section name header

Introduction

VA Class:IR100

ATC Class:A06AG

AHFS Class:

Generic Name(s):

Glycerin (glycerol), polyethylene glycol (PEG), and sorbitol are hyperosmotic laxatives.238,245,246,247,248,253

Dosage and Administration

[Section Outline]

Prior to bowel cleansing, a copy of the patient information (containing careful instructions on the proper methods of reconstitution and administration of the laxatives) provided by the manufacturer should be given to the patient.245,246,247,248,253

Reconstitution and Administration !!navigator!!

Glycerin solutions 239,242 and suppositories should be administered rectally.238,240,241,254,255 Polyethylene glycol 3350 electrolyte solutions are administered orally or through a nasogastric tube.244,245,246,247,248,253 Solutions of sorbitol (25-30%) usually are administered rectally.

Oral or Nasogastric Administration (Polyethylene glycol 3350, Polyethylene glycol 3350 with Electrolytes)

Reconstitution

When polyethylene glycol is used for constipation, polyethylene glycol 3350 powder for oral solution (MiraLAX®) should be reconstituted with 120-240 mL of water (cold, room temperature, or hot).244

When polyethylene glycol is used for bowel cleansing, polyethylene glycol 3350 powder (with electrolytes) for oral or nasogastric solution should be reconstituted with the appropriate amount of lukewarm water as directed by the manufacturer.245,246,247,248,252,253 The solution should be shaken vigorously until the ingredients are dissolved; additional ingredients (e.g., flavorings other than those provided by the manufacturers) are not recommended.245,246,247,248,252,253

The reconstituted solutions should be refrigerated.245,246,247,248,252,253 Palatability of the oral solution may be increased if the reconstituted solution is chilled prior to administration;245,247 however, a chilled polyethylene glycol 3350 electrolyte solution is not recommended for infants.253

Administration of Polyethylene Glycol 3350 Electrolyte Solutions for Bowel Cleansing

Patients should fast for approximately 3 or 4 hours before administration of polyethylene glycol 3350 electrolyte solution.245,246,247,253 In addition, patients should be advised not to eat solid foods for at least 2 hours prior to administration of the drug.245,246,247,253 Polyethylene glycol 3350 electrolyte solutions are administered orally, but may be given through a nasogastric tube if patients are unwilling or unable to drink the solution.245,246,247 Rapid drinking of each polyethylene glycol 3350 electrolyte solution portion is preferred to drinking small amounts continuously.245,246,247,252,253

Polyethylene glycol 3350 electrolyte solutions may be given by single-dose regimens (usually on the evening prior to the colonoscopy [e.g., 6 p.m.]) or, if the procedure is scheduled for midmorning or later, patients should be allowed 3 hours for drinking the solution and 1 hour for complete bowel evacuation).245,248,251,261,262 Alternatively, a divided-dose regimen (usually consuming a portion on the evening prior to the colonoscopy and the remaining solution on the morning of the colonoscopy) may be used.248,251,261,262 Clinical studies suggest that the divided-dose polyethylene glycol 3350 electrolyte solution regimen (e.g., 2-3 L the evening before and 1 L the morning of the procedure) is superior to the standard single-dose regimen (e.g., 4 L administered on the evening prior to the procedure).251,261,262 In one study, polyethylene glycol 3350 electrolyte solution consumption less than 5 hours before colonoscopy was superior to a regimen administered 19 hours or more before the procedure.251,260 If a patient has an afternoon colonoscopy, a portion of the polyethylene glycol 3350 solution should be administered on the morning of the colonoscopy to improve bowel cleansing results.251,260

Administration Precautions for Polyethylene glycol 3350 Electrolyte Solutions

Polyethylene glycol 3350 electrolyte solutions should be used with caution in patients with impaired gag reflex, unconscious or semiconscious patients, and those prone to regurgitation or aspiration; these patients should be observed during administration, especially if the solution is administered through a nasogastric tube.245,246,247,248,252,253

If severe discomfort or distention occurs while consuming polyethylene glycol 3350 electrolyte solutions, administration of the drug should be slowed or temporarily discontinued until symptoms abate.245,246,248,252,253

Rectal Administration (Glycerin)

Regular glycerin suppositories should be moistened with lukewarm water before insertion high into the rectum.269 (See Dosage and Administration: Administration, in the Cathartics and Laxatives General Statement 56:12.) With steady pressure, the tip of the suppository should be inserted gently high into rectum.238,240,241,254,255 Patients should be instructed to retain the suppository for 15 minutes; melting of the suppository is not required to produce laxative action.238,240,241,254,255

Before administering glycerin laxative enemas, the patient should initially lie on the left side with the right knee bent and arms resting comfortably239,242 or should kneel on the bed with the head and chest lowered and forward until the left side of the face is resting on the surface of the bed.239,269 With steady pressure, the enema nozzle should be inserted into the rectum with side-to-side movement with the tip pointing toward navel until the entire dose is expelled.239,242,269 While squeezing the container, the tip should be removed from rectum and the unit discarded.239,242 Use of glycerin laxative enemas should be discontinued if resistance is encountered.239,242 Enema fluids, if properly introduced, usually provide adequate evacuation if retained until definite lower abdominal cramping is felt.269 (See Dosage and Administration: Administration, in the Cathartics and Laxatives General Statement 56:12.)

Dosage !!navigator!!

Constipation

For the treatment of constipation, hyperosmotic laxatives should be administered only at infrequent intervals in single doses at the lowest effective dosage level, and usually for periods not exceeding 1 week; laxatives should be used for longer periods only under the management of a clinician and as part of a carefully planned therapeutic regimen.269 (See Dosage and Administration: Dosage, in the Cathartics and Laxatives General Statement 56:12.)

Only extremely high oral doses of sorbitol (25 g daily) or glycerin exert laxative action.269 (See Pharmacology: Hyperosmotic Laxatives, in the Cathartics and Laxatives General Statement 56:12.)

Glycerin

For the treatment of constipation, the usual rectal dose of glycerin for adults is 2-3 g as a suppository238,240 or 5.6-15.3 g (5-15 mL) as an enema.239 Children 2 to younger than 6 years of age may receive 1-1.2 g as a suppository240,241 or 2.3 g (2.3 mL) as an enema;242 children 6 years of age and older may be given 2-2.1 g as a suppository238,240 or 5.6 g (5.5 mL) as an enema.239

If a bowel movement does not occur after using the glycerin suppository or enema, the drug should be discontinued.239,241,242

Sorbitol

For the treatment of constipation, the usual rectal dose of sorbitol as a 25-30% solution is (administered as enemas) 120 mL for adults and children 12 years of age and older or 30-60 mL for children 2-11 years of age.

When used as an adjunct to sodium polystyrene sulfonate resin, 15 mL of a 70% sorbitol solution may be administered orally until diarrhea occurs or 20-100 mL of the solution may be used as an oral vehicle for the resin. Alternatively, the resin may be given rectally as a 25% solution of sorbitol (see Sodium Polystyrene Sulfonate 40:18.18.)

Polyethylene Glycol 3350

For the treatment of constipation, the usual oral dosage in adults is 17 g (MiraLAX®) daily as needed for up to 7 days.244

Bowel Cleansing

Polyethylene Glycol 3350 (with Electrolytes)

To empty the bowel prior to colonoscopy or barium radiologic examination, children 6 months of age or older may receive orally or by nasogastric tube 25 mL/kg (2.6 g/kg) per hour (NuLYTELY®or Trilyte®) until watery stool is clear and free of solid matter (NuLYTELY®or Trilyte®) or 4 L is consumed (Trilyte®).246,253

To empty the bowel prior to colonoscopy or barium radiologic examination, the recommended dosage given by nasogastric tube in adults is 4 L administered at a rate of 20-30 mL (1.18-1.77 g [Golytely®]; 2.1-3.15 g [Nulytely®]; 1.2-1.8 g [Colyte®]) per minute (1.2-1.8 L/hour).245,246,247,251,259

To empty the bowel prior to colonoscopy or barium radiologic examination, adults may receive 240 mL (about 14 g [GoLYTELY®], 25 g [NuLYTELY®], about 14 g [Colyte®], 25 g [Trilyte®]) orally every 10 minutes until rectal output is clear or 4 L is consumed.245,246,247,253,259 Alternatively, adults may receive a single-dose regimen of 240 mL (24 g [MoviPrep®]) orally every 15 minutes until 1 L is consumed followed by drinking of an additional 1 L (for a total of 2 L of MoviPrep®) 1.5 hours later.248 An additional 1 L of clear liquid shoudl be ingested during the evening prior the procedure.248

When using a divided-dose regimen, adults may receive 240 mL (24 g [MoviPrep®]) every 15 minutes until 1 L is consumed followed by drinking an additional 0.5 L of clear liquid in the evening before the procedure,248 On the morning of the procedure, these adults should receive 240 mL (24 g [MoviPrep®]) every 15 minutes until 1 L is consumed followed by drinking an additional 0.5 L of clear liquid at least 1 hour prior to the procedure.248

Alternatively, adults may receive a combination regimen of polyethylene glycol 3350 electrolyte solution and bisacodyl (HalfLytely®). In this regimen, patients initially should receive 20 mg of bisacodyl (four 5-mg bisacodyl delayed-release tablets) and wait for a bowel movement or a maximum of 6 hours, then drink 240 mL of polyethylene glycol 3350 electrolyte solution every 10 minutes until a total of 2 L has been consumed.

Other Information

[Section Outline]

Pharmacokinetics

Absorption !!navigator!!

Following rectal administration, glycerin and sorbitol are poorly absorbed; colonic evacuation of glycerin rectal suppositories or enemas occurs within 15-60 minutes, while colonic evacuation of oral sorbitol occurs within 24-48 hours.239,240,241,242,250

The manufacturers of polyethylene glycol 3350 preparations state that the osmotic effects of the drug result in virtually no net absorption or excretion of ions or water.245,247,248,252,253 Following oral administration of polyethylene glycol 3350 (MiraLAX®), colonic evacuation occurs in 1-3 days,244 while following oral administration of polyethylene glycol 3350 electrolyte solutions (GoLYTELY®, NuLYTELY®, Colyte®, MoviPrep®, Trilyte®), initial bowel movement usually occurs within 1 hour.245,246,247,248,250,253 In addition, following oral administration of polyethylene glycol 3350 electrolyte solutions (GoLYTELY®, NuLYTELY®, Trilyte®), complete bowel evacuation usually occurs within 4 hours.245,246,253 Following oral administration of polyethylene glycol 3350 electrolyte solution and bisacodyl (HalfLytely® bowel kit), initial bowel movement usually occurs within 1-6 hours after ingesting the bisacodyl tablets; a watery bowel movement usually occurs within 1 hour after ingesting the polyethylene glycol 3350 electrolyte solution portion of the kit.252

Distribution !!navigator!!

It is not known whether polyethylene glycol 3350 (MiraLAX®) is distributed into human milk.248

Elimination !!navigator!!

Sorbitol, a nonabsorbable disaccharide, is metabolized by colonic bacteria into acetic and other short chain fatty acids.250

Chemistry and Stability

Chemistry !!navigator!!

Glycerin (glycerol) and sorbitol are hyperosmotic laxatives.

Glycerin

Glycerin (glycerol), a trihydroxy alcohol, occurs as a clear, colorless, syrupy, hygroscopic liquid with a sweet taste and not more than a slight characteristic odor, which is neither harsh nor disagreeable. The drug is miscible with water and with alcohol and has a specific gravity of not less than 1.249.

Sorbitol

Sorbitol (d-glucitol), a polyalcohol of sorbose, occurs as white, hygroscopic powder, granules, or flakes having a sweet taste and is very soluble in water and slightly soluble in alcohol. Sorbitol solutions occur as clear, sweet-tasting liquids.

Stability !!navigator!!

Glycerin

Glycerin rectal suppositories should preferably be stored at less than 25°C.

Oral Polyethylene Glycol Powder for Solution

Polyethylene glycol 3350 Powder for Solution (MiraLAX®) should be stored at 20-25°C.244

Oral Polyethylene Glycol (with Electrolytes) Powder for Solution

Colyte® should be stored at 20-25°C (may be exposed to 15-30°C).247 Following reconstitution, the solution should be refrigerated and used within 48 hours; unused portions should be discarded.245

GoLYTELY® should be stored in tight containers at 15-30°C.245 Following reconstitution, the solution should be refrigerated and used within 48 hours; unused portions should be discarded.245

MoviPrep®should be stored at 25°C (may be exposed to 15-30°C).248 Following reconstitution, the solution should be refrigerated and used within 48 hours; unused portions should be discarded.248

NuLyTELY® should be stored in tight containers at 25°C.246 Following reconstitution the solution should be refrigerated and used within 48 hours; unused portions should be discarded.246

Sorbitol

Oral or rectal sorbitol 70% solution should be stored at 15-30°C.257

Additional Information

For further information on the pharmacology, uses, cautions, drug interactions, and dosage and administration of the hyperosmotic laxatives, see the Cathartics and Laxatives General Statement 56:12.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Glycerin (Glycerol)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Rectal

Solution

2.3 g

Fleet® Babylax®

Fleet

5.6 g

Fleet® Liquid Glycerin Suppositories

Fleet

Suppositories

1 g*

Fleet® Child Glycerin Suppositories

Fleet

1.2 g*

Colace® Glycerin Suppositories

Purdue

2 g*

Fleet® Adult Glycerin Suppositories

Fleet

2.1 g*

Colace® Glycerin Suppositories

Purdue

82.5%*

Sani Supp® Adult Glycerin Suppositories

G&W

Sani Supp® Pediatric Glycerin Suppositories

G&W

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Polyethylene Glycol 3350

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution

17 g

MiraLAX®

Schering-Plough

Polyethylene Glycol 3350 and Electrolytes

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution

Polyethylene glycol 200 g, ascorbic acid 9.4 g/, potassium chloride 2.03 g, sodium ascorbate 11.8 g, sodium chloride 5.38 g, and sodium sulfate 15 g/2 L

MoviPrep®

Salix

Polyethylene glycol 236 g, potassium chloride 2.97 g/L, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, and sodium sulfate 22.74 g/4 L

GoLYTELY®

Braintree

Polyethylene glycol 240 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium chloride 5.84 g, and sodium sulfate 22.72 g/4 L

Colyte®

Schwarz

Polyethylene glycol 420 g, potassium chloride 1.48 g/4 L, sodium bicarbonate 5.72 g, and sodium chloride 11.2 g/4 L

NuLYTELY®

Braintree

Trilyte®

Schwarz

Polyethylene Glycol 3350, Electrolytes and Bisacodyl Kit

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Kit

For solution, oral, Polyethylene glycol 210 g, sodium chloride 5.6 g, sodium bicarbonate 2.86 g, and potassium chloride 0.74 g/2 L

4 Tablets, enteric-coated, Bisacodyl 5 mg

HalfLytely®

Braintree

Sorbitol (d-Glucitol)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Copyright

AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

References

AHFS drug information 2007. McEvoy GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2919-23.

238. Fleet. Fleet® (glycerin) suppositories prescribing information. Lynchburg, VA. 2004.

239. Fleet. Fleet® (glycerin) liquid suppositories prescribing information. Lynchburg, VA. 2004.

240. Purdue. Colace® (glycerin) suppositories prescribing information. Stamford, CT; 2007.

241. Fleet. Fleet® (glycerin) children's suppositories prescribing information. Lynchburg, VA. 2004.

242. Fleet. Fleet® Babylax® (glycerin) children's liquid suppositories prescribing information. Lynchburg, VA. 2004.

243. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:739.

244. Schering-Plough. MiraLAX® (polyethylene glycol 3350) for oral solution prescribing information. Kenilworth, NJ. 2007. OTC Package insert

245. Braintree. GoLYTELY® (polyethylene glycol -3350 and electrolytes) for oral solution prescribing information. Braintree, MA; 2001 Nov.

246. Braintree. NuLYTELY® with flavor packs (polyethylene glycol -3350 with sodium chloride, sodium bicarbonate and potassium chloride) for oral solution prescribing information. Braintree; MA. 2004 Jun.

247. Schwarz. Colyte® with flavor packs (polyethylene glycol -3350 with electrolytes) for oral solution prescribing information. Milwaukee, WI. 2005 Jun.

248. Salix. MoviPrep® (polyethylene glycol 3350 with sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid) for oral solution prescribing information. Morrisville, NC. 2006 Aug.

249. Salix . MoviPrep® (polyethylene glycol 3350 with electrolytes) for oral solution patient information. Morrisville, NC; 2004 Jun.

250. Locke GR, Pemberton JH, Phillips SF for American Gastroenterological Association. AGA technical review on constipation. Gastroenterology . 2000; 119:1766-1778. Available at ([Web]). Accessed 2007 Aug 8. [PubMed 11113099]

251. Wexner SD, Beck DE, Baron TH et al. American Society of Colon and Rectal Surgeons, American Society for Gastrointestinal Endoscopy, Society of American Gastrointestinal and Endoscopic Surgeons. A consensus document on bowel preparation before colonoscopy: prepared by a task force from American Society of Colon and Rectal Surgeons, American Society for Gastrointestinal Endoscopy, and Society of American Gastrointestinal and Endoscopic Surgeons. Gastrointest Endosc. 2006; 63:894-909. Available at ([Web]). Accessed 2007 Aug 8. [PubMed 16733101]

252. Braintree. HalfLytely® with flavor packs (polyethylene glycol-3350 with sodium chloride, sodium bicarbonate and potassium chloride) for oral solution and bisacodyl delayed-release tablets (Bowel Prep Kit) prescribing information. Braintree, MA; 2006 May.

253. Schwarz. Trilyte® with flavor packs (polyethylene glycol -3350 with sodium chloride, sodium bicarbonate and potassium chloride) for oral solution prescribing information. Milwaukee, WI; 2006 Dec.

254. G & W. Sani Supp® (glycerin) adult suppositories prescribing information. South Plainfield, NJ. 2007 Jun.

255. G & W . Sani Supp® (glycerin) pediatric suppositories prescribing information. South Plainfield, NJ. 2007 Jun.

256. AHFS drug information 2007. McEvoy GK, ed. Sodium polystyrene sulfonate . Bethesda, MD: American Society of Health-System Pharmacists; 2007:2675-6.

257. Carolina Medical Products. Sorbitol solution prescribing information. Farmville, NC; 2005 May.

258. Anon. MoviPrep®: a new bowel prep for colonoscopy. Med Lett Drugs Ther . 2007; 49:47-8.

259. Anon. Colonoscopy preparations. Med Lett Drugs Ther . 2005; 47:53-4.

260. Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy—timing is the key! Dis Colon Rectum . 1998; 41:1223-5,

261. El Sayed AMA, Kanafani ZA, Mourad FH et al. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc . 2003; 58:36-40. [PubMed 12838218]

262. Park JS, Sohn CI, Hwang SJ et al. Quality and effect of single dose versus split dose of polyethylene glycol bowel preparation for early-morning colonoscopy. Endoscopy. 2007; 39:616-9. [PubMed 17611916]

263. AHFS drug information 2007. McEvoy GK, ed. Ascorbic Acid. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3631-4.

264. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther . 1982; 24:1-2.

265. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA . 1985; 254:400-2. [PubMed 2861297]

266. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm . 1984; 9:26,28-30.

267. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist . 1983; 48:54993-5.

268. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist . 1983; 48:31376-82.

269. AHFS drug information 2008. McEvoy GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2974-77.