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BEARBERRY - Arctostaphylos uva-ursi

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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 and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 8, 2015

Proper Name(s)

Arctostaphylos uva-ursi (L.) Spreng (Ericaceae) (USDA 2014)

Common Name(s)

  • Bearberry (USDA 2014)
  • Uva-ursi (USDA 2014)

Source Material(s)

Leaf (Grieve 1971; Felter 1922)

Route(s) of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to, capsules, chewables (e.g. tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

  • Traditionally used in Herbal Medicine as a mild diuretic to help relieve symptoms associated with minor urinary tract infections, such as burning sensation and/or frequent urination. (BHP 1983; Grieve 1971; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
  • Used in Herbal Medicine to help relieve symptoms associated with minor urinary tract infections, such as burning sensation and/or frequent urination. (EMEA 2012a; Godfrey and Saunders 2010; Hoffman 2003).
Note

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

Dose(s)

Statement(s) to the effect of

Sub population

Adults (≥ 18 years)

Quantity(ies)

All uses or purposes

Dry, powder, tincture, fluid extract

0.6 — 4 g dried leaves per day, in 2 or 3 divided doses; providing up to 1.33 g dried leaves per single dose (Newall 1996; Bradley 1992; BHP 1983; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).

Decoction

1.7 — 4 g dried leaves per day, in 2 or 3 divided doses; providing up to 1.33 g dried leaves per single dose (EMEA 2012a; WHO 2002; Blumenthal 2000; Newall 1996; Bradley 1992; BHP 1983; Felter and Lloyd 1898).

Used in Herbal Medicine (non-traditional use)

All standardized extracts

Dose equivalent to 100 — 210 mg anhydrous arbutin, 2 to 4 times per day; providing a maximum of 840 mg anhydrous arbutin per day (EMEA 2012a; ESCOP 2003; WHO 2002; Blumenthal 2000).

Note

See Appendix 1 for examples of appropriate dosage preparations according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Directions for use

  • Take a few hours before or after any medication or natural health product (Brinker 2010; Mills and Bone 2000).
  • Do not take with highly acidic foods (e.g. citrus fruits and juice) or medications which may acidify urine (ESCOP 2003; Duke 2002; WHO 2002; Brinker 2001; Blumenthal 2000; Mills and Bone 2000; Bradley 1992).

Duration of Use

Statement(s) to the effect of

Preparations equivalent to ≥ 60 mg dried leaves and/or preparations equivalent to ≥ 20 mg anhydrous arbutin per day

For occasional use only. Consult a health care practitioner for use beyond one week (EMEA 2012a; WHO 2002; Brinker 2001; Blumenthal 2000; Mills and Bone 2000; Bradley 1992).

Risk Information

Statement(s) to the effect of

Caution(s) and Warning(s)

All products

If symptoms persist or worsen, consult a health care practitioner.

Preparations equivalent to ≥ 60 mg dried leaves and/or preparations equivalent to ≥ 20 mg anhydrous arbutin per day

If you have a liver disorder, fever, painful urination (dysuria), spasms, or blood in urine, consult a health care practitioner prior to use (EMEA 2012a; Duke 2002; Newall 1996).

Contraindication(s)

If you are pregnant or breastfeeding, do not use this product (EMEA 2012; Brinker 2012; ESCOP 2003; WHO 2002; Brinker 2001; Blumenthal 2000; Mills and Bone 2000; Bradley 1992).

Known Adverse Reaction(s)

No statement required.

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

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-Prescription Health Products Directorate Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

BHP 1983: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.

Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications; 2000.

Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs - Companion Volume 1 of the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1992.

Brinker F. 2010. Final updates and additions for Next link will take you to another Web siteHerb Contraindications and Drug Interactions, 3rd edition. including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 January 9].

Brinker F. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.

Next link will take you to another Web siteDr. Duke's Phytochemical and Ethnobotanical Databases. [Accessed 2014 August 29].

Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1998 [Reprint of 1919 original].

EMEA 2012a: EMA/HMPC/573460/2009 Rev. 1. Next link will take you to another Web siteCommunity herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC); 2012 January 24. [Accessed 2012 February 29].

E/S/C/O/P 2003: European Scientific Cooperative of Phytotherapy. E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products, Second edition completely revised and expanded. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 2003.

Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].

Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Felter HW, Lloyd JU. King's American Dispensatory. Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Godfrey A, Saunders PR, Barlow K, Gilbert C, Gowan M, Smith F. Principles and Practices of Naturopathic Botanical Medicine, Volume 1: Botanical Medicine Monographs. Toronto (ON): CCNM Press; 2010.

Grieve, M. A Modern Herbal, Volume 2. 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.

Mills S, Bone K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Edinburg (GB): Churchill Livingston; 2000

Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A guide for health-care professionals. London (GB): The Pharmaceutical Press; 1996

USDA 2014: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Next link will take you to another Web siteArctostaphylos uva-ursi. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 29 February 2012].

WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 3. Geneva (CH): World Health Organization; 2002.

References reviewed

EMEA 2012b: EMEA/HMPC/573465/2009 Rev. 1. Next link will take you to another Web siteAssessment report on Arctostaphylos uva-ursi (L.) Spreng., folium. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC); 2012 January 24. [Accessed 2012 February 29].

Gardner and McGuffin. Botanical Safety Handbook second edition. American Herbal Products Association. CRC Press. Taylor and Francis Group 2013.

HC 2011: Health Canada. Next link will take you to another Web siteCanada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 February 28].

Sayre LE. Next link will take you to another Web siteA Manuel of Organic Materia Medica and Pharmacognosy [Internet] 4th edition. Philadelphia (PA): P. Blakiston's Son & Co.; 1917. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 March 28].

Appendix 1

Appendix 1

Examples of appropriate dosage preparations for standardised extracts

Dry extract (Extract ratio 3.5-5.5:1), 60% ethanol extraction, quantified to 23.5-29.3% hydroquinone derivates calculated as anhydrous arbutin: Dose is equivalent to 100-210 mg of anhydrous arbutin, 2 to 4 times per day (EMEA 2012a).

Dry extract (Extract ratio 2.5-4.5:1), water extraction, quantified to 20-28% hydroquinone derivatives calculated as anhydrous arbutin. Dose is equivalent to 100-210 mg of anhydrous arbutin, 2 to 4 times per day (EMEA 2012a).