Psyllium

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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.

Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion.

Date: August 4, 2009

Proper name(s), common name(s) and source material(s):

Table 1: Proper name(s), common name(s) and source material(s)

Proper name(s)	Common name(s)	Source material(s)
Plantago afra L. (Plantaginaceae) (USDA 2003a)	Psyllium (EMEA 2006a)	Seed (EMEA 2006a; ESCOP 2003a)
Plantago arenaria Waldst. & Kit. (Plantaginaceae) (USDA 2003b)	Psyllium (EMEA 2006a; ESCOP 2003a; McGuffin et al. 2000)	Seed (EMEA 2006a; ESCOP 2003a) Husk (USP 32)
Plantago ovata Forssk. (Plantaginaceae) (USDA 2003c)	Psyllium (McGuffin et al. 2000) Ispaghula (EMEA 2006b; EMEA 2006c; ESCOP 2003b; ESCOP 2003c; Bradley 1992)	Seed (EMEA 2006b; ESCOP 2003b) Husk (EMEA 2006c; ESCOP 2003c)

Route(s) 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:

• (Used in Herbal Medicine as a) bulk-forming laxative (ESCOP 2003a; ESCOP 2003b; ESCOP 20003c; Williamson 2003; FDA 1985).
• (Used in Herbal Medicine to) promote(s) bowel movements by increasing bulk volume and water content (Sweetman 2007; WHO 2007; ESCOP 2003a; ESCOP 2003b; ESCOP 20003c; Bradley 1992; FDA 1985).
• (Used in Herbal Medicine to) provide(s) gentle relief of constipation and/or irregularity (EMEA 2006a; EMEA 2006b; EMEA 2006c; Pray 2006; ESCOP 2003a; ESCOP 2003b; ESCOP 20003c; Blumenthal et al. 2000; Gennaro 2000; Bradley 1992; FDA 1985).

Dose(s):

Table 2: Dose information for psyllium seed

Subpopulation		Seed (g/day)
		Minimum	Maximum
Children and adolescents1	6-12 y	1.25	25 Not to exceed 8 g per dose*
Adolescents and adults2	≥ 13 y	2.5	40 Not to exceed 13 g per dose*

¹ EMEA 2006a; EMEA 2006b; ESCOP 2003a; ESCOP 2003b; WHO 1999; FDA 1985
² EMEA 2006a; EMEA 2006b; ESCOP 2003a; ESCOP 2003b; Williamson 2003; Blumenthal et al. 2000a; Blumenthal et al. 200b; WHO 1999; FDA 1985
* Note: The maximum single dose (13 g) for adults and adolescents (= 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

Table 3: Dose information for psyllium husk

Subpopulation		Husk (g/day)
		Minimum	Maximum
Children and adolescents1	6-12 y	1.25	15 Not to exceed 4 g per dose*
Adolescents and adults2	≥ 13 y	2.5	30 Not to exceed 8 g per dose*

¹ EMEA 2006c; ESCOP 2003c; FDA 1985
² EMEA 2006c; ESCOP 2003c; Williamson 2003; Blumenthal et al. 2000c; Bradley 1992; FDA 1985
*Note: The maximum single dose (8 g) for adults and adolescents (= 13 y) is based on the consensus of evidence from several references. The maximum single dose (4 g) for children and adolescents (6-12 y) was calculated as a fraction of the maximum adult doses.

Direction(s) for use: Statement(s) to the effect of:

• For each gram of psyllium, mix with 30 ml of liquid (water, milk, fruit juice or similar aqueous beverage). Stir briskly and drink immediately. Maintain adequate fluid intake (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c; WHO 1999).
• Take 2 hours before or after taking other medications (Sweetman 2007; EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000b; Blumenthal et al. 2000c; Bradley 1992).
• Effects observed 12-24 hours after first dose, and may take 2-3 days (EMEA 2006a; EMEA 2006b; EMEA 2006c).
• Optional: Take during the day (, not immediately prior to bedtime) (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).
• Optional (for products with a dosage range): Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
  (Note: Single doses are not to exceed the maximum single doses outlined in Tables 2 and 3).

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(s) of use: No statement 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; Repchinsky 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; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).
• 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; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c; Bradley 1992; FDA 1985).
• Consult a health care practitioner prior to use if you are taking medications which inhibit peristaltic movement (e.g. opioids, loperamide) (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).

Contraindication(s):

• Do not use if you have difficulty swallowing (EMEA 2006a; EMEA 2006b; EMEA 2006c).
• Do not use if you have diabetes mellitus in which blood sugar is difficult to regulate (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c; Bradley 1992).
• 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; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).

Known adverse reaction(s):

• Hypersensitivity, such as allergy, has been known to occur following inhaled and/or ingested psyllium; in which case, discontinue use (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c; Bradley 1992).
• May cause temporary gas and/or bloating (EMEA 2006a; EMEA 2006b; EMEA 2006c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Bradley 1992).

Non-medicinal ingredients:

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

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs. The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 4 below.

Table 4. Psyllium monographs published in the British, European and US Pharmacopoeias

Pharmacopoeia	Monograph
British Pharmacopoeia (BP)	Psyllium Seed, Ispaghula Seed Ispaghula Husk
European Pharmacopoeia (Ph. Eur.)	Psyllium Seed Ispaghula Seed Ispaghula Husk
United States Pharmacopoeia (USP)	Plantago Seed Psyllium Husk Psyllium Hydrophilic Mucilloid for Oral Suspension Psyllium Hemicellulose

References cited:

Blumenthal M, Goldberg A, Brinkmann J, editors. 2000a. Herbal Medicine: Expanded Commission E Monographs. Psyllium Seed, Black. Boston (MA): Integrative Medicine Communications.

Blumenthal M, Goldberg A, Brinkmann J, editors. 2000b. Herbal Medicine: Expanded Commission E Monographs. Psyllium Seed, Blonde. Boston (MA): Integrative Medicine Communications.

Blumenthal M, Goldberg A, Brinkmann J, editors. 2000c. Herbal Medicine: Expanded Commission E Monographs. Psyllium Seed Husk, Blonde. Boston (MA): Integrative Medicine Communications.

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.

EMEA 2006a. European Medicines Agency. Final Community Herbal Monograph on Plantago afra L. et Plantago indica L., semen. London (GB): 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 (GB): 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 (GB): 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 2003a: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Psyllii Semen (Psyllium Seed). Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.

ESCOP 2003b: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Plantaginis Ovatae Semen (Ispaghula Seed). Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.

ESCOP 2003c: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Plantaginis Ovatae Testa (Ispaghula Husk / Blonde Psyllium Husk). Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.

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. 2000. Remington: The Science and Practice of Pharmacy, 20^th edition. Baltimore (MD): Lippincott Williams & Wilkins.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2^nd edition. Silver Spring (MD): American Herbal Products Association.

Pray WS. 2006. Non-Prescription Product Therapeutics, 2^nd edition. New York (NY): Lippincott Williams & Wilkins.

Repchinsky C, editor. 2002. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association.

Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35^th edition. London (GB): Pharmaceutical Press.

USDA 2003a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. 2003. Plantago afra L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 January 27]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

USDA 2003b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. 2003. Plantago indica L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 January 27]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

USDA 2003c: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. 2003. Plantago ovata L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 January 27]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

WHO 2007: World Health Organization. 2007. WHO Monographs on Selected Medicinal Plants, Volume 3. Geneva (CH): World Health Organization.

WHO 1999: World Health Organization. 1999. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization.

Williamson EM. 2003. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited.

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. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association.

BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association.

BP 2007: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).

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.

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.

Ph. Eur. 2008: European Pharmacopoeia Commission. 2008. European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

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. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3^rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.

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)