sodium sulfate/potassium sulfate/magnesium sulfate (Rx)

Brand and Other Names:Suprep
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Dosing & Uses

AdultPediatricGeriatric

Dosage Form & Strengths

sodium sulfate/potassium sulfate/magnesium sulfate

oral solution for dilution

  • (17.5g/3.13g/1.6g)/6 oz bottle for adults
  • Each kit contains 2 bottles of concentrated oral solution (6 oz each) for further dilution and a mixing bottle

Bowel Prep

Indicated for cleansing of the colon in preparation for colonoscopy

Administer in a split dose (2-day regimen) for a total volume of 96 oz (2880 mL)

Day prior to colonoscopy

  • May consume light breakfast or only clear liquids on day before (no solid foods)
  • Avoid red and purple liquids, milk, and alcoholic beverages
  • Early evening before colonoscopy: Dilute 1st 6-oz bottle to 16 oz (480 mL) with water in provided mixing container and drink entire amount
  • Drink additional 32 oz (960 mL) of water over the next hour

Day of colonoscopy

  • Have only clear liquids until after colonoscopy
  • Avoid red and purple liquids, milk, and alcoholic beverages
  • Morning of colonoscopy (10-12 hr after evening dose and at least 3.5 hr before colonoscopy): Prepare 2nd 6-oz bottle by diluting contents to 16 oz (480 mL) in provided mixing container and drink entire amount
  • Drink additional 32 oz (960 mL) of water over the next hour
  • Complete all of the bowel kit and required water at least 2 hr before colonoscopy

Dosage Form & Strengths

sodium sulfate/potassium sulfate/magnesium sulfate

oral solution for dilution

  • (13.13g/2.35g/1.2g)/4.5 oz bottle for children aged ≥12 yr
  • Each kit contains 2 bottles of concentrated oral solution (4.5 oz each) for further dilution and a mixing bottle

Bowel Prep

Indicated for cleansing of the colon in preparation for colonoscopy for adolescents aged ≥12 yr

≥12 years

Administer in a split dose (2-day regimen) for a total volume of liquid using 2 bottles is 72 oz (~2130 mL)

  • Day prior to colonoscopy
    • May consume light breakfast or only clear liquids on day before (no solid food)
    • Avoid red and purple liquids, milk, and alcoholic beverages
    • Early evening before colonoscopy: Dilute 1st 4.5-oz bottle to 12 oz (360 mL) with cool water in provided mixing container and drink entire amount
    • Drink additional 24 oz (720 mL) of water over the next hour
  • Day of colonoscopy
    • Have only clear liquids until after colonoscopy
    • Avoid red and purple liquids, milk, and alcoholic beverages
    • Morning of colonoscopy (10-12 hr after evening dose and at least 3.5 hr before colonoscopy): Prepare 2nd 4.5-oz bottle by diluting contents to 12 oz (360 mL) in provided mixing container and drink entire amount
    • Drink additional 24 oz (720 mL) of water over the next hour
    • Complete all of the bowel kit and required water at least 2 hr before colonoscopy

In clinical trials, 25% of participants were aged 65 yr or older; no overall differences were noted with the split-dose (2-day) regimen; however, geriatric patients tended to have more vomiting when administered as a 1-day regimen

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Interactions

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            Adverse Effects

            >10%

            Adults

            • Discomfort (54%)
            • Abdominal distension (40%)
            • Abdominal pain (36%)
            • Nausea (36%)
            • Decreased bicarbonate (13%)
            • Hyperuricemia (23.5%)
            • Metabolic acidosis (12.7%)
            • Hypercalcemia (10.4%)

            Aged 12-16 years

            • Nausea
            • Abdominal pain
            • Abdominal bloating
            • Vomiting

            1-10% (Adults)

            Elevated anion gap (8.9%)

            Hyperbilirubinemia (8.5%)

            Vomiting (8%)

            Hyperosmolality (5.8%)

            Hyponatremia (3.1%)

            Hyperchloremia (2.4%)

            Elevated serum creatinine (1.9%)

            Hyperkalemia (1.8%)

            Elevated BUN (1.6%)

            Headache (1.1%)

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            Warnings

            Contraindications

            Hypersensitivity

            Gastrointestinal obstruction or ileus

            Bowel perforation

            Gastric retention

            Toxic colitis or toxic megacolon

            Cautions

            Caution with increased incidence of elevated serum electrolytes, serum creatinine, and BUN

            Caution in patients with renal impairment or patients taking concomitant medications that may affect renal function; patients may be at risk for renal injury; advise patients of importance of adequate hydration before, during and after use of product and consider performing baseline and post-colonoscopy laboratory tests

            Seizures: Reports of generalized tonic-clinic seizures with use of bowel preparations products; associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia); caution in patients at risk of seizures (alcohol withdrawal, drugs lowering seizure threshold, suspected/known hyponatremia)

            Cardiac arrhythmias: Rare reports of serious arrhythmias associated with ionic osmotic laxative products

            Osmotic laxative products may produce colonic mucosal aphthous ulcerations; reports of serious cases of ischemic colitis requiring hospitalization; coadministration with stimulant laxatives may increase risk

            If GI obstruction or perforation suspected, perform appropriate diagnostic studies to rule out these conditions before administering; caution with severe active ulcerative colitis

            Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of bowel prep solution

            Fluid and serum chemistry abnormalities

            • Advise patients to hydrate adequately before, during, and after use
            • Correct fluid and electrolyte abnormalities before treatment to avoid serious adverse effects (eg, arrhythmias, seizures, renal impairment)
            • Caution in patients with conditions or medications that increase risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment
            • If significant vomiting or signs of dehydration develops consider performing post-colonoscopy laboratory tests (eg, electrolytes, creatinine, BUN)
            • Can cause temporary elevations in uric acid; monitor patients with gout for acute flare

            Drug interaction overview

            • Oral medication administered within 1 hr before bowel prep may not be absorbed properly
            • Caution if coadministration with drugs that increase risk of fluid and electrolyte disturbances or may increase risk of seizure, arrhythmias, or prolonged QT
            • Avoid coadministration with stimulant laxatives owing to increased risk of mucosal ulceration or ischemic colitis
            • Caution if coadministered with medications that may affect renal function (eg, diuretics, ACE inhibitors, ARBs, NSAIDs)
            • Chelation with magnesium
              • Take tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine at least 2 hr before and not less than 6 hr after administration of bowel prep to avoid chelation
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            Pregnancy & Lactation

            Pregnancy

            Data are unavailable data on 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

            Lactation

            There are no data available on presence of drug combination in human or animal milk, effects on breastfed child, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for prep kit and any potential adverse effects on breastfed child from product or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Osmotic laxative; sulfate salts provide sulfate anions and associated cations causing water retention within bowel; osmotic effect of unabsorbed ions and large volume of water ingested produces copious watery diarrhea

            Pharmacokinetics

            Half-Life: 8.5 hr

            Peak Plasma Time (serum sulfate): 17 hr (1st dose); 5 hr (2nd dose); renal impairment increases Tmax by 44% and AUC by 54%

            Excretion (sulfate): predominantly in feces

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            Administration

            Oral Preparation

            Correct fluid and electrolyte abnormalities before treatment

            Dilute bowel prep kit in water before ingestion

            Consume additional water after each dose of bowel prep

            On day before colonoscopy, consume only a light breakfast or clear liquids (eg, water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit)

            On day of colonoscopy only consume clear liquids up to 2 hours before colonoscopy Do not eat solid food, drink milk, or eat or drink anything colored red or purple

            Do not drink alcohol

            Do not take other laxatives while taking bowel prep

            Do not take oral medications within 1 hr of starting each dose of bowel prep

            Stop consumption of all fluids at least 2 hr before colonoscopy

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            Patient Handout

            Patient Education
            sodium, potassium, and magnesium sulfates oral

            SODIUM/POTASSIUM/MAGNESIUM SULFATE SOLUTION - ORAL

            (SOE-dee-um/poh-TASS-ee-um/mag-NEE-zee-um/SUL-fate)

            COMMON BRAND NAME(S): Suprep

            USES: Sodium/potassium/magnesium sulfate solution is used to clean out the intestines before a certain bowel exam procedure (colonoscopy). It is a laxative that works by drawing large amounts of water into the colon. This causes watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

            HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Follow any special diet instructions provided by your doctor. Usually, you may have a small breakfast or only clear liquids on the day before your procedure. After breakfast, you may only drink clear liquids until after your procedure. Do not drink milk or alcoholic beverages or eat/drink anything colored red or purple. To prevent becoming dehydrated, drink as much clear liquid as you can before, during, and after drinking this medication unless otherwise directed by your doctor.Do not take any other medications by mouth within 1 hour of starting to drink the mixture. Ask your doctor or pharmacist if you are not sure when to take your other medications.Use this product as directed by your doctor, usually one dose the evening before the colonoscopy and the second dose the next day in the morning. The dosage is based on your age and medical condition.Before using this product, pour the contents into the mixing container as directed by the manufacturer. Add cool water, mix, and drink all of the mixture. After drinking the mixture, drink 2 additional containers filled with water over the next hour. Be sure to finish drinking all of the mixture and required water at least 2 hours before your procedure, or as directed.Ask your doctor or pharmacist if you have any questions about how to mix or take this product or what to expect after taking this product.Watery bowel movements usually begin about 1 hour after you drink the mixed liquid. The bowel movements can be very large and watery.

            SIDE EFFECTS: Very watery bowel movements are expected with this medication. Nausea, vomiting, bloating, or stomach/abdominal cramping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause your body to lose too much fluid and salts (dehydration, electrolyte problems). Tell your doctor right away if you have any of these serious side effects: severe dizziness, fainting, fast/irregular heartbeat, trouble keeping liquids down, prolonged vomiting, headache, seizure.Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain that is severe or doesn't go away, signs of kidney problems (such as change in the amount of urine), bloody stools, rectal bleeding.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blocked intestines (gastrointestinal obstruction), hole in the intestines, severe ulcers/swelling of the colon (ulcerative colitis), severe infection in the intestines (such as toxic colitis, toxic megacolon), stomach/intestines that empty slowly or are not moving (gastric retention, ileus), trouble swallowing, trouble keeping food down (regurgitation), history of breathing food/other substances into the lungs (aspiration), gout, heart problems (such as irregular heartbeat, chest pain, heart failure), kidney problems, seizure, regular use of alcohol or other sedatives.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include drugs that can change the amount of water, sodium, or potassium in your body, such as: heart/blood pressure medications called ARBs (such as valsartan), heart/blood pressure medications called ACE inhibitors (such as captopril, enalapril), nonsteroidal anti-inflammatory drugs - NSAIDs (such as ibuprofen, naproxen), "water pills" such as thiazide diuretics.Do not take/use other laxatives while taking this product.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab tests (such as sodium, potassium levels) may be done before or after taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you are unable to drink all of the solution and water as directed, call your doctor right away. Your test may need to be rescheduled.

            STORAGE: Store the unmixed container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.