(pol i ETH i leen GLY kol 3350)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
HealthyLax: (1 ea, 14 ea)
MiraLax: (1 ea, 10 ea, 12 ea, 24 ea)
Generic: (1 ea, 14 ea, 30 ea, 100 ea)
GaviLAX: 17 g/dose (238 g, 510 g)
GlycoLax: 17 g/dose (119 g, 255 g, 527 g)
MiraLax: 17 g/dose (1 ea, 119 g, 238 g, 510 g, 765 g)
PEGyLAX: 17 g/dose (527 g)
Generic: 17 g/dose (119 g, 238 g, 250 g [DSC], 255 g, 500 g [DSC], 510 g, 527 g, 850 g)
Brand Names: U.S.
- GaviLAX [OTC]
- GlycoLax [OTC]
- HealthyLax [OTC]
- MiraLax [OTC]
- Laxative, Osmotic
An osmotic agent, polyethylene glycol 3350 causes water retention in the stool; increases stool frequency.
Minimal (<0.28%; Pelham, 2008)
Feces (93%); urine (0.2%) (Pelham, 2008)
Onset of Action
Oral: 24 to 96 hours
Use: Labeled Indications
Constipation, occasional: Treatment of occasional constipation
Off Label Uses
Bowel preparation before colonoscopy
Based on the Consensus Document on Bowel Preparation Before Colonoscopy from The American Society of Colon and Rectal Surgeons (ASCRS), The American Society for Gastrointestinal and Endoscopy (ASGE), and The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), polyethylene glycol 3350 in combination with bisacodyl delayed-release tablets or magnesium citrate is effective and recommended for bowel preparation before colonoscopy [Wexner 2006].
Additional Off-Label Uses
Occasional constipation (infants, children, adolescents <17 years)
Hypersensitivity to polyethylene glycol or any component of the formulation; known or suspected bowel obstruction
OTC labeling: When used for self-medication, do not use if you have renal disease unless advised by a health care provider
Canadian labeling: Additional contraindications (not in US labeling): Relaxa: Use in children <18 years of age unless advised by a physician
Bowel preparation before colonoscopy (off-label use): Oral: 17 g (~1 heaping tablespoon) in 240 mL (8 ounces) of clear liquid every 10 minutes until 2,000 mL of volume are consumed (start within 6 hours after administering bisacodyl delayed-release tablets or magnesium citrate) (ASCRS/ASGE/SAGES [Wexner 2006])
Constipation, occasional: Oral: 17 g (~1 heaping tablespoon) dissolved in 120 to 240 mL (4 to 8 ounces) of beverage, once daily; do not use for >1 to 2 weeks (product specific) unless directed by health care provider. In a clinical trial, 34 g once daily was shown to be effective, but with increased adverse effects (DiPalma 1999).
Refer to adult dosing.
Bowel preparation before colonoscopy (off-label): Children >2 years of age and Adolescents: Limited data available: Oral: 1.5 g/kg/day for 4 days; maximum dose: 100 g/day (Pashankar 2004)
Constipation, occasional (off-label use):
Infants, Children, and Adolescents <17 years of age: Oral: 0.2 to 0.8 g/kg/day (NASPGHAN [Tabbers 2014]); higher initial dose of 1 g/kg has been suggested (Loening-Baucke 2004; Pashankar 2001); maximum daily dose: 17 g/day. Note: Dosage should be individualized to achieved desired effect, infants and young children may require higher doses than school-aged children (Loening-Buck 2004; Pashankar 2001)
Adolescents ≥17 years of age: Refer to adult dosing.
Fecal impaction, slow disimpaction (off-label use): Limited data available: Children and Adolescents: Oral: 1 to 1.5 g/kg daily for 3 to 6 consecutive days (NASPGHAN [Tabbers] 2014; Youssef 2002); maximum daily dose: 100 g/day (Youssef 2002); following disimpaction maintenance dose of 0.4 g/kg daily should be continued for ≥2 months (NASPGHAN [Tabbers] 2014)
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dissolve powder completely in 120 to 240 mL (4 to 8 ounces) of water, juice, soda, coffee, or tea.
Constipation, occasional: Stir powder in 120 to 240 mL (4 to 8 ounces) of water, juice, soda, coffee, or tea until dissolved and administer immediately.
Bowel preparation for colonoscopy (off-label use): Administer bisacodyl delayed-release tablets or magnesium citrate prior to polyethylene glycol administration. After bowel movement (or up to 6 hours later if no bowel movement), stir powder in 240 mL (8 ounces) of clear liquid until dissolved and administer immediately. Dose is repeated every 10 minutes until 2,000 mL of volume is consumed.
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).
Digoxin: Polyethylene Glycol 3350 may decrease the serum concentration of Digoxin. Monitor therapy
Frequency not defined.
Gastrointestinal: Abdominal cramps, bloating of the stomach, diarrhea, flatulence, nausea
Concerns related to adverse effects:
• Electrolyte imbalance: Prolonged, frequent, or excessive use may lead to electrolyte imbalance.
• Hypersensitivity: Do not use if you are hypersensitive to polyethylene glycol. If an allergic reaction develops (eg, rash, swelling, difficulty breathing), discontinue use immediately and seek medical care.
• Bowel obstruction: Evaluate patients with symptoms of bowel obstruction, appendicitis, or inflamed bowel (nausea, vomiting, abdominal pain or distension) prior to use; use is contraindicated in patients with known or suspected bowel obstruction.
• Renal impairment: Use with caution in patients with renal impairment. Do not use in renal impairment unless under supervision of a health care professional.
• Administration: If severe diarrhea occurs, discontinue use. When used for bowel preparation for colonoscopy (off-label use), oral medications should not be administered within 1 hour of start of therapy.
• Duration of therapy: Do not use for longer than 1 to 2 weeks (product specific); 2 to 4 days may be required to produce bowel movement.
• OTC labeling: When used for self-medication, patients should consult health care provider prior to use if they have nausea, vomiting, or abdominal pain, irritable bowel syndrome, or a sudden change in bowel habits for >2 weeks. Patients should be instructed to discontinue use and consult health care provider if they have severe diarrhea, rectal bleeding, if abdominal pain, bloating, cramping, or nausea gets worse, or if need to use for >1 week.
Polyethylene glycol (PEG) has minimal systemic absorption and would be unlikely to cause fetal malformations. However, until additional information is available, use to treat constipation in pregnancy should be avoided unless other preferred methods are inadequate (Mahadevan 2006). Use as a bowel preparation prior to colonoscopy in pregnant women may be considered (Wexner 2006).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience flatulence. Have patient report immediately to prescriber severe dizziness, passing out, severe nausea, severe vomiting, severe abdominal pain, severe abdominal cramps, severe bloating, severe diarrhea, rectal bleeding, or rectal pain (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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- Drug class: laxatives