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Drugs and Health Products

Carbon Dioxide-releasing Laxatives

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) 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 carbon dioxide-releasing laxatives is the release of carbon dioxide from several ingredients, inducing gentle pressure in the rectum which promotes bowel movement.

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 footnote * referrer

Footnote 2

The CAS number may be provided as additional information.

Return to table 1 footnote + referrer

Monobasic sodium phosphate/Sodium phosphate monobasic (USP 29; O'Neil et al. 2001)

Sodium biphosphate (O'Neil et al. 2001)

Sodium dihydrogen phosphate (O'Neil et al. 2001)

Monosodium orthophosphate (O'Neil et al. 2001)

Primary sodium phosphate (O'Neil et al. 2001)

Sodium phosphate monobasic Table 1 footnote * (USP 29; O'Neil et al. 2001) CAS No. 007558-80-7 Table 1 footnote +

Sodium phosphate monohydrate monobasic Table 1 footnote * (USP 29; O'Neil et al. 2001) CAS No. 010049-21-5 Table 1 footnote +

Sodium phosphate dihydrate monobasic Table 1 footnote * (USP 29; O'Neil et al. 2001) CAS No. 013472-35-0 Table 1 footnote +

Sodium acid pyrophosphate (O'Neil et al. 2001)

Disodium pyrophosphate (Gottschalck and McEwen 2006)

Sodium acid pyrophosphate (O'Neil et al. 2001)

Disodium dihydrogen pyrophosphate

(O'Neil et al. 2001)

Diphosphoric acid disodium salt (Gottschalck and McEwen 2006)

Disodium pyrophosphate (O'Neil et al. 2001) (No USP or BP pharmacopoeial grade) CAS No. 007758-16-9 Table 1 footnote +

Sodium acid pyrophosphate (O'Neil et al. 2001)

Disodium dihydrogen pyrophosphate (O'Neil et al. 2001)

Diphosphoric acid disodium salt (Gottschalck and McEwen 2006)

Sodium bicarbonate (Gottschalck & McEwen 2006; USP 29; Sweetman 2002; O'Neil et al. 2001)

Sodium bicarbonate (Gottschalck and McEwen2006; USP 29; Sweetman 2002; O'Neil et al. 2001)

Baking soda (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al. 2001)

Carbonic acid monosodium salt (Gottschalck and McEwen 2006; USP 29)

Sodium hydrogen carbonate (Gottschalck and McEwen 2006; Sweetman 2002; O'Neil et al. 2001)

Sodium bicarbonate Table 1 footnote * (Gottschalck and McEwen 2006; USP 29; Sweetman 2002; O'Neil et al. 2001) CAS No. 000144-55-8 Table 1 footnote +

Potassium bitartrate (USP 29; O'Neil et al. 2001)

Butanedioic acid 2,3-dihydroxy-, [R-(R*,R*)]-, monopotassium salt (USP 29)

Potassium bitartrate (USP 29; O'Neil et al. 2001)

Potassium acid tartrate (O'Neil et al. 2001)

Potassium hydrogen tartrate (O'Neil et al. 2001)

Cream of tartar (O'Neil et al. 2001)

Potassium bitartrate Table 1 footnote * (USP 29; O'Neil et al. 2001) CAS No. 000868-14-4 Table 1 footnote +

Potassium acid tartrate (O'Neil et al. 2001)

Potassium hydrogen tartrate (O'Neil et al. 2001)

Cream of tartar (O'Neil et al. 2001)

Route(s) of administration

Rectal (FDA 1985)

Dosage form(s)

Suppository (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 2002).

Dose(s)

Subpopulation(s)

Adults and children 12 years and older (FDA 1985)
Quantity(ies)

One suppository per day containing:

1.2-1.5 g Monobasic sodium phosphate + 0.04-0.05 g Sodium acid pyrophosphate + 1-1.5 g Sodium bicarbonate (FDA 1985)

One suppository per day containing:

0.6 g Sodium bicarbonate + 0.9 g Potassium bitartrate (FDA 1985)

Permitted combinations

Medicinal ingredients are not allowed singly; they are permitted only in the above combinations (FDA 1985).

Directions for use

Statements to the effect of

  • Do not take within 2 hours of another medicine as the desired effect of the other medicine may be reduced (Berardi et al. 2002).
  • Remove suppository from wrapper (for suppositories packaged in a wrapper) (FDA 1990).
  • Place under running water for 30 seconds, or in a cup of water for at least 10 seconds before insertion (FDA 1985).
  • Do not lubricate with mineral oil or petrolatum prior to rectal insertion (FDA 1985).
  • Gently insert in the rectum.
  • Allow 5-30 minutes to produce bowel movement (FDA 1985).

Duration of use

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

Risk information

Statements to the effect of

Cautions and warnings

  • Consult a health care practitioner before using if you are on a sodium-restricted diet (FDA 2004).
  • Consult a health care practitioner if condition persists or worsens (FDA 1990).
  • Consult a health care practitioner promptly in case of bleeding (FDA 1990).

Contraindications

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

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

  • 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.
  • FDA 2004: USA Department of Health and Human Services: Food and Drug Administration. Next link will take you to another Web site 21 CFR Part 201.Drug Labeling for Over-the-Counter Drugs; 2004. [Accessed 2006-02-28].
  • FDA 1990: USA Department of Health and Human Services: Food and Drug Administration. Next link will take you to another Web site 55 CFR Part 346. 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. Next link will take you to another Web site 21 CFR Part 334.Laxative Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; 1985. [Accessed 2005-08-30].
  • Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook. 10th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 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.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference. 33rd edition. Grayslake (IL): Pharmaceutical Press; 2002.
  • USP 29: United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.