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Drugs and Health Products

Monograph: Hyssop

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 label at the applicant's 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.

Date: 2009-08-19

NHPID Name

Hyssopus officinalis (USDA 2008)

Proper Name(s)

Hyssopus officinalis L. (Lamiaceae) ( USDA 1995 )

Common Name(s)

Hyssop ( McGuffin et al. 2000 )

Source Material

Herb top ( Bradley 2006 )

Route Of Administration

Oral

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include 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:

Dose(s):
3 - 16 Grams per day dried herb tops , not to exceed 4 Grams per single dose
 (Bradley 2006, Williamson 2003, BHP 1983, Felter and Lloyd 1983[1898], Grieve 1971[1931])


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 persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding.  (Bradley 2006, McGuffin et al. 2000)

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

  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • 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].
  • 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.
  • USDA 1995: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. 1995. Hyssopus officinalis L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 16 September 2008]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl.
  • 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.
  • Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1998.
  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2nd edition. Toronto (ON): McGraw-Hill.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • 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
  • Burkhard PR, Burkhardt K, Haenggeli CA, Landis T. Plant-induced seizures: reappearance of an old problem. Journal of Neurology 1999;246(8):667-670.
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • Leung AY, Foster S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics, 2nd edition. Hoboken (NJ): John Wiley & Sons, Inc; 2003.
  • Millet Y, Jouglard J, Steinmetz MD, Tognetti P, Joanny P, Arditti J. 1981. Toxicity of some essential plant oils. Clinical and experimental study. Clinical Toxicology 18(12):1485-98.
  • Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
  • Tisserand R, Balacs T. Essential oil safety. Edinburgh (GB): Churchill Livingstone; 1995.

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

Dried aerial parts:

2 - 4 g, 3 times per day (Bradley 2006; Williamson 2003; BHP 1983)

Infusion:

  • 4 drachms (approximately 16g) herb, per day (Felter and Lloyd 1983 [1898])
  • Directions for use: Infuse 4 drachms (approximately 16 grams) herb in 1 pint of boiling water (475 ml); may be given freely (Felter and Lloyd 1983 [1898]). (1 = drachm = 3.887 g) (3.887 x 4 = 15.55 g)
  • 1/4 ounce (approximately 8 g) dried flowers, in 3 doses per day (Grieve 1971[1931])
  • Directions for use: Pour 1 pint (475 ml) of boiling water over dried flowers and infuse for ten minutes. Taken frequently in doses of a wineglass (Grieve 1971 [1931]). 60 ml = 2 ounces = 1 wineglass (Felter and Lloyd 1983 [1898])
  • 1 ounce (approximately 31 g) herb, per day (Wren 1907)
  • Directions for use: Infuse 1 ounce (approximately 8 g) of herb in 1 pint (475 ml) of boiling water. Take in doses of a wineglass (Wren 1907). 60 ml = 2 ounces = 1 wineglass (Felter and Lloyd 1983 [1898])

Fluid extract:

  • 2-4 g dried equivalent, 3 times per day (1:1, 25% ethanol, 2-4 ml) (Bradley 2006)
  • 2-4 g dried equivalent, 3 times per day (1:1, 25% alcohol, 2-4 ml) (BHP 1983)
  • 30 to 60 drops (1.85-3.70 ml) (Grieve 1971 [1931]))
  • 1/2 - 1 drachm (1.85-3.7 ml) (Wren 1907)

Tincture:

  • 2-4 g dried equivalent, 3 times per day (1:5, 45% alcohol, 5-10 ml) (Bradley 2006)
  • 2-4g dried herb equivalent, 3 times per day (1:5, 45% alcohol, 2-4 ml) (BHP 1983)