Monograph: Ephedra

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Monograph: Ephedra (English) (PDF version - 84 K)
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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 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: 2019-08-05

NHPID name

Ephedra sinica ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

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

Common name(s)

Source material

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Used in Herbal Medicine as a decongestant/to relieve nasal congestion (due to hay fever/allergic rhinitis/allergies/sinusitis/the common cold/flu).

Dose(s)

Adults:

Preparation:

All Standardized 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
(HC 2007, MHRA 2005, US FDA 2004, HC 2003, Pickup et al. 1976)

Duration of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): Do not use this product if you are taking or have taken monoamine oxidase (MAO) inhibitors in the past two weeks. Known Adverse Reaction(s): Stop use in case of restlessness, irritability, dizziness, tremors, 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 (USP 32, BP 2009, Ph. Eur. 2007).

Specifications

References cited

References reviewed

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:

Fluid Extract:

 

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.