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Monograph: Ephedrine, L-

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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 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: 2010-07-06

NHPID Name

l-Ephedrine (O'Neil et al. 2012)

Proper Name(s)

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 and adolescents 12 and over:

Dose(s):
8 - 32 Milligrams per day , not to exceed 8 Milligrams per single dose
 (HC 2007, US FDA 2004, HC 2003, Pickup et al. 1976)


See Appendix 1 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 (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

  • 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 (BHMA) 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • Hioki C, Yoshimoto K, Yoshida T. 2004. Efficacy of Bofu-tsusho-san, an oriental herbal medicine, in obese Japanese women with impaired glucose tolerance. Clinical and Experimental Pharmacology and Physiology 31:614-619.
  • Hoffman D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • 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
  • 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.
  • 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.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • 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.
  • 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.
  • 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
  • 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
  • Ph. Eur. 2007: European Pharmacopoeia 6th Edition. 2007. European Directorate for the Quality of Medicines & HealthCare. Strasbourg: Council of Europe.
  • 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.
  • 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
  • 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

  • Aaronson AL, Ehrlich NJ, Frankel DB, Gutman AA, Aaronson DW. 1968. Effective oral nasal decongestion. A double-blind crossover analysis. Annals of Allergy 26(3):145-150.
  • Bent S, Tiedt TN, Odden MC, Shlipak, MG. 2003. The relative safety of ephedra compared with other herbal products. Annals of Internal Medicine 138: 468-471.
  • 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.
  • Glidden RS, DiBona FJ. 1977. Urinary retention associated with ephedrine. The Journal of Pediatrics 90(6):1013-1014.
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].
  • Gurley BJ, Gardner SF, White LM, Wang PL. 1998. Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (ma huang). Therapeutic Drug Monitoring 20(4):439-445.
  • HC 1996: TPD/NHPD Category IV Labelling Standard, Ephedra [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada.
  • HC 1996: TPD/NHPD Category IV Labelling Standard, Ephedrine/Pseudoephedrine [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada.
  • HC 2006: A Summary of NHP/DRUG Classification of TPD Category IV Labelling Standards Ingredients. Natural Health Products Directorate, Health Canada [Accessed 2009 December 23]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/list_mono4-eng.php
  • HC 2009: First Nations, Inuit & Aboriginal Health. Drug Benefit List 04:00 Antihistamine Drugs. [Accessed 23 December 2009]. Available from: http://www.hc-sc.gc.ca/fniah-spnia/nihb-ssna/provide-fournir/pharma-prod/med-list/04-00-eng.php
  • HC 2009: Guidance Document: Nonprescription oral paediatric cough and cold labelling standard. Health Products and Food Branch (HPFB). Health Canada. [Accessed November 20, 2009]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/pedlscc_pednecr-eng.php
  • HC 2009: Natural Health Products Ingredients Database. Ingredient Search: ephed [online]. Ottawa (ON). Natural Health Products Directorate, Health Canada. [Accessed 2009 November 27]. Available from: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredsReq.do?srchRchTxt=ephed&srchRchRole=-1&lang=eng
  • Herridge CF, A'Brook MF. 1968. Ephedrine psychosis. British Medical Journal 2:160.
  • Hutchins GM. 2001. Correspondence: Dietary supplements containing ephedra alkaloids. The New England Journal of Medicine 344(14):1094-1100.
  • IOM 2002: Institute of Medicine. 2002. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington: The National Academy of Sciences.
  • Jacobs KM, Hirsch KA. 2000. Psychiatric complications of Ma-Huang. Psychosomatics 41(1):58-62.
  • Katz JL. 2000. A psychotic manic state induced by an herbal preparation. Psychosomatics 41(1):73.
  • Kim HK, Choi YH, Chang WT, Verpoorte R. 2003. Quantitative analysis of ephedrine analogues from ephedra species using 1H-NMR. Chemical & Pharmaceutical bulletin 51(12):1382-1385.
  • Kitani Y, Zhu S, Omote T, Tanaka K, Batkhuu J, Sanchir C, Fushimi H, Mikage M, Komatsu K. 2009. Molecular analysis and chemical evaluation of ephedra plants in Mongolia. Biological & Pharmaceutical Bulletin 32 (7):1235-1243.
  • Laitinen LA, Empey DW, Bye C, Britton MG, McDonnell K, Hughes DTD. 1982. A comparison of the bronchodilator action of pseudoephedrine and ephedrine in patients with reversible airway obstruction. European Journal of Clinical Pharmacology 23:107-109.
  • Lake CR, Tenglinet R, Chernow B, Holloway, H. 1983. Psychomotor stimulant-induced mania in a genetically predisposed patient: a review of the literature and report of a case. Journal of Clinical Psychopharmacology 3(2):97-100.
  • Lambert MT. 1987. Paranoid psychoses after abuse of proprietary cold remedies. British Journal of Psychiatry 151:548-550.
  • Maglione M, Miotto K, Iguchi M, Jungvig L, Morton SC, Shekelle PG. 2005. Psychiatric effects of ephedra use: an analysis of Food and Drug Administration reports of adverse events. American Journal of Psychiatry 62(1):189-191.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
  • 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
  • MHRA 2009: MHRA Public Assessment Report - Controlling the risk of misuse of medicines containing pseudoephedrine and ephedrine. 2009. Medicines and Healthcare products Regulatory Agency. London (UK).
  • Miller SC, Waite C. 2003. Ephedrine-type alkaloid-containing dietary supplements and substance dependence. Psychosomatics 44(6):508-511.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, Tyler BA. 2007. Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. International Journal of Clinical Pharmacology and Therapeutics 45(4):230-236.
  • Munns GF, Aldrich CA. 1927. Ephedrine in the treatment of bronchial asthma in children. Journal of the American Medical Association 88(16):1233.
  • Nadir A, Agrawal S, King PD, Marshall JB. 1996. Acute hepatitis associated with the use of a Chinese herbal product, Ma-huang. American Journal of Gastroenterology 91(7):1436-1438.
  • NAPRA 2009: Outline of National Drug Schedules. Search: ephedr [online]. Ottawa (ON). National Association of Pharmacy Regulatory Authorities. [Accessed 2009 December 17]. Available from: http://napra.ca/pages/Schedules/Search.aspx
  • Ranieri TL, Ciolino LA. 2008. Rapid selective screening and determination of ephedrine alkaloids using GC-MS footnote mark. Phytochemical Analysis 19:127-135.
  • Rowe DJ, Baker AC. 2009. Perioperative risks and benefits of herbal supplements in aesthetic surgery. Aesthetic Surgery Journal 29(2):150-157.
  • Sagara K, Oshima T, Misaki T. 1983. A simultaneous determination of norephedrine, pseudoephedrine, ephedrine and methylephedrine in Ephedrae Herba and oriental pharmaceutical preparations by ion-pair high-performance liquid chromatography. Chemical & Pharmaceutical bulletin (Tokyo) 31(7):2359-2365.
  • Samenuk D, Link MS, Homoud MK, Contreras R, Theoharides TC, Wang PJ, Estes III NAM. 2002. Adverse cardiovascular events temporally associated with ma huang, an herbal source of ephedrine. Mayo Clinic Proceedings 77:12-16.
  • Slodki SJ, Montgomery CA. 1965. Clinical comparison of oxymetazoline and ephedrine in nasal congestion. Current Therapeutic Research, Clinical and Experimental 7:19-22.
  • Song HJ, Shim KN, Ryu KH, Kim TH, Jung SA, Yoo K. 2008. A case of ischemic colitis associated with the herbal food supplement ma huang. Yonsei Medical Journal 49(3):496-499.
  • TGA 2008: Australian Therapeutic Goods Administration. Personal Import Scheme for Unapproved Medicines [online]. Symonston (AU): Australian Government Department of Health and Ageing, Therapeutic Goods Administration. [Accessed 2009 November 23]. Available from: http://www.tga.gov.au/import/persimp.htm
  • Theoharides TC. 1997. Sudden death of a healthy college student related to ephedrine toxicity from a ma huang-containing drink. Journal of Clinical Psychopharmacology 17(5):437-439.
  • UMC 1997: Uppsala Monitoring Centre. WHO Collaborating Centre for International Drug Monitoring. ADRAC Bulletin, Vol 16, No 4, November 1997. [Accessed 2009 November 20] Available from: http://www.who-umc.org/DynPage.aspx?id=14325
  • US FDA 1993: United States Food and Drug Administration. Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC Bronchodilator Drug Products [online]. Federal Register, Volume 58, Number 201, October 20,1993, Final Rule. Docket Number 91N-0323. Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 November 23]. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm116064.pdf
  • US FDA 1997: United States Food and Drug Administration. Dietary Supplements Containing Ephedrine Alkaloids [online]. Federal Register, Volume 62, Number 107, June 4,1997, Proposed Rule. Docket Number 95N-0304. Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 November 23]. Available from: http://frwebgate1.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=999886443355+0+1+0&WAISaction=retrieve
  • Vahedi K, Domigo V, Amarenco P, Bousser MG. 2000. Ischaemic stroke in a sportsman who consumed MaHuang extract and creatine monohydrate for body building. Journal of Neurology, Neurosurgery, and Psychiatry 68:112-113.
  • Walton R, Manos GH. 2003. Psychosis related to ephedra-containing herbal supplement use. Southern Medical Journal 96(7):718-20.
  • White LM, Gardner SF, Gurley BJ, Marx MA, Wang PL, Estes M. 1997. Pharmacokinetics and cardiovascular effects of ma huang (Ephedra sinica) in normotensive adults. The Journal of Clinical Pharmacology 37:116-122.
  • Whitehouse AM, Duncan JM. 1987. Ephedrine psychosis rediscovered. British Journal of Psychiatry 150:258-261.
  • Whitfield AGW, Arnott WM, Waterhouse JAH. 1950. The effect of ephedrine in asthma and emphysema. Quarterly Journal of Medicine 19(76):319-326.
  • Wingert WE, Mundy LA, Collins GL, Chmara ES. 2007. Possible role of pseudoephedrine and other over-the-counter cold medications in the deaths of very young children. Journal of Forensic Science 52(2):487-490.
  • Zahn K, Li R, Purssell R. 1999. Cardiovascular toxicity after ingestion of "herbal ecstacy." The Journal of Emergency Medicine 17 (2):289-291.

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.