SUTAB 2.7 g/1
sodium sulfate, magnesium sulfate, and potassium chloride · TABLET · Braintree Laboratories, Inc.
SUTAB is a tablet containing sodium sulfate, magnesium sulfate, and potassium chloride at 2.7 g/1, taken oral. Manufactured by Braintree Laboratories, Inc..
Key Facts
- Brand Name
- SUTAB
- Generic Name
- sodium sulfate, magnesium sulfate, and potassium chloride
- NDC Code (Product)
52268-201- Manufacturer
- Braintree Laboratories, Inc.
- Strength
- 2.7 g/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA213135
- Marketing Start
- 11/10/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUTAB is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1 , 2.2 ) Preparation and Administration ( 2.1 ) Administration of two doses (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets. Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy. Must consume water with each dose and an additional 32 ounces of water after each dose. Do not take other laxatives. Administer oral medications at least 1 hour before starting each dose of SUTAB. 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. Recommended Split Dose (2-Day) Dosage Regimen ( 2.2 ) Day 1, Dose 1: On the Evening Prior to Colonoscopy: Open 1 bottle of 12 tablets. Remove and discard the desiccant. Remove and discard the desiccant from the second bottle and close the …
Contraindications
4 CONTRAINDICATIONS SUTAB is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precautions ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any ingredient in SUTAB [see Warnings and Precautions ( 5.7 ) 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 in SUTAB ( 4 , 5.7 )
Drug Interactions
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing 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 [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . 7.2 Potential for Reduced Drug Absorption SUTAB 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 SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and SUTAB may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUTAB [see Warnings and Preca…
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] 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 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug c…
Frequently Asked Questions
What is SUTAB used for?
SUTAB contains sodium sulfate, magnesium sulfate, and potassium chloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is SUTAB a controlled substance?
SUTAB is not classified as a controlled substance by the DEA.
What is the generic name for SUTAB?
The generic name for SUTAB is sodium sulfate, magnesium sulfate, and potassium chloride. There are no other listed brand versions of sodium sulfate, magnesium sulfate, and potassium chloride.
What is the NDC code for SUTAB 2.7 g/1?
The NDC (National Drug Code) for SUTAB 2.7 g/1 is 52268-201, listed by Braintree Laboratories, Inc..
Other SUTAB Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)