General MedicationsORALHigh Alert

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit

SODIUM SULFATE ANHYDROUS, POTASSIUM SULFATE, AND MAGNESIUM SULFATE

Standard Dose

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 ) Recommended sodium sulfate, potassium sulfate, and magnesium sulfate oral solution dosage is: Adults: Two 6-ounce doses. ( 2.3 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage and Administration Overview Administration of two bottles of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and additional water is required for a complete preparation for colonoscopy. One bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is equivalent to one dose. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is supplied in one dosage strength [see Dosage Forms and Strengths (3) ] . The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration (2.3) ] . Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.2 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Warnings and Precautions (5.1) ] Must dilute sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in water before ingestion. Must consume additional water after each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol. Do not take other laxatives while taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Do not take oral medications within one hour of starting each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Drug Interactions (7.2) ] . Stop consumption of all fluids at least 2 hours prior to the colonoscopy. 2.3 Recommended Dosage and Administration in Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults: Dose 1- On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids (no solid food). In the evening before the procedure, pour the contents of one bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Dose 2 - Day of Colonoscopy: Continue to consume only clear liquids. In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Complete all solution of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and required water at least two hours prior to colonoscopy.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients.

Summary

Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREPP® BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREPP® BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult patients. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 ) Recommended sodium sulfate, potassium sulfate, and magnesium sulfate oral solution dosage is: Adults: Two 6-ounce doses. ( 2.3 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage and Administration Overview Administration of two bottles of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and additional water is required for a complete preparation for colonoscopy. One bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is equivalent to one dose. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is supplied in one dosage strength [see Dosage Forms and Strengths (3) ] . The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration (2.3) ] . Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.2 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Warnings and Precautions (5.1) ] Must dilute sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in water before ingestion. Must consume additional water after each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol. Do not take other laxatives while taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Do not take oral medications within one hour of starting each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Drug Interactions (7.2) ] . Stop consumption of all fluids at least 2 hours prior to the colonoscopy. 2.3 Recommended Dosage and Administration in Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults: Dose 1- On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids (no solid food). In the evening before the procedure, pour the contents of one bottle of sodium sulfate, potassium sulfate, and magnesiu

Monitoring

• 5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use.
• ( 5.1 , 7.1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk.
• ( 5.2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.
• ( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing.

Interaction Notes

• 7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance.
• ( 7.1 ) 7.1 Drugs That May Increase Risk of Fluid and Electrolyte Abnormalities Use caution when prescribing sodium sulfate, potassium sulfate, and magnesium sulfate oral solution to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 ) ] .
• 7.2 Potential for Reduced Drug Absorption Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1) ] .
• Administer oral medications at least one hour before starting each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.