Monograph: Ephedrine, L-
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NHPID name
l-Ephedrine ( O'Neil et al. 2012 )Proper name(s)
- (1R,2S)-2-Methylamino-1-phenylpropan-1-ol ( O'Neil et al. 2009 )
- (alphaR)-alpha-[(1S)-1-(Methylamino)ethyl]-benzenemethanol ( NLM 2009 , O'Neil et al. 2009 )
- [R-(R*,S*)]-alpha-[1-(methylamino)ethyl]-benzenemethanol ( NLM 2009 , USP 32 )
- l-Ephedrine ( NLM 2009 , O'Neil et al. 2009 )
Common name(s)
- Ephedrine ( NLM 2009 , USP 32 )
- l-Ephedrine ( NLM 2009 , O'Neil et al. 2009 )
Source material
- l-Ephedrine (Unavailable)
- l-Ephedrine hydrochloride (Unavailable)
- l-Ephedrine sulfate (Unavailable)
Route Of administration
OralDosage 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:
Used as a decongestant/to relieve nasal congestion (due to hay fever/allergic rhinitis/allergies/sinusitis/the common cold/flu).Dose(s)
Adults:
1 Day per day
Duration of use
Consult a health care practitioner/health care provider/health care professional/doctor/physician 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):- Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use, if you are taking medication and/or natural health products for allergy symptoms, asthma, cough/cold or weight control.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use, if you are taking other products containing caffeine, ephedrine, phenylpropanolamine or pseudoephedrine.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use, if you have cardiovascular disease, diabetes, difficulty in urination due to prostate enlargement, glaucoma, thyroid problems, seizure disorders or a pre-existing psychiatric condition.
- Keep out of the reach of children.
- Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.
- Do not use this product if you are taking, or have taken monoamine oxidase inhibitors in the past two weeks.
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 (BP 2009, USP 32, 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).
- The medicinal ingredient may comply with the specifications outlined in the following monographs: (i) Ephedrine Anhydrous, Ephedrine Hydrochloride and Ephedrine Hydrochloride, Racemic published in the European Pharmacopoeia (Ph. Eur. 2007) and (ii) Ephedrine, Ephedrine Hydrochloride and Ephedrine Sulfate published in the U.S. Pharmacopeia (USP 32).
References cited
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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.
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Bensky D, Clavey S, Stoger E. Gamble A. 2004. Chinese Herbal Medicine: Materia Medica 3rd Edition. Seattle (WA): Eastland Press.
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BHP 1983: British Herbal Medicine Association (BHMA) Scientific Committee. 1983. British Herbal Pharmacopoeia 1983. Bournemouth (GB): British Herbal Medicine Association.
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Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
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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.
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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.
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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).
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Brinker F. 2001. Herb Contraindications and Drug Interactions, Third Edition. Sandy (OR): Eclectic Medical Publications.
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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
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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.
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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.
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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.
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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.
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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.
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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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Haller CA, Benowitz NL. 2000. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. The New England Journal of Medicine 343(25):1833-1838.
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Haller CA, Jacob P 3rd, Benowitz NL. 2004. Enhanced stimulant and metabolic effects of combined ephedrine and caffeine. Clinical Pharmacology and Therapeutics 75(4):259-273.
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HC 2003: Health Canada reminds Canadian of the dangers of Ephedra/ephedrine products. [Accessed November 20, 2009]. Available from: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2003/2003_43-eng.php
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HC 2007: Natural Health Products Compliance Guide. Natural Health Products Directorate (NHPD). Ottawa (ON): Minister of Health. [Accessed November 20, 2009]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/complian-conform_guide-eng.php
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JC 2010: Justice Canada. 2010. Precursor Control Regulations. Part 1 - Class A Precursors [online]. Ottawa (ON) Department of Justice Canada. [Accessed February 19, 2010]. Available from: http://laws.justice.gc.ca/eng/SOR-2002-359/index.html
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Kalman D, Colker C, Shi O, and Swain M. 2000. Effects of a weight-loss aid in healthy overweight adults: double-blind, placebo-controlled clinical trial. Current Therapeutic Research 61(4):199-205.
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Kuczkowski KM. 2006.Ephedrine containing oral nutritional supplements in a pregnant athlete: is it worth the risk? Acta Obstetricia et gynecologica Scandinavica 85(2):247-248.
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McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
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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.
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Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
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Naik SJ, Freudenberger RS. 2004. Ephedra-associated cardiomyopathy. The Annals of Pharmacotherapy 38:400-403.
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NLM 2009: National Institutes of Health. ChemIDplus advanced [online]. 2008. Search terms: Ephedrine, Ephedrine Hydrochloride, Ephedrine Sulfate. Bethseda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2009 November 20]. Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp
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O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2009. The Merck Index [online]: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2010 February 01]. Available from: http://www.medicinescomplete.com/mc/merck/current/03608.htm?q=ephedrine&t=search&ss=text&p=1#_hit
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Ph. Eur. 2007: European Pharmacopoeia 6th Edition. 2007. European Directorate for the Quality of Medicines & HealthCare. Strasbourg: Council of Europe.
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Pickup ME, May Ca, 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.
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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.
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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
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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.
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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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Glidden RS, DiBona FJ. 1977. Urinary retention associated with ephedrine. The Journal of Pediatrics 90(6):1013-1014.
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Appendix 1: Derivation of dosage quantities for l-ephedrine
Single maximal dose of l-ephedrine: 8 mg (US FDA 2004; HC 2003).
Minimum dose per day of l-ephedrine: 8 mg (US FDA 2004; HC 2003)
Maximum dose per day of l-ephedrine: 32 mg
Obtained as follows: 24 h daily ÷ 6 h half life of l-ephedrine x 8 mg per single dosage (HC 2003; Pickup et al. 1976)
Appendix 2: 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.