Version May 2024
Colon cleansing prior to colonoscopy: Oral:
Two-day regimen:
Evening before colonoscopy: Open 1 bottle of 12 tablets and fill provided container with 16 ounces of water (to fill line). Take each tablet with a sip of water and then drink entire contents of 16 ounces over 15 to 20 minutes. Approximately 1 hour after the last tablet is ingested, fill provided container with 16 ounces of water (to fill line) and drink entire contents of 16 ounces over 30 minutes; then ~30 minutes later fill provided container again with 16 ounces of water (to fill line) and drink entire contents of 16 ounces over 30 minutes. Note: May pause or slow rate of drinking additional water if bloating, cramping, or nausea occurs.
Morning of the colonoscopy (5 to 8 hours prior to colonoscopy and ≥4 hours from starting evening dose): Repeat entire process with the second bottle of 12 tablets. Complete at least 2 hours before the procedure. Note: May pause or slow rate of drinking additional water if bloating, cramping, or nausea occurs.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. Use with caution, ensure adequate hydration, and consider baseline and post-colonoscopy renal assessment.
There are no dosage adjustments provided in the manufacturer's labeling. However, no adjustment expected due to similar disposition to healthy patients in pharmacokinetic studies.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Serum hyperosmolarity (44%)
Gastrointestinal: Abdominal distention (29% to 34%), nausea (48% to 52%; severe nausea: 2% to 6%), upper abdominal pain (16% to 23%), vomiting (16% to 23%)
1% to 10%:
Endocrine & metabolic: Hypermagnesemia (2%)
Hepatic: Increased liver enzymes (3%, including increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum bilirubin)
<1%: Renal: Decreased creatinine clearance, increased blood urea nitrogen
Postmarketing:
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Gastric ulcer, gastritis
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (including severe hypersensitivity reaction)
Respiratory: Dyspnea
Hypersensitivity to sodium sulfate, magnesium sulfate, potassium chloride, or any component of the formulation; GI obstruction or ileus; bowel perforation; toxic colitis or toxic megacolon; gastric retention.
Concerns related to adverse effects:
• Arrhythmias: Serious arrhythmias have occurred rarely with the use of ionic osmotic laxative products; use caution in patients at increased risk for arrhythmias (eg, recent myocardial infarction, unstable angina, cardiomyopathy, history of prolonged QT, uncontrolled arrhythmias, heart failure).
• Fluid and electrolyte abnormalities: May cause fluid and electrolyte disturbances, particularly in patients at increased risk (eg, renal impairment, concomitant mediations that alter electrolyte balance). Any preexisting electrolyte abnormalities should be corrected prior to use and patients should be adequately hydrated before, during, and after use.
• GI effects: Osmotic laxatives may produce colonic mucosal aphthous ulcerations, including cases of ischemic colitis. Gastritis and gastric ulcerations may also occur. Use caution when interpreting colonoscopy results in patients with inflammatory bowel disease. Use caution in patients undergoing esophageal gastroduodenoscopy; mucosal ulcerations may occur.
• Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria, have been reported.
• Seizures: Seizures associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia) and low serum osmolality have occurred. Use with caution in patients with a history of seizures, underlying electrolyte disturbances, in patients at increased risk for seizures (eg, concomitant medications that lower seizure threshold, withdrawal from alcohol or benzodiazepines), or patients with hyponatremia (known or suspected).
Disease-related concerns:
• Renal impairment: Use caution in patients with renal impairment or using concomitant medications that may affect renal function; may increase risk of renal injury. Adequate hydration is particularly important in these patients.
• Ulcerative colitis: Use with caution in patients with severe, active ulcerative colitis.
Other warnings/precautions:
• Appropriate use: Evaluate patients with symptoms of bowel obstruction/perforation (nausea, vomiting, abdominal pain or distension) prior to use.
• Desiccant: Remove and discard desiccant from both bottles the evening prior to colonoscopy; there have been reports of patients ingesting the desiccant, which may lead to a risk of choking and/or gastrointestinal complications.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sutab: Sodium sulfate 1479 mg, magnesium sulfate 225 mg, and potassium chloride 188 mg
No
Tablets (Sutab Oral)
1479-225-188 mg (per each): $8.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: The evening prior to colonoscopy, remove and discard the desiccant from each bottle of tablets. Each dose must be consumed with water and an additional 32 ounces of water must be consumed after each dose. The entire contents of each bottle should be consumed, followed by each postdose hydration amount. Patients should avoid laxatives, solid food, red and purple liquids, milk, and alcoholic beverages on the day prior to and the day of the colonoscopy. Oral medications should not be administered within 1 hour of start of therapy; tetracyclines, fluoroquinolones, iron, digoxin, chlorpromazine, or penicillamine should not be administered within 2 hours prior to start of therapy or ≤6 hours after administration of therapy.
Day prior to colonoscopy: Patients may have a low-residue breakfast (eg, coffee, cottage cheese, eggs, grits, white bread, yogurt) or clear liquids (eg, water, strained fruit juice without pulp, plain coffee or tea, chicken broth, clear soda [eg, ginger ale], gelatin dessert without fruit or topping).
Day of the colonoscopy: Only clear liquids may be consumed; stop drinking clear liquids at least 2 hours before colonoscopy.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Sutab https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213135s004lbl.pdf#page=15
Colon cleansing prior to colonoscopy: For the cleansing of the colon as a preparation for colonoscopy in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alfacalcidol: May increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving alfacalcidol. If magnesium-containing products must be used with alfacalcidol, serum magnesium concentrations should be monitored closely. Risk D: Consider therapy modification
Alpha-Lipoic Acid: Magnesium Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Magnesium Salts. Management: Separate administration of alpha-lipoic acid from that of any magnesium-containing compounds by several hours. If alpha-lipoic acid is given 30 minutes before breakfast, then administer oral magnesium-containing products at lunch or dinner. Risk D: Consider therapy modification
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Calcitriol (Systemic): May increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving calcitriol. If magnesium-containing products must be used with calcitriol, serum magnesium concentrations should be monitored closely. Risk D: Consider therapy modification
Calcium Channel Blockers (Dihydropyridine): Magnesium Sulfate may enhance the adverse/toxic effect of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor therapy
Calcium Polystyrene Sulfonate: Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of calcium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of calcium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives. Risk X: Avoid combination
CNS Depressants: Magnesium Sulfate may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification
Dolutegravir: Magnesium Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral magnesium salts. Risk D: Consider therapy modification
Doxercalciferol: May enhance the hypermagnesemic effect of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving doxercalciferol. If magnesium-containing products must be used with doxercalciferol, serum magnesium concentrations should be monitored closely. Risk D: Consider therapy modification
Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification
Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification
Gabapentin: Magnesium Salts may enhance the CNS depressant effect of Gabapentin. Specifically, high dose intravenous/epidural magnesium sulfate may enhance the CNS depressant effects of gabapentin. Magnesium Salts may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after use of a magnesium-containing antacid. Monitor patients closely for evidence of reduced response to gabapentin therapy. Monitor for CNS depression if high dose IV/epidural magnesium sulfate is used. Risk D: Consider therapy modification
Laxatives (Stimulant): May enhance the adverse/toxic effect of Sodium Sulfate. Specifically, the risk of mucosal ulceration or ischemic colitis may be increased. Risk X: Avoid combination
Levonadifloxacin: Magnesium Salts may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Levothyroxine: Magnesium Salts may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and oral magnesium salts by at least 4 hours. Risk D: Consider therapy modification
Multivitamins/Fluoride (with ADE): Magnesium Salts may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, magnesium salts may decrease fluoride absorption. Management: To avoid this potential interaction separate the administration of magnesium salts from administration of a fluoride-containing product by at least 1 hour. Risk D: Consider therapy modification
Neuromuscular-Blocking Agents: Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification
Phosphate Supplements: Magnesium Salts may decrease the serum concentration of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral magnesium salt as possible to minimize the significance of this interaction. Risk D: Consider therapy modification
Quinolones: Magnesium Salts may decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar/enox-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe/enox-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider therapy modification
Raltegravir: Magnesium Salts may decrease the serum concentration of Raltegravir. Management: Avoid the use of oral / enteral magnesium salts with raltegravir. No dose separation schedule has been established that adequately reduces the magnitude of interaction. Risk X: Avoid combination
Ritodrine: May enhance the adverse/toxic effect of Magnesium Sulfate. Risk C: Monitor therapy
Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: Consider therapy modification
Sodium Polystyrene Sulfonate: Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of sodium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of sodium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives. Risk X: Avoid combination
Tetracyclines: Magnesium Salts may decrease the absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification
Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination
Colonoscopy during pregnancy is generally reserved for strong indications; elective procedures should be delayed until after delivery. Although data are insufficient to recommend a specific bowel preparation, use of other agents may be preferred (ESGE [Hassan 2019]; Gomes 2018).
It is not known if sodium sulfate, magnesium sulfate, or potassium chloride concentrations in breast milk are significantly changed following use of this combination.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Avoid solid food, red and purple liquids, milk, and alcoholic beverages.
Consider baseline and postprocedure electrolytes, BUN, and creatinine in patients at risk for renal impairment, seizure, or who have a history of electrolyte abnormality and patients who develop significant vomiting or dehydration from taking the tablets; ECG (prior to therapy and post-colonoscopy) in patients with risks for prolonged QT or arrhythmias.
Induces catharsis by the osmotic effects of the unabsorbed ions in the GI tract.
Excretion: Feces (primarily).
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