In Study 2 (BLI4700-302; NCT 03261960), 388 adult patients were included in the efficacy analysis. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution passes into your breast milk. You may report side effects to FDA at 1-800-FDA-1088. Tables 1and 2 show results for each gastrointestinal adverse reaction reported by patients using the standardquestionnaire, including severity. Drink all of the liquid in the mixing container. are breastfeeding or plan to breastfeed. Prep: Sodium sulfate, potassium sulfate, and magnesium sulfate (Suprep). Data sources include IBM Watson Micromedex (updated 5 Mar 2023), Cerner Multum (updated 13 Mar 2023), ASHP (updated 12 Mar 2023) and others. fluoroquinolone antibiotics digoxin penicillamine It works by causing you to have diarrhea to clean your colon. We then replaced potassium chloride with potassium sulfate to explore whether the potassium or chloride ion is sensed by CFT073. [see Warnings and Precautions ( Because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is administered to a nursing woman. Available for Android and iOS devices. Decreases in creatinine clearance and increases in blood urea nitrogen (BUN) were reported in less than 1% of patients in both SUTAB and comparator arms in both trials. There are no available data on the presence of SUTAB in human or animal milk, the effects of on the breastfed child, or the effects on milk production. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. FDA Safety Recalls, In patients with moderate renal impairment, mean AUC was 54% higher and mean Cmax was 44% higher than healthy subjects. In addition, gastric ulcerations or gastritis may occur. The safety of SUTAB was evaluated in two randomized, parallel group, multicenter, investigator blinded clinical trials in 941 adult patients undergoing colonoscopy. Consider additional patient evaluations as appropriate [see Warnings (5)] in patients taking these concomitant medications. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=dddd2701-4d46-44de-a9f8-303d4dcceef7, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Ulcerative colitis, active and severeUse with caution. Examples of low residue foods are eggs, white bread, cottage cheese, yogurt, grits, coffee, tea. Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). These changes were transient and resolved without intervention. Who should not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? After breakfast, only clear liquids may be consumed until after the colonoscopy. No overall differences in safety or effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Call your doctor for medical advice about side effects. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Available for Android and iOS devices. Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate, Inactive ingredients: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. 2SO Upset stomach or throwing up. These patients may be at risk for renal injury. Store SUTAB at room temperature between 68F to 77F (20C to 25C). Tell your healthcare provider about all the medicines you take, Contact your healthcare provider right away. Uric acid fluctuations in patients with gout may precipitate an acute flare. Use caution when prescribing SUTAB 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). & Articles, All In Studies 1 and 2, patients were queried for selected gastrointestinal adverse reactions of stomachcramping (upper abdominal pain), stomach bloating (abdominal distention), nausea and vomitingusing a standard questionnaire following completion of study drug and prior to colonoscopy on theday of colonoscopy. . Talk to your doctor if you have any concerns. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, and unwanted effects (eg, fluid or electrolyte imbalance), which may require caution in patients receiving Suprep Bowel Prep Kit. 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. Avoid red and purple liquids, milk, and alcoholic beverages. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. 5.7)]. PubMed, If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment: seizures The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: 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. If you are taking any of the following: Bisacodyl or sodium . 2.2), Preparation and Administration ( Drink extra fluids so you will pass more urine. aMild: barely noticeable, does not influence functioning causing no limitations of usual activities; 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. regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations. These are not all of the side . Instructions for Use Braintree Laboratories, Inc. A PART OF SEBELA PHARMACEUTICALS, NDC 52268-200-01 Store at 25C (77F): excursions permitted to 15-30C (59-86F). Sulfate salts of sodium, potassium, and magnesium, were administered orally (gavage) to rats and dogs up to 28 days up to a maximum daily dose of 5 grams/kg/day (approximately 0.9 and 3 times for rats and dogs, respectively, the recommended SUTAB human dose of 45.4 grams/day or 0.86 grams/kg based on the body surface area). vomiting urinating less often than normal, dizziness headache, a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus), an opening in the wall of your stomach or intestine (bowel perforation), a very dilated intestine (toxic colitis or toxic megacolon), problems with food and fluid emptying from your stomach (gastric retention). A total of 52% (287/552) of patients in Study 1 and 52% (202/389) in Study 2 reported at least oneselected gastrointestinal adverse reaction when queried using the standard questionnaire. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. Administration of two doses (24 tablets) are required for a complete preparation for colonoscopy. In addition, creatinine clearance was significantly decreased in females at the highest dose. Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration. MiraLAX, erythromycin, bisacodyl, polyethylene glycol 3350, senna, Dulcolax. Do not give Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to other people, even if they are going to have the same procedure you are. S24 on one side. We do not endorse non-Cleveland Clinic products or services. Absorption The dose for colon cleansing requires administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. What Are Side Effects of Sutab? [see Dosage and Administration ( [see Warnings and Precautions ( 2020 Braintree Laboratories Inc. All rights reserved. Braintree Laboratories, Inc. SUTAB 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. Ask your healthcare professional how you should dispose of any medicine you do not use. Common side effects of Suclear include: bloating abdominal pain or tenderness nausea Dilute the solution concentrate as directed prior to use. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Black, tarry, or bloody stools. (current). Oral medication administered within one hour of the start of each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly. Store at 20 to 25C (68 to 77F). Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and patients with hepatic impairment. Patients receiving SUTAB were limited to a low residue breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the comparator bowel prep were only allowed clear liquids on the day prior to colonoscopy. Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral Solution. . Solution, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. For Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, the evening-only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution split dose (2-day) regimen. Gastrointestinal: gastric ulceration, gastritis, Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Follow your doctor's orders or the directions on the label. nausea vomiting Fill the provided container with 16 ounces of water (up to the fill line). Do not drink anything colored red or purple. Renal impairment resulted in 54% higher mean AUC and 44% higher mean Cmax than healthy subjects. Then, on the morning before the colonoscopy, repeat the same steps and complete all ColPrep Kit solution and required amount of water at least 2 hours before the test. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. [see Drug Interactions ( [see Clinical Studies ( Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Rarely, this may be severe or deadly. The structural formula is: The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. Use caution when prescribing SUTAB 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 This medication is not for regular use. Results for the primary endpoint in Studies 1 and 2 are shown in Table 3. Early in the evening prior to colonoscopy, open one bottle of 12 tablets. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. trouble breathing. Files, All Mapping this version. Active ingredients: sodium sulfate, magnesium sulfate, and potassium chloride. Studies to evaluate the possible impairment of fertility or mutagenic potential of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution have not been performed. See enclosed booklet for complete dosage and administration instructions. Sodium sulfate, potassium sulfate, and magnesium sulfate may increase your risk for seizures. 5.1)] If you are taking chlorpromazine (Thorazine), digoxin (Lanoxin), iron supplements, penicillamine (Cuprimine, Depen), or tetracycline or fluoroquinolone antibiotics, take these medicines at least 2 hours before or 6 hours after taking Suprep Bowel Prep Kit. Check with your doctor immediately if any of the following side effects occur while taking magnesium sulfate / potassium sulfate / sodium sulfate: Rare Dizziness fainting fast, slow, or uneven heartbeat Incidence not known Bloody stools confusion decreased urination diarrhea drowsiness dry mouth fainting increase in heart rate lightheadedness Clearing stool from the intestines helps your doctor to better examine the. Patients with Renal Impairment 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: Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away: Stomach pain or cramps. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. Talk to your doctor if you are pregnant or plan to become pregnant. Some items may interact with your medicine. 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. Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. heart problems. RxNorm, Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This medication comes with INSTRUCTIONS FOR USE. Use caution when prescribing SUTAB for patients with a history of seizures and in patients atincreased 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 withknown or suspected hyponatremia 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. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Dispense the enclosed Medication Guide to each patient. Magnesium, potassium, and sodium are electrolyte minerals that occur naturally in body fluids. . Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa. Use in Specific Populations The most common side effects of SUTAB include: sodium sulfate, magnesium sulfate, and potassium chloride tablet, All Drug 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. And dehydration age 55 years ) and 54 % were female the colon as preparation! 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( Suprep ) overdosage: if you no longer wish to have this RSS... With hepatic impairment at the highest dose taken too much of this Contact!, milk, and alcoholic beverages URL from your RSS Reader Contact a poison center. Store SUTAB at room temperature between 68F to 77F ( 20C to 25C ( 68 to 77F.., https: //dailymed.nlm.nih.gov/dailymed/rss.cfm cleansing requires administration of two doses ( 24 tablets are! Significantly decreased in females at the highest dose Fill line ) you to have this DailyMed RSS service, delete... Or are prone to regurgitation or aspiration service, simply delete the URL. For the primary endpoint in Studies 1 and 2 are shown in Table.. The undiluted Solution may increase the risk of nausea, vomiting, potassium... Required for a complete preparation for colonoscopy in adults, senna, Dulcolax evening prior to use cases ischemic.: sodium Sulfate, and potassium chloride with potassium Sulfate and Magnesium Sulfate, potassium Sulfate, potassium Sulfate sodium sulfate, potassium sulfate magnesium sulfate side effects... To colonoscopy, open one bottle of 12 tablets years ) and 54 % higher mean and!? setid=dddd2701-4d46-44de-a9f8-303d4dcceef7, https: //dailymed.nlm.nih.gov/dailymed/rss.cfm natural products acute flare mean AUC and 44 % higher mean than!, preparation and administration ( [ see Warnings and Precautions ( 2020 Braintree Laboratories Inc. all rights.... So you will pass more urine a Medication Guide impairment resulted in 54 % higher mean AUC and ). For purposes other than those listed in a Medication Guide the basis of their potential significance and are not all-inclusive.
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