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Drug Interactions between Dual-Action Acid Controller Complete and Rythmol SR

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

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Interactions between your drugs

Moderate

famotidine propafenone

Applies to: Dual-Action Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide) and Rythmol SR (propafenone)

MONITOR: Famotidine may cause QTc prolongation. Theoretically, coadministration with other agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. According to the manufacturer, prolongation of the QT interval has been reported very rarely in patients with impaired renal function whose dose/dosing interval of famotidine may not have been adjusted appropriately. In general, the risk of an individual agent or a combination of these agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

MANAGEMENT: Caution and clinical monitoring are recommended if famotidine is used in combination with other drugs that can prolong the QT interval. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

References

  1. "Product Information. Pepcid (famotidine)." Merck & Co., Inc PROD (2002):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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Moderate

propafenone magnesium hydroxide

Applies to: Rythmol SR (propafenone) and Dual-Action Acid Controller Complete (calcium carbonate / famotidine / magnesium hydroxide)

MONITOR: Bowel cleansing as well as overuse of certain laxatives may cause electrolyte loss and increase the risk of torsade de pointes ventricular arrhythmia in patients treated with drugs that prolong the QT interval. Electrolyte disturbances including hypokalemia and hypomagnesemia have been reported with laxative abuse and are known risk factors for torsade de pointes associated with QT interval prolongation.

MANAGEMENT: Patients treated with drugs that prolong the QT interval should exercise caution when self-medicating with laxatives. The recommended dosage and duration of use should not be exceeded. Patients treated with lactulose for more than six months should be monitored periodically for electrolyte imbalance. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

References

  1. Chin RL "Laxative-induced hypokalemia." Ann Emerg Med 32 (1998): 517-8
  2. Muller-Lissner SA "Adverse effects of laxatives: fact and fiction." Pharmacology 47 (1993): 138-45
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Canadian Pharmacists Association "e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink" (2006):
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. Schaefer DC, Cheskin LJ "Constipation in the elderly." Am Fam Physician 58 (1998): 907-14
View all 6 references

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Minor

famotidine calcium carbonate

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

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Minor

famotidine magnesium hydroxide

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

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Drug and food interactions

Moderate

propafenone food

Applies to: Rythmol SR (propafenone)

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of propafenone. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Inhibition of hepatic CYP450 3A4 may also contribute. In over 90% of patients, propafenone is rapidly and extensively converted to 2 active metabolites: 5-hydroxypropafenone via CYP450 2D6 and N-depropylpropafenone (norpropafenone) via CYP450 3A4 and 1A2. In less than 10% of patients (approximately 6% of Caucasians in the U.S. population), however, metabolism of propafenone is slower because the 5-hydroxy metabolite is not formed, or minimally formed, due to a genetic deficiency in CYP450 2D6. In these poor metabolizers of CYP450 2D6, clearance of propafenone via the CYP450 3A4 and 1A2 metabolic pathways becomes more important, and inhibition of these pathways may substantially increase systemic exposure to propafenone. Likewise, patients taking concomitant inhibitors of CYP450 2D6 and 3A4 may experience similar pharmacokinetic effects. 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. Increased systemic exposure to propafenone may result in proarrhythmic events and exaggerated beta-adrenergic blocking activity.

MANAGEMENT: It may be advisable for patients to avoid the consumption of grapefruit, grapefruit juice, or supplements that contain grapefruit during treatment with propafenone.

References

  1. Botsch S, Gautier JC, Beaune P, Eichelbaum M, Kroemer HK "Identification and characterization of the cytochrome P450 enzymes involved in N-dealkylation of propafenone: molecular base for interaction potential and variable disposition of active metabolites." Mol Pharmacol 43 (1993): 120-6
  2. "Product Information. Rythmol SR (propafenone)." GlaxoSmithKline (2011):
  3. "Product Information. Apo-Propafenone (propafenone)." Apotex Incorporated (2023):
  4. "Product Information. Propafenone (propafenone)." Accord-UK Ltd (2022):
View all 4 references

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Moderate

calcium carbonate food

Applies to: Dual-Action 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." 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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Minor

famotidine food

Applies to: Dual-Action 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 "Effect of cimetidine and ranitidine on the hepatic and renal elimination of nicotine in humans." Eur J Clin Pharmacol 38 (1990): 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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