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Drugs and Health Products

Monograph: Figwort

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications 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 Product Licence Application 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: 2011-01-25

NHPID Name

Scrophularia nodosa (USDA 2008)

Proper Name(s)

Scrophularia nodosa L. (Scrophulariaceae) ( USDA 1997 )

Common Name(s)

Source Material

Herb top ( Hoffmann 2003 , BHP 1983 )

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:

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

Dose(s): 0.2 - 8 Grams per day, dried herb tops

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

Diuretic: For occasional use only  (Berardi et al. 2002, CPA 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 pregnant or breastfeeding
  • Consult a health care practitioner prior to use if you have heart disease  (Hoffmann 2003, Brinker 2001)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

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).

References cited

  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1998.
  • 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.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Bruneton J. Pharmacognosie, Phytochimie, Plantes Médicinales, 3rd edition. Paris (FR): Technique & Documentation; 1999.
  • CPA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
  • Passeportsanté 2011 : Passeportsanté.net Version 2.01 [Internet]. Lexique des plantes médicinales. Montréal (QC): Totalmédia inc. [Consulté le 25 janvier 2011]. Disponible à: http://www.passeportsante.net/fr/Solutions/DocumentsReference/Lexique.aspx
  • USDA 1997: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Scrophularia nodosa L.; Last updated: 26-Mar-1997. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2011-01-25]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
  • Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 2nd edition. Montvale (NJ): Medical Economics Co.; 1998.

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

Infusion:

2-8 g dried aerial parts, per day (BHP 1983)

Fluidextract:

  • 1-2 g dried equivalent, 3 times per day
    (1:1, 1-2 ml) (Bartram 1995)
  • 2-8 g dried equivalent, per day
    (1:1, 25% ethanol, 2-8 ml) (BHP 1983)
  • 1.8-3.6 g dried equivalent, per day
    (1:1, 1.8-3.6 ml, (30-60 drops)) (Felter and Lloyd 1983 [1898])

Tincture:

  • 0.4-0.8 g dried equivalent, three times per day
    (1:5, 40% ethanol, 2-4 ml) (Hoffmann 2003)
  • 0.2-0.4 g dried equivalent, per day
    (1:10, 45% ethanol, 2-4 ml) (BHP 1983)
  • 0.3-1.2 g dried equivalent, per day (Felter and Lloyd 1983 [1898])
    (1:2, 76% ethanol, 0.6-2.4 ml, (10-40 drops))