Polyethylene Glycol-Electrolyte Solution

Dosage Forms

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

Powder, for solution, oral:

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 [DSC]) [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]

Plenvu: Dose 1: PEG 3350 100 g, sodium sulfate 9 g, sodium chloride 2 g, potassium chloride 1 g [mango flavor; makes 473 mL of solution after mixing]; Dose 2, Pouch A: PEG 3350 40 g, sodium chloride 3.2 g, potassium chloride 1.2 g; Dose 2, Pouch B: sodium ascorbate 48.11 g, ascorbic acid 7.54 g [contains phenylalanine 491 mg/treatment; fruit punch flavor; makes 473 mL of solution after mixing]

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]

Generic: 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 [DSC]); 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)

Pharmacology

Mechanism of Action

Induces catharsis by strong electrolyte and osmotic effects

Pharmacokinetics/Pharmacodynamics

Onset of Action

Oral: ~1 to 2 hours

Use: Labeled Indications

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

Use: Off Label

Whole bowel irrigation for toxic ingestionsyes

Based on the American Academy of Clinical Toxicology (AACT) and European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) Position Paper on Whole Bowel Irrigation, polyethylene glycol-electrolyte solution given for whole bowel irrigation (WBI) for toxic ingestions (ie, Packets of illicit drugs [body packers, body stuffers], potentially toxic sustained-release or enteric-coated agents, substantial amounts of iron) should be considered to prevent absorption of the toxic substances and expel gastrointestinal contents. According to the position paper, WBI should not be used routinely in these settings. The use of polyethylene glycol-electrolyte solution for these toxic ingestions is based on volunteer studies and anecdotal reports.

Contraindications

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

Canadian labeling: Additional contraindications (not in US labeling): Acute surgical abdominal conditions (eg, acute appendicitis, diverticulitis); unconscious patients

Dosage and Administration

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 to 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.

Plenvu: Oral: Note: Two doses are required; may use either a “Two-Day” or “One-Day” dosing regimen:

Split dose (2 day regimen):

Dose 1: Evening before colonoscopy (~4 pm to 8 pm): 480 mL (16 oz) consumed over 30 minutes (entire contents of container). Then fill container with 480 mL (16 oz) of clear liquid and consume all of the liquid over next 30 minutes; consume additional clear liquids during the evening.

Dose 2: On the morning of the colonoscopy (~4 am and 8 am [~12 hours after the start of Dose 1]): 480 mL (16 oz) consumed over 30 minutes (entire contents of container). Then fill container with 480 mL (16 oz) of clear liquid and consume all of the liquid over next 30 minutes; consume additional water or clear liquids up to 2 hours before procedure.

One-day only morning dose (1 day regimen):

Dose 1: Morning of colonoscopy (~3 am and 7 am): 480 mL (16 oz) consumed over 30 minutes (entire contents of container). Then fill container with 480 mL (16 oz) of clear liquid and consume all of the liquid over next 30 minutes.

Dose 2: Morning of colonoscopy (minimum of 2 hours after start of dose 1): 480 mL (16 oz) consumed over 30 minutes (entire contents of container). Then fill container with 480 mL (16 oz) of clear liquid and consume all of liquid over next 30 minutes; consume additional water or clear liquids up to 2 hours before procedure.

Whole bowel irrigation (off-label use) (AACT 2004): Nasogastric: 1,500 to 2,000 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 (to prevent excessive fluid and electrolyte changes, use only products containing supplemental electrolytes for bowel cleansing): Patient should fast at least 2 hours (preferably 3 to 4 hours) prior to ingestion:

Infants ≥6 months, Children, and Adolescents: Oral, nasogastric: GaviLyte-N, NuLYTELY, and TriLyte: 25 mL/kg/hour until rectal effluent is clear (usually in ~4 hours). One study used 40 mL/kg/hour intermittently by mouth or continuously by nasogastric drip in patients ≥18 months (Sondheimer 1991). Although not FDA approved for pediatric patients, other preparations have been used in pediatric studies: Colyte, GoLYTELY (Sondheimer 1991; Tuggle 1987).

Fecal impaction; slow disimpaction: Limited data available: Children> 2 years and Adolescents: Oral, Nasogastric: 20 mL/kg/hour up to a maximum dose of 1 L/hour for 4 hours per day for 2 days was evaluated in a study comparing polyethylene glycol with electrolytes lavage (n=19, mean age: 6.44 ± 2.36 years) to mineral oil (n=17, mean age: 6.88 ± 3.26 years) (Tolia 1993)

Toxic ingestion (AACT 2004): Nasogastric:

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

Children ≥6 years: 1,000 mL/hour until rectal effluent is clear

Adolescents: 1,500 to 2,000 mL/hour until 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.

Reconstitution

Refer to manufacturer’s labeling for additional information.

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.

Plenvu: Must prepare 2 doses for complete preparation. For each dose (one pouch labeled Dose 1 and two pouches labeled Dose 2 pouch A and Dose 2 pouch B), empty contents into mixing container and add water to fill line (at least 480 mL); mix solution until completely dissolved (may take 2 to 3 minutes). No additional ingredients 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; do not take other laxatives, eat (including foods with pulp) or drink alcohol, milk, or anything colored red or purple. Chilling the solution may improve palatability; administration of a chilled solution is not recommended in infants. Other additional measures that may improve tolerability include drinking the solution through a straw or sucking on lemon slices or sugar-free menthol candy drops (A-Rahim 2018; Sharara 2013). If severe abdominal discomfort or distention occurs, stop drinking solution temporarily or drink each portion at longer intervals until symptoms diminish. Oral medications should not be administered within 1 hour of start of therapy. Refer to manufacturer’s labeling for additional information.

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. Contains phenylalanine.

Plenvu: Patient should not eat solid food from start of solution administration until after colonoscopy. For the 2 day split-dosing regimen, the day before the procedure the patient may have a light breakfast followed by a light lunch which must be completed 3 hours before start of colon prep. For the 1 day morning dosing regimen, the day before the procedure the patient may have a light breakfast, followed by a light lunch, and clear broth soup and/or plain yogurt for dinner all completed by ~8 pm. Patient may have clear liquids up to 2 hours before procedure. 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.

Plenvu: Prior to reconstitution, refrigerate or 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). After reconstitution, store solution in a refrigerator or at 20°C to 25°C (68°F to 77°F); use within 6 hours of preparation.

Drug Interactions

Bisacodyl: May enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Monitor therapy

Dichlorphenamide: Laxatives may enhance the hypokalemic effect of Dichlorphenamide. Monitor therapy

Senna: May enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Monitor therapy

Sodium Picosulfate: May enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Sleep disorder (evening only full dose: 35%), rigors (evening only full dose: 34%), malaise (18% to 27%)

Endocrine & metabolic: Increased thirst (evening only full dose: 47%)

Gastrointestinal: Abdominal distention (full dose: 60%; split dose: 1%), anorectal pain (≤52%), bloating (≤50%), epigastric fullness (≤50%), nausea (≤50%; split dose: 3% to 14%), abdominal pain (≤39%; split dose: ≤13%), hunger (evening only full dose: 30%)

1% to 10%:

Cardiovascular: Hypertension (1% to 2%)

Central nervous system: Dizziness (evening only full dose: 7%), fatigue (split dose: 2%), headache (1% to 2%)

Endocrine & metabolic: Dehydration (4%), electrolyte disorder (1% to 2%)

Gastrointestinal: Vomiting (4% to 8%), upper abdominal pain (6%), abdominal distress (≤3%), dyspepsia (split dose: 3%), gastritis (split dose: 1%), hiatal hernia (split dose: 1%)

Genitourinary: Decreased estimated GFR (eGFR; split dose: 2%)

Respiratory: Nasopharyngitis (split dose: 1%)

Frequency not defined:

Endocrine & metabolic: Decreased serum bicarbonate, hyperchloremia, hypermagnesemia, increased serum calcium, increased serum phosphate, increased serum sodium, increased uric acid (serum), serum hyperosmolarity

Gastrointestinal: Abdominal cramps

Renal: Decreased creatinine clearance, increased blood urea nitrogen

<1%, postmarketing, and/or case reports: Acute pulmonary edema, anaphylactic shock, anaphylaxis, angioedema, asthenia, asystole (>60 years old), atrial fibrillation, cardiac arrhythmia, chest tightness, chills, dermatitis, drowsiness, dyspnea, esophageal perforation (>60 years old), facial edema, fever, gastroesophageal reflux disease, generalized ache, hot flash, hypersensitivity reaction, hypokalemia (children), increased liver enzymes, lip edema, Mallory-Weiss syndrome (>60 years old), migraine, pain, palpitations, peripheral edema, pharyngeal edema, pruritus, pulmonary aspiration (>60 years), pulmonary edema (>60 years old), renal failure syndrome, renal insufficiency, rhinorrhea, seizure, sinus tachycardia, skin rash, syncope, tachycardia, tongue edema, tremor, upper gastrointestinal hemorrhage (>60 years old), urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmias: Serious arrhythmias have been reported (rarely) with the use of ionic osmotic laxative products (predominantly in patients with underlying cardiac risk factors and electrolyte disturbances). 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, HF, cardiomyopathy, or electrolyte imbalance); consider pre-dose and post-colonoscopy ECGs in patients at risk of serious cardiac arrhythmias.
• Fluid and electrolyte abnormalities: May cause fluid and electrolyte disturbances, which can lead to arrhythmias, seizures, and renal impairment. Correct fluid and electrolyte abnormalities before treatment. Advise patients to maintain adequate hydration before, during, and after treatment. Use with caution in patients taking concomitant medications that may increase the risk of electrolyte abnormalities (eg, diuretics, ACE inhibitors, ARBs). If patient becomes dehydrated or experiences significant vomiting after treatment, consider post-colonoscopy lab tests (electrolytes, creatinine, and BUN).
• Hypersensitivity: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus may occur; discontinue use and seek medical care if hypersensitivity reaction occurs.
• Ischemic colitis/mucosal aphthous ulcerations: 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 were associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality and 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:

• GI obstruction/perforation: If GI obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administration.
• Impaired gag reflex: Observe unconscious or semiconscious patients with impaired gag reflex, other swallowing abnormalities, 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); these patients should remain adequately hydrated before, during, and after use; consider pre-dose and post-colonoscopy lab tests (electrolytes, creatinine, BUN).
• 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, Plenvu: 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.
• Phenylalanine: MoviPrep, Plenvu: Contains phenylalanine; use with caution in patients with phenylketonuria (PKU).

Other warnings/precautions:

• Appropriate 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

BUN, creatinine, electrolytes (at baseline and postcolonoscopy in patients with renal impairment or as clinically indicated); serum glucose, urine osmolality; ECG (at baseline and postcolonoscopy in patients at risk for serious cardiovascular arrhythmias); 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

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

What is this drug used for?

• It is used to clean out the GI (gastrointestinal) tract

Frequently reported side effects of this drug

• Anal irritation
• Abdominal pain
• Bloating
• Feeling full
• Nausea
• Vomiting
• Trouble sleeping
• Increased appetite
• Abdominal cramps

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting
• Abdominal edema
• Vomiting blood
• Severe headache
• Black, red, or tarry stools
• Rectal bleeding
• Rectal pain
• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.