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Drugs and Health Products

Monograph: Ephedra

COMPLIANCE WITH PRECURSOR CONTROL REGULATIONS: The Precursor Control Regulations (PCR) (JC 2010) allows Canada to fulfill its international obligations with respect to the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988, and provides a framework for the regulation of activities involving precursor chemicals which can be used in the production of illicit drugs and substances. Under the PCR, regulated chemicals are grouped into two classes: Class A and Class B. For Class A precursors such as ephedra, ephedrine, and/or products containing them, persons wishing to be involved in activities such as importation, exportation, production, packaging, selling, and/or providing must first obtain a licence. Further information regarding compliance with the PCR, including application forms and guidance documents pertaining to the application for a Class A precursor licence, is available at: http://www.healthcanada.gc.ca/precursors.

Date: 2010-06-08

NHPID Name

Ephedra sinica (USDA 2008)

Proper Name(s)

Ephedra sinica Stapf (Ephedraceae) ( USDA 2002 , McGuffin et al. 2000 )

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:

Preparation: All Standardised Extracts

Dose(s): 400 - 1600 Milligrams per day, dried branchlet and/or branch, and/or stem 8-32 Milligrams l-Ephedrine per day , no more than 8 Milligrams per single dose


  • 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.
  • See Appendix 2 for dosage information.

Duration of use

Consult a health care practitioner for use beyond 7 days.  (Mills and Bone 2005, US FDA 2004, Blumenthal et al. 2000)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

Contraindication(s):
Do not use if you are taking, or have taken in the past two weeks monoamine oxidase (MAO) inhibitors.  (Brinker 2008, Greenway et al. 2004, Hoffman 2003, Brinker 2001, Blumenthal et al. 2000, Kalman et al. 2000, Dingemanse et al. 1996, Dawson et al. 1995, Elis et al. 1967)

Known Adverse Reaction(s):

Non-medicinal ingredients

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

Storage Conditions

Store protected from light and moisture (USP 32, BP 2009, Ph. Eur. 2007).

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

  • Astrup A, Buemann B, Christensen N J, Toubro S, Thorbek G, Victor O J, Quaade F. 1992. The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women. Metabolism 41(7):686-688.
  • Bensky D, Clavey S, Stoger E, Gamble A. 2004. Chinese Herbal Medicine: Materia Medica, 3rd edition. Seattle (WA): Eastland Press.
  • BHP 1983: British Herbal Medicine Association Scientific Committee. 1983. British Herbal Pharmacopoeia 1983. Bournemouth (GB): British Herbal Medicine Association.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
  • Boozer CN, Daly PA, Homel P, Solomon JL, Blanchard D, Nasser JA, Strauss R, Meredith T. 2002. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. International Journal of Obesity and Related Metabolic Disorders 26(5):593-604.
  • Boozer CN, Nasser JA, Heymsfield SB, Wang V, Solomon JL. 2001. An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial. International Journal of Obesity & Related Metabolic Disorders 25:316-324.
  • BP 2009: British Pharmacopoeia Commission. 2009. British Pharmacopoeia, 2009, Volume 1. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, Third edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2009 November 20]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Coffey CS, Steiner D, Baker BA, Allison DB. 2004. A randomized double-blind placebo-controlled clinical trial of a product containing ephedrine, caffeine, and other ingredients from herbal sources for treatment of overweight and obesity in the absence of lifestyle treatment. International Journal of Obesity & Related Metabolic Disorders 28(11):1411-1419.
  • Dawson JK, Earnshaw SM, Graham CS. 1995. Dangerous monoamine oxidase inhibitor interactions are still occurring in the 1990s. Journal of Accident and Emergency Medicine 12:49-51.
  • DerMarderosian A, Beutler JA 2002. The Review of Natural Products. St Louis (MO): Facts and Comparisons
  • Dingemanse J, Guentert T, Gieschke R, Stabl M. 1996. Modification of the cardiovascular effects of ephedrine by the reversible monoamine oxidase A-inhibitor moclobemide. Journal of Cardiovascular Pharmacology 28(6):856-861.
  • Elis J, Laurence DR, Mattie H, Prichard BNC. 1967. Modification by monoamine oxidase inhibitors of the effect of some sympathomimetics on blood pressure. British Medical Journal 2:75-78.
  • Greenway FJ, de Jonge L, Blanchard D, Frisard M, Smith, SR. 2004. Effect of a dietary herbal supplement containing caffeine and ephedra on weight, metabolic rate, and body composition. Obesity Research 12(7):1152-1157
  • Hackman RM, Havel PJ, Schwartz HJ, Rutledge JC, Watnik MR, Noceti EM, Stohs SJ, Stern JS, Keen CL. 2006. Multinutrient supplement containing ephedra and caffeine causes weight loss and improves metabolic risk factors in obese women: a randomized controlled trial. International Journal of Obesity 30:1545-1556.
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  • Liguo F, Yongfu Y, Riedl H. 1999. Ephedraceae. Flora of China 4:97-101.
  • 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. Silver Spring (MD): American Herbal Products Association.
  • Mehendale SR, Bauer BA,Yuan C. 2004. Ephedra-containing dietary supplements in the US versus ephedra as a Chinese Medicine. The American Journal of Chinese Medicine 32(1):1-10.
  • MHRA 2005: Medicines and Healthcare products Regulatory Agency. The Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977; S.I. 1977/2130 (UK).Available from: http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con009294.pdf.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Naik SJ, Freudenberger RS. 2004. Ephedra-associated Cardiomyopathy. The Annals of Pharmacotherapy 38:400-403.
  • Ph. Eur. 2007: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • Pickup ME, May CS, Ssendagire R, Paterson JW. 1976. The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment. British Journal of Clinical Pharmacology 3:123-134.
  • Shekelle PG, Hardy ML, Morton SC, Maglione M, Mojica WA, Suttorp MJ, Rhodes SL, Jungvig L, Gagné J. 2003. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. Journal of the American Medical Association 289(12):1537-1545.
  • US FDA 2004: United States Food and Drug Administration. Final Rules Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule [online]. Federal Register, Volume 69, Number 28, February 11, 2004, Rules and Regulations, Docket Number 1995N-0304. Rockville (MD): United States Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 November 23]. Available from: http://frwebgate5.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=999692306001+0+2+0&WAISaction=retrieve
  • USDA 2002: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Online database]. 2002. Ephedra sinica. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 November 20]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/taxon.pl?15236#common
  • USDA 2009: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Online database]. 2002. Ephedra sinica. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 November 20]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/taxon.pl?15236common
  • 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.
  • 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

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  • Bitsko RH, Reefhuis J, Louik C, Werler M, Feldkamp ML, Waller DK, Frias J, Honein MA. 2008. Periconceptional use of weight loss products including ephedra and the association with birth defects. Birth Defects Research Part A: Clinical and Molecular Teratology 82(8):553-562.
  • Burke LM. 2000. Positive drug tests from supplements. Sportscience 4(3):1-5.
  • CRN 2000: Council for Responsible Nutrition. Safety Assessment and Determination of a Tolerable Upper Limit for Ephedra. [online] Mississauga (ON): Cantox Health Sciences International. [Accessed 2009 November 23]. Available from: http://www.crnusa.org/pdfs/Cantoxreport.doc
  • Cui J, Zhou T. 1991. Analysis of alkaloids in chinese ephedra species by gas chromatographic methods. Phytochemical Analysis 2:116-119.
  • Doyle H. 1996. Herbal stimulant containing ephedrine has also caused psychosis. British Medical Journal 313:756.
  • Drew CD, Knight GT, Hughes DT, Bush M. 1978. Comparison of the effects of D-(-)-ephedrine and L-(+)-pseudoephedrine on the cardiovascular and respiratory systems in man. British Journal of Clinical Pharmacology 6(3):221-225.
  • Farel RM, Fanta CH. 2009. Drug Therapy for Asthma. New England Journal of Medicine 360 (24):2578-2579.
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  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].
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  • HC 1996: TPD Labelling Standard, Ephedra [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada.
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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Dried stem and/or branches:

1.2 - 2.3 g cut herb containing a maximum of 1.3% total alkaloids calculated as ephedrine per day (Blumenthal et al. 2000)

Infusion or Decoction:

1.2-2.3 g in 150 ml water (Blumenthal et al. 2000)

Tincture:

  • 1:5 (g/ml): 5.75-11.5 ml (Blumenthal et al. 2000)
  • 1:4 in 45% alcohol. Dose 6-8 ml (BHP 1983)

Fluid Extract:

  • 1:1 (g/ml): 1.2-2.3 ml (Blumenthal et al. 2000)
  • 1:1 in 45% alcohol. Dose 1-3 ml (BHP 1983)

 

Appendix 2:

Derivation of dosage quantities for ephedra

According to the Natural Health Product Compliance Guide, the dosage restriction on Ephedra is:

Minimum dosage Ephedra:

400 mg (HC 2007)

Maximum dosage Ephedra:

1600 mg (HC 2007)

 

Minimum dosage Ephedrine:

8 mg (US FDA 2004; HC 2003)

Maximum dosage Ephedrine:

32 mg

Obtained as follows:

24 h daily ÷ 6 h half life of ephedrine x 8 mg per single dosage (HC 2003; Pickup et al. 1976)

 

Appendix 3:

Background on Monograph

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. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.