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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.
Date: April 24, 2008
Proper and common name(s):
Table 1: Proper and common name(s)
| Proper name(s) | Common name(s) |
|---|---|
| Betula pendula Roth. (Betulaceae) (USDA 1998) | Birch, European white birch, silver birch, weeping birch (McGuffin et al. 2000) |
| Betula pubescens Ehrh. (Betulaceae) Synonym: Betula alba L. (Betulaceae) (USDA 1998) |
Birch, downy birch, white birch (McGuffin et al. 2000) |
Source material(s): Leaf (Bradley 2006; ESCOP 2003)
Route(s) of administration: Oral
Dosage form(s): Those suited to the allowable route(s) of administration.
This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.
Use(s) or Purpose(s): Statement(s) to the effect of
Used in Herbal Medicine as a diuretic (Bradley 2006; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 1998).
Dose(s): Preparations equivalent to 0.6-9 g dried leaf, per day (Bradley 2006; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 1998).
See Appendix 1 for examples of appropriate dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
Duration of use: Statement(s) to the effect of:
For occasional use only (Berardi et al. 2002; CPA 2002)
Risk information: Statement(s) to the effect of:
Caution(s) and warning(s):
Contraindication(s): No statement required.
Known adverse reaction(s): Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use (Brinker 2001).
Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
Specifications:
References cited:
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, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
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. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
CPA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
Hoffmann D. Medical Herbalism. 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.
USDA 1998: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Betula pendula Roth., Betula alba L./Betula pubescens Ehrh. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-04-24]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
References reviewed:
Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2008. [Accessed 2008-04-24]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use
Dried leaf: 2-3 g, several times per day [not to exceed 9 g per day] (Blumenthal et al. 1998)
Infusion:
Directions for use: Pour 250 ml of boiling water on dried leaf and steep for 10 minutes (Hoffmann 2003).
Tincture: