Dosing
- Two doses of SUFLAVE are required for a complete preparation
- Each dose consists of 1 bottle and 1 flavor enhancing packet
- Open 1 flavor-enhancing packet and pour the contents into 1 bottle.
- Fill the provided bottle with lukewarm water up to the fill line. After capping the bottle, gently shake the bottle until all the powder has dissolved. For the best taste, refrigerate the solution for 1 hour before drinking. Do not freeze. Use within 24 hours.
- Drink 8 ounces of solution every 15 minutes until the bottle is empty.
- Drink an additional 16 ounces of water during the evening.
Bottles and packets not shown actual size.
If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
- Repeat Steps 1 through 3 from Day 1, Dose 1.
- Drink an additional 16 ounces of water during the morning.
- Stop drinking liquids at least 2 hours prior to colonoscopy.
Bottles and packets not shown actual size.
If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
INDICATION
SUFLAVE™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing
of the colon in preparation for colonoscopy in adults.
DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are
required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor enhancing packet are equivalent to
one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy.
CONTRAINDICATIONS
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any
ingredient in SUFLAVE.
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use;
Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at
increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting
colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function:
Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.
ADVERSE REACTIONS
Most common adverse reactions (≥ 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache.
DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.
View the Full Prescribing Information and Medication Guide.
References
1. SUFLAVE [package insert]. Braintree, MA: Braintree Laboratories, Inc.
2. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894
3. Data on file. Braintree Laboratories, Inc.
4. Walker ML, Cleveland MV, Hague KM, et al. A formulation development study of BLI4900, a novel flavor enhanced bowel preparation for colonoscopy. Gastrointest Endosc. 2022;95(6 Suppl). Accessed Jan 2, 2024. https://doi.org/10.1016/j.gie.2022.04.188
5. Wiener G, Winkle P, McGowan JD, et al. A phase 2 evaluation of a new flavored PEG and sulfate solution compared to an over-the-counter laxative, PEG and sports drink bowel preparation combination. BMC Gastroenterol. 2023;23:433. doi:10.1186/s12876-023-03069-8
6. Hernández G, Gimeno-García AZ, Quintero E. Strategies to improve inadequate bowel preparation for colonoscopy. Front Med (Lausanne). 2019;6:245. doi:10.3389/fmed.2019.00245
7. D’Souza SM, Parekh PJ, Johnson DA. The dirty side of colonoscopy: predictors of poor bowel preparation and novel approaches to overcome the shortcomings. Br J Gastroenterol. 2019;1:106-115. doi:10.31488/bjg.1000103
8. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi:10.1038/ajg.2017.174
9. Corley DA, Jensen CD, Marks AR, et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014;370:1298-1306. doi:10.1056/NEJMoa1309086
10. Liem B, Gupta N. Adenoma detection rate: the perfect colonoscopy quality measure or is there more? Transl Gastroenterol Hepatol. 2018;3:19. doi:10.21037/tgh.2018.03.04
11. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. doi:10.1016/j.gie.2014.07.058
12. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
