Polyethylene glycol (PEG-3350) and electrolytes are used in combination with bisacodyl delayed-release tablets for bowel cleansing prior to colonoscopy in adults. HalfLytely and Bisacodyl Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate, potassium chloride for oral solution and bisacodyl delayed-release tablets) is a combination kit that contains a 2-liter electrolyte lavage solution and two 5 mg (10 mg total dose) bisacodyl tablets. By starting with a dose of bisacodyl, a stimulant laxative, patients are able to ingest a reduced volume (2-liters) of PEG-3350; electrolytes solution, as compared to the usual 4 liters that are typically required with other PEG-3350; electrolytes bowel preparations. The reduced solution volume may result in greater patient compliance as well as decreased discomfort (nausea, bloating) while maintaining comparable bowel cleansing efficacy. In a clinical study comparing the safety and efficacy of a 2 liter PEG-3350; electrolytes lavage solution verses the standard 4 liter, participating patients (n=300) were randomized into two groups. One group received a dose of 20 mg bisacodyl at 12 noon followed by 2 liters PEG-3350; electrolytes solution at 6PM the evening before the procedure; a second group received 4 liters PEG-3350; electrolytes solution at 6PM the evening before the procedure. Among patients receiving the bisacodyl plus 2 liter regimen, only 1 patient (0.6%) could not finish the bowel preparation due to adverse GI complaints (abdominal cramps, bloating, nausea/vomiting) as opposed to 11 patients (7.3%) receiving the 4 liter regimen; no patients in the 4 liter group reported abdominal cramps. Bowel cleanliness, as assessed by an endoscopist, was scored from 0% to 100% with 100% representing a perfectly clean bowel. Scores averaged 95.9% in the bisacodyl plus 2 liter regimen group and 95.3% in the 4 liter regimen group. Clinicians should note that HalfLytely and Bisacodyl Bowel Prep Kit, when first approved, contained a total bisacodyl dose of 20 mg. However, postmarketing adverse events of abdominal cramping following the 20 mg bisacodyl dose lead the manufacturer to evaluate if a 10 mg bisacodyl dose would result in reduced adverse events while preserving bowel cleansing efficacy. In a multicenter-controlled trial, the patients (n=455) undergoing colonoscopy were randomized into two groups receiving 10 or 20 mg bisacodyl tablets plus a 2 liter PEG-3350; electrolytes lavage solution. Endoscopists, blinded to group assignments, observed no differences in the colon cleansing effects between the two groups. In addition, the group receiving 10 mg bisacodyl had lower symptom scores for abdominal cramping (p < 0.001) and overall discomfort (p = 0.001). HalfLytely and Bisacodyl Bowel Prep Kit was first approved by the FDA in May 2004. On September 24, 2007 the FDA accepted a supplemental new drug application which provided for the reduction of the bisacodyl dosage from 20 mg to 10 mg.
General Administration Information
For storage information, see specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-No solid food or milk should be consumed; only clear liquids should be consumed by the patient on the day of bowel preparation.
-The contents of the kit are for oral use only.
-Bisacodyl tablets should be administered before the administration of the electrolyte solution.
-After taking the bowel preparation, patients should not ingest large quantities of clear liquids until after their procedure is completed.
Oral Solid Formulations
-Bisacodyl tablets should be taken with water; the tablets should not be crushed or chewed. The first bowel movement should occur approximately 1 to 6 hours after bisacodyl administration.
Oral Liquid Formulations
-Prepare the PEG; electrolytes solution as directed.
-Wait for a bowel movement (or a maximum of 6 hours) then have the patient drink the 2 liter of the PEG; electrolytes solution at a rate of 8 ounces every 10 minutes. The patient should drink all of the solution as directed.
Reconstitution of PEG-electrolytes solution:
-If desired, add the provided flavoring packets to the 2 liter container. The preparation can be used with or without the addition of the provided flavoring packets.
-DO NOT add additional flavors or diluents to the solution as this may alter the osmolality of the solution.
-Fill the container to the 2 liter mark with water. Reconstitute only with water; DO NOT reconstitute with other liquids and/or add starch-based thickeners to the mixing container as this can lead to choking and aspiration in certain patients.
-Cap the container and shake vigorously to dissolve the powder.
-After reconstitution, the solution may be refrigerated; the solution is more palatable if chilled before administration. Use within 48 hours of reconstitution. Discard unused portion.
During controlled, clinical evaluation of polyethylene glycol; electrolytes; bisacodyl (5 mg bisacodyl) versus polyethylene glycol; electrolytes; bisacodyl (10 mg bisacodyl) the most common adverse reactions, observed in at least 3% of patients in either group were overall discomfort (57-66%), abdominal pain reported as abdominal fullness (40-53%) and abdominal cramping (38-46%), nausea (34-42%), and vomiting (7-10%).
Sodium and fluid retention or edema occur rarely with large volume (4 liter) polyethylene glycol; electrolytes colon preparation products and may occur with polyethylene glycol; electrolytes; bisacodyl. There is also an increased risk for fluid and electrolyte disturbance, and renal impairment.
During post marketing surveillance of polyethylene glycol; electrolytes; bisacodyl, allergic reactions have been reported. Cases of urticaria, rhinorrhea, dermatitis, and anaphylactoid reactions have been reported with polyethylene glycol-based products which may represent allergic reactions. Because these reactions are reported voluntarily it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Flatulence and diarrhea (or increased stool frequency) are expected effects and may cause fecal urgency or fecal incontinence. These adverse reactions are transient and subside rapidly. Post-marketing reports in patients over 60 years of age demonstrate serious adverse events following the administration of polyethylene glycol-based products. These adverse events include: upper GI bleeding from a Mallory-Weiss tear, GI perforation (esophageal), asystole, as well as sudden dyspnea with pulmonary edema and a 'butterfly-like' infiltrate on chest x-ray after vomiting and aspirating the solution. In addition, two deaths in end stage renal failure patients who developed diarrhea, vomiting, and dysnatremia have been reported during administration of 4 liters of polyethylene glycol; electrolytes colon cleansing preparation. Ischemic colitis has been reported with use of polyethylene glycol; electrolytes; bisacodyl for colon preparation prior to colonoscopy; however, a causal relationship has not been established. Cases of choking and potential aspiration were reported in patients with dysphagia who received polyethylene glycol (PEG)-based oral solutions mixed with starch-thickened liquids. When polyethylene glycol (PEG) is mixed with starch-thickened liquids, it reduces the viscosity of the starch-thickened liquid resulting in thinning of the liquid.
There have been rare reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) polyethylene glycol; electrolytes colon preparation products in patients with no prior history of seizures (see Contraindications). The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Cases of dizziness and syncope have also been reported.
Polyethylene glycol; electrolytes; bisacodyl is contraindicated for use in those with known polyethylene glycol hypersensitivity or bisacodyl hypersensitivity or with hypersensitivity to any of the components of this specific commercial product. Hives and skin rashes have been reported with PEG-3350 based products that are suggestive of an allergic reaction.
Polyethylene glycol; electrolytes; bisacodyl is contraindicated for use in patients with known or suspected GI obstruction, GI perforation, toxic colitis, or toxic megacolon. Patients with symptoms suggestive of bowel obstruction (e.g., acute abdomen or symptoms of appendicitis, abdominal pain, distension, nausea, or vomiting) should be evaluated prior to initiating bowel evacuation. Use with caution in the presence of ileus, gastric retention, inflammatory bowel disease such as severe ulcerative colitis, or other conditions where there may be compromised integrity of the bowel wall as use of these products may lead to very rare instances of bowel perforation in such patients. If patients develop severe abdominal pain or rectal GI bleeding, patients should be evaluated as soon as possible. Due to the potential choking hazard, use polyethylene glycol; electrolytes solution with caution in those patients prone to aspiration or regurgitation (e.g., coma, gag reflex depression, dysphagia, esophageal stricture, semiconscious, or impaired mental status, like dementia). Do not combine polyethylene glycol; electrolytes solution with starch-based thickeners. When polyethylene glycol (PEG) is mixed with starch-thickened liquids, it reduces the viscosity of the starch-thickened liquid resulting in thinning of the liquid; cases of choking and potential aspiration were reported in patients with dysphagia.
A large volume of liquid must be ingested during preparation prior to polyethylene glycol;electrolytes; bisacodyl use, patients with fluid restrictions such as patients with renal disease (including renal impairment and renal failure) or patients taking diuretics should be closely monitored. Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.
There have been rare reports of generalized tonic-clonic seizures associated with use of polyethylene glycol colon preparation products in patients with no prior history of seizure disorder. The cases of seizures were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, polyethylene glycol; electrolytes; bisacodyl should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities or in patients with known or suspected hyponatremia. Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. Also consider laboratory tests if patients develop severe vomiting and/or signs of dehydration, even if the patient is otherwise healthy.
Use caution when administering polyethylene glycol; electrolytes; bisacodyl bowel preparation in geriatric patients. Of the 222 patients who received polyethylene glycol; electrolytes; bisacodyl in clinical trials, 73 (33%) were 65 years of age or older, and 18 (8%) were 75 years of age or older. Although no overall differences in safety or effectiveness were observed in the elderly patients, greater sensitivity of some older individuals cannot be ruled out.
The safety and efficacy of polyethylene glycol; electrolytes; bisacodyl in children have not been established.
Administer polyethylene glycol; electrolytes; bisacodyl (PEG-3350 with electrolytes and bisacodyl kits) for bowel preparation during pregnancy only if clearly needed and with caution. Animal reproduction studies have not been performed. While high-molecular weight polyethylene glycol 3350 is not significantly absorbed from the GI tract, there are no data to inform a drug-associated risk for adverse developmental outcomes when these bowel preparation products are used as intended. However, when use is absolutely necessary, evidence appears to favor PEG-electrolyte solutions as preferred agents versus sodium phosphate (which might have a higher association with fluid and electrolyte abnormalities) when complete bowel evacuation is necessary during pregnancy. Kits with bisacodyl in addition to PEG-3350 with electrolytes may be unnecessary for successful bowel evacuation.
According to the manufacturer, caution should be exercised when polyethylene glycol; electrolytes; bisacodyl are administered to a nursing woman. It is not known if polyethylene glycol; electrolytes; bisacodyl is distributed into human breast-milk. The safest bowel evacuants for use in lactating women are those that are not systemically absorbed. Polyethylene glycol 3350 (PEG 3350) is a common food additive and is not significantly absorbed from the GI tract. Only 0.2% of an oral dose would be absorbed systemically by the lactating mother and significant passage to the milk seems unlikely. Consensus documents indicate that PEG-containing bowel preparations represent a low risk when used during breast-feeding. In addition, clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females. Thus, clinical risk to the infant is negligible; no special precautions exist for nursing infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For use as a bowel evacuant to clean the colon prior to colonoscopy (bowel preparation):
NOTE: Patients should be well hydrated before, during, and after the colon preparation. However, patients should not drink large quantities of clear liquids after taking the polyethylene glycol; electrolytes solution until the colonoscopy has been completed.
Oral dosage:
Adults: To start, 2 delayed-release bisacodyl tablets (10 mg total dose) should be taken PO. Following the first bowel movement (or after a maximum of 6 hours following the bisacodyl dose), administer the prepared solution at a rate of 240 mL (approximately 8 oz) PO every 10 minutes until 2 liters are consumed. Rapid drinking of each portion is preferred to drinking small amounts continuously. The first bowel movement should occur approximately between 1 and 6 hours after taking the 2 bisacodyl delayed release tablets.
Adolescents: Safety and efficacy have not been established.
Children: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
2 liters/24 hours PO polyethylene glycol; electrolytes solution and 10 mg/24 hours PO delayed-release bisacodyl tablets.
-Elderly
2 liters/24 hours PO polyethylene glycol; electrolytes solution and 10 mg/24 hours PO delayed-release bisacodyl tablets.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Acetaminophen; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as bisacodyl, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events. (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as polyethylene glycol, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Aluminum Hydroxide: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aluminum Hydroxide; Magnesium Carbonate: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aluminum Hydroxide; Magnesium Hydroxide: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aluminum Hydroxide; Magnesium Hydroxide; Simethicone: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aluminum Hydroxide; Magnesium Trisilicate: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Amoxicillin; Clarithromycin; Omeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Antacids: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Aspirin, ASA; Omeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Atropine; Difenoxin: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
Bisacodyl: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Bumetanide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy. (Moderate) Monitor renal function and serum electrolytes and ensure adequate hydration before and after concomitant loop diuretic and polyethylene glycol 3350 use. Concomitant use may increase the risk for fluid and electrolyte abnormalities and renal injury.
Calcium Carbonate: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour. (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour.
Calcium Carbonate; Simethicone: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour.
Calcium Phosphate, Supersaturated: (Moderate) Sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous should not be combined with additional laxatives or purgatives when being used to evacuate the bowel prior to colonic radiologic examinations or surgery. (Moderate) Sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous should not be combined with additional laxatives or purgatives when being used to evacuate the bowel prior to colonic radiologic examinations or surgery. Use in patients using small doses of polyethylene glycol 3350 (e.g., Miralax) may be permissable, as long as the patient does not use their chronic laxative therapy on the day of the preparation. Watch for electrolyte and fluid abnormalities in all patients using bowel preparations.
Calcium; Vitamin D: (Moderate) By increasing intragastric pH, calcium carbonate can affect the dissolution of oral bisacodyl tablets; administration should be separated by 1 hour.
Castor Oil: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Chlorpheniramine; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as bisacodyl, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events. (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as polyethylene glycol, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Cimetidine: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Dexlansoprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Dichlorphenamide: (Moderate) Use dichlorphenamide and bisacodyl together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including laxatives. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy. (Moderate) Use dichlorphenamide and polyethylene glycol; electrolytes together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including laxatives. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
Diphenoxylate; Atropine: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
Docusate Sodium; Senna: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Esomeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Ethacrynic Acid: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy. (Moderate) Monitor renal function and serum electrolytes and ensure adequate hydration before and after concomitant loop diuretic and polyethylene glycol 3350 use. Concomitant use may increase the risk for fluid and electrolyte abnormalities and renal injury.
Famotidine: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Food: (Minor) The concomitant use of bisacodyl oral tablets with milk-containing products can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid ingesting milk products within 1 hour before or after the bisacodyl dosage.
Furosemide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy. (Moderate) Monitor renal function and serum electrolytes and ensure adequate hydration before and after concomitant loop diuretic and polyethylene glycol 3350 use. Concomitant use may increase the risk for fluid and electrolyte abnormalities and renal injury.
H2-blockers: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Homatropine; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as bisacodyl, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events. (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as polyethylene glycol, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as bisacodyl, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events. (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as polyethylene glycol, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone; Ibuprofen: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as bisacodyl, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events. (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as polyethylene glycol, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Ibuprofen; Famotidine: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Lactulose: (Major) In general, other laxatives, such as bisacodyl, should not be used concurrently with lactulose, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved. (Major) In general, other laxatives, such as polyethylene glycol 3350, should not be used concurrently with lactulose, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved.
Lansoprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Lansoprazole; Amoxicillin; Clarithromycin: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Loop diuretics: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy. (Moderate) Monitor renal function and serum electrolytes and ensure adequate hydration before and after concomitant loop diuretic and polyethylene glycol 3350 use. Concomitant use may increase the risk for fluid and electrolyte abnormalities and renal injury.
Magnesium Hydroxide: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Magnesium Salts: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate: (Major) Avoid use of stimulant laxatives, such as bisacodyl, with magnesium sulfate; potassium sulfate; sodium sulfate. Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
Naproxen; Esomeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Nizatidine: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Omeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Omeprazole; Amoxicillin; Rifabutin: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Omeprazole; Sodium Bicarbonate: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage. (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Pantoprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Pimozide: (Moderate) According to the manufacturer of pimozide, the drug should not be coadministered with drugs known to cause electrolyte imbalances, such as polyethylene glycol used in colon-cleansing regimens, except when indicated. Use in patients using small doses of polyethylene glycol 3350 (e.g., Miralax) may be permissable, as long as not excessive. Pimozide is associated with a well-established risk of QT prolongation and torsade de pointes (TdP), and electrolyte imbalances (e.g., hypokalemia, hypocalcemia, hypomagnesemia) may increase the risk of life-threatening arrhythmias. Pimozide is contraindicated in patients with known hypokalemia or hypomagnesemia.
Polyethylene Glycol; Electrolytes: (Major) Avoid use of stimulant laxatives, such as bisacodyl, with magnesium sulfate; potassium sulfate; sodium sulfate. Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
Polyethylene Glycol; Electrolytes; Ascorbic Acid: (Major) Avoid use of stimulant laxatives, such as bisacodyl, with magnesium sulfate; potassium sulfate; sodium sulfate. Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
Proton pump inhibitors: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Rabeprazole: (Minor) The concomitant use of bisacodyl oral tablets with drugs that raise gastric pH like proton pump inhibitors can cause the enteric coating of the bisacodyl tablets to dissolve prematurely, leading to possible gastric irritation or dyspepsia. When taking bisacodyl tablets, it is advisable to avoid PPIs within 1 hour before or after the bisacodyl dosage.
Ranitidine: (Minor) The concomitant use of bisacodyl tablets with H2-blockers can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid H2-blockers within 1 hour before or after the bisacodyl dosage.
Senna: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Sodium Bicarbonate: (Minor) The concomitant use of bisacodyl tablets with antacids can cause the enteric coating of the bisacody tablet to dissolve prematurely, leading to possible gastric irritation or dyspepsia. Avoid antacids within 1 hour before or after the bisacodyl dosage.
Sodium Phosphate Monobasic Monohydrate; Sodium Phosphate Dibasic Anhydrous: (Moderate) Sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous should not be combined with additional laxatives or purgatives when being used to evacuate the bowel prior to colonic radiologic examinations or surgery. (Moderate) Sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous should not be combined with additional laxatives or purgatives when being used to evacuate the bowel prior to colonic radiologic examinations or surgery. Use in patients using small doses of polyethylene glycol 3350 (e.g., Miralax) may be permissable, as long as the patient does not use their chronic laxative therapy on the day of the preparation. Watch for electrolyte and fluid abnormalities in all patients using bowel preparations.
Stimulant Laxatives: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Torsemide: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy. (Moderate) Monitor renal function and serum electrolytes and ensure adequate hydration before and after concomitant loop diuretic and polyethylene glycol 3350 use. Concomitant use may increase the risk for fluid and electrolyte abnormalities and renal injury.
Mechanism of Action:
-PEG-3350: Polyethylene glycol; electrolytes solution contains polyethylene glycol 3350 (PEG 3350), an osmotic agent that binds water and causes water to be retained within the stool. The lack of intestinal enzymatic degradation or bacterial metabolism of PEG 3350 contributes to the drug's effectiveness. PEG 3350 softens stool consistency, increases stool frequency, and facilitates stool evacuation. PEG 3350 does not affect colonic transit time. A balance of electrolytes (e.g., sodium, chloride, potassium and bicarbonate) are added to the solution to counteract losses resulting from bowel evacuation. The concentration of electrolytes in the polyethylene glycol; electrolytes solution causes no net absorption or secretion of electrolytes; thus water and electrolyte balance are usually maintained even after administration of large volumes.
-Bisacodyl: Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.
Pharmacokinetics:
-PEG-3350: Polyethylene glycol; electrolytes solution is administered orally as a solution in water. Roughly 0.2% of a dose has been absorbed systemically in some studies of PEG 3350, systemically absorbed amount is quickly excreted in the urine.
-Bisacodyl: Bisacodyl is administered orally. Bisacodyl distributes locally, and the circulating drug undergoes hepatic metabolism and is then excreted in the urine.
-Route-Specific Pharmacokinetics
Oral Route
-PEG-3350: After oral administration, the dosage essentially remains within the GI tract until the time of rectal elimination. Complete recovery of an administered dose occurs. Roughly 0.2% of a dose has been absorbed systemically in some studies of PEG 3350. PEG 3350 is not fermented within the GI tract by the colonic microflora and no metabolism occurs locally.
-Bisacodyl: Bisacodyl is minimally absorbed, and the onset of action of the drug begins 6-8 hours after an oral dose.