Suflave FDA Approval History
Last updated by Judith Stewart, BPharm on June 27, 2023.
FDA Approved: Yes (First approved June 15, 2023)
Brand name: Suflave
Generic name: polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride
Dosage form: Powder for Oral Solution
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation
Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
- Colonoscopy is the most common detection method for colorectal cancer and successful screening is dependent upon adequate cleansing of the colon. Many of the available bowel preparation products require the consumption of large volumes of poor-tasting solutions, which can result in low patient compliance.
- Suflave is a powder that is reconstituted with water to make a low-volume solution with a taste that is similar to a lemon-lime sports drink.
- Suflave works as a laxative due to the osmotic effects of polyethylene glycol 3350, sodium sulfate and magnesium sulfate. By increasing water retention in the lumen of the colon, the stools become loose and the colon is cleared.
- Suflave is administered as a split dose regimen over two days. The first dose is taken the evening before the colonoscopy, and the second dose is taken the following morning, 5 to 8 hours prior to the colonoscopy and no sooner than 4 hours after the first dose.
- Warnings and precautions associated with Suflave include an increased risk of fluid and electrolyte abnormalities, increased potential for colonic mucosal ulcerations, and hypersensitivity reactions. Suflave should be used with caution in patients with cardiac arrhythmias, patients who have seizures, and patients with renal impairment or those who are taking concomitant medications that affect renal function.
- Common adverse reactions include nausea, abdominal distension, vomiting, abdominal pain and headache.
Development timeline for Suflave
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
