ECHINACEA - 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

Date

December 18, 2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation

Echinacea purpurea

  • Eastern purple-coneflower
  • Echinacea
  • Purple coneflower

Echinacea purpurea

Herb top

  • Dried
  • Juice
  • Root
  • Herb top and root

Dried

References: Proper name: USDA 2018; Common names: Blumenthal et al. 2000, McGuffin et al. 2000, 1997; Source materials: Barnes et al. 2007, ESCOP 2003.

Route 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 forms by age group:

Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Herbal Medicine to help relieve symptoms of colds and upper respiratory tract infections (Goel et al. 2004; Schulten et al. 2001; Brinkeborn et al. 1999; Moerman 1998; Hoheisel et al. 1997; Bräunig et al. 1992; Grieve 1971; Remington and Wood 1918).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

HERB TOP

Table 2. Dose information for Echinacea purpurea herb top per day
Subpopulation(s) Dried herb top (gram/day)
Minimum Maximum

Children1

2-4 years

0.4

1.0

5-9 years

0.6

1.5

10-11 years

1.3

3.0

Adolescents1

12-14 years

1.3

3.0

15-17 years

2.5

6.0

Adults2,3

18 years and older

2.5

6.0

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2018). The use of Echinacea purpurea herb top in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

2Adult dose supported by the following reference: Mills and Bone 2000.

3Includes pregnant and breastfeeding women.

ROOT

Table 3. Dose information for Echinacea purpurea root per day
Subpopulation(s) Dried root (gram/day)
Minimum Maximum

Children1

2-4 years

0.15

0.8

5-9 years

0.23

1.1

10-11 years

0.45

2.3

Adolescents1

12-14 years

0.45

2.3

15-17 years

0.90

4.5

Adults2,3

18 years and older

0.90

4.5

1Children 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

2Adult dose supported by the following references: Mills and Bone 2000; Bräunig et al. 1992

3Includes pregnant and breastfeeding women

HERB TOP and ROOT

Table 4. Dose information for Echinacea purpurea root per day
Subpopulation(s) Dried herb top and root (gram/day)
Minimum Maximum

Children1

2-4 years

0.5

0.9

5-9 years

0.8

1.4

10-11 years

1.5

2.8

Adolescents1

12-14 years

1.5

2.8

15-17 years

3.0

5.5

Adults2,3

18 years and older

3.0

5.5

1Children 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.

2Adult dose supported by the following reference: Mills and Bone 2000.

3Includes pregnant and breastfeeding women.

Method of preparation: Juice

HERB TOP

Table 5. Dose information for the juice of Echinacea purpurea herb top per day
Subpopulation(s) Juice of herb top (milliliter/day)
Minimum Maximum

Children1

2-4 years

0.7

1.7

5-9 years

1.0

2.5

10-11 years

2.0

5.0

Adolescents1

12-14 years

2.0

5.0

15-17 years

3.9

10.0

Adults2,3

18 years and older

3.9

10.0

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2018). The use of Echinacea purpurea herb top in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

2Adult dose supported by the following references: Schulten et al. 2001; Hoheisel et al. 1997.

3Includes pregnant and breastfeeding women.

Direction(s) 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).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 8 weeks (ESCOP 2003; Blumenthal et al. 2000).

Risk Information

Caution(s) and warning(s)

Contraindication(s)

No statement required.

Known adverse reaction(s)

Preparations containing herb top

Stop use if hypersensitivity/allergy occurs (MHRA 2018; 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.

Storage conditions

No statement required.

Specifications

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