Sodium sulfate, potassium sulfate, and magnesium sulfate, unspecified form
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Dosing in kidney impairment
Renal Impairment Use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions] .
Preparation and administration
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 two dosage strengths [see Dosage Forms and Strengths] . The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration]. Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration].
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] 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] . Stop consumption of all fluids at least 2 hours prior to the colonoscopy.
Recommended Dosage and Administration for 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.
Recommended Dosage and Administration for Pediatric Patients 12 Years of Age and Older The recommended Split-Dose (two-day) regimen for pediatric patients 12 years of age and older consists of two 4.5-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 2.25 quarts. The following are recommended dosage and administration instructions for pediatric patients 12 years of age and older and/or their caregivers: 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 12-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 12-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 12-ounce fill line on the container, mix, and drink the entire amount.
Drink two additional containers filled with water to the 12-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.
Drug interactions
Check sodium sulfate, potassium sulfate, and magnesium sulfate, unspecified form against a medication listLabel text (4 paragraphs)
Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 )
7.1 Drugs That May Increase Risks 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. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to avoid chelation with magnesium.
7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.5 )] .
Contraindications
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precautions ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.8 ) and Description ( 11 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient ( 4 , 5.8)
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution use in pregnant women 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 sodium sulfate, potassium sulfate, and magnesium sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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