Monograph: Arnica
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Date:
2019-08-05
NHPID name
Arnica montana ( Germplasm Resources Information Network Taxonomy )Proper name(s)
Arnica montana ( USDA 2009 , McGuffin et al 2000 )Common name(s)
- Arnica ( USDA 2009 , McGuffin et al 2000 )
- Arnica flower
- Arnica Tincture
- European arnica ( USDA 2009 , McGuffin et al 2000 )
- Leopard's bane
- Leopardsbane
- Mountain arnica
- Mountain-tobacco
- Oil of Arnica
- Wolf's bane
Source material
Flower ( Bradley 2006 , Mills and Bone 2005 , Wichtl 2004 )Route Of administration
TopicalDosage 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 (such as sprains, bruises and/or joint pain). (Williamson EM et al. 2003, Felter 2001, Blumenthal et al. 2000, Felter and Lloyd 1983[1898], Grieve 1971[1931])Dose(s)
Adults:
Dose(s):
1 Day per day
Directions for use:
- Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until the preparation disappears.
- Avoid contact with the eyes and mucous membranes.
- Do not apply on or near the nipple.
- Do not apply to wounds or damaged skin.
- Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.
- Do not bandage.
- For each millilitre of tincture, dilute with 3-10 ml of water.
- For each millilitre of tincture, dilute with 3-10 ml of water. Apply to affected area as needed.
- For each millilitre of tincture, dilute with 5 ml of water. Apply to affected area as needed.
- For external use only.
- Pour 100 ml boiling water over flowers and infuse from 10-15 minutes. Let cool.
- Applicants are not required to disclose a quantity of crude equivalent (QCE) for arnica preparations.
- Extraction ratios are required on the Product Licence Application and product label for tinctures and ointments containing tinctures.
- For tinctures and ointments, see Appendix 1 for examples of appropriate 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 is requiredRisk information
Statement(s) to the effect of:
Caution(s) and Warning(s): Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen. Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs. (Brinker F 2010, Bradley 2006, Mills and Bone 2005, ESCOP 2003b, Hoffmann 2003)Non-medicinal ingredients
Must be chosen from the current Natural health products ingredients database 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 NHPD Quality of natural health products guide.
- The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).
- 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.
References cited
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Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
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BP 2011: British Pharmacopoeia 2011. Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2010.
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Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
-
Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
-
Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
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Brinker F. Final Updates and Additions for Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Internet]. [Last update 2010 July 13; Accessed 2011 June 23]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
-
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.
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ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
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Felter HW. 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]. Available from: http://www.swsbm.com/FelterMM/Felters_Materia_Medica.pdf
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Fenner B. A 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]. Available from: http://www.swsbm.com/Fenners/Complete%20Formulary-3b.pdf
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Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
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Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
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McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
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McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association
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Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
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Ph.Eur. 2011: European Pharmacopoeia, 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2011.
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Pray WS. Non-Prescription Product Therapeutics. 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
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Remington JP, Woods HC, editors. 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]. Available from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
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USDA 2009: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Online Database]. National Germplasm Resources Laboratory, Beltsville (MD). [Arnica montana L. Last updated 2009 December 28; Accessed 2011 June 23]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
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Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
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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
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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.
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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.
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Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated; 2001.
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Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
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Merck 2010: The Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16]. Available from: http://www.medicinescomplete.com/mc/merck/current/monographs.htm
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Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006.
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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.
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Sweetman SC, editor. Martindale: The Complete Drug Reference. [Online]. London (GB): Pharmaceutical Press; 2011. [Arnica: Last modified 2010 November 27; Accessed 2011 February 1]. Available from: http://www.medicinescomplete.com
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 fluid ounces, 6 1/2 fluidrachms] (Remington and Woods 2008 [1918]).
- Tinctura Arnicae Florum / Tincture of Arnica Flowers - Arnica Flowers, 20 parts or 6 1/4 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, the 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; Mr346.42). 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)