Medication Guide App

Polyethylene Glycol and Electrolytes (Local)


VA CLASSIFICATION
Primary: GA209



Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Evacuant (bowel){16}{19}

Indications

Accepted

Bowel evacuation, preoperative, and
Bowel evacuation, pre-radiography—Polyethylene glycol (PEG) 3350 and electrolytes oral solution is indicated for bowel cleansing prior to gastrointestinal examination (e.g., colonoscopy, barium enema, intravenous pyelography) and colon surgery. {01} {02} {03} {04} {05} {06} {08} {09} {13} {14} {20} {21} {22}
—For double contrast barium enema, administration of the PEG-electrolyte solution alone has not been found to be an adequate method of bowel cleansing. PEG-electrolyte solution followed by oral administration of bisacodyl has been reported to achieve better removal of feces and correct degraded mucosal coating. {04} {07}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
{23}    Potassium chloride: 74.55
    Sodium bicarbonate: 84.01
    Sodium chloride: 58.44
    Sodium sulfate: 322.20


Osmolality
    280 mOsmol per kg of water. {01}

Mechanism of action/Effect:

Evacuant (bowel)—Cleansing of the bowel is achieved by fluid overload with the osmotically balanced PEG-electrolyte solution, which induces a liquid stool within a short period of time. The concentration of electrolytes in the solution causes no net absorption or secretion of ions; thus no significant changes in water or electrolyte balance occur. {01} {04} {05} {06} {09} {14} {15} {16} {17} {18} {20} {21} {22}

Absorption:

Negligible absorption from gastrointestinal tract. {01} {04} {10}

Onset of action:

30 to 60 minutes. {01}

Elimination:
    Negligible renal excretion (<0.1%). {10}


Precautions to Consider

Carcinogenicity/Mutagenicity

Studies to evaluate carcinogenic or mutagenic potential have not been performed. {14} {20} {21} {22}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals.

FDA Pregnancy Category C. {01} {14} {20} {21}

Breast-feeding

It is not known whether PEG-electrolyte solution is distributed into breast milk. However, problems in humans have not been documented.

Pediatrics

Studies performed in children ranging in age from 6 months to 18 years have not demonstrated pediatrics-specific problems that would limit the usefulness of PEG-electrolyte solution in children. {04} {12} {17} {18}


Geriatrics


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of PEG-electrolyte solution in the elderly. {02} {05} {11}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

» Oral medications, other    (other oral medications administered within 1 hour of administration of PEG-electrolyte solution may be flushed from the gastrointestinal tract and not absorbed {01} {14} {20} {21})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Barium sulfate, rectal    (administration of PEG-electrolyte solution on the same day as a barium enema [either single or double contrast] may result in retained fluid and thus barium dilution and may prevent barium coating of the intestinal wall {05} {16})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Intestinal obstruction or
» Paralytic ileus or
» Perforated bowel or
» Toxic colitis or
» Toxic megacolon    (condition may be aggravated; colonic perforation may occur in patients with intestinal obstruction or toxic colitis {01} {03} {04} {14} {20} {21} {22})


Risk-benefit should be considered when the following medical problems exist
Aspiration, predisposition to or
Impaired gag reflex or
Regurgitation, predisposition to or
Unconscious or semiconscious state    (administration via nasogastric tube may increase risk of complications {01} {14} {20} {21} {22})


Ulcerative colitis, severe{01}{14}{20}{21}    (condition may be aggravated)




Side/Adverse Effects

Note: Hypothermia was reported in one patient after ingestion of 5 liters of chilled PEG-electrolyte solution. {02} {04}
One patient experienced cardiac asystole after a large bowel movement following administration of PEG-electrolyte solution. Further studies are needed to establish a causal relationship. {04}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Allergic reaction{01}{20}{21} (skin rash)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Bloating{01}{04}{05}{06}{14}{20}{21}{22}
    
nausea{01}{04}{05}{14}{20}{21}{22}

Incidence less frequent
    
Abdominal or stomach cramps{01}{04}{05}{06}{14}{20}{21}
    
anal irritation{01}{04}{14}{20}{21}
    
vomiting{01}{05}{14}{20}{21}{22}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Polyethylene Glycol and Electrolytes (Local).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Other oral medicines administered within 1 hour of solution
Other medical problems, especially intestinal obstruction, paralytic ileus, perforated bowel, toxic colitis, or toxic megacolon

Proper use of this medication
Special preparatory instructions may be given; patient should inquire in advance

» Taking solution exactly as directed for best test results

» Drinking all the solution for best results, unless otherwise directed by physician

» Fasting for at least 3 hours prior to ingestion of solution; clear liquids are allowed after ingestion of solution

Directions for the preparation of the powder dosage form

» Proper dosing

» Proper storage


Side/adverse effects
Signs of potential side effects, especially allergic reaction


General Dosing Information

Diet/Nutrition
Fasting is recommended for at least 3 hours prior to administration of the PEG-electrolyte solution. {01} {14} {20} {21} {22}

The PEG-electrolyte solution may be administered on the morning of the examination, as long as enough time is allowed for the patient to drink the solution (3 hours) and for complete bowel evacuation (1 additional hour). If the patient is having a barium enema examination, the PEG-electrolyte solution should be administered early (e.g., 6 pm) the evening before the examination to permit proper mucosal coating by barium. No foods except clear liquids are allowed after administration of the solution. {01} {16}

Rapid drinking of each portion of the the PEG-electrolyte solution is recommended rather than drinking small amounts continuously. {01} {14} {20} {21} {22}


Oral Dosage Forms

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES ORAL SOLUTION

Usual adult and adolescent dose
Bowel evacuant
Oral, 240 mL every ten minutes, up to 4 L, or until the fecal discharge is clear and free of solid matter.{01}{14}{17}{20}{21}{22}{25}{26}

Note: May also be given via nasogastric tube at a rate of 20 to 30 mL per minute{01}{02}{14}{20}{21} (1.2 to 1.8 L per hour).{14}{20}{21}{25}{26}



Usual Pediatric Dose
Bowel evacuant
Oral or by continuous nasogastric drip, 25 to 40 mL per kg of body weight per hour until the fecal discharge is clear and free of solid matter. {16} {17}


Usual Geriatric Dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


Product
Content (mg/100 mL)
PEG 3350
NaCl
NaHCO 3
Na 2SO 4
KCl
U.S.—
         
OCL (Rx)
6000
146
168
569
75
Canada—
         
Peglyte (OTC)
5960
150
170
570
80

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F). Store in a tight container.

Incompatibilities:
The addition of flavoring agents, such as sugar, nutritional supplements, or other sweeteners, is not recommended. Such additives may change the osmolality of the solution; sucrose or glucose may cause fluid and electrolyte absorption. Additives may also predispose to colonic bacterial fermentation and formation of combustible gases. {01} {04}{25}{26}


POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION USP

Usual adult and adolescent dose
Bowel evacuant
See Polyethylene Glycol 3350 and Electrolytes Oral Solution


Usual Pediatric Dose
Bowel evacuant
See Polyethylene Glycol 3350 and Electrolytes Oral Solution


Usual Geriatric Dose
See Polyethylene Glycol 3350 and Electrolytes Oral Solution.

Strength(s) usually available
U.S.—


Product

Content (mg/100 mL)
PEG 3350
NaCl
NaHCO 3
Na 2SO 4
KCl
U.S.—
Co-Lav (Rx)
Colovage (Rx)
Colyte (Rx)
Colyte-flavored (Rx)
Colyte with Flavor Packs (Rx)
Go-Evac (Rx)
GoLYTELY (Rx)
PEG-3350 & Electrolytes (Rx)
6000
146
168
568
74.5
NuLYTELY (Rx)
10500
280
143

37
NuLYTELY,
Cherry
Flavor (Rx)
         
Canada—
Colyte (OTC)
GoLYTELY (OTC)
Klean-Prep (OTC)
6000
146
168
568
75
Peglyte (OTC)
6000
150
170
570
80

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F) {20} {21}, unless otherwise specified by manufacturer. Store in a tight container. {24}{25}{26}.

Note: After reconstitution, solution should be refrigerated to improve palatability. {04}


Preparation of dosage form:
See manufacturer's package label for complete instructions on reconstitution.{01}

Tap water must be used for reconstitution.{01}

To assure that all ingredients have dissolved, solution must be shaken vigorously.{01}

Stability:
Reconstituted solution should be used within 48 hours. Unused portion should be discarded. {14} {20}{21}{22}{25}{26}

Incompatibilities:
The addition of flavoring agents, such as sugar, nutritional supplements, or other sweeteners, is not recommended. {14} {20} {21} {22}{25}{26} Such additives may change the osmolality of the solution; sucrose or glucose may cause fluid and electrolyte absorption. Additives may also predispose to colonic bacterial fermentation and formation of combustible gases. {01} {04}



Revised: 08/29/2000



References
  1. OCL package insert (Abbott—US), Rev 1986, Rec 2/24/92.
  1. Ernstoff JJ, Howard DA, Marshall JB, et al. A randomized blinded clinical trial of a rapid colonic lavage solution (Golytely) compared with standard preparation for colonoscopy and barium enema. Gastroenterology 1983; 84: 1512-6.
  1. Beck DE, Harford FJ, DiPalma JA, et al. Bowel cleansing with polyethylene glycol electrolyte lavage solution. Southern Med J 1985; 78(12): 1414-6.
  1. DiPalma JA, Brady CE. Colon cleansing for diagnostic and surgical procedures: polyethylene glycol-electrolyte lavage solution. Am J Gastroenterol 1989; 84(9): 1008-16.
  1. AMA Drug evaluations. 6th ed. Chicago: American Medical Association, September 1986: 979.
  1. Thomas G, Brozinsky JI. Patient acceptance and effectiveness of a balanced lavage solution (Golytely) versus the standard preparation for colonoscopy. Gastroenterology 1982; 82: 435-7.
  1. Girard CM, Rugh KS, DiPalma JA, et al. Comparison of Golytely lavage with standard diet/cathartic preparation for double contrast barium enema. Am J Roentgenol 1984; 142: 1147-9.
  1. Beck DE, Harford FJ, DiPalma JA. Comparison of cleansing methods in preparation for colonic surgery. Dis Colon Rectum 1985; 28: 491-5.
  1. Davis GR, Santa Ana CA, Morawski SG, et al. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology 1980; 78: 991-5.
  1. Brady CE III, DiPalma JA, Morawski SG, et al. Urinary excretion of polyethylene glycol 3350 and sulfate after gut lavage with polyethylene glycol electrolyte lavage solution. Gastroenterology 1986; 90: 1914-8.
  1. DiPalma JA, Brady CE III, Pierson WP. Colon cleansing: acceptance by older patients. Am J Gastroenterol 1986; 81: 652-5.
  1. Tolia V, Fleming S, Dubois RS. Use of Golytely in children and adolescents. J Pediatr Gastroenterol Nutr 1984; 29: 177.
  1. Beck DE, Fazio VW, Jagelman DG. Comparison of oral lavage methods for preoperative colonic cleansing. Dis Colon Rectum 1986; 29: 699-703.
  1. Cherry Flavor NuLYTELY package insert (Braintree—US), Rev 8/94, Rec 3/31/95.
  1. Schiller LR, Emmett M, Santa Ana CA, et al. Osmotic effects of polyethylene glycol. Gastroenterology 1988; 94: 933-41.
  1. Reviewers" responses to monograph revision of 2/24/92.
  1. Goodale EP, Noble TA. Pediatric bowel evacuation with a polyethylene glycol and iso-osmolar solution. DICP Ann Pharmacother 1989; 23: 1008.
  1. Sondheimer JM, Sokol RJ, Taylor SF. Safety, efficacy, and tolerance of intestinal lavage in pediatric patients undergoing diagnostic colonoscopy. J Pediatr 1991; 119: 148-52.
  1. Peglyte (Pharmascience). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 27th ed. Ottawa: Canadian Pharmaceutical Association, 1992: 858.
  1. Colyte (Reed & Carnrick). In: PDR Physicians" desk reference. 49th ed. 1995. Montvale, NJ: Medical Economics Data, 1995: 1948-9.
  1. GoLYTELY (Braintree). In: PDR Physicians" desk reference. 49th ed. 1995. Montvale, NJ: Medical Economics Data, 1995: 657-8.
  1. Klean-Prep (Richmond). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 30th ed. Ottawa: Canadian Pharmaceutical Association, 1995: 672-3.
  1. Fleeger CA, editor. USP dictionary of USAN and international drug names 1995. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 547, 617, 620.
  1. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 1241-2.
  1. Product Information: Colyte with Flavor Packs for oral solution, PEG-3350 and electrolytes. Schwarz Pharma, Milwaukee, WI, (PI revised 11/1998) reviewed 08/2000.
  1. Product Information: PEG-3350 & Electrolytes for oral solution, polyethylene glycol & electrolytes. Kremers Urban, Mequon, WI, (PI revised 11/1996) reviewed 08/2000.
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