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POLYETHYLENE GLYCOL

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Polyethylene glycol is an osmotic agent which causes water to be retained with the stool.

Specific Substances

    1) Carbowax
    2) Jeffox
    3) Macrogol
    4) Nycoline
    5) PEG
    6) PEG-ELS
    7) PEG 3350
    8) Pluracol E
    9) Poly-G
    10) Polyglycol E
    11) Solbase
    12) Molecular Formula: HO(C2-H4-O)nH
    13) POLYAETHYLENGLYKOLE (GERMAN)
    14) POLYAETHYLENGLYKOLE 200(GERMAN)
    1.2.1) MOLECULAR FORMULA
    1) (C2-H4-O)n-H2-O

Available Forms Sources

    A) FORMS
    1) The commercial preparation of polyethylene glycol involves the addition of ethylene oxide to ethylene glycol, diethylene glycol, or water in the presence of a catalyst. The molecular weight of the resulting compound is dependent upon the proportions of the reactants used (HSDB , 2002; Bingham et al, 2001; Lewis, 1997).
    2) Polyethylene glycol electrolyte solutions (GoLytely(R), CoLyte(R) and NuLytely(R)) are used as bowel evacuants. These solutions contain PEG 3350 in reconstituted amounts of 6 grams per 100 mL in combination with electrolytes.
    3) Polyethylene glycol (PEG) refers to a mixture of glycols and is labeled according to average molecular weight.
    PEG TYPEMOLECULAR WEIGHT
    PEG 400380 to 420
    PEG 600570 to 630
    PEG 14501300 to 1600
    PEG 33503000 to 3700

    4) Lower molecular weight compounds (200 to 700) are liquids while higher molecular weight compounds are solids (PEG 1000 to 10,000).
    B) USES
    1) PEG electrolyte lavage solution is effective in cleansing the colon prior to gastrointestinal examination (eg; colonoscopy, barium enema examination, intravenous pyelography) and colon surgery (USPDI , 2002). PEG is also indicated for occasional constipation (Prod Info MiraLax(R), 2000).
    a) Whole bowel irrigation using PEG electrolyte solutions are also used for gut decontamination following poisonings, such as iron and sustained-release products (Goldfrank, 2002).
    b) Wound decontamination using PEG 300 or 400 solution is used for dermal phenol exposures (Harbison, 1998).
    2) Polyethylene glycols are used as water-soluble lubricants for textile fibers, rubber molds, and metal-forming operations, as well as in water paints, paper coatings, and polishes, and in the ceramics industry (S Budavari , 2001).
    3) Polyethylene glycols with low molecular weights (600 or less) are used primarily as reactive intermediates in the manufacture of fatty acid surfactants and as solvents in gas processing (Bingham et al, 2001).
    4) The applications of polyethylene glycols with average molecular weights of 1000 to 2000 are used in pharmaceutical ointments and toothpaste formulations and as bases for cosmetic creams and lotions (Bingham et al, 2001).
    5) Higher-molecular weight polyethylene glycols (3500 to 20,000) find use as binders, plasticizers, stiffening agents, molding compounds, and paper adhesives (Bingham et al, 2001).
    6) Carbowax 1500 is a solid consisting of equal portions of PEG 1540 and PEG 300. PEGs are extensively used as vehicles in topical medicaments, cosmetics, and hair products. PEG ointment USP is a mixture of PEG 4000 and 300. In industry, PEGs are used as solvents for plasticizers and lubricants.

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Polyethylene glycol (PEG) has pharmaceutical and industrial uses. Pharmaceutical uses include cleansing the colon prior to gastrointestinal examination or surgery and for the treatment of constipation. Industrial uses include lubrication for textile fibers, rubber molds, and metal-forming operations, as well as in water paints, paper coatings, and polishes, and in the ceramics industry. Low molecular weights (600 dalton or less) are used as reactive intermediates in the manufacture of fatty acid surfactants as solvents in gas processing and as diluents in pharmaceuticals (lorazepam contains 18% PEG 400). Intermediate weight (1000 to 2000 dalton) are used in pharmaceutical ointments and toothpaste formulations and as bases for cosmetic creams and lotions. Higher-molecular weight polyethylene glycols (3500 to 20,000) find use as binders, plasticizers, stiffening agents, molding compounds, and paper adhesives. Carbowax 1500 is a solid consisting of equal portions of PEG 1540 and PEG 300.
    B) PHARMACOLOGY: PEG 3500 is an osmotic agent, which causes water to be retained in the stool, enhancing bowel movement through the colon.
    C) EPIDEMIOLOGY: Exposure is uncommon and toxicity is extremely rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: COMMON: Nausea, vomiting, abdominal fullness, delayed gastric emptying, diarrhea, and taste disorders may develop after ingestion. Contact dermatitis and immediate urticarial reactions may develop after dermal exposures.
    2) SEVERE: Metabolic acidosis, increased serum osmolality, acute renal failure, increased total serum calcium with normal or decreased ionized calcium, and ventricular dysrhythmias (PVCs, ventricular tachycardia) may develop. Aspiration causes severe pulmonary edema that is usually reversible. Acute pancreatitis and angioedema have been reported rarely.
    E) WITH POISONING/EXPOSURE
    1) TOXICOLOGY: High and intermediate molecular weight PEG is generally considered nontoxic, as it is not absorbed following ingestion. Acute toxicity decreases with increasing molecular weight. Massive ingestion, prolonged IV infusion, and prolonged application of low weight PEG products have been associated with metabolic acidosis and renal injury. Hypercalcemia occurs and might be related to specific PEG diacid metabolites (3-oxapentane-1,5-dicarboxylic acid and 3,6-dioxaoctane-1,8-dicarboxylic acid), which are avid calcium binders. With binding of ionized calcium, parathyroid hormone is stimulated and total serum calcium increases. Toxicity is unlikely following ingestion of small amounts or from contact with intact skin. Immediate and delayed allergic contact dermatitis has been observed.
    0.2.20) REPRODUCTIVE
    A) At the time of this review, no human reproductive studies regarding teratogenicity or effects on pregnancy or breastfeeding were found for PEG, although some animal studies have shown teratogenicity. The polyethylene glycol 3350 and electrolytes oral solution and polyethylene glycol 3350/electrolytes/sodium ascorbate/ascorbic acid oral solution are classified as FDA pregnancy category C.
    0.2.21) CARCINOGENICITY
    A) No human studies regarding the carcinogenic effects of PEG were found at the time of this review.

Laboratory Monitoring

    A) Monitor acid-base balance, osmolal gap, serum electrolytes, renal function and pulmonary function in symptomatic patients.
    B) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites.
    C) Monitor pulmonary function and chest x-ray in cases of suspected PEG aspiration or systemic fluid overload. Assess adequacy of oxygenation with pulse oximetry or arterial blood gases.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Patients will generally recover with supportive care. Administer IV fluids to maintain adequate urine output. Acute anaphylactic reactions associated with PEG administration are managed as anaphylaxis from other causes. Aspiration may require supplemental oxygen and mechanical ventilation with PEEP, bronchoalveolar lavage may be used for treatment. For patients with dermal exposure, irrigate the site of exposure and provide supportive care.
    C) DECONTAMINATION
    1) PREHOSPITAL: Not routinely recommended.
    2) HOSPITAL: Gastrointestinal decontamination and activated charcoal is not required. Gastric aspiration soon after an acute ingestion of a large amount of low molecular weight PEG solution may be beneficial.
    D) AIRWAY MANAGEMENT
    1) Endotracheal intubation may be necessary in patients who have aspirated PEG solutions.
    E) ANTIDOTE
    1) There is no specific antidote. Competitive antidiuretic hormone inhibitor therapy (eg, fomepizole, ethanol) may inhibit PEG metabolism. However, efficacy on clinical outcomes after PEG intoxication is unknown and they are not generally recommended.
    F) ACIDOSIS
    1) Acidosis is usually self-limited but severe acidosis may require sodium bicarbonate therapy. Initiate 1-2 mEq/kg over 5 minutes for adults, and 1 mEq/kg for children. Repeat every 1 to 2 hours as required. Dosage adjustment should be based on arterial blood gases. Titrate to serum pH greater than 7.25.
    G) ENHANCED ELIMINATION
    1) Extracorporeal techniques may be helpful in managing patients with PEG toxicity, particularly with hepatic or renal dysfunction. Dialysis can correct acid base and electrolyte abnormalities, and reduce the osmolal gap. It is rarely necessary as most patients do well with supportive care. Hemodialysis has been used to treat a patient with PEG 400 toxicity.
    H) PATIENT DISPOSITION
    1) HOME CRITERIA: Asymptomatic adults and children can be kept home after inadvertent exposure. Any patient with significant industrial exposure or ingestion in suicidal attempt should be referred to a healthcare facility.
    2) ADMISSION CRITERIA: Patients signs of respiratory toxicity, significant persistent gastrointestinal symptoms, renal impairment, or anion gap metabolic acidosis, should be admitted.
    3) CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    I) PITFALLS
    1) When managing overdose with polyethylene glycol, the possibility of coingestants should be considered.
    J) PHARMACOKINETICS
    1) Molecular weights greater than 1000 are not extensively absorbed from the GI tract. Polyethylene glycol is metabolized to corresponding diacids, hydroxyglycolic acids, and diglycolic substances. Urinary elimination of PEG is dependent on the molecular weight, reflecting poor absorption at higher weights. The mean half-life of PEG 3350 in adults given 240 grams was estimated to be 7.74 hours
    K) DIFFERENTIAL DIAGNOSIS
    1) Includes other agents that can cause metabolic acidosis, such as propylene glycol and ethylene glycol.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).
    2) Provide supportive care and relief of symptoms associated with irritation. Allergic contact dermatitis may occur in some individuals.
    a) Treat dermal irritation or burns with standard topical therapy. Patients developing dermal hypersensitivity reactions may require treatment with systemic or topical corticosteroids or antihistamines.
    0.4.6) PARENTERAL EXPOSURE
    A) Monitor acid-base balance, osmolal gap, serum electrolytes, renal function and pulmonary function in symptomatic patients.
    B) ACIDOSIS: Usually self-limited but severe acidosis may require sodium bicarbonate therapy. Initiate 1-2 mEq/kg over 5 minutes for adults, and 1 mEq/kg for children. Repeat every 1 to 2 hours as required. Dosage adjustment should be based on arterial blood gases. Titrate to serum pH greater than 7.25.
    C) ACUTE LUNG INJURY: Maintain ventilation and oxygenation and evaluate with frequent arterial blood gases and/or pulse oximetry monitoring. Early use of PEEP and mechanical ventilation may be needed.
    D) HEMODIALYSIS: May be indicated in severe acid-base disturbances or in renal failure.

Range Of Toxicity

    A) TOXICITY: Acute toxicity increases with decreasing molecular weight of polyethylene glycol (PEG). Liquid forms of PEG have a lower molecular weight and are used as vehicles for intravenous or topical medications. Toxicity has resulted in patients receiving prolonged, high dose infusions of lorazepam containing PEG 400 and in burn patients receiving repeat dermal application of PEG 200 to 400. An intentional oral ingestion of 2 liters of PEG 400 by an adult resulted in serious toxicity. Solid forms of PEG have a higher molecular weight (MW greater than 3000) and are not readily absorbed with oral ingestion; therefore, these formulations rarely produce toxicity.
    B) THERAPEUTIC DOSE: COLONOSCOPY PREPARATION: NASO-GASTRIC TUBE: 20 to 30 ml/min until rectal effluent is clear or 4 liters of volume is consumed. ORAL: 1.2 to 1.8 L/hr (20 to 30 ml/min) until diarrhea fluid is clear without particulate matter or 4 liters are consumed. CONSTIPATION: 17 grams of polyethylene glycol 3350 (powder) should be dissolved in 8 ounces of clear liquid (eg, water, coffee, tea or juice) and taken once daily. PEDIATRICS: CONSTIPATION: 0.84 g/kg daily orally, given in 2 divided doses has been studied in pediatric patients.

Clinical Effects

Summary Of Exposure

    A) USES: Polyethylene glycol (PEG) has pharmaceutical and industrial uses. Pharmaceutical uses include cleansing the colon prior to gastrointestinal examination or surgery and for the treatment of constipation. Industrial uses include lubrication for textile fibers, rubber molds, and metal-forming operations, as well as in water paints, paper coatings, and polishes, and in the ceramics industry. Low molecular weights (600 dalton or less) are used as reactive intermediates in the manufacture of fatty acid surfactants as solvents in gas processing and as diluents in pharmaceuticals (lorazepam contains 18% PEG 400). Intermediate weight (1000 to 2000 dalton) are used in pharmaceutical ointments and toothpaste formulations and as bases for cosmetic creams and lotions. Higher-molecular weight polyethylene glycols (3500 to 20,000) find use as binders, plasticizers, stiffening agents, molding compounds, and paper adhesives. Carbowax 1500 is a solid consisting of equal portions of PEG 1540 and PEG 300.
    B) PHARMACOLOGY: PEG 3500 is an osmotic agent, which causes water to be retained in the stool, enhancing bowel movement through the colon.
    C) EPIDEMIOLOGY: Exposure is uncommon and toxicity is extremely rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: COMMON: Nausea, vomiting, abdominal fullness, delayed gastric emptying, diarrhea, and taste disorders may develop after ingestion. Contact dermatitis and immediate urticarial reactions may develop after dermal exposures.
    2) SEVERE: Metabolic acidosis, increased serum osmolality, acute renal failure, increased total serum calcium with normal or decreased ionized calcium, and ventricular dysrhythmias (PVCs, ventricular tachycardia) may develop. Aspiration causes severe pulmonary edema that is usually reversible. Acute pancreatitis and angioedema have been reported rarely.
    E) WITH POISONING/EXPOSURE
    1) TOXICOLOGY: High and intermediate molecular weight PEG is generally considered nontoxic, as it is not absorbed following ingestion. Acute toxicity decreases with increasing molecular weight. Massive ingestion, prolonged IV infusion, and prolonged application of low weight PEG products have been associated with metabolic acidosis and renal injury. Hypercalcemia occurs and might be related to specific PEG diacid metabolites (3-oxapentane-1,5-dicarboxylic acid and 3,6-dioxaoctane-1,8-dicarboxylic acid), which are avid calcium binders. With binding of ionized calcium, parathyroid hormone is stimulated and total serum calcium increases. Toxicity is unlikely following ingestion of small amounts or from contact with intact skin. Immediate and delayed allergic contact dermatitis has been observed.

Vital Signs

    3.3.3) TEMPERATURE
    A) WITH POISONING/EXPOSURE
    1) CASE REPORT: A 12-year-old boy (27.3 kg) with cerebral palsy and fecal impaction developed abdominal discomfort and distention, fever (101.8 degrees F) and hypokalemia (serum potassium 2.1 mmol/L) after an unintentional large IV administration of polyethylene glycol (Golytely(R), 470 mL) over 6 hours. He recovered completely with supportive care (Tuckler et al, 2002).

Heent

    3.4.3) EYES
    A) ANIMAL STUDIES: Application of PEG 200 to 4000 to rabbit eyes was found to cause no injury after 24 hours (Grant & Schuman, 1993).
    B) DILATED PUPILS: A 5-year-old girl developed tachypnea, tachycardia, warm distal extremities, and wide open eyes with dilated pupils after inadvertently receiving 4 grams of electrolyte-free polyethylene glycol (PEG) 4000 dissolved in 50 mL tap water intravenously instead of enteral administration. Following supportive care, her condition improved and she was discharged on day 7 (Nijkamp et al, 2012).
    C) WITH THERAPEUTIC USE
    1) Ocular flushing with 1:2 and 1:4 solutions of PEG 400 in water was found to be completely nonirritating. Solutions of 1:1 PEG 400 in water caused a slight burning sensation with no injury. These solutions have been used for decontamination after phenol accidents (Grant & Schuman, 1993).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) VENTRICULAR ARRHYTHMIA
    1) WITH THERAPEUTIC USE
    a) Increased ventricular ectopy has been associated with administration of PEG electrolyte solutions.
    b) CASE SERIES: In a study of 22 patients undergoing 24 colonoscopic exams, an increase in ventricular ectopy was demonstrated in 12 of the 24 exams. This occurred during the administration of 1 gallon of a PEG 3350-electrolyte peroral colonic lavage solution while continuous EKG monitoring was in progress. Two of the 12 patients demonstrated ventricular tachycardia, 4 patients manifested complex ventricular ectopy without ventricular tachycardia, and 6 patients demonstrated an increase in simple premature ventricular contractions (Marsh et al, 1986).
    c) CASE REPORT: Multifocal PVCs, PSVT, and ventricular bigeminy were observed in a 67-year-old man during colonic lavage with PEG-electrolyte solution (Gholson, 1987).
    B) ANGIOEDEMA
    1) WITH THERAPEUTIC USE
    a) Angioedema may occur after PEG-electrolyte administration (Franga & Harris, 2000).
    C) TACHYCARDIA
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT: A 5-year-old girl with Worster-Drought syndrome who was receiving amoxicillin/clavulanic acid and oxygen for aspiration pneumonia, inadvertently received 4 grams of electrolyte-free polyethylene glycol (PEG) 4000 dissolved in 50 mL tap water administered intravenously in 2 minutes via the infusion pump, instead of enteral administration. She developed moderate tachypnea, tachycardia (HR 160 beats/min), warm distal extremities, and wide open eyes with dilated pupils a few minutes later. She received supportive care, including IV bolus of 500 mL sodium chloride 0.9% to reduce the risk of vaso-occlusive effects and hyperhydration (2000 mL/m(2)/day) for 2 days. All laboratory analyses were normal within the first 72 hours after the incident. No hemodynamic, neurological or metabolic effects were observed. She was discharged on day 7 (Nijkamp et al, 2012).

Respiratory

    3.6.2) CLINICAL EFFECTS
    A) ACUTE LUNG INJURY
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: Pulmonary edema was reported in an 8-year-old child given 1 L of balanced electrolyte polyethylene glycol intestinal lavage solution by NG tube (Paap & Ehrlich, 1993). Two hours following administration, the child began vomiting and gagging and appeared to be in moderate respiratory distress, possibly due to aspiration or fluid overload.
    1) Bilateral pulmonary edema was seen on chest x-ray. Respiratory status deteriorated, with a respiratory rate of 72 breaths/minute and signs of hypoxemia. Endotracheal intubation was performed. The child recovered and was extubated 50 hours later (Paap & Erlich, 1993).
    b) CASE REPORT: An 80-year-old woman with an existing medical history of anemia, weight loss, and hypertension as well as heart and renal disease experienced a suspected case of polyethylene glycol(PEG) PEG-induced toxic-allergic pulmonary edema while undergoing colonoscopy to exclude colonic cancer. Signs included vomiting, aspiration, and sudden severe dyspnea following approximately 2.5 liters(L) of PEG via nasogastric tube over 3 hours. She was treated with immediate bronchoalveolar lavage, orotracheal intubation, and mechanical ventilation with positive end-expiratory pressure (PEEP). The patient recovered (Marschall & Bartels, 1998).
    c) CASE REPORT: A 59-year-old man with chronic abdominal pain and weight loss underwent colonoscopy. Following nasogastric administration of approximately 1.5 liters of polyethylene glycol (PEG) over 2 hours, he experienced vomiting and aspiration. He was thought to have PEG-induced toxic-allergic pulmonary edema and was immediately treated with IV prednisolone and furosemide. The patient recovered (Marschall & Bartels, 1998).
    d) CASE REPORT: A 78-year-old woman with no history of cardiopulmonary disease received 11 liters of polyethylene glycol (PEG) via a nasogastric tube the day before surgery for rectal cancer. Upon removal of the tube, the patient began vomiting and immediately suffered form severe dyspnea. She was treated with diuretics and nitroglycerine; however, severe pneumonia and adult respiratory distress syndrome (ARDS) developed and the patient died 2 weeks later (Marschall & Bartels, 1998).
    2) WITH POISONING/EXPOSURE
    a) CASE REPORT: An 11-year-old girl developed life-threatening acute lung injury after the accidental infusion of NuLytely(R) (200 mL/hour) into the lungs. After 1 hour of infusion, she developed significant respiratory distress with paroxysmal coughing and oxygen desaturations noted on the pulse oximeter. Chest roentgenogram revealed bilateral diffuse fluffy infiltrates compatible with pulmonary edema, indicative of acute respiratory distress syndrome (ARDS). She developed respiratory failure requiring tracheal intubation and mechanical ventilation. After 3 days, she recovered without any sequelae (Narsinghani et al, 2001).
    B) SUFFOCATING
    1) WITH THERAPEUTIC USE
    a) Aspiration pneumonitis with respiratory insufficiency developed in 2 children (aged 9 and 15 years) who were administered polyethylene glycol-electrolyte solution (PEGs) by NG tube for constipation. Chest x-ray revealed bronchial NG tube misplacement in both cases. One child required mechanical ventilation for 24 hours. Signs and symptoms resolved after removal of the agent and oxygen therapy (Pace & Robertson, 1997).
    C) TACHYPNEA
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT: A 5-year-old girl with Worster-Drought syndrome who was receiving amoxicillin/clavulanic acid and oxygen for aspiration pneumonia, inadvertently received 4 grams of electrolyte-free polyethylene glycol (PEG) 4000 dissolved in 50 mL tap water administered intravenously in 2 minutes via the infusion pump, instead of enteral administration. She developed moderate tachypnea, tachycardia (HR 160 beats/min), warm distal extremities, and wide open eyes with dilated pupils a few minutes later. She received supportive care, including IV bolus of 500 mL sodium chloride 0.9% to reduce the risk of vaso-occlusive effects and hyperhydration (2000 mL/m(2)/day) for 2 days. All laboratory analyses were normal within the first 72 hours after the incident. No hemodynamic, neurological or metabolic effects were observed. She was discharged on day 7 (Nijkamp et al, 2012).
    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RESPIRATORY DISORDER
    a) ANIMAL STUDIES: In rats, a 2-week aerosol inhalation exposure to PEG 3350 (20% in w/w in water) at airborne concentrations of 0, 109, 567, and 1008 mg/m(3) caused a 50% increase in neutrophil counts, a slight decrease in body weight gain, increased lung weights, and a slight increase in alveolar macrophages. Overall, inhalation of PEG 3350 aerosols produced relatively little toxicity. The lung was the target organ and the NOAEL was between 109 and 567 mg/m(3) (Klonne et al, 1989).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) COMA
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: Stage 2 coma and acidosis was described 5 hours after ingestion of 2 L of PEG 400 in a 59-year-old woman (Belaiche et al, 1983).
    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    a) ANIMAL STUDY: Impairment of nerve conduction was found following intrathecal steroid injections using a 3% PEG solution as a vehicle in rabbits. Myelinated and unmyelinated rabbit nerves in vitro were exposed to PEG 3350 concentrations ranging from 3% to 40% . The results showed that the stronger the concentration of PEG 3350, the slower the nerve conduction. Forty percent PEG 3350 completely eliminated the action potentials (Goldfrank, 2002).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) VOMITING
    1) WITH THERAPEUTIC USE
    a) Nausea and vomiting may develop (Prod Info polyethylene glycol 3350 oral powder, 2006; Belaiche et al, 1983). Nausea was reported in 18% of approximately 80 patients administered PEG lavage solution (Girard et al, 1984).
    B) GASTROINTESTINAL COMPLICATION
    1) WITH THERAPEUTIC USE
    a) Complications of vomiting after PEG administration have included hematemesis from Mallory-Weiss tears (Santaro et al, 1993) (Hroncich, 1992; Brinberg & Stein, 1986) and esophageal perforation (McBride & Vanagunas, 1993; Pham et al, 1993) .
    b) CASE REPORT: Rectal prolapse has been reported in a patient undergoing PEG bowel prep (Korkis et al, 1992).
    C) TASTE SENSE ALTERED
    1) WITH THERAPEUTIC USE
    a) CASE SERIES: Twenty-eight percent of approximately 80 patients experienced a bad taste after drinking PEG electrolyte lavage solution (Girard et al, 1984).
    D) FLATULENCE/WIND
    1) WITH THERAPEUTIC USE
    a) Abdominal fullness and flatulence is a common effect following oral therapy of PEG 3500 (Prod Info polyethylene glycol 3350 oral powder, 2006). Abdominal fullness was reported in 9% of approximately 80 patients administered PEG electrolyte lavage solution (Girard et al, 1984).
    2) WITH POISONING/EXPOSURE
    a) CASE REPORT: A 12-year-old boy developed abdominal discomfort and distention, fever (101.8 degrees F), and hypokalemia (serum potassium 2.1 mmol/L) after an unintentional large IV administration of polyethylene glycol (Golytely(R), 470 mL) over 6 hours. He recovered completely with supportive care (Tuckler et al, 2002).
    E) DIARRHEA
    1) WITH THERAPEUTIC USE
    a) Diarrhea is common with therapeutic use.
    2) ANIMAL STUDIES: During a 13-week gavage study with PEG 400 in rats, loose feces, increased water consumption, and increased serum osmolality were noted (Hermansky et al, 1998).
    F) PANCREATITIS
    1) WITH THERAPEUTIC USE
    a) A 75-year-old woman developed severe acute pancreatitis (serum amylase 1138 IU/L, lipase 4447 IU/L) after consuming 4 L of polyethylene glycol (PEG)-electrolyte bowel preparation within 2 hours. It is suggested that colonic inertia caused a functional obstruction, leading to increased intraluminal duodenal distention and pressure. This resulted in increased pancreatic duct pressure and caused duodenal contents to reflux into the pancreatic duct causing acute pancreatitis (Franga & Harris, 2000).
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) GASTRIC MOTILITY DECREASED
    a) ANIMAL STUDIES: Rats administered PEG 400 by either gavage or parenteral injection had dose-dependent decreases of gastric blood flow and gastric motility (Hermansky et al, 1998).

Hepatic

    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATOCELLULAR DAMAGE
    a) Cloudy swelling of liver parenchyma has been observed in animals given intraperitoneal doses of PEG 200, 400, 1000, and 4000(Smyth et al, 1947).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) ACUTE RENAL FAILURE SYNDROME
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT: Following ingestion of the contents of a lava lamp in a suicide attempt, a 65-year-old man developed acute renal failure. The lamp contained 13% of a PEG 200 solution, along with water, paraffin, kerosene, and wax.
    1) The patient was admitted and within 48 hours developed oliguria and had an anion gap metabolic acidosis. While the initial renal failure was felt to be multifactorial, residual kidney dysfunction 3 months later was felt to be related to PEG component (Goldfrank, 2002).
    B) ACUTE TUBULAR NECROSIS
    1) WITH THERAPEUTIC USE
    a) Higher than recommended doses of IV medications that utilize polyethylene glycol as a vehicle (eg, lorazepam) has led to acute tubular necrosis. Patients with renal impairment are at higher risk (Prod Info ATIVAN(R) intramuscular, intravenous injection, 2006).
    b) CASE SERIES: Renal proximal tubular necrosis, with oliguria and azotemia, has been associated with IV administration of PEG 300 (40 mL/day) in 7 patients; 2 fatalities occurred (McCabe et al, 1959).
    c) CASE SERIES: Fatal renal failure was described in 9 patients receiving repeated applications of Furacin soluble dressing for burn care. Furacin contains 63% PEG 300, 5% PEG 1000, and 32% PEG 4000. Death occurred 12 to 27 days after initiation of therapy (Bruns et al, 1982).
    1) Oxalate crystals were seen in 2 cases (Bruns et al, 1982).
    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RENAL ABSCESS
    a) Similar renal lesions were produced after application to denuded rabbit skin twice daily for 7 days (Sturgill et al, 1982).
    b) Rats administered PEG 400 by gavage had decreased absolute and relative kidney weights (Hermansky et al, 1998). This effect was attributed to the osmotic effects of PEG 400 or its metabolites in the urine.

Acid-Base

    3.11.2) CLINICAL EFFECTS
    A) ACIDOSIS
    1) WITH THERAPEUTIC USE
    a) High anion gap acidosis (33 to 57 mmol/L), hypercalcemia, and hyperosmolality were described in burn patients treated with topical PEG dressings (Bruns et al, 1982).
    b) CASE SERIES: Acidosis was associated with administration of PEG 300 in a parenteral nitrofurantoin preparation in at least 25 patients (Sweet, 1958).
    c) CASE REPORT: Ingestion of 2 liters of PEG 400 resulted in metabolic acidosis in an adult (Belaiche et al, 1983).
    2) ANIMAL STUDIES: Rats administered PEG 400 by gavage had increased urine concentration and decreased urinary pH as compared with controls (Hermansky et al, 1998).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) CONTACT DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Delayed eczematous reactions and immediate urticarial reactions have been observed following topical application of low molecular weight liquid polyethylene glycols (mw 200 to 400) (Bajaj et al, 1990; Daly, 1987; Fisher, 1978; Fisher, 1977; Maibach, 1975) .
    b) Cross-sensitization occurs with polyethylene glycols of similar molecular weight (Fisher, 1978).
    B) URTICARIA
    1) WITH THERAPEUTIC USE
    a) Urticaria has been reported after use of PEG electrolyte lavage solution (Prod Info polyethylene glycol 3350 oral powder, 2006) (Brullet et al, 1992).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) WITH THERAPEUTIC USE
    a) Allergic reactions may occur after PEG-electrolyte administration (Franga & Harris, 2000; Prod Info polyethylene glycol 3350 oral powder, 2006).
    b) RARE EFFECT: CASE REPORT: Anaphylaxis has been described following ingestion of a multiple vitamin tablet containing PEG 8000 and PEG 20,000 by a 36-year-old man (Kwee & Dolovish, 1982).

Reproductive

    3.20.1) SUMMARY
    A) At the time of this review, no human reproductive studies regarding teratogenicity or effects on pregnancy or breastfeeding were found for PEG, although some animal studies have shown teratogenicity. The polyethylene glycol 3350 and electrolytes oral solution and polyethylene glycol 3350/electrolytes/sodium ascorbate/ascorbic acid oral solution are classified as FDA pregnancy category C.
    3.20.2) TERATOGENICITY
    A) LACK OF INFORMATION
    1) POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES SOLUTION
    a) At the time of this review, no data were available to assess the teratogenic potential of this combination product (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    2) POLYETHYLENE GLYCOL 3350/ELECTROLYTES/SODIUM ASCORBATE/ASCORBIC ACID
    a) At the time of this review, no data were available to assess the teratogenic potential of this combination product (Prod Info MOVIPREP(R) oral solution, 2013)
    B) ANIMAL STUDIES
    1) Polyethylene glycol 200 has been reported to be teratogenic in mice and the occurrence of facial malformations has also been reported (HSDB , 2002).
    2) In another study, rat fetuses from mothers treated with toxic doses of PEG 200 showed no abnormalities (HSDB , 2002).
    3) Using S9 mix from mice, rats, hamsters, rabbit and man as an activation system, PEG 200 showed teratogenic potential with mouse S9 mix at 0.25 and .5 percent. The abnormalities involved brain development. PEG 200 was embryolethal at 0.5 and 0.75 percent in rat, hamster, rabbit and human S9 mix. At a concentration of 1 percent in any S9 mix, PEG 200 was always embryolethal (HSDB , 2002).
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES SOLUTION
    a) At the time of this review, no data were available to assess the potential effects of exposure to this combination product during pregnancy in humans (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    2) POLYETHYLENE GLYCOL 3350/ELECTROLYTES/SODIUM ASCORBATE/ASCORBIC ACID
    a) At the time of this review, no data were available to assess the potential effects of exposure to this combination product during pregnancy in humans (Prod Info MOVIPREP(R) oral solution, 2013)
    B) PREGNANCY CATEGORY
    1) Polyethylene glycol colon lavage preparation is classified as FDA Pregnancy Category C by the manufacturer (Prod Info Golytely(R), PEG electrolyte lavage solution, 1991; Prod Info Colyte(R), PEG electrolyte lavage solution, 1991).
    2) The polyethylene glycol 3350 and electrolytes oral solution is classified as FDA pregnancy category C (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    3) The polyethylene glycol 3350/electrolytes/sodium ascorbate/ascorbic acid oral solution is classified as FDA pregnancy category C (Prod Info MOVIPREP(R) oral solution, 2013).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) LACK OF INFORMATION
    1) POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES SOLUTION
    a) At the time of this review, no data were available to assess the potential effects of exposure to this combination product during lactation in humans (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013).
    2) POLYETHYLENE GLYCOL 3350/ELECTROLYTES/SODIUM ASCORBATE/ASCORBIC ACID
    a) At the time of this review, no data were available to assess the potential effects of exposure to this combination product during lactation in humans (Prod Info MOVIPREP(R) oral solution, 2013)
    3.20.5) FERTILITY
    A) LACK OF INFORMATION
    1) POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES SOLUTION
    a) At the time of this review, no data were available to assess the potential effects on fertility from exposure to this combination product (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    2) POLYETHYLENE GLYCOL 3350/ELECTROLYTES/SODIUM ASCORBATE/ASCORBIC ACID
    a) At the time of this review, no data were available to assess the potential effects on fertility from exposure to this combination product (Prod Info MOVIPREP(R) oral solution, 2013)

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS25322-68-3 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    3.21.2) SUMMARY/HUMAN
    A) No human studies regarding the carcinogenic effects of PEG were found at the time of this review.
    3.21.4) ANIMAL STUDIES
    A) CARCINOMA
    1) Polyethylene glycol has produced cell fusion, resulting in malignant cell hybrids in vitro (Pontecervo, 1975). Experimental animal studies reported lung lymphosarcomas in rats, vaginal tumors in mice, and a weak tumor initiator effect in mice (Smyth et al, 1947; Boyland et al, 1961; Field & Roe, 1965). Contaminants in early commercial preparations may have contributed to or accounted for the observed carcinogenicity.
    2) Recent rat studies have shown that high molecular weight PEG solution (PEG 8000) may be a potent cancer chemopreventive agent. This has been attributed to high osmotic pressures induced by PEG in vitro (Parnaud et al, 2001).
    3) Polyethylene glycol has produced cell fusion, resulting in malignant cell hybrids in vitro (Pontecervo, 1975).

Genotoxicity

    A) At the time of this review, no human data were available to assess the possible genetic effects of exposure to polyethylene glycol. It is sometimes used as a solvent in short-term genetic assays. One study has shown chromosome aberrations in Chinese hamster epithelial liver cells. Another study has shown that genetic transformation occurred in bacteria and yeast.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor acid-base balance, osmolal gap, serum electrolytes, renal function and pulmonary function in symptomatic patients.
    B) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites.
    C) Monitor pulmonary function and chest x-ray in cases of suspected PEG aspiration or systemic fluid overload. Assess adequacy of oxygenation with pulse oximetry or arterial blood gases.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Determine osmolal gap, anion gap, acid-base status, serum calcium, and renal function tests.
    2) Increased total serum calcium with decreased or normal ionized calcium may be used to distinguish PEG toxicity from that of other glycols.
    4.1.3) URINE
    A) URINALYSIS
    1) Calcium oxalate crystals may be seen in the urine (Bruns et al, 1982).

Radiographic Studies

    A) CHEST RADIOGRAPH
    1) Monitor chest X-ray in cases of suspected PEG aspiration, inadvertent tracheal/bronchial instillation, or fluid overload.

Methods

    A) MULTIPLE ANALYTICAL METHODS
    1) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites (Herold et al, 1982).
    2) OSMOLALITY measured by freezing point depression osmometer was higher than that by measured by vapor pressure osmometer. The vapor pressure method is believed to be more accurate (Schiller et al, 1988).
    3) PEG of molecular weight 106 to 634 has been quantified in urine using gas-liquid chromatography (McClung et al, 1983) and thin-layer chromatography (Sloan et al, 1983).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Monitor acid-base balance, osmolal gap, serum electrolytes, renal function and pulmonary function in symptomatic patients.
    B) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites.
    C) Monitor pulmonary function and chest x-ray in cases of suspected PEG aspiration or systemic fluid overload. Assess adequacy of oxygenation with pulse oximetry or arterial blood gases.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) PEG is essentially inert when taken orally, unless very large amounts of low-molecular-weight compounds are ingested. Syrup of ipecac-induced emesis and administration of activated charcoal are most likely unnecessary.
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) Gastrointestinal decontamination and activated charcoal is not required. Gastric aspiration soon after an acute ingestion of a large amount of low molecular weight PEG solution may be beneficial.
    6.5.3) TREATMENT
    A) MONITORING OF PATIENT
    1) Monitor acid-base balance, osmolal gap, serum electrolytes, renal function and pulmonary function in symptomatic patients.
    2) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites.
    3) Monitor pulmonary function and chest x-ray in cases of suspected PEG aspiration or systemic fluid overload. Assess adequacy of oxygenation with pulse oximetry or arterial blood gases.
    B) ACIDOSIS
    1) Acidosis is usually self-limited but severe acidosis may require sodium bicarbonate therapy.
    2) METABOLIC ACIDOSIS: Treat severe metabolic acidosis (pH less than 7.1) with sodium bicarbonate, 1 to 2 mEq/kg is a reasonable starting dose(Kraut & Madias, 2010). Monitor serum electrolytes and arterial or venous blood gases to guide further therapy.
    3) Repeat every 1 to 2 hours as required. Titrate to serum pH greater than 7.25.
    C) ACUTE LUNG INJURY
    1) ONSET: Onset of acute lung injury after toxic exposure may be delayed up to 24 to 72 hours after exposure in some cases.
    2) NON-PHARMACOLOGIC TREATMENT: The treatment of acute lung injury is primarily supportive (Cataletto, 2012). Maintain adequate ventilation and oxygenation with frequent monitoring of arterial blood gases and/or pulse oximetry. If a high FIO2 is required to maintain adequate oxygenation, mechanical ventilation and positive-end-expiratory pressure (PEEP) may be required; ventilation with small tidal volumes (6 mL/kg) is preferred if ARDS develops (Haas, 2011; Stolbach & Hoffman, 2011).
    a) To minimize barotrauma and other complications, use the lowest amount of PEEP possible while maintaining adequate oxygenation. Use of smaller tidal volumes (6 mL/kg) and lower plateau pressures (30 cm water or less) has been associated with decreased mortality and more rapid weaning from mechanical ventilation in patients with ARDS (Brower et al, 2000). More treatment information may be obtained from ARDS Clinical Network website, NIH NHLBI ARDS Clinical Network Mechanical Ventilation Protocol Summary, http://www.ardsnet.org/node/77791 (NHLBI ARDS Network, 2008)
    3) FLUIDS: Crystalloid solutions must be administered judiciously. Pulmonary artery monitoring may help. In general the pulmonary artery wedge pressure should be kept relatively low while still maintaining adequate cardiac output, blood pressure and urine output (Stolbach & Hoffman, 2011).
    4) ANTIBIOTICS: Indicated only when there is evidence of infection (Artigas et al, 1998).
    5) EXPERIMENTAL THERAPY: Partial liquid ventilation has shown promise in preliminary studies (Kollef & Schuster, 1995).
    6) CALFACTANT: In a multicenter, randomized, blinded trial, endotracheal instillation of 2 doses of 80 mL/m(2) calfactant (35 mg/mL of phospholipid suspension in saline) in infants, children, and adolescents with acute lung injury resulted in acute improvement in oxygenation and lower mortality; however, no significant decrease in the course of respiratory failure measured by duration of ventilator therapy, intensive care unit, or hospital stay was noted. Adverse effects (transient hypoxia and hypotension) were more frequent in calfactant patients, but these effects were mild and did not require withdrawal from the study (Wilson et al, 2005).
    7) However, in a multicenter, randomized, controlled, and masked trial, endotracheal instillation of up to 3 doses of calfactant (30 mg) in adults only with acute lung injury/ARDS due to direct lung injury was not associated with improved oxygenation and longer term benefits compared to the placebo group. It was also associated with significant increases in hypoxia and hypotension (Willson et al, 2015).

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DERMAL DECONTAMINATION
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).
    6.9.2) TREATMENT
    A) MONITORING OF PATIENT
    1) Monitor acid-base balance, renal function and pulmonary function in symptomatic patients.
    2) Blood levels are not generally available or clinically useful. A tandem quadrupole mass spectrometry technique can identify PEG and its metabolites.
    3) Monitor pulmonary function and chest x-ray in cases of suspected PEG aspiration or systemic fluid overload. Assess adequacy of oxygenation with pulse oximetry or arterial blood gases.
    B) ACIDOSIS
    1) Acidosis is usually self-limited but severe acidosis may require sodium bicarbonate therapy. Initiate 1-2 mEq/kg over 5 minutes for adults, and 1 mEq/kg for children. Repeat every 1 to 2 hours as required. Dosage adjustment should be based on arterial blood gases. Titrate to serum pH greater than 7.25.
    C) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Enhanced Elimination

    A) HEMODIALYSIS
    1) May be indicated in patients with severe acid-base disturbance or renal failure.

Abstracts

Case Reports

    A) ADULT
    1) Ingestion of 2 L of a PEG 400 colonic lavage solution by a 59-year-old woman over less than 3 hours resulted in vomiting, malaise, and lethargy after the first liter, which progressed to coma 5 hours postingestion (Belaiche et al, 1983).
    2) Metabolic acidosis (pH 6.99, anion gap 34 mEq/L, pCO2 12.5 mmHg) was present. Serum calcium was normal, as were renal function tests. No oxalates were found in the urine.
    3) The patient was treated with bicarbonate and extracorporeal elimination, and had return of consciousness over 48 hours (Belaiche et al, 1983).
    B) PEDIATRIC
    1) Paap & Ehrlich (1993) reported the case of an 8-year-old girl who developed acute bilateral pulmonary edema and severe respiratory distress from suspected aspiration of BE-PEG intestinal lavage solution. The patient was intubated. Elevated WBC count, lactate dehydrogenase, and alkaline phosphatase, decreased blood glucose, and an anion gap metabolic acidosis were present.
    2) Therapy with fluids, furosemide, antibiotics, and positive airway pressure was initiated. Improvement in respiratory function was noted over the next 24 hours. The patient was extubated 50 hours following initial intubation.

Range Of Toxicity

Summary

    A) TOXICITY: Acute toxicity increases with decreasing molecular weight of polyethylene glycol (PEG). Liquid forms of PEG have a lower molecular weight and are used as vehicles for intravenous or topical medications. Toxicity has resulted in patients receiving prolonged, high dose infusions of lorazepam containing PEG 400 and in burn patients receiving repeat dermal application of PEG 200 to 400. An intentional oral ingestion of 2 liters of PEG 400 by an adult resulted in serious toxicity. Solid forms of PEG have a higher molecular weight (MW greater than 3000) and are not readily absorbed with oral ingestion; therefore, these formulations rarely produce toxicity.
    B) THERAPEUTIC DOSE: COLONOSCOPY PREPARATION: NASO-GASTRIC TUBE: 20 to 30 ml/min until rectal effluent is clear or 4 liters of volume is consumed. ORAL: 1.2 to 1.8 L/hr (20 to 30 ml/min) until diarrhea fluid is clear without particulate matter or 4 liters are consumed. CONSTIPATION: 17 grams of polyethylene glycol 3350 (powder) should be dissolved in 8 ounces of clear liquid (eg, water, coffee, tea or juice) and taken once daily. PEDIATRICS: CONSTIPATION: 0.84 g/kg daily orally, given in 2 divided doses has been studied in pediatric patients.

Therapeutic Dose

    7.2.1) ADULT
    A) COLONOSCOPY PREPARATION
    1) NASOGASTRIC
    a) COLYTE AND GOLYTELY AND NULYTELY: A combination product (oral solution; containing PEG-3350 227.1 g with other electrolytes), supplied in one gallon packet. The recommended dose is 20 to 30 mL/minute (1.2 to 1.8 L/hr) via nasogastric tube until rectal effluent is clear or 1 gallon (4 L) is consumed (Prod Info GoLYTELY oral solution, 2013; Prod Info NuLYTELY(R) oral solution, 2013; Prod Info COLYTE(R) oral solution, 2005).
    2) ORAL POWDER FOR SOLUTION
    a) COLYTE AND GOLYTELY: A combination product (oral solution; containing PEG-3350 227.1 g/gallon [60 g/L] with other electrolytes), supplied in one gallon packet. The recommended dose is 240 mL orally every 10 minutes until rectal effluent is clear or 1 gallon (4 L) is consumed (Prod Info Colyte(R) with Flavor Packs oral solution, 2013; Prod Info GoLYTELY oral solution, 2013).
    b) HALFLYTELY AND BISACODYL BOWEL PREP: A combination product (powder for oral solution; containing bisacodyl 5 mg delayed-release tablet and the HalfLytely powder (PEG-3350 210 mg with other electrolytes) dissolved in 2 L of water. DO NOT chew or crush tablet. The recommended dose is one 5 mg bisacodyl tablet with water should be taken. After a bowel movement (or maximum of 6 hours later), then drink all the HalfLytely solution at a rate of 8 ounces (240 mL) every 10 minutes (Prod Info HALFLYTELY(R) AND BISACODYL TABLET BOWEL PREP KIT oral solution, oral delayed-release tablets, 2010).
    c) MOVIPREP: A combination product (powder for oral solution; containing 2 pouches labeled pouch A [containing PEG-3350 100 g with other electrolytes] and 2 pouches labeled pouch B [other electrolytes). Combine 1 pouch A and 1 pouch B into the container provided and add 1 L of lukewarm water. Mix until completely dissolved. Two possible dosing regimens (Split-dose [2-day] and Evening only [1-day]). Overall, 2 L (64 ounces) of solution is taken during the dosing regimen (Prod Info MOVIPREP(R) oral solution, 2013).
    d) NULYTELY AND TRILYTE: A combination product (powder for oral solution; containing PEG-3350 420 g with other electrolytes) supplied with a 4 L container. The recommended dose is 240 mL orally every 10 minutes until rectal effluent is clear or up to 4 L consumed (Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    e) SUCLEAR: A combination product, supplied as oral solution (Dose 1; one 6-ounce bottle containing other electrolytes) and for oral solution (Dose 2; one 2-L jug with powder containing PEG-3350 210 g with other electrolytes). It should be reconstituted with cool water before use. Two dosing regimens are recommended (Prod Info SUCLEAR(TM) oral solution, 2013).
    B) CONSTIPATION
    1) ORAL SOLUTION
    a) 17 g PEG-3350 powder dissolved in 4 to 8 ounces of liquid orally per day, for up to 2 weeks (Prod Info polyethylene glycol 3350 oral powder for solution, 2011).
    7.2.2) PEDIATRIC
    A) Safety and efficacy in pediatric patients have not been established (Prod Info polyethylene glycol 3350 oral powder for solution, 2011; Prod Info GoLYTELY oral solution, 2013; Prod Info MOVIPREP(R) oral solution, 2013; Prod Info HALFLYTELY(R) AND BISACODYL TABLET BOWEL PREP KIT oral solution, oral delayed-release tablets, 2010; Prod Info SUCLEAR(TM) oral solution, 2013).
    B) COLONOSCOPY PREPARATION
    1) NULYTELY AND TRILYTE (UNDER 6 MONTHS): Safety and efficacy have not been established (Prod Info NuLYTELY(R) oral solution, 2013)
    2) NULYTELY AND TRILYTE (6 MONTHS AND OLDER): A combination product (powder for oral solution; containing PEG-3350 420 g with other electrolytes) supplied with a 4 L container. The recommended dose is 25 mL/kg/hr orally or via nasogastric tube until rectal effluent is clear without particulate matter (Prod Info NuLYTELY(R) oral solution, 2013; Prod Info TriLyte(R) with flavor packs oral solution powder, 2011).
    C) GENERAL
    1) Meadows & Conyers (1983) state that they have administered 3 to 5 liters of PEG electrolyte lavage solution to patients as young as 12 years of age (Meadows & Conyers, 1983).
    2) 25 mL/kilogram/hour for 3 to 7 hours of PEG-electrolyte solution was administered to 29 children aged 3 weeks to 14 years without causing adverse effects (Tuggle et al, 1987).
    3) CONSTIPATION: polyethylene glycol (PEG) as a powder to be mixed with fluid (MIRALAX(R), PEG 3350) was effectively dosed at mean 0.84 gram/kilogram daily orally, given in 2 divided doses (range 0.27 to 1.42 grams/kilogram/day); 17 grams of powder were added to 240 mL of fluid (14 mL/gram). This amount of PEG was found to be the mean effective dose for treatment of chronic constipation, based on an 8-week study in children 18 months to 11 years of age (n=20) (Pashankar & Bishop, 2001).

Maximum Tolerated Exposure

    A) GENERAL/SUMMARY
    1) Acute toxicity decreases with increasing molecular weight. Oral toxicity is extremely low. Ingestion of 2 liters of PEG 400 by an adult resulted in severe toxicity (Guzman et al, 2002; Belaiche et al, 1983).
    2) Guzman et al (2002) reported an accidental IV infusion of polyethylene glycol (Golytely(R), 391 mL infused) in a 4-year-old girl that did not result in systemic toxicity (Guzman et al, 2002).
    3) CASE REPORT: A 12-year-old boy developed abdominal discomfort and distention, fever (101.8 degrees F) and hypokalemia (serum potassium 2.1 mmol/L) after an unintentional large intravenous administration of polyethylene glycol (Golytely(R), 470 mL) over 6 hours. He recovered completely with supportive care (Tuckler et al, 2002).
    4) CASE REPORT: A 5-year-old girl developed tachypnea, tachycardia, warm distal extremities, and wide open eyes with dilated pupils after inadvertently receiving 4 grams of electrolyte-free polyethylene glycol (PEG) 4000 dissolved in 50 mL tap water intravenously instead of enteral administration. Following supportive care, her condition improved and she was discharged on day 7 (Nijkamp et al, 2012).

Workplace Standards

    A) ACGIH TLV Values for CAS25322-68-3 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS25322-68-3 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS25322-68-3 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS25322-68-3 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    B) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 7500 mg/kg
    2) LD50- (ORAL)MOUSE:
    a) 34 g/kg
    3) LD50- (ORAL)RAT:
    a) 34 g/kg
    b) 28 g/kg
    C) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) 31 g/kg
    2) LD50- (INTRAPERITONEAL)RAT:
    a) 17,000 mg/kg
    3) LD50- (ORAL)RAT:
    a) 39 g/kg
    b) 27,500 mg/kg
    D) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 9953 mg/kg
    2) LD50- (ORAL)MOUSE:
    a) 28,915 mg/kg
    b) 36 g/kg
    c) 29 g/kg
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 9708 mg/kg
    4) LD50- (ORAL)RAT:
    a) 30 mL/kg (Budavari, 1996)
    b) 44 g/kg
    c) 33 g/kg
    E) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) 47 g/kg
    b) 36 g/kg
    2) LD50- (ORAL)RAT:
    a) male, 33 g/kg
    b) female, 30 g/kg
    c) 38,100 mg/kg
    F) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 2000 mg/kg
    2) LD50- (ORAL)MOUSE:
    a) >50 g/kg
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 15,570 mg/kg
    4) LD50- (ORAL)RAT:
    a) 32 g/kg
    b) 42 g/kg
    G) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (INTRAPERITONEAL)RAT:
    a) 17,700 mg/kg
    2) LD50- (ORAL)RAT:
    a) 44,200 mg/kg
    b) 44 g/kg
    H) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) >50 g/kg
    2) LD50- (ORAL)RAT:
    a) 51 g/kg
    I) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) >50 g/kg
    2) LD50- (ORAL)RAT:
    a) male, 45 g/kg
    b) female, >50 g/kg
    J) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) >50 g/kg
    2) LD50- (SUBCUTANEOUS)MOUSE:
    a) 18 g/kg
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 11,550 mg/kg
    4) LD50- (ORAL)RAT:
    a) >50 g/kg
    b) 59 g/kg
    K) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) >50 g/kg
    2) LD50- (INTRAPERITONEAL)RAT:
    a) 6790 mg/kg
    3) LD50- (ORAL)RAT:
    a) >50 g/kg
    L) References: Clayton & Clayton, 1994 Lewis, 2000 RTECS, 1999
    1) LD50- (ORAL)MOUSE:
    a) 50 g/kg
    2) LD50- (ORAL)RAT:
    a) 50 g/kg

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Polyethylene glycol 3350 is a relatively nonabsorbable, nonmetabolizable substance which increases osmotic pressure of colonic lavage fluids, thereby minimizing water absorption (Schiller et al, 1988).
    B) Polyethylene glycol electrolyte solutions (Golytely(R); Colyte(R)) appear to be a safe and effective bowel cleansing agents in children, infants, and patients with cardiac, pulmonary, and renal disease (Tuggle et al, 1987).

Toxicologic Mechanism

    A) Hypercalcemia occurs and might be related to specific PEG diacid metabolites (3-oxapentane-1,5-dicarboxylic acid and 3,6-dioxaoctane-1,8-dicarboxylic acid) which are avid calcium binders.
    1) With binding of ionized calcium, parathyroid hormone is stimulated and total serum calcium increases.

Physicochemical

Physical Characteristics

    A) Polyethylene glycols exist as either clear viscous liquids or as white solids. They to dissolve in water to form transparent solutions (S Budavari , 2001; HSDB , 2002).
    B) At room temperature, polyethylene glycols with an average molecular weight of 600 or less exist as liquids. Those having an average molecular weight of 1000 to 2500 exist as soft to firm solids, and those with an average molecular weight of 3500 to 20,000 exist as firm to hard, brittle, waxlike solids (Bingham et al, 2001).

Molecular Weight

    A) Polyethylene glycol 200: 190-210 (S Budavari , 2001)
    B) Polyethylene glycol 400: 380-420 (S Budavari , 2001)
    C) Polyethylene glycol 600: 570-630 (S Budavari , 2001)
    D) Polyethylene glycol 1500: 1300-1600 (S Budavari , 2001)
    E) Polyethylene glycol 4000: 3000-3700 (S Budavari , 2001)
    F) Polyethylene glycol 6000: 7000-9000 (S Budavari , 2001)

References

General Bibliography

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