Miralax (Polyethylene Glycol) 17g/Dose Packet: KOP or DOT?
Miralax (Polyethylene Glycol) 17g/Dose packets should be considered DOT (Discard Open Packet) based on FDA labeling and clinical guidelines. 1
Rationale for DOT Classification
FDA Labeling Requirements
- The FDA label for Polyethylene Glycol specifically states that users should "ensure that the powder is fully dissolved before drinking" and "do not drink if there are any clumps" 1
- The label further instructs to mix the powder in 4-8 ounces of beverage (cold, hot, or room temperature) and drink immediately after mixing 1
- These requirements make it inappropriate for keeping open packets, as the medication must be fully dissolved and consumed promptly
Clinical Considerations
- PEG 3350 (Miralax) is an osmotic laxative that works by attracting water into the colon to soften stool 2
- The efficacy of the medication depends on proper dissolution and dosing (17g once daily) 3
- Keeping open packets could lead to:
- Inaccurate dosing if partial packets are used
- Decreased efficacy due to moisture absorption from the environment
- Potential contamination of the powder
Administration Guidelines
Proper Preparation
- Each 17g packet should be completely dissolved in 4-8 ounces of liquid 1
- The solution can be prepared with water, juice, coffee, or tea 2
- The powder must be fully dissolved before consumption 1
- Do not combine with starch-based thickeners used for difficult swallowing 1
Duration of Use
- For general constipation, FDA labeling recommends not using for more than 7 days without consulting a doctor 1
- For chronic idiopathic constipation, clinical guidelines indicate it can be used safely for up to 6 months 3, 2
Clinical Efficacy and Safety
- PEG 3350 has demonstrated effectiveness for constipation with approximately 2.9 more complete spontaneous bowel movements per week compared to placebo 2
- The medication is well-tolerated with minimal side effects including bloating, flatulence, and abdominal discomfort 2
- Long-term studies have shown safety for up to 12 months of continuous use 4
Key Takeaway
Due to the requirement for complete dissolution before consumption, the need for precise dosing, and the potential for degradation or contamination if left open, Miralax 17g/Dose packets should be treated as DOT (Discard Open Packet) rather than KOP (Keep Open Packet).