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Echinacea purpurea

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label 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.

Date:

July 18, 2017

Proper name(s):

Echinacea purpurea L. Moench (Asteraceae) (USDA 2012)

Common name(s):

  • Echinacea (Blumenthal et al. 2000; McGuffin et al. 1997)
  • Purple coneflower (McGuffin et al. 2000)

Source material(s):

Herb top and/or root (Barnes et al. 2007; ESCOP 2003)

Route(s) of administration

Oral

Dosage form(s):

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

  • Traditionally used in Herbal Medicine to help relieve cold symptoms (Moerman 1998; Grieve 1971; Remington and Wood 1918).
  • (Traditionally) used in Herbal Medicine to help fight off infections, especially of the upper respiratory tract (Hoffmann 2003; Mills and Bone 2000; Grieve 1971; Remington and Wood 1918).
  • Supportive therapy in the treatment of upper respiratory tract infections (p.ex. common colds) (Goel et al. 2004; Schulten et al. 2001; Brinkeborn et al. 1999; Hoheisel et al. 1997; Bräunig et al. 1992).
  • Helps to relieve the symptoms (Goel et al. 2004; Schulten et al. 2001; Brinkeborn et al. 1999; Hoheisel et al. 1997; Bräunig et al. 1992) and shorten the duration (Goel et al. 2004; Schulten et al. 2001; Hoheisel et al. 1997; Bräunig et al. 1992) of upper respiratory tract infections.

Note
A claim for traditional use must include the term "Herbal Medicine".

Dose(s)

Table 1: Dose information expressed as "quantity dried equivalent" of Echinacea purpurea herb top presented as dose per day
Subpopulation Quantity dried equivalent (herb top) (g/day)
Minimum Maximum

Table 1 Footnotes

Table 1 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea purpurea herb top in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Adult dose supported by the following reference: Mills and Bone 2000.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 1 footnote3 referrer

Children Table 1 Footnote1 2-4 y 0.4 1.0
Children and adolescents Table 1 Footnote1 5-9 y 0.6 1.5
Adolescents Table 1 Footnote1 10-14 y 1.3 3.0
Adolescents and adults Table 1 Footnote1 Table 1 Footnote2 Table 1 Footnote3 ≥ 15 y 2.5 6.0
Table 2: Dose information for the pressed juice of Echinacea purpurea herb top presented as dose per day
Subpopulation Pressed juice (herb top) (ml/day)
Minimum Maximum

Table 2 Footnotes

Table 2 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea purpurea herb top in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Return to Table 2 footnote1 referrer

Table 2 Footnote 2

Adult dose supported by the following references: Schulten et al. 2001; Hoheisel et al. 1997.

Return to Table 2 footnote2 referrer

Table 2 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 2 footnote3 referrer

Children Table 2 Footnote1 2-4 y 0.7 1.7
Children and adolescents Table 2 Footnote1 5-9 y 1.0 2.5
Adolescents Table 2 Footnote1 10-14 y 2.0 5.0
Adolescents and adults Table 2 Footnote1 Table 2 Footnote2 Table 2 Footnote3 ≥ 15 y 3.9 10.0
Table 3: Dose information expressed as "quantity dried equivalent" of Echinacea purpurea root presented as dose per day
Subpopulation Quantity dried equivalent (root) (g/day)
Minimum Maximum

Table 3 Footnotes

Table 3 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea purpurea root in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Return to Table 3 footnote1 referrer

Table 3 Footnote 2

Adult dose supported by the following references: Mills and Bone 2000; Bräunig et al. 1992.

Return to Table 3 footnote2 referrer

Table 3 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 3 footnote3 referrer

Children Table 3 Footnote1 2-4 y 0.15 0.8
Children and adolescents Table 3 Footnote1 5-9 y 0.23 1.1
Adolescents Table 3 Footnote1 10-14 y 0.45 2.3
Adolescents and adults Table 3 Footnote1 Table 3 Footnote2 Table 3 Footnote3 ≥ 15 y 0.9 4.5
Table 4: Dose information expressed as "quantity dried equivalent" of Echinacea purpurea preparations containing both herb top and root presented as dose per day
Subpopulation Quantity dried equivalent herb top and root (g/day)
Minimum Maximum

Table 4 Footnotes

Table 4 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea purpurea in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Return to Table 4 footnote1 referrer

Table 4 Footnote 2

Adult dose supported by the following reference: Mills and Bone 2000.

Return to Table 4 footnote2 referrer

Table 4 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 4 footnote3 referrer

Children Table 4 Footnote1 2-4 y 0.5 0.9
Children and adolescents Table 4 Footnote1 5-9 y 0.8 1.4
Adolescents Table 4 Footnote1 10-14 y 1.5 2.8
Adolescents and adults Table 4 Footnote1 Table 4 Footnote2 Table 4 Footnote3 ≥ 15 y 3.0 5.5

Directions for use

Take at the first sign of infection (Goel et al. 2004; Schulten et al. 2001; Brinkeborn et al. 1999; Hoheisel et al. 1997).

Note
Refer to Appendix 1 for examples of dosage preparations and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use:

For use beyond 8 weeks, consult a health care practitioner (ESCOP 2003; Blumenthal et al. 2000).

Risk information:

Caution(s) and warning(s)

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS, or HIV infection, consult a health care practitioner prior to use (Brinker 2010; Brinker 2001; McGuffin et al. 1997).
  • If you have an auto-immune disorder, consult a health care practitioner prior to use (Brinker 2010; McGuffin et al. 1997).
  • If you are taking immunosuppressants, consult a health care practitioner prior to use (Brinker 2010; Mills and Bone 2005).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Preparations containing herb top:
Rare cases of severe allergic reactions have been known to occur; use caution if you are allergic to plants of the Daisy family. (MHRA 2012; EMA 2010; Kligler 2003; WHO 1999).

Non-medicinal ingredients:

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

Specifications:

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 5 below.
Table 5: Echinacea purpurea monographs published in the European (Ph.Eur.) and United States (USP) Pharmacopoeias.
Pharmacopeia Monograph
Ph.Eur. Purple Coneflower Herb
Purple Coneflower Root
USP Echinacea purpurea Aerial Parts
Echinacea purpurea Root
Powdered Echinacea purpurea
Powdered Echinacea purpurea Extract

References cited:

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
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  • Bräunig B, Dorn M, Limburg, Knick E, Bausendorf. 1992. Echinaceae purpureae radix: zur Stärkung der körpereigenen Abwehr bei grippalen Infekten. Zeitschrift für Phytotherapie 13:7-13.
  • Brinkeborn RM, Shah DV, Degenring FH. 1999. Echinaforce and other Echinacea fresh plant preparations in the treatment of the common cold. A randomized, placebo controlled, double-blind clinical trial. Phytomedicine 6(1):1-6.
  • Brinker F. 2010. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: Next link will take you to another Web site http://www.eclecticherb.com/emp/updatesHCDI.html
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  • EMA 2010: European Medicines Agency (GB). EMA/HMPC/577784/2008. Next link will take you to another Web site Community herbal monograph on Echinacea purpurea (L.) Moench., radix. Draft. [2010 March 11; Accessed 2013 January 30].
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
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  • MHRA 2012: Medicines and Healthcare products Regulatory Agency (GB). Press release: Echinacea herbal products should not be used in children under 12 years old. [Press release 2012 August 20; Accessed 2013 January 31]. Available from:  http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627
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Appendix 1 Examples of appropriate dosage preparations, frequencies of use and directions for use (for adults only)

Herb top

Dried herb top:

2.5-6 g, per day (Mills and Bone 2000)

Pressed juice

  • 5 ml, 2 times per day (22% alcohol) (Schulten et al. 2001)
  • 1.3 ml (20 drops), per dose (22% alcohol) (Hoheisel et al. 1997)
  • Direction for use: Take each dose in a half glass of water every two hours for the first day, followed by three times per day until symptoms disappear [not to exceed 10 ml, per day] (Hoheisel et al. 1997).

Root:

Dried root:

1.5-4.5 g, per day (Mills and Bone 2000)

Tincture:

  • 1.5-4.5 g dried equivalent, per day (1:2, 3-9 ml) (Mills and Bone 2000)
  • 1.5-4.5 g dried equivalent, per day (1:5, 7.5-22.5 ml) (Mills and Bone 2000)
  • 0.9 g dried equivalent, per day (1:5, 55% ethanol) (Bräunig et al. 1992)

Preparations containing herb top and root:

Fluidextract:

3-5.5 g dried equivalent, per day(1:1, 3-5.5 ml) (Mills and Bone 2000)