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Drug Interactions between HalfLytely and Bisacodyl and ketoconazole

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

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Interactions between your drugs

Moderate

ketoconazole sodium bicarbonate

Applies to: ketoconazole and HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)

ADJUST DOSING INTERVAL: The dissolution of oral ketoconazole requires an acidic environment. Medications that decrease the acidity of the stomach, such as omeprazole or H2 antagonists can reduce the bioavailability of ketoconazole by 75% to 80%. Antacids are also expected to impair ketoconazole absorption. Levoketoconazole, which is an enantiomer of ketoconazole is expected to have similar interactions.

MANAGEMENT: It is recommended to administer antacids at least 1 hour before or 2 hours after ketoconazole. Patients should be monitored for altered antifungal effects and the ketoconazole dosage adjusted if necessary. Levoketoconazole manufacturer recommends administering antacids at least 2 hours after taking levoketoconazole. Patients should be monitored for diminished levoketoconazole effects.

References (8)
  1. Brass C, Galgiani JN, Blaschke TF, et al. (1982) "Disposition of ketoconazole, an oral antifungal, in humans." Antimicrob Agents Chemother, 21, p. 151-8
  2. Van der Meer JW, Keuning JJ (1980) "The influence of gastric acidity on the bio-availability of ketoconazole." J Antimicrob Chemother, 6, p. 552-4
  3. Carlson JA, Mann HJ, Canafax DM (1983) "Effect of pH on disintegration and dissolution of ketoconazole tablets." Am J Hosp Pharm, 40, p. 1334-6
  4. Chin TWF, Loeb M, Fong IW (1995) "Effects of an acidic beverage (coca-cola) on absorption of ketoconazole." Antimicrob Agents Chemother, 39, p. 1671-5
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  6. Cerner Multum, Inc. (2015) "Canadian Product Information."
  7. Cerner Multum, Inc (2015) "ANVISA Bulário Eletrônico."
  8. (2019) "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc
Moderate

ketoconazole bisacodyl

Applies to: ketoconazole and HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)

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

ketoconazole polyethylene glycol 3350

Applies to: ketoconazole and HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)

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

sodium bicarbonate bisacodyl

Applies to: HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride) and HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)

ADJUST DOSING INTERVAL: By increasing gastric pH, antacids may reduce the resistance of the enteric coating of bisacodyl tablets, resulting in earlier release of bisacodyl and gastric irritation and dyspepsia.

MANAGEMENT: The administration of antacids and bisacodyl should be separated by at least one hour.

References (1)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
Moderate

bisacodyl polyethylene glycol 3350

Applies to: HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride) and HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)

GENERALLY AVOID: Concomitant use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) may increase the risk of serious gastrointestinal adverse effects associated with certain osmotic laxatives (e.g., polyethylene glycol (PEG), oral sulfate solution), such as colonic mucosal ulcerations or ischemic colitis. There have been isolated case reports of ischemic colitis occurring with the use of PEG-based bowel cleansing products in combination with higher dosages of bisacodyl (usually greater than 10 mg). Bisacodyl can cause colonic ischemia due to transient reduction in splanchnic blood flow. When administered in conjunction with an osmotic laxative such as PEG, increased intramural pressure secondary to increased peristalsis may lead to ischemic colitis and perforation.

MANAGEMENT: The manufacturers for some osmotic bowel cleansing products recommend avoiding the concurrent use of stimulant laxatives. However, stimulant laxatives, in particular bisacodyl and sodium picosulfate, are sometimes used with PEG in certain bowel cleansing regimens to help reduce dose volume and improve patient tolerability and acceptance. Please consult individual product labeling for specific recommendations and guidance. Patients using osmotic bowel cleansing products and stimulant laxatives who present with sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis should be evaluated promptly.

References (15)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. Baudet JS, Castro V, Redondo I (2010) "Recurrent ischemic colitis induced by colonoscopy bowel lavage." Am J Gastroenterol, 105, p. 700-1
  4. (2010) "Product Information. Suprep Bowel Prep Kit (magnesium/potassium/sodium sulfates)." Braintree Laboratories
  5. Ajani S, Hurt RT, Teeters DA, Bellmore LR (2012) "Ischaemic colitis associated with oral contraceptive and bisacodyl use." BMJ Case Rep, 2012
  6. (2016) "Product Information. MoviPrep (polyethylene glycol 3350 with electrolytes)." Physicians Total Care
  7. (2020) "Product Information. Plenvu (polyethylene glycol 3350 with electrolytes)." Bausch Health US (formerly Valeant Pharmaceuticals)
  8. (2022) "Product Information. GaviLyte-H and Bisacodyl with Flavor Packs (bisacodyl-PEG 3350 with electrolytes)." Gavis Pharmaceuticals
  9. "Product Information. Bi-Peglyte (bisacodyl-PEG 3350 with electrolytes)." Pendopharm
  10. Vaizman K, Li J, Iswara K, Tenner S (2007) "Ischemic colitis induced by the combination of Bisacodyl and polyethylene glycol in preparation for colonoscopy." Am J Gastroenterol, 102, S267
  11. Belsey J, Epstein O, heresbach D (2009) "Systematic review: adverse event reports for oral sodium phosphate and polyethylene glycol." Aliment Pharmacol Ther, 29, p. 15-28
  12. Hung SY, Chen HC, Chen WT (2020) "A randomized trial comparing the bowel cleansing efficacy of sodium picosulfate/magnesium citrate and polyethylene glycol/Bisacodyl (The Bowklean Study)" Sci Rep, 10, p. 5604
  13. Adamcewicz M, Bearelly D, Porat G, Friedenberg FK (2011) "Mechanism of action and toxicities of purgatives used for colonoscopy preparation." Expert Opin Drug Metab Toxicol, 7, p. 89-101
  14. Anastassopoulos K, Farraye FA, Knight T, Colman S, Cleveland MvB, Pelham RW (2016) "A comparative study of treatment-emergent adverse events following use of common bowel preparations among a colonoscopy screening population: results from a post-marketing observational study." Dig Dis Sci, 61, p. 2993-3006
  15. Barbeau P, Wolfe D, Yazdi F, et al. (2018) "Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis." BMJ Open, 8, e021892

Drug and food interactions

Moderate

ketoconazole food

Applies to: ketoconazole

GENERALLY AVOID: Excessive use of alcohol or products containing alcohol together with ketoconazole or levoketoconazole may potentiate the risk of liver injury. Serious hepatotoxicity has been reported with levoketoconazole. Hepatotoxicity requiring liver transplantation has been reported with the use of oral ketoconazole, of which levoketoconazole is an enantiomer. Some patients had no obvious risk factors for liver disease. In addition, use of alcohol or products containing alcohol during ketoconazole or levoketoconazole therapy may result in a disulfiram-like reaction in some patients. Symptoms of disulfiram-like reaction include flushing, rash, peripheral edema, nausea, and headache.

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of ketoconazole or levoketoconazole. The mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. Inhibition of hepatic CYP450 3A4 may also contribute. 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.

When administered to healthy volunteers with a high-fat meal (875 calories; 62% fat), levoketoconazole systemic exposure (AUC) increased by 30% while peak plasma concentration (Cmax) did not change and the time to reach Cmax (Tmax) was delayed from 2 to 4 hours, compared to fasted conditions.

MANAGEMENT: Levoketoconazole may be administered with or without food. Excessive consumption of alcohol should generally be avoided during ketoconazole or levoketoconazole therapy. Patients should preferably avoid or limit consumption of grapefruit, grapefruit juice, or any supplement containing grapefruit extract during ketoconazole or levoketoconazole therapy. Patients receiving ketoconazole or levoketoconazole should be instructed to contact their doctor immediately if they experience swelling, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark colored urine, light colored stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage.

References (4)
  1. (2019) "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc
  2. (2022) "Product Information. Recorlev (levoketoconazole)." Xeris Pharmaceuticals Inc
  3. Auchus R, Pivonello R, Fleseriu M, et al. (2022) Levoketoconazole: a novel treatment for endogenous Cushing's syndrome. https://www.tandfonline.com/doi/pdf/10.1080/17446651.2021.1945440
  4. (2021) "Product Information. Ketoconazole (ketoconazole)." Burel Pharmaceuticals Inc

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.