Magnesium sulfate; potassium sulfate; sodium sulfate is an osmotic laxative used for bowel cleansing prior to colonoscopy in adults and pediatric patients 12 years and older. This sulfate salt laxative is administered as a 2-day regimen containing poorly absorbed sulfate ions that cause water to be retained in the GI tract. The ions and ingested water flush the bowel and produce a purgative effect. Several safe and effective bowel preparations are currently marketed; however, issues surrounding their use have been raised. Disadvantages include complaints of large volumes for ingestion with some products and an increased risk of acute phosphate nephropathy associated with sodium phosphate salt laxatives. A sulfate salt osmotic laxative may represent a low-volume alternative that provides effective bowel cleansing without significant fluid and electrolyte shifts. A non-inferiority study evaluated the cleansing efficacy of a split-dose sulfate regimen (SUPREP) compared to a polyethylene glycol electrolyte solution with ascorbic acid regimen (MoviPrep). Among the 364 subjects in the split-dose strategy trial (181 SUPREP, 183 MoviPrep), 97.2% of patients who received the sulfate solution were considered to have a successful preparation for colonoscopy compared to 95.6% of patients who received the polyethylene glycol electrolyte solution. In addition, more preparations in the sulfate salt group (63.3%) were considered 'excellent' compared to the polyethylene glycol electrolyte group (52.5%) (p = 0.043). Related gastrointestinal adverse events were generally mild and infrequent.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
Oral Liquid Formulations
-For oral use only.
Bowel Prep Kit Oral Solution (i.e., SUPREP)
-Adults:
--SUPREP Bowel Prep Kit for Adults contains two 6-ounce bottles of oral solution and one 16-ounce mixing container. The contents of each bottle must be diluted prior to administration.
-Early in the evening prior to the colonoscopy, pour the entire contents of the first bottle of solution into the mixing container. Then, add enough water to the solution in the mixing container to bring the fluid level to the 16-ounce fill line. Instruct the patient to drink the entire amount and then to drink 2 additional containers filled to the 16-ounce line with water over the next hour.
-On the morning of colonoscopy (approximately 10 to 12 hours after the first dose), repeat the process using the second bottle of solution. Again, after the diluted solution is consumed, instruct the patient to drink 2 additional mixing containers filled to the 16-ounce line with water. Consumption should be completed at least 2 hours before the colonoscopy.
-Pediatric patients:
--SUPREP Bowel Prep Kit for Pediatric Patients 12 years and older contains two 4.5-ounce bottles of oral solution and one 12-ounce mixing container. The contents of each bottle must be diluted prior to administration.
-Early in the evening prior to the colonoscopy, pour the entire contents of the first bottle of solution into the mixing container. Then, add enough water to the solution in the mixing container to bring the fluid level to the 12-ounce fill line. Instruct the patient to drink the entire amount and then to drink 2 additional containers filled to the 12-ounce line with water over the next hour.
-On the morning of colonoscopy (approximately 10 to 12 hours after the first dose), repeat the process using the second bottle of solution. Again, after the diluted solution is consumed, instruct the patient to drink 2 additional mixing containers filled to the 12-ounce line with water. Consumption should be completed at least 2 hours before the colonoscopy.
-The day before the colonoscopy, a light breakfast or clear liquids may be consumed (no solid foods). On the day of the colonoscopy, only clear liquids should be consumed. Consumption of all fluids should be stopped at least 2 hours before the colonoscopy.
-Avoid red and purple liquids, milk, and alcohol.
Diarrhea or increased stool frequency are expected effects after the administration of magnesium sulfate; potassium sulfate; sodium sulfate; fecal urgency or fecal incontinence may occur.
During clinical evaluation in adult patients, magnesium sulfate; potassium sulfate; sodium sulfate was compared to polyethylene glycol and electrolytes (PEG + E). Both regimens were administered in a split-dose (2-day) method. The most common adverse reactions were gastrointestinal-related and included the following: abdominal distention (40% vs. 52%), abdominal pain (36% vs. 43%), nausea (36% vs. 33%), and vomiting (8% vs. 4%). Of note, patients who received magnesium sulfate; potassium sulfate; sodium sulfate were limited to a light breakfast, then clear liquids, but patients who received PEG + E were allowed to have a normal breakfast, light lunch, and then clear liquids. In pediatric clinical studies with magnesium sulfate; potassium sulfate; sodium sulfate, nausea, abdominal pain, abdominal bloating, and vomiting were reported in more than 10% of patients.
Administration of osmotic laxatives may produce colonic mucosal aphthous ulcerations, and there have been reports of serious cases of ischemic colitis (bowel ischemia) requiring hospitalization. Use magnesium sulfate; potassium sulfate; sodium sulfate solution with caution in patients with known or suspected inflammatory bowel disease (IBD) including severe active ulcerative colitis. When interpreting colonoscopic findings in IBD patients, consider the potential for mucosal ulcerations caused by the bowel preparation.
Like other osmotic bowel preparation products, magnesium sulfate; potassium sulfate; sodium sulfate can cause electrolyte abnormalities, especially if patients become dehydrated. During clinical evaluation, magnesium sulfate; potassium sulfate; sodium sulfate was compared to polyethylene glycol and electrolytes (PEG + E); both regimens were administered in a split-dose (2-day) method. Baseline serum chemistry for study subjects was determined before bowel preparation. Laboratory shifts recorded on the day of colonoscopy were reported (percentage of patients with normal baseline values who had a shift to abnormal values) for magnesium sulfate; potassium sulfate; sodium sulfate and PEG + E, respectively, and included: low bicarbonate (13% vs. 15%), hyperbilirubinemia (9% vs. 12%), high BUN (2% vs. 3%), hypercalcemia (10% vs. 4%), hyperchloremia (2% vs. 12%), high osmolality (6% vs. 13%), and hyperuricemia (24% vs. 10%). Laboratory shifts from baseline recorded on Day 30 post-colonoscopy were also reported for magnesium sulfate; potassium sulfate; sodium sulfate and PEG + E, respectively, and included: low bicarbonate (4% vs. 3%), hyperbilirubinemia (0% vs. 2%), high BUN (11% vs. 15%), hypercalcemia (5% vs. 4%), hyperchloremia (4% vs. 4%), and hyperuricemia (12% vs. 17%). High creatinine and hyperkalemia have also been reported with magnesium sulfate; potassium sulfate; sodium sulfate use. Other electrolyte disturbances that could occur after the use of bowel preparation products include hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, and low serum osmolality. Significant electrolyte disturbances can lead to serious adverse reactions such as cardiac arrhythmias, convulsions, and renal dysfunction.
Serious cardiac arrhythmias have been reported after bowel preparation with ionic osmotic laxative products. The use of magnesium sulfate; potassium sulfate; sodium sulfate may cause arrhythmia exacerbation in patients at an increased risk of arrhythmias. In one clinical study that included 190 patients who received magnesium sulfate; potassium sulfate; sodium sulfate, one case of AV block occurred.
There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with the use of bowel preparation products in patients with no prior history of seizure disorder. Seizure cases were associated with electrolyte abnormalities, including hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, and low serum osmolality. After the correction of fluid and electrolyte abnormalities, neurologic abnormalities resolved.
Magnesium sulfate; potassium sulfate; sodium sulfate is contraindicated in patients with an ileus, GI obstruction, GI perforation, gastric retention (e.g., gastroparesis, pyloric stenosis), toxic colitis or toxic megacolon, and in patients with known allergies to any components of the kit. If GI obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering a bowel cleansing agent. In addition, the administration of osmotic laxatives may produce colonic mucosal aphthous ulcerations. There have been reports of serious cases of ischemic colitis requiring hospitalization; the concurrent use of stimulant laxatives may increase these risks. Use with caution in patients with known or suspected inflammatory bowel disease (IBD), including severe active ulcerative colitis. When interpreting colonoscopic findings in IBD patients, consider the potential for mucosal ulcerations caused by the bowel preparation. Also, use with caution in patients with gag reflex depression or patients prone to regurgitation or aspiration; such patients should be monitored during administration.
Before administering magnesium sulfate; potassium sulfate; sodium sulfate solution, patients with existing electrolyte imbalance (e.g., hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia) should have them corrected as fluid and electrolyte disturbances may lead to serious adverse events such as heart arrhythmias, seizures, and renal dysfunction. Cautious use is recommended in patients with conditions that may increase the risk for fluid and electrolyte disturbances, including taking certain concurrent medications that affect fluid and electrolyte balance. Advise patients to properly hydrate before, during, and after bowel preparation. Instruct patients on the proper dilution and administration of the solution to ensure safe and effective bowel cleansing. If a patient develops significant vomiting or signs of dehydration, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). In addition, magnesium sulfate; potassium sulfate; sodium sulfate solution can cause temporary elevations in uric acid. The potential for uric acid elevation should be considered before bowel cleansing is initiated in patients with gout or hyperuricemia. Uric acid fluctuations in patients with gout may precipitate an acute flare.
Serious cardiac arrhythmias have been reported after bowel preparation with ionic osmotic laxative products. Use magnesium sulfate; potassium sulfate; sodium sulfate with caution in patients at an increased risk of arrhythmias. Patients at increased risk of arrhythmias include patients with QT prolongation or on concurrent medications that may increase the likelihood of QT prolongation, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy. Consider performing a diagnostic ECG on high risk patients before and after a colonoscopic procedure.
There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with the use of bowel preparation products in patients with no prior history of seizure disorder. The seizures were associated with electrolyte abnormalities including hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, and low serum osmolality. After the correction of fluid and electrolyte abnormalities, neurologic abnormalities resolved. Therefore, magnesium sulfate; potassium sulfate; sodium sulfate solution should be used with caution in patients with a seizure history or at an increased risk for seizures. Patients taking concomitant medications that lower the seizure threshold, patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia may be at an increased risk.
Use caution when prescribing sulfate salt bowel preparations in patients with renal impairment or in patients taking concomitant medications that may affect renal function. Advise patients to properly hydrate before, during, and after bowel preparation; consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) in at-risk patients. In addition, after the oral administration of magnesium sulfate; potassium sulfate; sodium sulfate, serum sulfate concentrations are higher in patients with renal impairment compared to healthy subjects.
Clinical evaluation of magnesium sulfate; potassium sulfate; sodium sulfate solution included 94 patients >= 65 years of age and 25 patients >= 75 years of age. When administered as a 2-day, split regimen as recommended in the product labeling, no differences in safety or efficacy were found in the geriatric population. However, when administered as a 1-day regimen, geriatric patients reported more vomiting. According to the manufacturer, an evening-only (1-day) dosing regimen is not recommended. In general, medication use should be more cautious in the elderly and consideration should be made for differences in renal or cardiac systems as well as concomitant disease states and medications.
There are no available data on magnesium sulfate; potassium sulfate; sodium sulfate use in human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with magnesium sulfate; potassium sulfate; sodium sulfate.
There are no data available on the presence of magnesium sulfate; potassium sulfate; sodium sulfate in human or animal milk, the effects on the breastfed child, or the effects on milk production. 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: On the day before the colonoscopy, a light breakfast or clear liquids may be consumed (no solid foods). On the day of the colonoscopy, only clear liquids should be consumed. Avoid red and purple liquids, milk, and alcoholic beverages.
Oral dosage:
NOTE: Suprep Bowel Prep Kit is available in 2 dosage strengths. For adults, the kit contains two, 6-oz doses, and for pediatric patients, the kit contains two, 4.5-oz doses. Ensure that the correct dosage kit is used.
Adults: In the evening prior to the colonoscopy, give 1 bottle of oral solution (6 oz) diluted with water to a total volume of 16 oz PO; use the mixing container provided with the kit. Over the next hour, instruct the patient to drink an additional 32 oz of water. On the day of the colonoscopy (10 to 12 hours after the first dose), repeat the process using the second bottle of solution (6 oz). Again, instruct the patient to drink an additional 32 oz of water over the next hour. Consumption should be complete at least 2 hours before the colonoscopy.
Children and Adolescents 12 to 17 years: In the evening prior to the colonoscopy, give 1 bottle of oral solution (4.5 oz) diluted with water to a total volume of 12 oz PO; use the mixing container provided with the kit. Over the next hour, instruct the patient to drink an additional 24 oz of water. On the day of the colonoscopy (10 to 12 hours after the first dose), repeat the process using the second bottle of solution (4.5 oz). Again, instruct the patient to drink an additional 24 oz of water over the next hour. Consumption should be complete at least 2 hours before the colonoscopy.
Maximum Dosage Limits:
-Adults
Two 6-oz bottles of solution (diluted) PO per bowel evacuation.
-Geriatric
Two 6-oz bottles of solution (diluted) PO per bowel evacuation.
-Adolescents
Two 4.5-oz bottles of solution (diluted) PO per bowel evacuation.
-Children
12 years: Two 4.5-oz bottles of solution (diluted) PO per bowel evacuation.
1 to 11 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
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
Dosage adjustments for patients with renal impairment are not available; the manufacturer recommends using with caution. Ensure adequate hydration in these patients.
*non-FDA-approved indication
Acetaminophen; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as magnesium sulfate; potassium sulfate; sodium sulfate, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Acetaminophen; Ibuprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Amiloride: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Amiloride; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Amlodipine; Benazepril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Amlodipine; Celecoxib: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Amlodipine; Olmesartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Amlodipine; Valsartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Angiotensin II receptor antagonists: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Angiotensin-converting enzyme inhibitors: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Atenolol; Chlorthalidone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
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.
Azilsartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Azilsartan; Chlorthalidone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Benazepril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Bisacodyl: (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.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Bumetanide: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Bupivacaine; Meloxicam: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Candesartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Candesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Captopril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Celecoxib: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Celecoxib; Tramadol: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Chlorothiazide: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Chlorpheniramine; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as magnesium sulfate; potassium sulfate; sodium sulfate, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Chlorpromazine: (Major) Administer chlorpromazine at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of chlorpromazine may be reduced by chelation with magnesium sulfate.
Chlorthalidone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Ciprofloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Delafloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Demeclocycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Dichlorphenamide: (Moderate) Use dichlorphenamide and magnesium sulfate; potassium sulfate; sodium sulfate 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.
Diclofenac: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Diclofenac; Misoprostol: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Diflunisal: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Digoxin: (Moderate) Administer digoxin at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of digoxin may be reduced by chelation with magnesium sulfate.
Diphenhydramine; Ibuprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Diphenhydramine; Naproxen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
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.
Diuretics: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Doxycycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Enalapril, Enalaprilat: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Eprosartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Ethacrynic Acid: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Etodolac: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Fenoprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Ferric Maltol: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Flurbiprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Fosinopril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Furosemide: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Gemifloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Homatropine; Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as magnesium sulfate; potassium sulfate; sodium sulfate, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Hydrocodone: (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as magnesium sulfate; potassium sulfate; sodium sulfate, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Hydrocodone; Ibuprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs). (Minor) Concurrent use of hydrocodone with strong laxatives that rapidly increase gastrointestinal motility, such as magnesium sulfate; potassium sulfate; sodium sulfate, may decrease hydrocodone absorption. Closely monitor patients for changing analgesic requirements or adverse events.
Ibuprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen; Famotidine: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen; Oxycodone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen; Pseudoephedrine: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Indapamide: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Indomethacin: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Irbesartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Irbesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Iron Salts: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Iron: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Ketoprofen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Ketorolac: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Levofloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Lisinopril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Losartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Losartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Meclofenamate Sodium: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Mefenamic Acid: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Meloxicam: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Metolazone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Minocycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Moexipril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Moxifloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Nabumetone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Naproxen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Naproxen; Esomeprazole: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Naproxen; Pseudoephedrine: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Nebivolol; Valsartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Nonsteroidal antiinflammatory drugs: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Ofloxacin: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Olmesartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Olmesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Omadacycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Oxaprozin: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Penicillamine: (Major) Administer penicillamine at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of penicillamine may be reduced by chelation with magnesium sulfate.
Perindopril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Perindopril; Amlodipine: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Piroxicam: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Polyethylene Glycol; Electrolytes; Bisacodyl: (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.
Polysaccharide-Iron Complex: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Quinapril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Quinolones: (Major) Administer quinolones at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of quinolones may be reduced by chelation with magnesium sulfate.
Ramipril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Sacubitril; Valsartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Sarecycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Spironolactone: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Spironolactone; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Sulindac: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Sumatriptan; Naproxen: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Telmisartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Telmisartan; Amlodipine: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Telmisartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Tetracycline: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Tetracyclines: (Major) Administer tetracyclines at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of tetracyclines may be reduced by chelation with magnesium sulfate.
Tolmetin: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Torsemide: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Trandolapril: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Trandolapril; Verapamil: (Moderate) Monitor renal function during concomitant angiotensin-converting enzyme inhibitor and magnesium sulfate; potassium sulfate; sodium sulfate bowel preparation due to risk for renal injury; ensure adequate hydration.
Triamterene: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Triamterene; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Valsartan: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists.
Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin II receptor antagonists. (Moderate) Use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as diuretics.
Sodium sulfate; potassium sulfate; magnesium sulfate is an osmotic laxative. The sulfate salts, which provide poorly absorbed sulfate anions. Unabsorbed sulfate anions and associated cations cause water to be retained within the gastrointestinal tract. When ingested orally with a large volume of water, the osmotic effect of the unabsorbed ions produces a copious watery diarrhea.
Magnesium sulfate; potassium sulfate; sodium sulfate solution is administered orally as a solution in water. Fecal excretion is the primary route of sulfate elimination. After oral administration in six healthy adult subjects, Tmax was approximately 17 hours after the first half dose or approximately 5 hours after the second dose and then declined with a half-life of 8.5 hours.
-Route-Specific Pharmacokinetics
Oral Route
After oral administration, magnesium sulfate; potassium sulfate; sodium sulfate solution is poorly absorbed; the majority of the dose remains within the GI tract until the time of rectal elimination.
-Special Populations
Hepatic Impairment
Oral administration of magnesium sulfate; potassium sulfate; sodium sulfate solution has been studied in patients with hepatic impairment. In a study including 6 patients with mild to moderate hepatic impairment (Child-Pugh grades A and B), the AUC and Cmax of serum sulfate were comparable between healthy subjects and patients with mild to moderate hepatic impairment. Similar to heathy subjects, serum sulfate concentrations in patients with hepatic impairment returned to baseline by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours, starting after the first half dose, was also similar between healthy subjects and the patients with hepatic impairment.
Renal Impairment
Oral administration of magnesium sulfate; potassium sulfate; sodium sulfate solution has been studied in patients with renal impairment. In a study of 6 patients with moderate renal impairment (CrCl 30-49 ml/min), the mean AUC and Cmax were 54% and 44%, respectively higher than those of healthy subjects. Similar to healthy subjects, serum sulfate concentrations in the patients with renal impairment returned to baseline by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours, starting after the first half dose, was approximately 16% lower in patients with moderate renal impairment than in healthy subjects.