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Monograph: European Pennyroyal

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Note: 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 or the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2012-02-29

NHPID Name

Mentha pulegium (USDA 2008)

Proper Name(s)

Mentha pulegium L. (Lamiaceae) ( USDA 2011 )

Common Name(s)

European pennyroyal ( McGuffin et al. 2000 )

Source Material

Herb top ( 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: Fluid extract

Dose(s): 3 - 4 Grams 1-3 times per day, dried herb tops, (1:1, 45% alcohol, 3-4 ml)
Preparation: Powder & Infusion

Dose(s): 3 - 4 Grams 1-3 times per day, dried herb tops
Preparation: Tincture

Dose(s): 600 - 1200 Milligrams 1 time per day, dried herb tops, (1:5, 40-45% alcohol)
Dose(s): 300 - 600 Milligrams 2 times per day, dried herb tops, (1:5, 40-45% alcohol)
Dose(s): 400 Milligrams 3 times per day, dried herb tops, (1:5, 40-45% alcohol)

Refer to Appendix 1 for examples of 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 or worsen
  • Consult a health care practitioner prior to use if you are taking acetaminophen  (Brinker 2000)
  • Consult a health care practitioner prior to use if you have liver or kidney problems  (Brinker 2000, McGuffin et al. 1997)

Contraindication(s):
Do not use if you are pregnant or breastfeeding  (Brinker 2010)

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

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications; 2001. [Updated July 13, 2010; Accessed 2012 February 13]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. The Toxicity of Botanical Medicines. Sandy (OR): Eclectic Medical Publications; 2000.
  • 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, 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.
  • USDA 2011: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Beltsville (MD): National Germplasm Resources Laboratory,. [Mentha pulegium L. Lamiaceae: Last updated: 20-Sep-2011; Accessed 2012 January 21]. 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.

References reviewed

  • Bakerink JA, Gospe SM Jr, Dimand RJ, Eldridge MW. Multiple organ failure after ingestion of pennyroyal oil from herbal tea in two infants. Pediatrics 1996;98(5):944-947.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd edition, including extensive appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. Sandy (OR): Eclectic Medical Publications; 2001.
  • Buechel DW, Haverlah VC, Gardner ME. Pennyroyal oil ingestion: report of a case. The Journal of the American Osteopathic Association 1983;82(10):793-794.
  • Burkhard PR, Burkhardt K, Haenggeli CA, Landis T. Plant-induced seizures: reappearance of an old problem. Journal of Neurology 1999;246(8):667-670.
  • Duke JA, Bogenschutz-Godwin MJ, DuCellier J, Duke PK. 2002. Handbook of Medicinal Herbs, 2nd edition. Boca Raton (FL): CRC Press.
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 2nd edition. Montvale (NJ): Medical Economics Co.; 1998.
  • Sullivan JB Jr, Rumack BH, Thomas H Jr, Peterson RG, Bryson P. Pennyroyal oil poisoning and hepatotoxicity. Journal of the American Medical Association 1979;242(26):2873-2874.
  • Thomassen D, Slattery JT, Nelson SD. Menthofuran-dependent and independent aspects of pulegone hepatotoxicity: roles of glutathione. The Journal of pharmacology And experimental therapeutics 1990;253(2):567-572.
  • Tisserand R, Balacs T. Essential oil safety. Edinburgh (GB): Churchill Livingstone; 1995.
  • Vallance WB. Pennyroyal poisoning: A fatal case. Lancet 1955;269(6895):850-851.

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

Dried aerial parts:

1 - 4 g, 3 times per day (BHP 1983)

Infusion:

1 - 4 g dried aerial parts, 3 times per day (BHP 1983)

Fluid extract:

  • 1 - 4 g dried equivalent, 3 times per day (1:1, 45% alcohol, 1-4 ml) (BHP 1983)
  • 2 - 4 g dried equivalent, per day (1:1, 1-4 ml) (Grieve 1971 [1931])

Tincture:

  • 1 2 ml three times a day (1:5 in 40%)(Hoffman 2003)
  • 3 6 ml/d of a 1:5 tincture (Mills and Bone 2005)