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Polyethylene Glycol-Electrolyte Solution

Pronunciation

(pol i ETH i leen GLY kol ee LEK troe lite soe LOO shun)

Index Terms

  • Electrolyte Lavage Solution
  • Peg/Electrolytes

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Powder, for solution, oral: PEG 3350 240 g, sodium sulfate 22.72 g, sodium bicarbonate 6.72 g, sodium chloride 5.84 g, and potassium chloride 2.98 g (4000 mL); PEG 3350 236 g, sodium sulfate 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, and potassium chloride 2.97 g (4000 mL); PEG 3350 240 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, and potassium chloride 1.48 g (4000 mL); PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, and potassium chloride 1.48 g (4000 mL)

Colyte: PEG 3350 227.1 g, sodium sulfate 21.5 g, sodium bicarbonate 6.36 g, sodium chloride 5.53 g, and potassium chloride 2.82 g (3785 mL) [supplied with cherry, lemon lime, and orange flavor packs]

Colyte: PEG 3350 240 g, sodium sulfate 22.72 g, sodium bicarbonate 6.72 g, sodium chloride 5.84 g, and potassium chloride 2.98 g (4000 mL) [supplied with cherry, citrus berry, lemon lime, orange, and pineapple flavor packs]

GaviLyte-C: PEG 3350 240 g, sodium sulfate 22.72 g, sodium bicarbonate 6.72 g, sodium chloride 5.84 g, and potassium chloride 2.98 g (4000 mL) [supplied with lemon flavor packet]

GaviLyte-G: PEG 3350 236 g, sodium sulfate 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, and potassium chloride 2.97 g (4000 mL) [supplied with lemon flavor packet]

GaviLyte-N: PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, and potassium chloride 1.48 g (4000 mL) [supplied with lemon flavor packet]

GoLYTELY: PEG 3350 227.1 g, sodium sulfate 21.5 g, sodium bicarbonate 6.36 g, sodium chloride 5.53 g, and potassium chloride 2.82 g per packet (1s) [regular flavor; makes 1 gallon of solution after mixing]

GoLYTELY: PEG 3350 236 g, sodium sulfate 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, and potassium chloride 2.97 g (4000 mL) [regular and pineapple flavor]

MoviPrep: Pouch A: PEG 3350 100g, sodium sulfate 7.5 g, sodium chloride 2.69 g, potassium chloride 1.02 g; Pouch B: Ascorbic acid 4.7 g, sodium ascorbate 5.9 g (1000 mL) [contains phenylalanine 131 mg/treatment; lemon flavor; packaged with 2 of Pouch A and 2 of Pouch B in carton and a disposable reconstitution container]

NuLYTELY: PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, and potassium chloride 1.48 g (4000 mL) [supplied with cherry, lemon-lime, orange, and pineapple flavor packs]

TriLyte: PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, and potassium chloride 1.48 g (4000 mL) [supplied with cherry, citrus berry, lemon lime, orange, and pineapple flavor packs]

Brand Names: U.S.

  • Colyte
  • GaviLyte - C
  • GaviLyte - G
  • GaviLyte - N
  • GoLYTELY
  • MoviPrep
  • NuLYTELY
  • TriLyte

Pharmacologic Category

  • Laxative, Osmotic

Pharmacology

Induces catharsis by strong electrolyte and osmotic effects

Onset of Action

Oral: ~1 hour

Use: Labeled Indications

Bowel cleansing prior to colonoscopy or barium enema X-ray examination

Use: Unlabeled

Whole bowel irrigation (WBI) in the following toxic ingestions: Packets of illicit drugs (body packers, body stuffers), potentially toxic sustained-release or enteric-coated agents, substantial amounts of iron (AACT, 2004)

Contraindications

Hypersensitivity to polyethylene glycol or any component of the formulation; ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon

Dosing: Adult

Bowel cleansing:

CoLyte, GaviLyte-C, GaviLyte-G, GaviLyte-N, GoLYTELY, NuLYTELY, TriLyte:

Oral: 240 mL (8 oz) every 10 minutes until 4 L are consumed or the rectal effluent is clear; rapid drinking of each portion is preferred to drinking small amounts continuously

Nasogastric: 20-30 mL/minute until 4 L are administered or the rectal effluent is clear

MoviPrep: Oral: Administer 2 L total with an additional 1 L of clear fluid prior to colonoscopy as follows:

Split dose (2 day regimen) (preferred method):

Dose 1: Evening before colonoscopy (10-12 hours before dose 2): 240 mL (8 oz) every 15 minutes until 1 L (entire contents of container) is consumed. Then fill container with 480 mL (16 oz) of clear liquid and consume prior to going to bed.

Dose 2: On the morning of the colonoscopy (beginning at least 3.5 hours prior to procedure): 240 mL (8 oz) every 15 minutes until 1 L (entire contents of container) is consumed. Then fill container with 480 mL (16 oz) of clear liquid and consume at least 2 hours before the procedure.

Evening only dose (1 day regimen) (alternate method):

Dose 1: Evening before colonoscopy (at least 3.5 hours before bedtime): 240 mL (8 oz) every 15 minutes until 1 L (entire contents of container) is consumed

Dose 2: ~90 minutes after starting dose 1: 240 mL (8 oz) every 15 minutes until 1 L (entire contents of container) is consumed. Then fill container with 1 L (32 oz) of clear liquid and consume all of the liquid prior to going to bed.

Whole bowel irrigation (off-label use; AACT, 2004): Nasogastric: 1500-2000 mL/hour until the rectal effluent is clear. Note: Continue treatment at least until the rectal effluent is clear; treatment duration may be extended based on corroborative evidence of continued presence of poisons in the GI tract as determined by radiographic means or the presence of the poison in the effluent.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Bowel cleansing: Infants ≥6 months, Children, and Adolescents: GaviLyte-N, NuLYTELY, TriLyte: Oral, Nasogastric: 25 mL/kg/hour until the rectal effluent is clear (maximum total dose: 4 L)

Whole bowel irrigation (off-label use; AACT, 2004): Nasogastric:

Infants ≥9 months and Children <6 years: 500 mL/hour until the rectal effluent is clear

Children ≥6 years: 1000 mL/hour until the rectal effluent is clear

Adolescents: 1500-2000 mL/hour until the rectal effluent is clear

Note: Continue treatment at least until the rectal effluent is clear; treatment duration may be extended based on corroborative evidence of continued presence of poisons in the GI tract as determined by radiographic means or the presence of the poison in the effluent.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling. Use with caution due to risks of fluid and electrolyte abnormalities.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Reconstitution

CoLyte, GaviLyte-C, GaviLyte-G, GaviLyte-N, GoLYTELY, NuLYTELY, TriLyte: Using the container provided, add lukewarm water (may use tap water) up to the 4 L water mark; shake vigorously several times to ensure dissolution of the powder. No additional ingredients or flavors should be added to the solution (other than the flavor packets provided).

MoviPrep: Mix the contents of pouch A and pouch B (one each) in container provided. Add lukewarm water to fill line (~1 L); mix the solution until dissolved. No additional ingredients or flavors should be added to the solution.

Concentrations for reconstituted solutions:

CoLyte, GaviLyte-C: When dissolved in sufficient water to make 4 L, the final solution contains PEG-3350 18 mmol/L, sodium 125 mmol/L, sulfate 80 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L, and potassium 10 mmol/L

GaviLyte-G, GoLYTELY: When dissolved in sufficient water to make 4 L, the final solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L, and potassium 10 mmol/L

GaviLyte-N, NuLYTELY, TriLyte: When dissolved in sufficient water to make 4 L, the final solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L, and potassium 5 mmol/L.

Administration

Oral: Rapid drinking of each portion is preferred to drinking small amounts continuously. No additional ingredients or flavors (other than the flavor packets provided) should be added to the polyethylene glycol-electrolyte solution. Chilling the solution may improve palatability; administration of a chilled solution is not recommended in infants. Oral medications should not be administered within 1 hour of start of therapy.

Nasogastric administration: CoLyte, GaviLyte-C, GaviLyte-G, GaviLyte-N, GoLYTELY, NuLYTELY, TriLyte: The solution may be administered via nasogastric tube for bowel cleansing and whole bowel irrigation (preferred route; off-label use) in patients who are unwilling or unable to drink the solution.

Dietary Considerations

CoLyte, GaviLyte-C, GaviLyte-G, GaviLyte-N, GoLYTELY, NuLYTELY, TriLyte: Ideally, the patient should fast for ~3-4 hours prior to administration, but in no case should solid food be given for at least 2 hours before the solution is given. Some products contain aspartame which is metabolized to phenylalanine.

MoviPrep: Patient should not eat solid food from start of solution administration until after colonoscopy. Patient may have clear liquid soup/plain yogurt for dinner; finish at least 1 hour before start of colon prep. MoviPrep contains phenylalanine.

Storage

CoLyte, GaviLyte-C, GaviLyte-G, GaviLyte-N, GoLYTELY, NuLYTELY, TriLyte: Prior to reconstitution, store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Refrigerate reconstituted solution. Use within 48 hours of preparation; discard any unused portion.

MoviPrep: Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Refrigerate reconstituted solution in an upright position. Use within 24 hours of preparation; discard any unused portion.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Central nervous system: Sleep disorder (35%; evening prep vs oral sodium phosphate solution [90 mL]), rigors (34%; evening prep vs oral sodium phosphate solution [90 mL]), malaise (18% to 27%; MoviPrep split dose vs 4 L PEG with electrolytes [18%]; evening dose vs oral sodium phosphate solution [90 mL] [53%])

Endocrine & metabolic: Increased thirst (<47%)

Gastrointestinal: Abdominal distention (<60%; evening prep vs oral sodium phosphate solution [90 mL]), anorectal pain (<52%; evening prep vs oral sodium phosphate solution [90 mL]), bloating (≤50%), nausea (14% to ≤50%; split dose vs 4 L PEG with electrolytes [20%]; evening prep vs oral sodium phosphate solution [90 mL] [47%]), abdominal pain (6% to 39%; evening prep vs oral sodium phosphate solution [90 mL] [32%]; split dose vs PEG with electrolytes [6%]), hunger (30%; evening prep vs oral sodium phosphate solution [90 mL]), vomiting (7% to 12%; evening MoviPrep vs oral sodium phosphate solution (90 mL) [8%]; split dose vs PEG with electrolytes [13%])

1% to 10%:

Central nervous system: Dizziness (3% to 7%; evening prep vs oral sodium phosphate solution [90 mL]), headache (2%; evening prep vs oral sodium phosphate solution [90 mL])

Endocrine & metabolic: Hypokalemia (children 0%; evening prep vs oral sodium phosphate solution [90 mL] [6%])

Gastrointestinal: Dyspepsia (1% to 3%)

Frequency not defined, postmarketing, and/or case reports: Anaphylaxis, angioedema, aspiration, asystole (older adults >60 years), chest tightness, esophageal perforation (older adults >60 years), hypersensitivity reaction, ischemic colitis, Mallory-Weiss syndrome (older adults >60 years), pulmonary edema (older adults >60 years), rhinorrhea, seizure, shock, tightness in chest and throat, upper gastrointestinal hemorrhage (older adults >60 years), urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmias: Serious arrhythmias have been reported (rarely) with the use of ionic osmotic laxative products. Use with caution in patients who may be at risk of cardiac arrhythmias (eg, patients with a history of prolonged QT, uncontrolled arrhythmias, recent MI, unstable angina, CHF, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in these patients.

• Fluid and electrolyte abnormalities: Fluid and electrolyte disturbances can lead to arrhythmias, seizures, and renal impairment. Advise patients to maintain adequate hydration before, during, and after treatment. If patient becomes dehydrated or experiences significant vomiting after treatment, consider post-colonoscopy lab tests (electrolytes, creatinine, and BUN).

• Ischemic colitis: Cases of ischemic colitis have been reported; concomitant use of stimulant laxatives may increase the risk and is not recommended. The potential for mucosal aphthous ulcerations as a result of the bowel preparation should be considered, especially when evaluating colonoscopy results in patients with known or suspected inflammatory bowel disease.

• Seizures: Generalized tonic-clonic seizures and/or loss of consciousness have occurred rarely in patients with no prior history of seizures. Seizures resolved with the correction of fluid and electrolyte abnormalities. Use with caution in patients with a history of seizures or who are at an increased risk of seizures (eg, concomitant administration of medications that lower the seizures threshold, patients withdrawing from alcohol or benzodiazepines) and in patients with known or suspected hyponatremia or low serum osmolality.

Disease-related concerns:

• Impaired gag reflex: Observe unconscious or semiconscious patients with impaired gag reflex or those who are otherwise prone to regurgitation or aspiration during administration. Use with caution.

• Renal impairment: Use with caution in patients with renal impairment and/or in patients taking medications that may adversely affect renal function (eg, diuretics, NSAIDs, ACE inhibitors, ARBs). Patients with impaired renal function should be instructed to remain adequately hydrated; consider pre-dose and post-colonoscopy lab tests (electrolytes, creatinine, BUN) in these patients.

• Ulcerative colitis: Use with caution in patients with severe ulcerative colitis.

Special populations:

• Elderly: Use with caution in patients >60 years of age; serious adverse events have been reported (eg, asystole, esophageal perforation, chest infiltration following vomiting and aspiration, Mallory-Weiss tear with GI bleeding, pulmonary edema with sudden dyspnea).

• Pediatric: Use in patients <2 years of age may result in hypoglycemia, dehydration, and hypokalemia; use with caution and monitor closely.

Dosage form specific issues:

• MoviPrep: Use with caution in patients with G6PD deficiency (especially patients with an active infection, history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions) due to the presence of sodium ascorbate and ascorbic acid in the formulation. Contains phenylalanine.

Other warnings/precautions:

• Appropriate use: Evaluate patients with symptoms of bowel obstruction or perforation (nausea, vomiting, abdominal pain or distension) prior to use; if a patient develops severe bloating, distention or abdominal pain during administration, slow the rate of administration or temporarily discontinue use until the symptoms subside. Correct electrolyte abnormalities in patients prior to use. No additional ingredients or flavors (other than the flavor packets provided) should be added to the polyethylene glycol-electrolyte solution.

Monitoring Parameters

Electrolytes, serum glucose, BUN, urine osmolality; children <2 years of age should be monitored for hypoglycemia, dehydration, hypokalemia

Whole bowel irrigation (off-label use; AACT, 2004): Rectal effluent (continue until clear or the poison is completely removed)

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Information related to the use of polyethylene glycol-electrolyte solution in pregnancy is limited (Neri, 2004). Colonoscopy in pregnant women is generally reserved for strong indications or life-threatening emergencies; until additional safety data for polyethylene glycol-electrolyte solution is available, other agents may be preferred for this purpose (Siddiqui, 2006; Wexner, 2006).

Patient Education

• 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 anal irritation, bloating, feeling full, abdominal cramps, vomiting, or nausea. Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or nausea or vomiting), abdominal pain, abdominal edema, severe headache, vomiting blood, or bloody diarrhea (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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