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Drugs and Health Products

Monograph: Senna

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: (i) Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) Claims for traditional use must include the term "Herbal Medicine".

Date: 2009-06-24

NHPID Name

Senna alexandrina (USDA 2008)

Proper Name(s)

Common Name(s)

Source Material


Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • 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)

Adults and adolescents 11 and over:

Preparation: All Standardised Extracts

Dose(s): calculated as sennoside B 15-30 Milligrams Hydroxyanthracene derivatives per day
Directions For Use:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.5 - 3 Grams per day, dried fruit/pod and/or dried leaf/leaflet
Directions For Use:


  • For products which provide a dosage range, the following directions for use is considered optional: The correct individual dose is the smallest required to produce a comfortable, soft-formed stool (EMEA 2007a: EMEA2007b; ESCOP 2003; Blumenthal et al. 2000; WHO 1999).
  • 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

Consult a health care practitioner for use beyond 7 days  (Berardi et al. 2002)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are taking thiazide diuretics, corticosteroids, licorice root or other medications or health products which may aggravate electrolyte imbalance  (EMEA 2007b, Brinker 2001, Blumenthal et al. 2000, WHO 1999)
  • Consult a health care practitioner prior to use if you have a kidney disorder or are taking cardiac medications such as cardiac glycosides or antiarrhythmic medications  (EMEA 2007b, Brinker 2001, Blumenthal et al. 2000, WHO 1999)
  • Consult a health care practitioner prior to use if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever  (EMEA 2007b, WHO 1999)
  • Reduce dose or discontinue use if you experience abdominal pain, cramps, spasms and/or diarrhoea  (EMEA 2007b, Blumenthal et al. 2000, WHO 1999, McGuffin et al. 1997)

Contraindication(s):

Known Adverse Reaction(s):
Hypersensitivity is known to occur, in which case, discontinue use  (EMEA 2007b)

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 the following pharmacopoeial monographs: (i) 'Senna Leaf', 'Senna Leaf Dry Extract, Standardised', 'Alexandrian senna fruit', 'Tinnevelly senna fruit', 'Senna Liquid Extract', 'Standardised Senna Granules', 'Senna Tablets' monographs from the British Pharmacopoeia, (ii) 'Senna Leaf', 'Senna Leaf Dry Extract, Standardized', 'Senna Pods, Alexandrian', 'Senna Pods, Tinnevelly' monographs from the European Pharmacopoeia and (iii) 'Senna Leaf', 'Senna Fluid Extract', 'Senna Pods', 'Senna Oral Solution' monographs from the US Pharmacopoeia

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.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • European Medicines Agency. Community Herbal Monograph on Cassia senna L. and Cassia angustifolia Vahl, folium. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 15 October 2007. [Accessed 2008-04-11]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/sennae_folium/5186906en.pdf
  • European Medicines Agency. Community Herbal Monograph on Cassia Senna L., fructus and Cassia angustifolia Vahl, fructus. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 15 October 2007. [Accessed 2008-04-11]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/sennae_fructus/5187106en.pdf
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
  • Repchinsky C, Welbanks L, Bisson R, Bhalla A, Dang T, Fortin K, et al., editors. Compendium of Pharmaceuticals and Specialties. The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2005.
  • 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
  • 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.
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
  • 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

  • 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.
  • Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Accessed 2015 June 4]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • HC 1997. Health Canada. TPD/NHPD Category IV Labelling Standard, Stimulating Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxstimu-eng.php [Accessed 08 October 2008].
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.

Appendix 1: Examples of dosage preparations, frequencies of use and directions for use

Dried fruit/pod and/or leaf/leaflet:

  • 0.5 to 2 g of dried pods, per day (Mills and Bone 2005)
  • 0.5-2 g powdered leaves, per day (Williamson 2003)
  • 0.6-2 g powdered fruits/pods, per day (Blumenthal et al. 2000)
  • 1-2 g powdered leaves or fruit, per day (WHO 1999)
  • 2-3 g powdered leaf, per day (Felter and Lloyd 1983 [1898])

Infusion: 0.6-2 g dried fruits/pods or leaf, per day (Blumenthal et al. 2000)

Directions for use:
Pour 150 ml of warm or hot water over dried fruit/pods or leaf/leaflet and infuse for 10-30 minutes (Blumenthal et al. 2000).

Fluid extract:

  • 0.5-2 g dried equivalent, per day (1:1, 0.5-2 ml) (Williamson 2003)
  • 0.6-2 g dried equivalent, per day (1:1, 0.6-2 ml) (Blumenthal et al. 2000)

Tincture:

0.75 to 3 g dried equivalent, per day (1:2, 1.5-6 ml) (Mills and Bone 2005)

Preparations providing the following quantities of hydroxyanthracene derivatives (calculated as sennoside B):

  • 15-30 mg, per day (EMEA 2006a; EMEA 2006b; Mills and Bone 2005; ESCOP 2003)
  • 20-30 mg, per day (Blumenthal et al. 2000)
  • 10-30 mg, per day (WHO 1999)