(pol i ETH i leen GLY kol 3350)
Occasional constipation: Treatment of occasional constipation
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: Relaxa: Additional contraindications (not in US labeling): Use in children <18 years of age unless advised by a physician
Occasional constipation: 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
Canadian labeling (not in US labeling): Oral: 17 g (~1 heaping tablespoon) dissolved in 240 mL (8 ounces) of beverage once daily; do not use for >1 week unless directed by health care provider
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])
Refer to adult dosing.
Occasional constipation (off-label use):
Infants, Children, and Adolescents <17 years: 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: Refer to adult dosing.
Bowel preparation before colonoscopy (off-label use): Adolescents ≥17 years: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Dissolve powder completely in 120 to 240 mL (4 to 8 ounces) of water, juice, soda, coffee, or tea. Canadian labeling states to dissolve powder completely in 250 mL of a non-alcoholic beverage.
Oral:
Occasional constipation: 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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Packet, Oral:
HealthyLax: (1 ea, 14 ea)
MiraLax: (1 ea, 10 ea, 12 ea, 24 ea)
Generic: (1 ea, 14 ea, 30 ea, 100 ea)
Powder, Oral:
GaviLAX: (238 g, 510 g)
GlycoLax: (119 g, 255 g, 527 g)
MiraLax: (1 ea, 119 g, 238 g, 510 g, 765 g)
PEGyLAX: (527 g)
Generic: 17 g/dose (119 g, 238 g, 510 g); (119 g, 238 g, 250 g [DSC], 255 g, 500 g [DSC], 510 g, 527 g, 850 g)
Digoxin: Polyethylene Glycol 3350 may decrease the serum concentration of Digoxin. Monitor therapy
Frequency not defined:
Dermatologic: Urticaria
Gastrointestinal: Abdominal bloating, cramping, diarrhea, flatulence, nausea
Postmarketing and/or case report: Anaphylactic shock (observed with PEG 6000)
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.
Disease-related concern:
- 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.
Other warnings/precautions:
- 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. Canadian labeling states to discontinue use in elderly patients experiencing diarrhea and do not administer with other medications within 2 hours of a polyethylene glycol dose.
- 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).
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)
Oral: 24 to 96 hours
- 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.