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Drugs and Health Products

ARNICA

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For arnica products in semi-solid dosage forms, refer to the "Arnica semi-solid dosage forms" monograph.

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

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • 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 and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

June 24, 2011

Proper name(s)

Arnica montana L. (Asteraceae) (USDA 2009; McGuffin et al. 2000)

Common name(s)

  • Arnica (USDA 2009; McGuffin et al. 2000)
  • European arnica (USDA 2009; McGuffin et al. 2000)

Source material(s)

Flower (Bradley 2006; Mills and Bone 2005; Wichtl 2004)

Route(s) of administration

Topical

Dosage form(s)

The dosage forms suited to topical administration except semi-solid dosage forms, such as creams, gels, ointments, and salves.

Use(s) or Purpose(s)

Statement(s) to the effect of:

(Traditionally) used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain) (Bradley 2006; ESCOP 2003; Williamson 2003; Felter 2001 [1922]; Blumenthal et al. 2000; Felter and Lloyd 1983 [1898]; Grieve 1971 [1931]).

Note: Claims for traditional use must include the term "Herbal Medicine".

Dose(s)

Subpopulation(s)

Adults (≥ 19 years) and adolescents (13-18 years)

Quantity(ies):

Infusion:

2g of arnica flowers (Bradley 2006; Wichtl 2004)
Directions for use: Pour 100 ml boiling water over flowers and infuse from 10-15 minutes (Bradley 2006; Wichtl 2004). Let cool.

Tincture:

200g powdered dried flowers (1:5, diluted alcohol) (Remington and Woods 2008 [1918]; Bradley 2006; Mills and Bone 2005; Fenner 2001 [1918])
Directions for use: For each millilitre of tincture, dilute with 3-10 ml of water (Bradley 2006; Mills and Bone 2005; Wichtl 2004; Blumenthal et al. 2000).

Tincture:

100g powdered dried flowers (1:10, 45% alcohol) (Remington and Woods 2008 [1918]; Bradley 2006; Mills and Bone 2005)
Directions for use: For each millilitre of tincture, dilute with 3-10 ml of water (Bradley 2006; Mills and Bone 2005; Wichtl 2004; Blumenthal et al. 2000).

Medicated oil:

1:5 ratio of arnica flower to vegetable fatty oil (Bradley 2006; Wichtl 2004; Blumenthal et al. 2000; Cech 2000)

Directions for use:

Statement(s) to the effect of:

For all products:

  • Apply thinly and evenly to affected area up to 3 to 4 times per day (Pray 2006). Rub and/or massage into skin until the preparation disappears.
  • For external use only.
  • Avoid contact with the eyes and mucous membranes.
  • Do not apply to wounds or damaged skin (Brinker 2010; Bradley 2006; Pray 2006; Mills and Bone 2005; Felter 2001 [1922]).
  • Do not bandage (Pray 2006; Felter 2001 [1922]).
  • Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn (Pray 2006).

For breastfeeding women:

Do not apply on or near the nipple (Brinker 2010; Mills and Bone 2005).

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

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s)

Consult a health care practitioner if symptoms persist or worsen.

Contraindication(s)

Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family (Brinker 2010; Bradley 2006; Pray 2006; Mills and Bone 2005).

Known adverse reaction(s)

Hypersensitivity/allergy has been known to occur; in which case, discontinue use (Brinker 2010; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003).

Non-medicinal ingredients

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

Specifications

  • The finished product must comply with the minimum specifications outlined in the current NNHPD Compendium of Monographs.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 1 below.
Table 1: Monographs published in the British and the European pharmacopoeias
Pharmacopoeia Monograph
British Pharmacopoeia (BP) Arnica Flower
European Pharmacopoeia (Ph.Eur.) Arnica Flower (Arnicae flos)
Arnica Tincture (Arnicae tinctura)

References cited

  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • BP 2011: British Pharmacopoeia 2011. Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2010.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • Brinker F. Next link will take you to another Web site Final Updates and Additions for Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Internet]. [Last update 2010 July 13; Accessed 2011 June 23].
  • Cech R. Making Plant Medicine. Williams (OR): Horizon Herbs; 2000.
  • ESCOP 2003: E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotherapy in collaboration with Georg Thieme Verlag and Thieme; 2003.
  • Felter HW. Next link will take you to another Web site The Eclectic Materia Medica, Pharmacology and Therapeutics. Cincinnati (OH): John K. Scudder; 1922. [Internet]. Reprinted and abridged by Southwest School of Botanical Medicine; 2001. [Accessed 2011 February 2].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Fenner B. Next link will take you to another Web siteA Complete Formulary and Hand-book of Valuable Information for Pharmacists, Manufacturers of Chemical and Pharmaceutical Preparations, Physicians and Students of Pharmacy and Medicine. 6th edition. Westfield (NJ): B. Fenner, Publisher and Proprietor; 1888. [Internet]. Scanned by Southwest School of Botanical Medicine; 2001. [Accessed 2011 January 28].
  • Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Ph.Eur. 2011: European Pharmacopoeia, 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2011.
  • Pray WS. Non-Prescription Product Therapeutics. 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
  • Remington JP, Woods HC, editors. Next link will take you to another Web site The Dispensatory of the United States of America, 20th edition , 1918. [Internet]. Scanned by Southwest School of Botanical Medicine as Abridged - botanicals only; 2008. [Accessed 2011 January 28].
  • USDA 2009: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web siteGermplasm Resources Information Network (GRIN). [Online Database]. National Germplasm Resources Laboratory, Beltsville (MD). [Arnica montana L. Last updated 2009 December 28; Accessed 2011 June 23].
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
  • Williamson EM, Evans FJ, Wren RC. Potter's Herbal Cyclopaedia: The Authoritative Reference Work on Plants with a Known Medicinal Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.

References reviewed

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Blumenthal M. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in cooperation with Integrative Medicine Communications; 1998.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated; 2001.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Merck 2010: Next link will take you to another Web siteThe Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16].
  • Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006.
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists: With reference to Commission E Monographs of the Federal Department of Health in Germany. Includes 100 Commission E monographs and 15 ESCOP Monographs. Stuttgart (DE): Medpharm Scientific Publishers; 1997.
  • Sweetman SC, editor.Next link will take you to another Web site Martindale: The Complete Drug Reference. [Online]. London (GB): Pharmaceutical Press; 2011. [Arnica: Last modified 2010 November 27; Accessed 2011 February 1].

Appendix 1: Examples of dosage preparations and directions for use

Tincture:
  • 1:10 extraction ratio (Bradley 2006)
    Directions for use: For each millilitre of tincture, dilute with 3-10 ml of water (Bradley 2006). Apply to affected area as needed.
  • 1:5 extraction ratio (Mills and Bone 2005)
    Directions for use: For each millilitre of tincture, dilute with 5 ml of water (Mills and Bone 2005). Apply to affected area as needed.
  • Tincturae Arnicae: 1 part drug to 10 parts ethanol 70% v/v, manufactured according to DAB Tincturae monograph (Wichtl 2004).
  • Tincture of Arnica Flowers: No. 20 powder, 100 grammes; Alcohol (45 per cent.), sufficient to produce 1000 millilitres. Moisten the powder with two hundred millilitres of the Alcohol, and complete the percolation process. (Remington and Woods 2008 [1918])
  • Tincture of Arnica Flowers: No. 20 powder, two hundred grammes [or 7 ounces av., 24 grains]; Diluted Alcohol, a sufficient quantity, to make one thousand mils [or 33 fluidounces, 61/2 fluidrachms]. (Remington and Woods 2008 [1918])
  • Tinctura Arnicae Florum / Tincture of Arnica Flowers Arnica Flowers, 20 parts or 6¼ ounces av. Diluted Alcohol, sufficient to make 100 parts or 2 pints. Moisten the Arnica Flowers with 12 fl. ounces of diluted Alcohol and macerate for 24 hours, then pack it firmly in a cylindrical percolator and gradually pour diluted Alcohol upon it until 2 pints of Tincture are obtained. (Fenner 2001 [1888])
  • The German formula directs 1 part of the Flowers to 10 parts of diluted Alcohol (Fenner 2001 [1888]).
  • Arnica tincture / Arnicae tinctura

    DEFINITION
    Tincture produced from Arnica flower
    Content: minimum of 0.04 per cent sesquiterpene lactones expressed as dihydrohelenalin tiglate (C20H26O5; Mr 346.42).
    PRODUCTION
    The tincture is produced from the herbal drug by a suitable procedure using 10 parts of ethanol (60-70 % V/V) for 1 part of drug. (Ph.Eur. 2010)

Infusion:
2 g drug/herb per 100 ml water (Wichtl 2004; Blumenthal et al. 2000)