Is Suflave approved by the FDA?

Suflave was approved by the FDA on June 15, 2023. It is a prescription laxative used to cleanse the bowel in preparation for colonoscopy in adults.

What is Suflave?

Suflave is a combination, osmotic prescription laxative that contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride. It is supplied as a powder that is mixed with water before consuming. Suflave has a lemon-lime sports drink taste, improving compliance compared to other bowel preparation products that require large volumes of poor-tasting solutions.

How does Suflave work?

Suflave works by osmosis, drawing water into the bowel, increasing the volume and reducing the consistency of stools, making them loose and easily cleared. It is administered as a split-dose regimen over two days, making it effective for bowel preparation before a colonoscopy.

Warnings and Precautions:

Fluid and Electrolyte Abnormalities: Follow the instructions exactly and drink additional water to prevent dehydration and electrolyte imbalances.
Heart Problems: Pre-dose and post-colonoscopy ECGs may be needed for patients at increased risk of heart problems.
Renal Impairment: Use with caution in patients with renal impairment or those taking medications that affect renal function.
Other Conditions: Use cautiously in patients with cardiac arrhythmias, seizures, and known or suspected inflammatory bowel disease. Patients at risk for aspiration should be observed during administration.

Who should not take Suflave?

Patients with bowel obstruction or ileus.
Patients with bowel perforation.
Patients with toxic colitis or toxic megacolon.
Patients with gastric retention.
Patients allergic to any of the active or inactive ingredients in Suflave.

How is Suflave taken?

Suflave is administered as a split-dose regimen:

Day 1, Dose 1: The evening before the colonoscopy, mix one flavor-enhancing packet with water and drink the solution in increments of 8 ounces every 15 minutes until the bottle is empty. Drink an additional 16 ounces of water.
Day 2, Dose 2: The morning of the colonoscopy, 5 to 8 hours before the procedure, repeat the steps with the second packet and bottle, and drink an additional 16 ounces of water.

Possible Side Effects:

Common: Abdominal distension, abdominal pain, headache, nausea, vomiting.
Serious: Dehydration, electrolyte imbalances, abnormal heartbeats, seizures, kidney problems, severe abdominal pain, rectal bleeding, and allergic reactions.

Drug Interactions:

Medications that treat electrolyte imbalance, heart problems, kidney problems, seizures, depression, mental health issues, NSAIDs, and diuretics.
Avoid taking oral medications within 1 hour before starting each dose of Suflave.

Pregnancy and Breastfeeding:

The effects of Suflave on an unborn baby or breastfed infant are not known. Consult your healthcare provider if you are pregnant or breastfeeding.

Storage:

Store unopened packets at room temperature (68°F to 77°F or 20°C to 25°C).
Store reconstituted solution in the refrigerator (36°F to 46°F or 2°C to 8°C) and use within 24 hours. Do not freeze.

Suflave offers an effective and palatable option for bowel preparation before a colonoscopy, ensuring adequate cleansing and improving patient compliance. Always follow your healthcare provider's instructions and inform them of any medical conditions or medications you are taking.

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