Ephedrine, L-

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Monograph: Ephedrine, L(English) (PDF Version - 36 K)

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.

Notes Compliance with Precursor Control Regulations:

The Precursor Control Regulations (PCR) (JC 2018) 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

July 31, 2018

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Common name(s)
  • (1R,2S)-2-Methylamino-1-phenylpropan-1-ol
  • (alphaR)-alpha-[(1S)-1-(Methylamino)ethyl]-benzenemethanol
  • [R-(R*,S*)]-alpha-[1-(Methylamino)ethyl]-benzenemethanol
  • l-Ephedrine
  • l-Ephedrine
  • Ephedrine
  • l-Ephedrine
  • l-Ephedrine hydrochloride
  • l-Ephedrine sulfate

References: Proper names: NLM 2018, O'Neil et al. 2009, USP32 2009; Common names: NLM 2018, O'Neil et al. 2009, USP32 2009; Source materials: NLM 2018, O'Neil et al. 2009.

Route(s) of administration

Oral

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage form for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Used as a decongestant/to relieve nasal congestion (due to hay fever/allergic rhinitis/allergies/sinusitis/the common cold/flu) (Mills and Bone 2005; Hoffman 2003; Williamson 2003; Blumenthal et al. 2000; BHP 1983).

Dose(s)

Subpopulation(s)

Adolescents 12 to 17 years and adults 18 years and older

Quantity(ies)

8-32 milligrams l-Ephedrine per day; Not to exceed 8 milligrams per single dose (HC 2007; US FDA 2004; HC 2003; Pickup et al. 1976).

Direction(s) for use

No statement required.

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

Caution(s) and warning(s)

Contraindication(s)

Do not use this product if you are taking, or have taken monoamine oxidase inhibitors in the past two weeks (Brinker 2018; 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)

Stop use in case of restlessness, irritability, dizziness, tremor, severe headache, insomnia, loss of appetite, nausea, rapid heartbeat, shortness of breath and/or disturbance of urination (Mills and Bone 2005; Bensky et al. 2004; Mehendale et al. 2004; Shekelle et al. 2003; Boozer et al. 2001; Blumenthal et al. 2000; McGuffin et al. 1997; Astrup et al. 1992).

Non-medicinal ingredients

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

Storage conditions

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

Specifications

References cited

References reviewed