SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate 17.5 g/mL; 3.13 g/mL; 1.6 g/mL Solution, Concentrate, 2 bottles
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Magnesium sulfate, potassium sulfate, and sodium sulfate is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) in adults and children 12 years of age and older so that the doctor will have a clear view of the walls of the colon. Magnesium sulfate, potassium sulfate, and sodium sulfate is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon.
Read the full MedlinePlus article ↗- This solution works by drawing water into your intestines so your bowel is thoroughly flushed out before your colonoscopy — your doctor needs a clear, clean view of the colon wall....
- What exactly does this prep do, and why do I have to drink so much water with it?
- Yes, but timing matters. Take all your regular oral medications at least one hour before you start each dose of the prep, since the solution can reduce how well your body absorbs o...
- Can I take my regular medications while I'm doing the prep?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.325 | $115.17 / 354.8 ml |
| Medicaid paysCMS SDUD · 12 mo | $118.57 | $42,069.81 / 354.8 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.3393 | $120.38 / 354.8 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 17.5 g/mL; 3.13 g/mL; 1.6 g/mL 10572-0012-01 | Affordable | 2 bottles | $0.093 | AA | Availability likely | save 71% |
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 17.5 g/mL; 3.13 g/mL; 1.6 g/mL 52536-0175-01 | Wilshire | 2 bottles | $0.093 | AA | Availability likely | save 71% |
| SUPREP Bowel Prep 17.5 g/mL; 3.13 g/mL; 1.6 g/mLthis 52268-0012-01 | Braintree | 2 bottles | $0.325 | AA | Availability likely | — |
| SUPREP Bowel Prep 17.5 g/mL; 3.13 g/mL; 1.6 g/mL 24338-0175-01 | Azurity | 2 bottles | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| ODE-315 | Orphan Drug Exclusivity (7-year) | Aug 5, 2027 |
Is there a generic version of SUPREP BOWEL PREP KIT?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 52268-0012-01 You're viewing this | 2 BOTTLE, PLASTIC in 1 CARTON (52268-012-01) / 177.4 mL in 1 BOTTLE, PLASTIC | 2010-08-05 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 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 SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy.
( 2.1 , 2.3 , 2.4 ) Recommended SUPREP Bowel Prep Kit dosage is: º Adults: Two 6-ounce doses. ( 2.3 ) º Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses. ( 2.4 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information.
( 2.1 , 2.2 , 2.3 , 2.4 )
2.1Dosage and Administration Overview Administration of two bottles of SUPREP Bowel Prep Kit and additional water is required for a complete preparation for colonoscopy. One bottle of SUPREP Bowel Prep Kit is equivalent to one dose. SUPREP Bowel Prep Kit is supplied in two dosage strengths [see Dosage Forms and Strengths ( 3 )] .
The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3 )] . Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration ( 2.4 )] .
2.2Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with SUPREP Bowel Prep Kit [see Warnings and Precautions ( 5.1 )] Must dilute SUPREP Bowel Prep Kit in water before ingestion. Must consume additional water after each dose of SUPREP Bowel Prep Kit. 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 SUPREP Bowel Prep Kit. Do not take oral medications within one hour of starting each dose of SUPREP Bowel Prep Kit. 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 SUPREP Bowel Kit [see Drug Interactions ( 7.2 )] .
Stop consumption of all fluids at least 2 hours prior to the colonoscopy.
2.3Recommended Dosage and Administration for Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of SUPREP Bowel Prep Kit: 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 SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit into the mixing container provided.
Add cool drinking water to the 16-ounce fill line on the container, mix,…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SUPREP Bowel Prep Kit (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. SUPREP Bowel Prep Kit (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5 ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless.
SUPREP Bowel Prep Kit (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. ( 3 ) SUPREP Bowel Prep Kit (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS SUPREP Bowel Prep Kit is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in SUPREP Bowel Prep Kit [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 )
⚠️ Warnings and Cautions ▾
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. ( 5.4 , 7.1 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 4 , 5.6 ) Patients at risk for aspiration : Observe during administration.
( 5.7 ) Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ( 5.8 )
5.1Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUPREP Bowel Prep Kit. If a patient develops significant vomiting or signs of dehydration after taking SUPREP Bowel Prep Kit, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.
Correct fluid and electrolyte abnormalities before treatment with SUPREP Bowel Prep Kit. Use SUPREP Bowel Prep Kit with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions ( 7.1 )] . SUPREP Bowel Prep Kit can cause temporary elevations in uric acid [see Adverse Reactions ( 6.1 )] .
Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering SUPREP Bowel Prep Kit to patients with gout or other disorders of uric acid metabolism.
5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing SUPREP Bowel Prep Kit for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
5.3Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing SUPREP Bowel Prep Kit for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )] .
5.4Use in Patients with Risk of Renal Injury Use SUPREP Bowel Prep Kit with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )]
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. Adults The safety of SUPREP Bowel Prep Kit was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies ( 14 )] . Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving SUPREP Bowel Prep Kit or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens.
Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial Symptom Split-Dose (2-Day) Regimen SUPREP Bowel Prep Kit % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 * reported in at least 2% of patients Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either SUPREP Bowel Prep Kit or PEG+E administered as a split-dose (2-day) regimen.
Table 2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen 1 Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) SUPREP 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) SUPREP 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) SUPREP 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) SUPREP 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) SUPREP 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) SUPREP 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) SUPREP 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table.
2 Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest. Less Common Adverse Reactions AV Block (1 case) and CK increase. Adverse Reactions with Unapproved Use In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with SUPREP Bowel Prep Kit as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen. overall discomfort, abdominal distention, nausea, and vomiting total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high)…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 )
7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing SUPREP Bowel Prep Kit 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 )].
7.2Potential for Reduced Drug Absorption SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of SUPREP Bowel Prep Kit to avoid chelation with magnesium.
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and SUPREP Bowel Prep Kit may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUPREP Bowel Prep Kit [see Warnings and Precautions ( 5.5 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on SUPREP Bowel Prep Kit 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 (SUPREP Bowel Prep Kit). 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.
8.2Lactation Risk Summary There are no data available data on the presence of SUPREP Bowel Prep Kit in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUPREP Bowel Prep Kit and any potential adverse effects on the breastfed child from SUPREP Bowel Prep Kit or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of SUPREP Bowel Prep Kit (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of SUPREP Bowel Prep Kit in this age group is supported by evidence from an adequate and well-controlled trial of SUPREP Bowel Prep Kit in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] . In the pediatric trial, SUPREP Bowel Prep Kit (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to SUPREP Bowel Prep Kit (two 4.5-ounce doses).
Therefore, SUPREP Bowel Prep Kit (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] . The safety profile of SUPREP Bowel Prep Kit (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of SUPREP Bowel Prep Kit in pediatric patients less than 12 years of age have not been established.
8.5Geriatric Use Of the 375 patients who received SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when SUPREP Bowel Prep Kit was given as a one-day preparation (not a recommended regimen).
Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] .
8.6Renal Impairment Use SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on SUPREP Bowel Prep Kit 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 (SUPREP Bowel Prep Kit). 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SUPREP Bowel Prep Kit (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of SUPREP Bowel Prep Kit in this age group is supported by evidence from an adequate and well-controlled trial of SUPREP Bowel Prep Kit in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] . In the pediatric trial, SUPREP Bowel Prep Kit (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to SUPREP Bowel Prep Kit (two 4.5-ounce doses).
Therefore, SUPREP Bowel Prep Kit (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] . The safety profile of SUPREP Bowel Prep Kit (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of SUPREP Bowel Prep Kit in pediatric patients less than 12 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 375 patients who received SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when SUPREP Bowel Prep Kit was given as a one-day preparation (not a recommended regimen).
Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of more than the recommended dose of SUPREP Bowel Prep Kit may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ] . Monitor for fluid and electrolyte disturbances and treat symptomatically.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.
12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with SUPREP Bowel Prep Kit.
12.3Pharmacokinetics Absorption and Elimination After administration of SUPREP Bowel Prep Kit in six healthy subjects, the time at which serum sulfate reached its highest point (Tmax) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Excretion Fecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of SUPREP Bowel Prep Kit was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min).
In patients with moderate renal impairment, mean AUC was 54% higher and mean Cmax was 44% higher, than healthy subject s. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects.
These differences are not considered clinically meaningful. Patients with Hepatic Impairment The disposition of sulfate after ingestion of SUPREP Bowel Prep Kit was studied in patients (N=6) with mild to moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and patients with hepatic impairment.
The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for adults) (NDC 52268-012-01) contains: Two bottles (NDC 52268-011-01) each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 16-ounce fill line.
Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for pediatric patients 12 years of age and older) (NDC 52268-112-01) contains: Two bottles (NDC 52268-111-01) each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 12-ounce fill line.
Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.
📋 Description ▾
11 DESCRIPTION SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP.
SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP.
Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, purified The chemical name is K 2 SO 4 .
The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37.
The structural formula is: Each SUPREP Bowel Prep Kit also contains a polypropylene mixing container. Na2so4 k2so4 structure mgso4 structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients or caregivers: Must dilute SUPREP Bowel Prep Kit before ingestion. Must consume additional water after each dose of SUPREP Bowel Prep Kit.
On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Two doses of SUPREP Bowel Prep Kit are required for a complete preparation for colonoscopy.
One bottle of SUPREP Bowel Prep Kit is equivalent to one dose. Do not to take other laxatives while taking SUPREP Bowel Prep Kit. Do not eat solid food or drink milk or eat or drink anything colored red or purple.
Do not drink alcohol. Do not take oral medications within one hour of starting each dose of SUPREP Bowel Prep Kit. 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 SUPREP Bowel Prep Kit [see Drug Interactions ( 7.2 )] .
Stop consumption of all fluids at least 2 hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUPREP Bowel Prep Kit or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.8 )] .
Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 Please see www.sebelapharma.com for patent information.
💬 Medication Guide ▾
MEDICATION GUIDE SUPREP®(Soo-prep) Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) oral solution Read and understand this Medication Guide at least 2 days before your colonoscopy and again before you start taking SUPREP Bowel Prep Kit. What is the most important information I should know about SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit and other bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.
These changes can cause: o abnormal heartbeats that can cause death. o seizures. This can happen even if you have never had a seizure. o kidney problems. Your chance of having fluid loss and changes in body salts with SUPREP Bowel Prep Kit is higher if you: have heart problems have kidney problems take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUPREP Bowel Prep Kit: o vomiting o urinating less often than normal o dizziness o headache See "What are the possible side effects of SUPREP Bowel Prep Kit?" for more information about side effects.
What is SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. SUPREP Bowel Prep Kit cleans your colon by causing you to have diarrhea.
Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if SUPREP Bowel Prep Kit is safe and effective in children under 12 years of age. Do not take SUPREP Bowel Prep Kit if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction). • an opening in the wall of your stomach or intestine (bowel perforation). • a very dilated intestine (toxic megacolon). • problems with the emptying of food and fluid from your stomach (gastric retention). • an allergy to any of the ingredients in SUPREP Bowel Prep Kit.
See the end of this Medication Guide for a complete list of ingredients in SUPREP Bowel Prep Kit. Before taking SUPREP Bowel Prep Kit, tell your healthcare provider about all of your medical conditions, including if you: • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). • have gout. • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation". • have a history of seizures or take medicines for seizures. • are withdrawing from drinking alcohol or from taking benzodiazepines. • have a low blood salt (sodium) level. • have kidney problems or take medicines for kidney problems. • have stomach or bowel problems including ulcerative colitis. • have problems with swallowing or gastric reflux. • are pregnant or plan to become pregnant.
It is not known if SUPREP Bowel Prep Kit will harm your unborn baby. Talk to your healthcare provider if you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if SUPREP Bowel Prep Kit passes into your breast milk.
You and your healthcare provider should decide if you will take SUPREP Bowel Prep Kit while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SUPREP Bowel Prep Kit may affect how other medicines work.
Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUPREP Bowel Prep Kit. Especially tell your healthcare provider if you take: • medicines for blood pressure or heart problems. • medicines for kidney problems. • medicines for seizures. • water pills (diuretics). • non-steroidal anti-inflammatory medicines (pain medicines). • medicines for depression or mental health problems. • laxatives. Do not take other laxatives while taking…