Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Hyperosmotic Laxatives

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 7, 2006

Note: The mechanism of action for hyperosmotic laxatives is the attraction of water into the stool, promoting bowel movement.

Table 1: Medicinal ingredients
Proper name(s) Common name(s) Source material(s)

Table 1 Footnotes

Table 1 Footnote 1

Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs Guidance Document ) or requires citation of an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

The CAS number may be provided as additional information.
Note: Optional pharmacopoeial standard formulations are shown in Appendix 1.

Return to Table 1 footnote2 referrer

Glycerine/glycerol
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
Glycerine/glycerol
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
Glycerine/glycerol1
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
CAS No. 000056-81-52
Sorbitol/D-glucitol
(NF 24; BP 2003; O'Neil et al. 2001)
Sorbitol/D-glucitol
(NF 24; BP 2003; O'Neil et al. 2001)
Sorbitol/D-glucitol1
(NF 24; BP 2003; O'Neil et al. 2001)
CAS No. 000050-70-42

Route(s) of administration

Rectal (FDA 1985)

Dosage form(s)

Suppository, enema (FDA 1985)

Use(s) or Purpose(s)

Statement(s) to the effect of

  • For relief of occasional constipation (irregularity of the bowel; lack of regular bowel movement) (FDA 1985)
  • Laxative (FDA 1985)
  • Promotes evacuation of the lower bowel (Sweetman).

Dose

Subpopulation(s)

For all products:

Adults and children 2 years and older (FDA 1985)

Quantity(ies)

Glycerine rectal suppository:

Children 2-5 years: 1.0-1.7 g per day (FDA 1985)
Adults and children 6 years and older: 2-3 g per day (FDA 1985)

Glycerine rectal enema:

Children 2-5 years: 2-5 mL of 80% v/v solution per day (FDA 1985)
Adults and children 6 years and older: 5-15 mL of 80% v/v solution (FDA 1985)

Sorbitol rectal enema:

Children 2-11 years: 30-60 mL of 25-30% w/v solution (FDA 1985)
Adults and children 12 years and older: 120 mL of 25-30% w/v solution (FDA 1985)

Directions for use

Statement(s) to the effect of

For all products:

Do not take within 2 hours of another medicine as the desired effect of the other medicine may be reduced (Berardi et al. 2002).

For suppositories:

  • Remove suppository from wrapper (for suppositories packaged in a wrapper) (FDA 1990).
  • Gently insert into the rectum
  • Allow 15 minutes to 1 hour to produce bowel movement (FDA 1985).

For enemas:

  • Lubricate anus with petroleum jelly before inserting the enema applicator (USP DI 1997).
  • Gently insert the tip of the enema applicator to prevent damage to the rectal wall (USP DI 1997).
  • Allow 15 minutes to 1 hour to produce bowel movement (FDA 1985).

Duration of use

Do not use for more than 7 days (FDA 1985).

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

For all products:
  • Consult a health care practitioner if condition persists or worsens (FDA 1990).
  • Consult a health care practitioner promptly in case of bleeding (FDA 1990).
For products containing glycerine:

Discontinue use and consult a health care practitioner if rectal discomfort or a burning sensation occurs (FDA 1985).

Contraindication(s)

For all products:

Do not use in the presence of abdominal pain, nausea, fever or vomiting (FDA 1985).

For products containing glycerine:

Do not use if you have rectal irritation (Berardi et al. 2002).

Non-medicinal ingredients

Must be chosen from the current List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications

Must comply with the minimum specifications outlined in the current Compendium of Monographs..

References cited

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • BP 2003: British Pharmacopoeia Commission. British Pharmacopoeia. London (UK): The Stationary Office; 2003.
  • FDA 1990. USA Department of Health and Human Services: Food and Drug Administration. 55 CFR Part 346. Next link will take you to another Web site Anorectal Drug Products for Over-the-Counter Human Use; Final Monograph; 1990. [Accessed 2006-01-26].
  • FDA 1985. USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 334. Next link will take you to another Web site Laxative Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; 1985. [Accessed 2005-12-23].
  • NF 24: United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th edition. Whitehouse Station (NJ): Merck and Co., Inc; 2001.
  • USP 29: United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.
  • USP DI 1997. Advice for the Patient, Volume II, 17th edition. Rockville (MD): United States Pharmacopoeial Convention; 1996.

Appendix 1: Optional pharmacopoeial standard formulations

Formulation USP 29 BP 2003
Glycerol/glycerine suppositories X X