and food on absorption of famotidine." Br J Clin Pharmacol, 24, p. 551-3
  4. Bodemar G, Norlander B, Walan A (1979) "Diminished absorption of cimetidine caused by antacids." Lancet, 02/24/79, p. 444-5
  5. Steinberg WM, Lewis JH, Katz DM (1982) "Antacids inhibit absorption of cimetidine." N Engl J Med, 307, p. 400-4
  6. Barzaghi N, Gatti G, Crema F, Perucca E (1989) "Impaired bioavailability of famotidine given concurrently with a potent antacid." J Clin Pharmacol, 29, p. 670-2
  7. Russell WL, Lopez LM, Normann SA, et al. (1984) "Effect of antacids on predicted steady-state cimetidine concentrations." Dig Dis Sci, 29, p. 385-9
  8. Shelly DW, Doering PL, Russell WL, Guild RT, Lopez LM, Perrin J (1986) "Effect of concomitant antacid administration on plasma cimetidine concentrations during repetitive dosing." Drug Intell Clin Pharm, 20, p. 792-5
  9. Albin H, Vincon G, Begaud B, Bistue C, Perez P (1987) "Effect of aluminum phosphate on the bioavailability of ranitidine." Eur J Clin Pharmacol, 32, p. 97-9
  10. Mihaly GW, Marino AT, Webster LK, Jones DB, Louis WJ, Smallwood RA (1982) "High dose of antacid (Mylanta II) reduces bioavailability of ranitidine." Br Med J, 285, p. 998-9
  11. Covington TR, eds., Lawson LC, Young LL (1993) "Handbook of Nonprescription Drugs." Washington, DC: American Pharmaceutical Association
  12. Bachmann KA, Sullivan TJ, Jauregui L, Reese J, Miller K, Levine L (1994) "Drug interactions of h-2-receptor antagonists." Scand J Gastroenterol, 29, p. 14-9
View all 12 references

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Minor

famotidine magnesium hydroxide

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide)

Antacids and some aluminum, calcium, and magnesium salts may decrease the plasma concentrations of H2-receptor antagonists during oral coadministration. The mechanism of interaction is unknown, but may involve reduced oral absorption due to increased gastric pH. Study data vary, with no changes to nearly 60% reductions in systemic exposures (AUCs) reported for cimetidine, famotidine, and ranitidine. The clinical significance has not been established. As a precaution, patients may consider taking H2-receptor antagonists one to two hours before antacids.

References

  1. Donn KH, Eshelman FN, Plachetka JR, et al. (1984) "The effects of antacid and propantheline on the absorption of oral ranitidine." Pharmacotherapy, 4, p. 89-92
  2. Albin H, Vincon G, Demotes-Mainard F, et al. (1984) "Effect of aluminium phosphate on the bioavailability of cimetidine and prednisolone." Eur J Clin Pharmacol, 26, p. 271-3
  3. Lin JH, Chremos AN, Kanovsky SM, Schwartz S, Yeh KC, Kann J (1987) "Effects of antacids and food on absorption of famotidine." Br J Clin Pharmacol, 24, p. 551-3
  4. Bodemar G, Norlander B, Walan A (1979) "Diminished absorption of cimetidine caused by antacids." Lancet, 02/24/79, p. 444-5
  5. Steinberg WM, Lewis JH, Katz DM (1982) "Antacids inhibit absorption of cimetidine." N Engl J Med, 307, p. 400-4
  6. Barzaghi N, Gatti G, Crema F, Perucca E (1989) "Impaired bioavailability of famotidine given concurrently with a potent antacid." J Clin Pharmacol, 29, p. 670-2
  7. Russell WL, Lopez LM, Normann SA, et al. (1984) "Effect of antacids on predicted steady-state cimetidine concentrations." Dig Dis Sci, 29, p. 385-9
  8. Shelly DW, Doering PL, Russell WL, Guild RT, Lopez LM, Perrin J (1986) "Effect of concomitant antacid administration on plasma cimetidine concentrations during repetitive dosing." Drug Intell Clin Pharm, 20, p. 792-5
  9. Albin H, Vincon G, Begaud B, Bistue C, Perez P (1987) "Effect of aluminum phosphate on the bioavailability of ranitidine." Eur J Clin Pharmacol, 32, p. 97-9
  10. Mihaly GW, Marino AT, Webster LK, Jones DB, Louis WJ, Smallwood RA (1982) "High dose of antacid (Mylanta II) reduces bioavailability of ranitidine." Br Med J, 285, p. 998-9
  11. Covington TR, eds., Lawson LC, Young LL (1993) "Handbook of Nonprescription Drugs." Washington, DC: American Pharmaceutical Association
  12. Bachmann KA, Sullivan TJ, Jauregui L, Reese J, Miller K, Levine L (1994) "Drug interactions of h-2-receptor antagonists." Scand J Gastroenterol, 29, p. 14-9
View all 12 references

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Drug and food interactions

Moderate

calcium carbonate food

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

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Moderate

rilpivirine food

Applies to: Juluca (dolutegravir / rilpivirine)

GENERALLY AVOID: Coadministration with grapefruit or grapefruit juice may increase the plasma concentrations of rilpivirine. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall induced by certain compounds present in grapefruit. In 15 study subjects given rilpivirine (150 mg once daily) with the potent CYP450 3A4 inhibitor ketoconazole (400 mg once daily), mean rilpivirine peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) were increased by 30%, 49% and 76%, respectively. In 16 study subjects given a single 500 mg dose of a less potent CYP450 3A4 inhibitor chlorzoxazone two hours after rilpivirine (150 mg once daily), mean rilpivirine Cmax, AUC, and Cmin were increased by 17%, 25%, and 18%, respectively. Because grapefruit juice inhibits primarily intestinal rather than hepatic CYP450 3A4, the magnitude of interaction is greatest for those drugs that undergo significant presystemic metabolism by CYP450 3A4 (i.e., drugs with low oral bioavailability). In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Pharmacokinetic interactions involving grapefruit juice are also subject to a high degree of interpatient variability, thus the extent to which a given patient may be affected is difficult to predict.

ADJUST DOSING INTERVAL: The administration of rilpivirine in a fasting state may decrease its oral absorption. Under fasted conditions, the systemic exposure to rilpivirine was 40% lower compared to normal or high-fat caloric meals (533 to 928 Kcal). The systemic exposure was 50% lower when rilpivirine was taken with a protein-rich nutritional beverage.

MANAGEMENT: Coadministration of grapefruit or grapefruit juice with rilpivirine should preferably be avoided. For optimal absorption, it is recommended to take rilpivirine on a regular schedule with a meal.

References

  1. (2011) "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals
  2. Cerner Multum, Inc. (2015) "Canadian Product Information."

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Minor

dolutegravir food

Applies to: Juluca (dolutegravir / rilpivirine)

Food increases the extent of absorption and slows the rate of absorption of dolutegravir. When administered with a low-, moderate- or high-fat meal, dolutegravir peak plasma concentration (Cmax) increased by 46%, 52% and 67%, systemic exposure (AUC) increased by 33%, 41% and 66%, and time to reach Cmax (Tmax) increased from 2 hours to 3, 4 and 5 hours, respectively, compared to administration under fasted conditions. Dolutegravir may be taken with or without food.

References

  1. (2013) "Product Information. Tivicay (dolutegravir)." ViiV Healthcare

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Minor

famotidine food

Applies to: Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide)

H2 antagonists may reduce the clearance of nicotine. Cimetidine, 600 mg given twice a day for two days, reduced clearance of an intravenous nicotine dose by 30%. Ranitidine, 300 mg given twice a day for two days, reduced clearance by 10%. The clinical significance of this interaction is not known. Patients should be monitored for increased nicotine effects when using the patches or gum for smoking cessation and dosage adjustments should be made as appropriate.

References

  1. Bendayan R, Sullivan JT, Shaw C, Frecker RC, Sellers EM (1990) "Effect of cimetidine and ranitidine on the hepatic and renal elimination of nicotine in humans." Eur J Clin Pharmacol, 38, p. 165-9

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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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