Note: 17 g=1 capful=1 heaping tablespoonful (Ref).
Bowel preparation: Limited data available: Children >2 years and Adolescents: Oral: 1.5 g/kg/day for 4 days; in the trial, daily dose was administered in 2 to 3 divided doses; maximum daily dose: 100 g/day (Ref).
Constipation: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 0.4 to 0.8 g/kg/day once daily or in divided doses; doses should be individualized to achieve desired effect; usual maintenance dose: 0.2 to 1.5 g/kg/day. Usual maximum daily dose: 17 g/day (Ref).
Fecal impaction: Limited data available: Children and Adolescents: Oral: 1 to 1.5 g/kg/day once daily for 3 to 6 consecutive days (Ref); maximum daily dose: 100 g/day (Ref); following disimpaction, maintenance dose of 0.4 to 1 g/kg/day should be continued for ≥2 months followed by gradual decrease of therapy (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Polyethylene glycol 3350: Drug information")
Bowel preparation before colonoscopy (off-label use):
MiraLAX: Oral: 238 g (8.3 oz bottle) or 255 g (8.9 oz bottle [generic]) mixed in ~1,900 mL (64 ounces) of Gatorade® until dissolved (lemon-lime is typically used; do not use red). Administered as either the split-dose regimen or the evening-only regimen; both regimens are given with bisacodyl delayed-release oral tablets prior to the MiraLAX solution (Ref). Note: Timing of doses depends on when the procedure is scheduled and varies by institution preference.
Split-dose ( 2-day regimen) (preferred method due to improvement in adenoma detection rates) (Ref):
Dose 1: Evening before colonoscopy: Oral: 240 mL (8 oz) every 10 minutes for 4 doses until 960 mL (32 oz) is consumed.
Dose 2: On the morning of the colonoscopy (typically given 5 hours prior to procedure): Oral: 240 mL (8 oz) every 10 minutes for 4 doses until 960 mL (32 ounces) is consumed.
Evening-only dose (1-day regimen) (alternate method):
Dose 1: Evening before colonoscopy: Oral: 240 mL (8 oz) every 10 minutes until ~1900 (64 oz) (entire contents of container) is consumed (Ref).
Chronic idiopathic constipation (off-label use): Oral: 17 g dissolved in 240 mL (8 oz) of liquid once daily (Ref).
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 (Ref).
Irritable bowel syndrome with constipation (adjunct) (alternative agent) (off-label use):
Note: Reserve for patients with persistent constipation despite soluble fiber or who are intolerant to other laxatives (Ref).
Oral: Initial: 17 g dissolved in 120 to 240 mL (4 to 8 ounces) of liquid, once daily as needed; may increase to a maximum dose of 34 g per day (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (systemic absorption limited) (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be dialyzed: No supplemental dose or dosage adjustment necessary (systemic absorption limited) (Ref).
Peritoneal dialysis: Unlikely to be dialyzed: No dosage adjustment necessary (systemic absorption limited) (Ref).
CRRT: No dosage adjustment necessary (systemic absorption limited) (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (systemic absorption limited) (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Postmarketing:
Gastrointestinal: Gastrointestinal signs and symptoms (including abdominal cramps, abdominal distention, abdominal pain, bloating, diarrhea, dyspepsia, eructation, flatulence, frequent bowel movements, loose stools, nausea, rectal hemorrhage, stomach discomfort) (DiPalma 2007a, DiPalma 2007b)
Hypersensitivity: Anaphylactic shock (Lee 2015), anaphylaxis (Lee 2016), hypersensitivity reaction (Sari Gökay 2018), type I hypersensitivity reaction (Stone 2019)
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
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.
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.
• Appropriate use: Do not combine with starch-based thickeners; choking and potential aspiration may occur.
• 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.
The effects of long-term use or large doses of polyethylene glycol in children are unknown. The FDA has received reports of metabolic acidosis (with and without anion gap) and neuropsychiatric events in children taking polyethylene glycol; however, direct causality with the drug has not been established. Neuropsychiatric adverse events reported may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors (including repetitive chewing and sucking), paranoia and mood swings. Studies are underway to define the metabolic processes and pathways polyethylene glycol (and any metabolites) in pediatric patients and to determine gastrointestinal absorption properties if any (FDA 2013). As of 2014, the FDA decided no action was necessary based upon available data (FDA 2014). Monitor pediatric patients closely for signs of metabolic acidosis or neuropsychiatric changes.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Kit, Oral:
Gialax: [contains aspartame, fd&c yellow #5 (tartrazine), polyethylene glycol (interact starch)]
Packet, Oral:
HealthyLax: 17 g/dose (14 ea, 30 ea, 100 ea) [contains polyethylene glycol (interact starch)]
MiraLax: 17 g/dose (1 ea [DSC], 10 ea [DSC], 12 ea [DSC], 24 ea [DSC]) [contains polyethylene glycol (interact starch)]
Generic: 17 g/dose (1 ea, 14 ea, 30 ea, 100 ea)
Powder, Oral:
FT ClearLax: 17 g/dose (119 g) [grit free, sugar free; contains polyethylene glycol (interact starch)]
FT ClearLax: 17 g/dose (238 g, 510 g) [sugar free; contains polyethylene glycol (interact starch)]
GaviLAX: 17 g/dose (238 g, 510 g) [contains polyethylene glycol (interact starch)]
GlycoLax: 17 g/dose (119 g [DSC], 255 g, 527 g) [contains polyethylene glycol (interact starch)]
MiraLax: 17 g/dose (1 ea, 119 g [DSC], 238 g, 510 g, 765 g [DSC]) [contains polyethylene glycol (interact starch)]
Generic: 17 g/dose (119 g, 238 g, 255 g [DSC], 510 g, 527 g [DSC], 850 g)
May be product dependent
Pack (HealthyLax Oral)
17 g (per each): $1.76
Pack (Polyethylene Glycol 3350 Oral)
17 g (per each): $0.80 - $2.75
Powder (GlycoLax Oral)
17GM/SCOOP (per gram): $0.03
Powder (MiraLax Oral)
17GM/SCOOP (per gram): $0.04
Powder (Polyethylene Glycol 3350 Oral)
17GM/SCOOP (per gram): $0.02 - $0.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Stir powder in 120 to 240 mL (4 to 8 ounces) of water, juice, soda, coffee, or tea until dissolved and administer.
Oral:
Constipation, occasional: Stir powder in 120 to 240 mL (4 to 8 ounces) of water, juice, soda, coffee, or tea (do not combine with starch-based thickeners) until dissolved and administer immediately.
Bowel preparation for colonoscopy (off-label use): After mixing MiraLAX powder in Gatorade® (do not combine with starch-based thickeners), may chill in the refrigerator to increase palatability. Administer bisacodyl delayed-release tablets prior to polyethylene glycol administration. Administer using the split-dose (2-day regimen) or the evening-only dose (1-day regimen) prior to colonoscopy (Ref).
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).
Treatment of occasional constipation (OTC product: FDA approved in ages ≥17 years and adults).
MiraLax may be confused with Mirapex
Polyethylene glycol 3350 may be confused with polyethylene glycol electrolyte solution, propylene glycol
MiraLax may be confused with Murelax brand name for oxazepam [Australia]
Polyethylene glycol 3350 may be confused with polyethylene glycol 4000 [international markets]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Dichlorphenamide: Laxatives may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy
Digoxin: Polyethylene Glycol 3350 may decrease the serum concentration of Digoxin. Risk C: Monitor therapy
Polyethylene glycol (PEG) has minimal systemic absorption and would be unlikely to cause fetal malformations. Treatment of constipation in pregnant women is similar to that of nonpregnant patients and medications may be used when diet and lifestyle modifications are not effective. Polyethylene glycol may be used when an osmotic laxative is needed (Gomes 2018; Shin 2015).
Stool frequency and consistency, fluid status; serum electrolytes (as clinically appropriate or with prolonged use).
An osmotic agent, polyethylene glycol 3350 causes water retention in the stool; increases stool frequency.
Onset of action: Oral: 24 to 96 hours
Absorption: Minimal (<0.28%; Pelham, 2008)
Excretion: Feces (93%); urine (0.2%) (Pelham, 2008)
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