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Drugs and Health Products

Sage – Salvia Officinalis – Buccal & Topical

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

Date

February 28, 2013

Proper name(s)

Salvia officinalis L. (Lamiaceae) (USDA 2001; McGuffin et al. 2000)

Common name(s)

  • Sage (USDA 2001; McGuffin et al. 2000)
  • Common sage (McGuffin et al. 2000)
  • Dalmation sage (McGuffin et al. 2000)
  • Garden sage (McGuffin et al. 2000)

Source material(s)

Leaf (Blumenthal et al. 2000; BHP 1983; Cook 1869)

Route(s) of administration

  • Buccal (Barnes 2007; BHP 1983)
  • Topical (BHC 2006; Bone 2003)

Dosage form(s)

  • Those dosage forms suited to buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient such as gargles, lozenges, rinses, and mouthwashes.
  • Those pharmaceutical dosage forms suited to topical administration.
  • 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 to provide relief of the inflammation of nose and throat mucosa (such as sore throat), gingivitis and aphthous ulcer/canker sore (BHC 2006; Mills and Bone 2005; Witchl 2004; Blumenthal et al. 2000; ESCOP 1996; BHP 1983; Culbreth 1927; Felter 1922).

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

Dose(s)

Statement(s) to the effect of

Sub-population(s)

Adults (≥ 19 years)
Quantity(ies)

Fluidextract:
3-12 g per day (1:1 extract, 45% alcohol, 3-12 ml) (BHP 1983)

Infusion or Powder:
1-12 g dried leaf, per day (Mills and Bone 2005; BHP 1983).

Directions for use

Buccal:
Gargle, mouthwash or rinse:

  • Pour 100 ml boiling water over 3 g of dried leaf and infuse (BHC 2006); or
  • For each 5 ml of fluidextract, dilute with 150 ml of water (Blumenthal et al. 2000)

Topical:
Fluideextract:
Apply the undiluted fluidextract to the affected area with a brush or swab (Blumenthal et al. 2000).

Note
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

Statement(s) to the effect of

No statement required.

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

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

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

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

Storage conditions

No statement required.

Specifications

References cited

  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines.3rd edition. London (GB): The Pharmaceutical Press; 2007.
  • BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs - Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • BHP 1983: 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.
  • Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.
  • Cook WMH.Next link will take you to another Web site The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com, Boulder (CO). [Accessed 2012 April 18].
  • Culbreth DMR.Next link will take you to another Web site A Manual of Materia Medica and Pharmacology [Internet] 7th ed. Philadelphia (PA): Lea & Febiger; 1927. Abridged and alphabetized by Michael Moore, director. The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 18].
  • ESCOP 1996: European Scientific Cooperative of Phytotherapy. Monographs on the Medicinal Uses of Plant Drugs. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 1996.
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics [Internet]. Cincinnati (OH): John K. Scudder; 1922. Reprint version by Michael Moore, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 18].
  • 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.
  • USDA 2001:Next link will take you to another Web site United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Salvia officinalis L. Last updated: 31-Dec-2001; Accessed 2012 August 1].
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.

References reviewed

  • ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
  • AU TGA 1999: Australian Therapeutic Goods AdministrationNext link will take you to another Web site TGA Approved Terminology for Medicines, Section 3 – Herbal Substances. July 1999. [Internet]. Symonston (AU): Australian Government Department of Health and Ageing, Therapeutic Goods Administration. [Accessed 2012 Apr 18].
  • Azevedo MF, Lima CF, Fernandes-Ferreira M, Almeida MJ, Wilson JM, Pereira-Wilson C. Rosmarinic acid, major phenolic constituent of Greek sage herbal tea, modulates rat intestinal SGLT1 levels with effects on blood glucose. Mol Nutr Food Res 2011; 55(Suppl 1): S15025.
  • Bartram T. Bartram's Encyclopaedia of Herbal Medicine: The definitive guide to the herbal treatment of diseases. New York: Marlowe & Company; 1998.
  • Blumenthal M, Brusse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in Cooperation with Integrative Medicine Communications; 1998
  • Bommer S, Klein P, Suter A. First time proof of sage's tolerability and efficacy in menopausal women with hot flushes. Adv Ther 2011; 28(6): 490-500.
  • Brinker F. Herb Contraindications & Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Brinker, F.Next link will take you to another Web site Updates and Additions for Herb Contraindications and Drug Interactions, 3rd ed including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals and complementary adjuncts with drugs. [Internet] Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 April 18].
  • Next link will take you to another Web site Canadian Nutrient File (CNF), 2012 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012-02-10; Accessed 2012 Apr 18].
  • Christensen KB, Jorgensen M, Kotowska D, Petersen RK, Kristiansen K, Christensen LP. Activation of the nuclear receptor PPAR? by metabolities isolated from sage (Salvia officinalis L.). J Ethnopharmacol. 2010; 132(1): 127-33.
  • Cook WMH.Next link will take you to another Web site The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com, Boulder (CO). [Accessed 2012 April 18].
  • Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke P-AK. Handbook of Medicinal Herbs. 2nd ed. Boca Raton (FL): CRC Press LLC; 2002.
  • European Medicines Agency.Next link will take you to another Web site Community Herbal Monograph on Salvia officinalis L., Folium. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 03 February 2010. [Accessed 2012 April 18]
  • European Medicines Agency.Next link will take you to another Web site Community Herbal Monograph on Salvia officinalis L., Folium. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 12 November 2009. [Accessed 2012 April 18]
  • European Medicines Agency.Next link will take you to another Web site Public statement on Salvia officinalis L., aetheroleum London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 19 October 2010. [Accessed 2012 April 18]
  • Facciola S. Cornucopia II: A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Felter HW, Lloyd JU.Next link will take you to another Web site Kings American Dispensatory [Internet]. 18th ed, 3rd revision. Cincinnati (OH): Ohio Valley Co.; 1898. Scanned version by Henriette Kress 1999-2011. [Accessed 2012 April 18].
  • Grieve, M. A Modern Herbal, Volume 1-2. New York (NY): Dover Publications, 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines. 4th ed. Montvale (NJ): Thomson Healthcare Inc; 2007.
  • Halicioglu O, Astarcioglu G, Yaprak I, Aydinlioglu H. Toxicity of Salvia officinalis in a newborn and a child: an alarming report. Pediatr Neurol 2011; 45(4): 259-60
  • Health Canada.Next link will take you to another Web site Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 18].
  • Kennedy DO, Scholey AB. The psychopharmacology of European herbs with cognition-enhancing properties. Curr Pharm Des 2006; 12(35): 4613-23
  • Lima CF, Andrade PB, Seabra RM, Fernandes-Ferreira M, Pereira-Wilson C. The drinking of a Salvia officinalis infusion improves liver antioxidant status in mice and rats. J Ethnopharmacol 2005; 97(2): 383-9
  • Lima CF, Azevedo MF, Araujo R, Fernandes-Ferreira M, Pereira-Wilson C. Metform-like effect of Salvia officinalis (common sage): is it useful in diabetes prevention? Br J Nutr 2006; 92(2): 326033
  • Martindale 2010:Sweetman SC, editor.Next link will take you to another Web site Martindale: The Complete Drug Reference. 37th edition. London (GB): Pharmaceutical Press; 2012. [Sage: Salvia officinalis, Date of monograph revision 20101127; Accessed 2012 August 1].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press LLC; 1997
  • Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-care Professionals. London (GB): Pharmaceutical Press; 1996
  • Next link will take you to another Web site National Nutrient Database for Standard Reference. Spices, sage, ground. United States Department of Agriculture, Agricultural Research Service; 2011 [Accessed 2012 April 18].
  • Next link will take you to another Web site Natural Standard. Sage (Salvia officinalis, Salvia lavandulaefolia, Salvia lavandulifolia) Copyright 2012 [Internet]. [Accessed 2012 April 18].
  • Perry NS, Bollen C, Perry EK, Ballard C. Salvia for dementia therapy: review of pharmacological activity and pilot tolerability clinical trial. Pharmacol Biochem Behav 2003; 75(3): 651-9
  • Remington JP, Woods HC, editors. 1918.Next link will take you to another Web site The Dispensatory of the United States of America [Internet] 20th edition. Abridged; botanicals only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2011 April 18].
  • Sá CM, Ramos AA, Azevedo MF, Lima CF, Fernandes-Derreira M, Pereira-Wilson C. Sage tea drinking improves lipid profile and antioxidant defences in humans. Int J Mol Sci 2009; 10(9): 3937-50
  • Swanston-Flatt SK, Day C, Flatt PR, Gould BJ, Bailey CJ. Diabetes Res. 1989; 10(2): 69-73
  • Umezu T. Evaluation of the effects of plant-derived essential oils on central nervous system function using discrete shuttle-type conditioned avoidance response in mice. Phytotherapy Research 2012;26(6):884-891.
  • Weiss RF. Fintelmann VF. Herbal Medicine. Second edition, revised and expanded. Stuggart (NY): Thieme; 2000.
  • World Health Organization. International Programme on Chemical Safety.Next link will take you to another Web site Toxicological Evaluation of Certain Food Additives: WHO Food Additives Series 16. [Internet]. Geneva (CH): World Health Organization; 1981. [Accessed 2012 April 18].
  • World Health Organization. Next link will take you to another Web site Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives. Thujone [Internet]. [Accessed 2012 April 18].
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Appendix 1

Examples of dosage preparations and directions for use

Mills and Bone 2005

Typical dosage forms & Dosage
Typical adult dosage ranges are:
  • 3 to 12g/day of dried leaf or by infusion
  • 2 to 12 ml/day of a 1:1 liquid extract
Blumenthal et al. 2000

Dosage and Administration
Unless otherwise prescribed: 4-6 g per day of cut leaf for infusions, alcoholic extracts for gargles, rinses and other topical applications, and for internal use.

External:
Gargle or rinse: Use warm infusion: 2.5g cut leaf in 100 ml water; or use 5 ml of fluidextract diluted in 1 glass of water.
Paint: Apply the undiluted alcoholic fluidextract to the affected area with a brush or swab.

BHC 2006
For topical use in mouthwashes and gargles:
2.5g of dried leaf to 100 ml of water as an infusion.

Blumenthal et al. 1998
For gargles and rinses:
2.5g of herb in 100 ml of water as infusion or 5g of alcoholic extract in 1 glass water
External:
Undiluted alcohol extract

BHP 1983
(thrice daily):
Dried herb. Dose 1-4g or by infusion.
Liquid extract 1:1 in 45% alcohol. Dose 1-4 ml.