Drugplain

SUPREP Bowel Prep 1.2 g/133.1mL

sodium sulfate, potassium sulfate, magnesium sulfate · SOLUTION, CONCENTRATE · Braintree Laboratories, Inc.

No Recall HistoryCurrently in Shortage
Plain English

SUPREP Bowel Prep is a solution, concentrate containing sodium sulfate, potassium sulfate, magnesium sulfate at 1.2 g/133.1mL, taken oral. Manufactured by Braintree Laboratories, Inc..

Key Facts

Brand Name
SUPREP Bowel Prep
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
NDC Code (Product)
52268-112
Manufacturer
Braintree Laboratories, Inc.
Strength
1.2 g/133.1mL
Dosage Form
SOLUTION, CONCENTRATE
Route
ORAL
Marketing Status
Application #
NDA022372
Marketing Start
08/05/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vomiting1,635 reports
nausea1,143 reports
abdominal distension393 reports
drug ineffective380 reports
abdominal pain377 reports
headache368 reports
dizziness225 reports
abdominal pain upper194 reports
wrong technique in product usage process171 reports
tremor159 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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 ) 2.1 Dosage 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 K…

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 )

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 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 )]. 7.2 Potential 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. 7.3 Stimulant 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., bisacod…

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 )] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observ…

Frequently Asked Questions

What is SUPREP Bowel Prep used for?

SUPREP Bowel Prep contains sodium sulfate, potassium sulfate, magnesium sulfate. It is a solution, concentrate taken oral. Consult your doctor for specific uses.

Is SUPREP Bowel Prep a controlled substance?

SUPREP Bowel Prep is not classified as a controlled substance by the DEA.

What is the generic name for SUPREP Bowel Prep?

The generic name for SUPREP Bowel Prep is sodium sulfate, potassium sulfate, magnesium sulfate. There are 6 other brand versions of sodium sulfate, potassium sulfate, magnesium sulfate.

What is the NDC code for SUPREP Bowel Prep 1.2 g/133.1mL?

The NDC (National Drug Code) for SUPREP Bowel Prep 1.2 g/133.1mL is 52268-112, listed by Braintree Laboratories, Inc..

Product NDC

52268-112

Package NDC

52268-112-01

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