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Drugs and Health Products

Monograph: Psyllium - Plantago afra

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 ingredient. It is a referenced document to be used as a labelling standard. Notes: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion.

Date: 2009-06-18

NHPID Name

Plantago afra (USDA 2008)

Proper Name(s)

Plantago afra L. (Plantaginaceae) ( USDA 2008 )

Common Name(s)

Psyllium ( McGuffin et al. 2000 )

Source Material

Seed ( EMEA 2006 , ESCOP 2003 )

Route Of Administration

Oral

Dosage Form(s)

The only acceptable pharmaceutical dosage forms are powder and capsules. This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Children and adolescents 6 - 12 years:

Preparation: Dry, Powder & Fresh

Dose(s):
Seed:
1.25 - 25 Grams per day , not to exceed 8 Grams per single dose
 (EMEA 2006, ESCOP 2003, WHO 1999, FDA 1985)

Directions For Use:

Adults and adolescents 13 and over:

Preparation: Dry, Powder & Fresh

Dose(s):
Seed:
2.5 - 40 Grams per day , not to exceed 13 Grams per single dose
 (EMEA 2006, ESCOP 2003, Williamson 2003, Blumenthal et al. 2000)

Directions For Use:


  • For psyllium seed, the maximum single dose (13 g) for adults and adolescents (equal or greater than 13 y) is based on the consensus of evidence from several references. The maximum single dose (8 g) for children and adolescents (6-12 y) was calculated as a fraction of the maximum adult doses
  • See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms worsen or if laxative effect does not occur within seven days  (Pray 2006, CPA 2002)
  • Consult a health care practitioner immediately if you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product  (EMEA 2006a, ESCOP 2003)
  • Consult a health care practitioner prior to use if you are taking medications which inhibit peristaltic movement (e.g. opioids, loperamide)  (EMEA 2006a, ESCOP 2003)
  • Consult a health care practitioner prior to use if you have symptoms such as abdominal pain, nausea, vomiting or fever (as these could be signs of abnormal constrictions of the gastrointestinal tract, diseases of the oesophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, faecal impaction, inflamed bowel or appendicitis)  (EMEA 2006a, ESCOP 2003, Blumenthal et al. 2000, Bradley 1992, FDA 1985)

Contraindication(s):
  • Do not use if you are experiencing a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative product  (EMEA 2006a, ESCOP 2003)
  • Do not use if you have diabetes mellitus in which blood sugar is difficult to regulate  (EMEA 2006a, ESCOP 2003, Blumenthal et al. 2000, Bradley 1992)
  • Do not use if you have difficulty swallowing  (EMEA 2006a)

Known Adverse Reaction(s):

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in one of the following pharmacopoeial monographs: 'Psyllium Seed' or 'Ispaghula Seed' monograph in British Pharmacopoeia, 'Psyllium Seed' or 'Ispaghula Seed' monograph in European Pharmacopoeia, and 'Plantago Seed' or 'Psyllium Hydrophilic Mucilloid for Oral Suspension' or 'Psyllium Hemicellulose' monograph in US Pharamcopoeia.

References cited

  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • CPA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • EMEA 2006a. European Medicines Agency. Final Community Herbal Monograph on Plantago afra L. et Plantago indica L., semen. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/psyllii_semen/34086505enfin.pdf
  • EMEA 2006b. European Medicines Agency. Final Community Herbal Monograph on Plantago ovata Forssk., seminis tegumentum. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/plantaginis_ovatae_seminis_tegumentum/34085705enfin.pdf
  • EMEA 2006c. European Medicines Agency. Final Community Herbal Monograph on Plantago ovata Forssk., semen. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/plantaginis_ovatae_semen/34086105enfin.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • FDA 1985: Unites States Food and Drug Administration. Laxative Drug Products for Over-the-Counter Human Use; Tentative Final Monograph. Proposed Rules sections 334.10 and 334.52. [online]. Federal Register Volume 50, Number 10, Tuesday, January 15, 1985. Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 January 27]. Available from: http://www.fda.gov/cder/otcmonographs/category_sort/laxative.htm
  • Gennaro AR, editor. Remington: The Science and Practice of Pharmacy, 20th edition. Washington (DC): Lippincott Williams and Wilkins; 2000
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.
  • WHO 2007: World Health Organization (WHO) Monographs on Selected Medicinal Plants, Volume 3. Geneva (CHE): World Health Organization.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.

References reviewed

  • Ashraf W, Pfeiffer RF, Park F, Lof J, Quigley EM. 1997. Constipation in Parkinson's disease: objective assessment and response to psyllium. Movement Disorders: Official Journal of the Movement Disorder Society 12(6):946-951.
  • 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.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Cheskin LJ, Kamal N, Crowell MD, Schuster MM, Whitehead WE. 1995. Mechanisms of constipation in older persons and effects of fiber compared with placebo. Journal of the American Geriatrics Society 43(6):666-669.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, Bulk Forming Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2009 January 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxb_laxm-eng.php
  • HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, General Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2009 January 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxat-eng.php
  • Liel Y, Harman-Boehm I and Shany S. 1996. Evidence for a clinically important adverse effect of fiber-enriched diet on the bioavailability of levothyroxine in adult hypothyroid patients. Journal of Clinical Endocrinology and Metabolism 81(2):857-859.
  • Marteau P, Flourié B, Cherbut C, Corrèze JL, Pellier P, Seylaz J, Rambaud JC.1994. Digestibility and bulking effect of ispaghula husks in healthy humans. Gut 35(12):1747-1752.
  • McRorie JW, Daggy BP, Morel JG, Diersing PS, Miner PB, Robinson M. 1998. Psyllium is superior to docusate sodium for treatment of chronic constipation. Alimentary Pharmacology & Therapeutics 12(5):491-497.
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

Appendix 1: Examples of appropriate dosage preparations and frequencies of use

Seed:

Adults and adolescents, ≥ 13 years:

Plantago seed (P. ovata, P. arenaria or P. afra (USP 32; WHO 1999)):

  • 7.5 g, 1-3 times per day (WHO 1999)
  • 2.5-30 g, per day (FDA 1985)

P. arenaria and P. afra:

  • 25-40 g divided into 3 doses, per day (EMEA 2006a)
  • 10-30 g, per day (ESCOP 2003a)
  • 6-12 g, per day (Williamson 2003)
  • 5-10 g, 2-3 times per day (Blumenthal et al. 2000a)

P. ovata:

  • 8-40 g divided into 2-3 doses, per day (EMEA 2006b)
  • 7-30 g, per day (ESCOP 2003b)
  • 5-10 g, per day (Williamson 2003)
  • 5-10 g, 3-4 times per day (Blumenthal et al. 2000b)

Children and adolescents, 6-12 years:

Plantago seed (P. ovata, P. arenaria or P. afra (WHO 1999)):

  • 3.8 g, 1-3 times per day (WHO 1999)
  • 1.25-15 g, per day (FDA 1985)

P. arenaria and P. afra:

  • 12-25 g divided into 3 doses, per day (EMEA 2006a)
  • 5-15 g, per day (ESCOP 2003a)

P. ovata:

  • 4-25 g divided into 2-3 doses, per day (EMEA 2006b)
  • 3.5-15 g, per day (ESCOP 2003b)

Seed Husk:

Adults and adolescents, ≥ 13 years:

Psyllium seed husks (P. ovata or P. arenaria):

2.5-30 g, per day (FDA 1985)

P. ovata:

  • 7-11 g divided into 1-3 doses, per day (EMEA 2006c)
  • 4-20 g divided into 2-3 doses, per day (ESCOP 2003c)
  • 3.5-7 g, per day (Williamson 2003)
  • 4-5 g, 1-4 times per day (Blumenthal et al. 2000c)
  • 3-5 g, 1-3 times per day (Bradley 1992)

Children and adolescents, 6-12 years:

Psyllium seed husks (P. ovata or P. arenaria):

1.25-15 g, per day (FDA 1985)

P. ovata:

  • 3-8 g [divided into] in 1-3 doses, per day (EMEA 2006c)
  • 2-10 g [divided into] in 2-3 doses, per day (ESCOP 2003c)