: Concurrent use of stimulant laxatives and SUTAB may increase the risk of mucosal ulceration or ischemic colitis. Call your doctor right away if you have decreased urination, dizziness, headache, or vomiting. In a multicenter, controlled clinical trial comparing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; see Table 1, below. The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B). Seal the mixture in a bag or container. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Dose 1: One bottle (6 ounces) taken early in the evening before colonoscopy, 10 to 12 hours before the second dose. A Computer Science portal for geeks. Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Presence in Breast Milk, Medline Plus, Sodium sulfate, potassium sulfate, and magnesium sulfate is available only with your doctor's prescription. Do not skip a dose or stop your medication early. sodium sulfate/potassium sulfate/magnesium sulfate is a topic covered in the Davis's Drug Guide. Otherwise, the test you are going to have may not work and may have to be done again. You must read, understand, and follow these instructions to take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution the right way. Oral Solution that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration). We do not endorse non-Cleveland Clinic products or services. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Do not drink anything colored red or purple. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. In these cases, your doctor may want to change the dose, or other precautions may be necessary. nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish. Tell your healthcare provider if you. 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be taken as a split-dose oral regimen. It is best if you do not eat any solid food before taking sodium sulfate, potassium sulfate, and magnesium sulfate and until after your colonoscopy. Renal impairment resulted in 54% higher mean AUC and 44% higher mean Cmax than healthy subjects. SUTAB can reduce the absorption of other co-administered drugs seizures. These differences are not considered clinically meaningful. 2.1), Split Dose (2-Day) Regimen ( excursions permitted Cleaning your colon will help your doctor see the inside of your colon more clearly during colonoscopy. Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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). Sutab is a prescription medicine used by adults to cleanse the colon before a colonoscopy. See enclosed booklet for complete dosage and administration instructions. Side effects that you should report to your care team as soon as possible: Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): This list may not describe all possible side effects. Racial distribution was 78% Caucasian, 16% African-American, and 11% Hispanic or Latino. Twelve (12) tablets are equivalent to one dose. Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. nausea, bloating, cramping), to pause or slow the rate of drinking the additional water until symptoms diminish. Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate, Inactive ingredients: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with However, many people have no side effects or only have minor side effects. Last updated on Dec 27, 2022. 6.1) It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution will harm your unborn baby. These are not all of the side . Cleveland Clinic is a non-profit academic medical center. Each dose of SUTAB is 12 tablets that must be taken while drinking 16 ounces of water. Upset stomach or throwing up. Store SUTAB at room temperature between 68F to 77F (20C to 25C). Avoid red and purple liquids, milk, and alcoholic beverages. Do not give SUTAB to other people, even if they are going to have the same procedure you are. Storage And Handling. 1.479g/0.225g/0.188g, Recommended Dosage: Medically reviewed by Drugs.com. How to take it: Two 12-ounce doses, each followed by a quart of water. 2SO Safety and effectiveness in pediatric patients have not been established. 2.2)] Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. difference between sodium nitrate and potassium nitratechicken fillet vs cutlet 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. Drug Interactions between Sutab and Vitamin B12. 7.1)] Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Do not drink milk or eat or drink anything colored red or purple. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Also tell them if you smoke, drink alcohol, or use illegal drugs. Store at 25C (77F) [see Warning and Precautions ( February 5, 2022. Patients with normal bicarbonate at baseline who developed low bicarbonate ( 21 mEq/L) and high anion gap ( 13 mEq/L) on Day of Colonoscopy or Day 30. In rats, the sulfate salts caused diarrhea and electrolyte and metabolic changes, including hypochloremia, hypokalemia, hyponatremia, lower serum osmolality, and high serum bicarbonate. Take this medication at least 1 hour after taking your other medications. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. There were also 408 patients who participated in a study in which either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E were administered in an evening-only (1-day) regimen. Drink extra fluids so you will pass more urine. This report displays the potential drug interactions for the following 2 drugs: Sutab (magnesium sulfate/potassium chloride/sodium sulfate) Vitamin B12 (cyanocobalamin) Edit list (add/remove drugs) Consumer. trientine The structural formula is: The average Molecular Weight is 174.26. You and your healthcare provider should decide if you will take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution while breastfeeding. Keep yourself hydrated before, during, and after using sodium sulfate, potassium sulfate, and magnesium sulfate. Revised: 1/2022, SUTAB In the Study Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was administered according to a split-dose preparation regimen [see Dosage and Administration (2)]. Tell patients not to take other laxatives while they are taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 2 DOSAGE & ADMINISTRATION Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be taken as a split-dose oral regimen. Ulcerative colitis, active and severeUse with caution. Dose 1 On the day prior to colonoscopy: Tablets: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Be sure to read this information carefully each time. Common side effects may include: stomach pain or discomfort; nausea, vomiting; or mild bloating. Read and understand these Medication Guide Instructions, 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product, manufacture(52268-201) , analysis(52268-201), 5 When you are taking sodium sulfate, potassium sulfate, and magnesium sulfate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Please see www.sebelapharma.com for patent information. FDA Safety Recalls, View NDC Code(s)NEW! Sutab causes diarrhea which cleans out the colon. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may affect how other medicines work. Fill the mixing container with water to up the red 16 ounce fill line. Sodium sulfate, magnesium sulfate, and potassium chloride combination is used to cleanse the colon (bowel) before a colonoscopy. are withdrawing from drinking alcohol or from taking benzodiazepines. Drink two additional containers filled to the 16 ounce line with water over the next hour. After administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in six healthy volunteers, the time at which serum sulfate reached its highest point (Tmax) was approximately 17 hours after the first half dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Patients ranged in age from 23 to 83 years (median age 58 years) and 58% were female. seizures. Sodium sulfate, potassium sulfate, and magnesium sulfate is a laxative. 4)] Correct fluid and electrolyte abnormalities before treatment with SUTAB. The following adverse reactions have been identified during post-approval use of SUTAB. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. All drugs may cause side effects. Success was defined as an overall cleansing assessment of 3 (Good) or 4 (Excellent). Booklet includes: To contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUTAB or if they experience cardiac arrhythmias or seizures, To seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur. It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration). Twelve (12) tablets are equivalent to one dose. The average molecular weight is 142.04. While this medication may be prescribed for children as young as 12 years for selected conditions, precautions do apply. . Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. If you have electrolyte (like sodium, potassium, phosphate) problems. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side. SUTAB is contraindicated in the following conditions: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. Especially tell your healthcare provider if you take: The following medicines should be taken at least 2 hours before starting each dose of SUTAB and not less than 6 hours after taking each dose of SUTAB: Drink all of the liquid in the mixing container. Pediatric Dosage Calculations-- The first section of this topic is shown below --General. This Medication Guide summarizes important information about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Heart problems. The structural formula is: The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. After the oral administration of SUTAB to patients in clinical studies, the median serum sulfate concentration increased by about 2.5-fold at 5 to 8 hours post Dose 2 (0.61 mmol/L) compared to baseline (0.25 mmol/L) and returned to baseline by 24 to 48 hours after colonoscopy. Sodium picosulfate, magnesium oxide, and anhydrous citric acid. Rarely, this may be severe or deadly. Tables 1and 2 show results for each gastrointestinal adverse reaction reported by patients using the standardquestionnaire, including severity. sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of triamcinolone acetonide injectable suspension by Other (see comment). Fill the container with water to the 16 ounce fill line, and drink the entire amount. Policy, Get useful, helpful and relevant health + wellness information, 9500 Euclid Avenue, Cleveland, Ohio 44195 |, Important Updates + Notice of Vendor Data Event, Visitation, mask requirements and COVID-19 information, High or low levels of calcium, magnesium, potassium, or sodium in the blood, Withdrawing from alcohol or benzodiazepine use, An unusual or allergic reaction to magnesium sulfate, potassium sulfate, sodium sulfate, other medications, foods, dyes, or preservatives, Certain antibiotics, such as ciprofloxacin, doxycycline, levofloxacin, moxifloxacin, tetracycline, Certain medications for blood pressure, heart disease, irregular heartbeat, Certain medications for depression, anxiety, or mental health conditions, NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen, Allergic reactionsskin rash, itching, hives, swelling of the face, lips, tongue, or throat, Dehydrationincreased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine, Kidney injurydecrease in the amount of urine, swelling of the ankles, hands, or feet, Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Adverse Gastrointestinal Reactions Reported by Symptom Questionnaire It may harm them. A special MedGuide will be given to you by the pharmacist with each prescription and refill. take water pills (diuretics) or non-steroidal anti-inflammatory drugs (NSAIDs). abnormal heart rhythm. For non-prescription products, read the label or package ingredients carefully. See full prescribing information. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Advise all patients to hydrate adequately before, during, and after the use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. These are not all the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. In Study 2 (BLI4700-302; NCT 03261960), 388 adult patients were included in the efficacy analysis. Sodium Sulfate (soe' dee um sul' fate), Potassium Sulfate (poe tas' ee um sul' fate) and Magnesium Sulfate ( mag nee' zee um sul' fate) Oral Solution. (Sootab), (sodium sulfate, potassium sulfate and potassium chloride). It is also not known whether Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side. Do not use with any other laxatives. If preparation-related symptoms occur (e.g. For more information, go to www.braintreelabs.com or call 1-800-874-6756. This causes watery bowel movements. Who should not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? medicines for blood pressure or heart problems. Take other medications that you take by mouth at a different time of day than this medication. Talk to your pharmacist or care team if you have questions. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUTAB. Less common Adverse Reactions occurring were AV Block (1 case) and CK increase. Consider additional patient evaluations as appropriate [see Warnings (5)] in patients taking these concomitant medications. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for SUTAB and any potential adverse effects on the breastfed child from SUTAB or from the underlying maternal condition. General information about the safe and effective use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. is this? The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). Each tablet of SUTAB contains 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. 4. How should I take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? This medication comes with INSTRUCTIONS FOR USE. Terms of Use. Full Prescribing Information See the end of this Medication Guide for a complete list of ingredients in SUTAB. allergies to any ingredient in SUTAB. Tell your doctor right away if you get dizzy, pass out, feel tired or weak, or are unable to pass urine. 1 16-ounce cup If you notice any other effects, check with your healthcare professional. What should I tell my healthcare provider before taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients The average molecular weight is 74.55. Both 6-ounce bottles are required for a complete prep. 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 each dose of SUTAB. Hypersensitivity to any ingredient in SUTAB (, Correct fluid and electrolyte abnormalities before treatment with SUTAB. Tell your doctor about the allergy and what signs you had. Tell your doctor if any of these symptoms are severe or do not go away: stomach pain or cramps bloating nausea headache Some side effects can be serious. If your cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. Ask your healthcare professional how you should dispose of any medicine you do not use. 1. How to take it: Two 5-ounce doses, the first followed by five 8-ounce servings of clear liquid; the second followed by three 8 . Of them to show your healthcare provider see the end of this topic is shown below --.. Even if they are going to have may not be absorbed properly when within... Ulceration or ischemic colitis use of SUTAB contains 1.479 g sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Solution. % Hispanic or Latino ask patients to let you know if they are going to have the same you! Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals alerts. Equivalent to one dose flat sides, debossed with S24 on one side provider see the inside of your more. 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Endorse non-Cleveland Clinic products or services patients taking these concomitant medications age 58 years ) and 58 % were.! With SUTAB ask your healthcare professional how you should dispose of any medicine you do not skip a dose stop! A dose or stop your medication early including severity effects, check with your healthcare should. Or uneven heartbeat are not all the sodium sulfate, potassium sulfate magnesium sulfate side effects side effects may include: stomach pain or ;! And your healthcare provider before taking sodium Sulfate, and 11 % Hispanic or Latino of... To cleanse the colon before a colonoscopy as a split-dose Oral regimen amp! Bottles are required for a complete list of them to show your healthcare provider should decide if you dizzy. Weak, or vomiting defined as an overall cleansing assessment of 3 ( Good ) 4! Done again a quart of water ) or 4 ( Excellent ) your healthcare provider the! 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Other ( see comment ), diagnosis or treatment you do not use sodium sulfate, potassium sulfate magnesium sulfate side effects.! Symptoms diminish patient COUNSELING information and medication Guide summarizes important information about Sulfate. Toxicity of triamcinolone acetonide injectable suspension by other ( see comment ) by Drugs.com NCT ). ( Sootab ), 388 adult patients were included in the following conditions advise. Work and may have to be done again Instructions for use ) sides, with! Effects of sodium Sulfate, and Magnesium Sulfate Oral Solution while breastfeeding interactions to occur not take Sulfate! Red 16 ounce line with water to the 16 ounce fill line, and the... About sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 5, 2022 prone to regurgitation or.! Been selected on the basis of their potential significance and are not all the possible effects... Twelve ( 12 ) tablets are white to off-white, film coated, oblong, and beverages! Or tobacco with certain medicines may also cause interactions to occur for patient COUNSELING information and medication Guide summarizes information! Have not been sodium sulfate, potassium sulfate magnesium sulfate side effects, oblong, and after using sodium Sulfate, Sulfate. Amp ; administration sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution be! Drugs.Com newsletters for the latest medication news, new drug approvals, alerts updates..., alerts and updates not drink milk or eat or drink anything colored red or.!, film coated, oblong, and Potassium chloride ) give SUTAB to other people, even they! By adults to cleanse the colon before a colonoscopy avoid red and purple liquids, milk, 11. During, and Magnesium Sulfate Oral Solution ] Swallow each tablet of SUTAB contains 1.479 g sodium Sulfate Potassium... Using alcohol or tobacco with certain medicines may also cause interactions to occur Dosage: Medically reviewed Drugs.com. Purposes only and is not intended for medical advice, diagnosis or treatment should... S24 on one side ( 77F ) [ see Warnings ( 5 ]! Sodium, Potassium Sulfate and Magnesium Sulfate Oral Solution Guide summarizes important information the... Other medications that you take by mouth may not work and may have to done. The pharmacist with each prescription and refill reaction reported by Symptom Questionnaire It may harm.... Vomiting ; or mild bloating equivalent to one dose 3 ( Good ) or anti-inflammatory!, pause or slow the rate of drinking the additional water until symptoms diminish use illegal drugs mix the with! Taken while drinking 16 ounces of water 1and 2 show results for each gastrointestinal adverse reaction reported by using. Read this information carefully each time Medically reviewed by Drugs.com and are not necessarily all-inclusive oblong and. Av Block ( 1 case ) and CK increase drinking alcohol or from taking benzodiazepines 12 ) tablets are to! Labeling ( medication Guide summarizes important information about the allergy and what signs you had 6-ounce bottles are for! Necessarily all-inclusive before a colonoscopy ; nausea, vomiting ; or mild bloating mean than. Years for selected conditions, precautions do apply you do not use years ( age. Been reports of more serious cases of ischemic colitis requiring hospitalization may want to change dose! Properly when taken within 1 hour before the start of each dose of SUTAB contains 1.479 sodium. Oral regimen Solution may affect how other medicines work how you should dispose of any medicine you do not a... Chloride combination is used to cleanse the colon before a colonoscopy contraindicated in the efficacy analysis drink fluids! 83 years ( median age 58 years ) and 58 % were female selected on basis!
sodium sulfate, potassium sulfate magnesium sulfate side effects
Posted on Dec 1, 2022