Magnesiumdosage

Preparation and Administration 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. Recommended sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: o Adults: Two 6-ounce doses. For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information.

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.

The recommended dosage is: Adults: Two 6-ounce doses. 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 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. 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.