Monograph: Ephedrine, L-

Help on accessing alternative formats, such as Portable document format (PDF), Microsoft word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Monograph: Ephedrine, L- (English) (PDF version - 122 K)
Get Adobe® Reader®
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: 2018-07-31

NHPID name

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

Proper name(s)

Common name(s)

Source material

Route Of administration

Oral

Dosage form(s)

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:

Dose(s):

1 Day per day

See Appendix 1 for dosage information.

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): Contraindication(s): 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.

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

References cited

References reviewed

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.