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Drugs and Health Products

SAGE - SALVIA OFFICINALIS

Oral

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

Date

October 30, 2018

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s)
Source information
Source material(s) Part(s) Preparation(s)

Salvia officinalis

  • Common sage
  • Dalmatian sage
  • Garden sage
  • Sage

Salvia officinalis

Leaf

Dried

References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000; Source information: Blumenthal et al. 2000, BHP 1983, Cook 1869.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

  • Source of/Provides antioxidants (BHC 2006; Lima et al. 2005).
  • (Traditionally) used in Herbal Medicine as a carminative/to help provide relief of upset stomach and flatulence (flatulent dyspepsia) (Godfrey et al. 2010; EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).
  • Traditionally used in Herbal Medicine as a diaphoretic/to increase perspiration/sweating (PDR 2007; Culbreth 1927; Felter 1922; Cook 1869).
  • Traditionally used in Herbal Medicine to reduce hyperhidrosis/excessive sweating or perspiration (antihidrotic) (EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).
  • Used in Herbal Medicine to help reduce hot flushes/flashes and/or night sweats associated with menopause (Romm 2010; BHC 2006; Mills and Bone 2000).
  • (Traditionally) used in Herbal Medicine to stop the production of breast milk (antigalactagogue) (Godfrey et al. 2010; Wichtl 2004; Yarnell et al. 2003; Felter and Lloyd 1983; Culbreth 1927; Cook 1869).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

Methods of preparation: Dry, Infusion

Not to exceed 12 grams of dried leaf, per day (BHC 2006; Mills et Bone 2005; Blumenthal et al. 2000; BHP 1983; Culbreth 1927).

Note: Dried leaves should be prepared as an infusion (see direction for use).

Method of preparation: Tincture

Not to exceed 2.25 grams of dried leaf, per day (EMEA 2009; Mills and Bone 2005; ESCOP 2003).

Method of preparation: Fluid extract

Not to exceed 6 grams of dried leaf, per day (EMEA 2009; BHC 2006; Mills and Bone 2005; ESCOP 2003; BHP 1983).

Other uses

Methods of preparation: Dry, Infusion

1-12 grams of dried leaf, per day (Mills and Bone 2005; Blumenthal et al. 2000; BHP 1983; Culbreth 1927).

Note: Dried leaves should be prepared as an infusion (see direction for use).

Method of preparation: Tincture

0.3-2.25 grams dry leaf, per day (EMEA 2009; Mills and Bone 2005; ESCOP 2003).

Method of preparation: Fluid extract

1-6 grams of dried leaf, per day (EMEA 2009; BHC 2006; Mills and Bone 2005; ESCOP 2003; BHP 1983).

Direction(s) for use

Night sweats

Take one hour before bedtime (EMEA 2009).

Dried leaf - All uses

Pour hot boiled water on dried herb and steep.

Dried leaf - Antihidrotic

Let infusion cool before drinking (BHC 2006; Mills and Bone 2005; BHP 1983; Culbreth 1927; Felter 1922).

Dried leaf - Diaphoretic

Drink infusion while still warm (PDR 2007; Culbreth 1927; Felter 1922; Cook 1869).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks (Wichtl 2004; ESCOP 2003; McGuffin et al. 1997).

Risk Information

Caution(s) and warning(s)

Carminative, Diaphoretic, Antihidrotic and Antigalactagogue:

Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

Do not use this product if you are pregnant, breastfeeding or have a seizure disorder such as epilepsy (BHC 2006; Mills and Bone 2005; McGuffin et al. 1997).

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

All products, except those encapsulated

Store protected from light and moisture (Martindale 2010; Wichtl 2004)

Specifications

  • 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.
  • Sage contains thujone. For adults, the upper limit for total daily intake of thujone from health products is 6 mg. Product licence applications for oral products should include a copy of a certificate of analysis or any other equivalent document demonstrating that the thujone content of a daily dose of the product is acceptable. Because thujone content of the herbal materials can vary, the thujone content should be determined for each batch during production of the product.

References Cited

  • BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drug-Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • 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. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): American Botanical Council. 2000.
  • Cook WMH. 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 2018 August 14]. Available from: http://www.henriettesherbal.com/eclectic/cook/index.html
  • Culbreth DMR. A Manual of Materia Medica and Pharmacology. 7th edition [Internet] Philadelphia (PA): Lea & Febiger; 1927. Abridged and alphabetized by Michael Moore, director. The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2018 August 14].
    Available from: http://www.swsbm.com/ManualsOther/Culbreth.html
  • ESCOP 2003: E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. Second edition. Completely revised and Expanded. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotheraphy in collaboration with Georg ThiemeVerlag and Thieme; 2003.
  • EMEA 2009: EMA/HMPC/331653/2008 Community herbal monograph on Salvia officinalis L., folium. Final. 12 November 2009. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC). [Accessed 2018 August 14]. Available from: http://www.ema.europa.eu
  • 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 2018 August 14]. Available from: http://www.swsbm.com/FelterMM/Felters.html
  • 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.
  • 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. Journal of Ethnopharmacology 2005;97(2):383-389.
  • Martindale 2010: Sweetman SC, editor. Martindale: The Complete Drug Reference. 37th edition [Internet]. London (GB): Pharmaceutical Press; 2012. [Sage: Salvia officinalis, Date of monograph revision 2010-11-27; Accessed 2018 August 14]. Available from: http://ovidsp.tx.ovid.com/
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press LLC; 1997.
  • 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. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • PDR 2007: Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines. 4th ed. Montvale (NJ): Thomson Healthcare Inc; 2007.
  • Romm A. Botanical Medicine for Women's Health. St. Louis (MO): Churchill Livingstone; 2010.
  • USDA 2018: 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 2018 August 14]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
  • Yarnell E, Abascal JD, Hooper CG. Clinical Botanical Medicine. Larchmont (NY): Mary Ann Leibert Inc.; 2003.

References Reviewed

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  • AU TGA 1999: Australian Therapeutic Goods Administration. 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 April 27]. Available from: http://www.tga.gov.au/pdf/medicines-approved-terminologyherbal.pdf
  • 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. Molecular Nutrition & Food Research 2011;55(S1): S15-S25.
  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines. 3rd edition. London (GB): The Pharmaceutical Press; 2007.
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  • Bommer S, Klein P, Suter A. First time proof of sage's tolerability and efficacy in menopausal women with hot flushes. Advances in Therapy 2011;28(6):490-500.
  • Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts With Medicines, expanded 4th Edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • Brinker F. Final updates and additions for Herb 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 April 27]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 27]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
  • Canadian Nutrient File (CNF), 2012 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012-02-10; Accessed 2012 Apr 27]. Available from: http://webprod3.hc-sc.gc.ca/cnf-fce/index-eng.jsp
  • Christensen KB, Jorgensen M, Kotowska D, Petersen RK, Kristiansen K, Christensen LP. Activation of the nuclear receptor PPARγ by metabolities isolated from sage (Salvia officinalis L.). Journal of Ethnopharmacology 2010;132(1):127-133.
  • derMarderosian A, Beutler JA, editors. The Review of Natural Products. "Sage: Date of Issue February 2010" St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated to May 2012.
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  • European Medicines Agency. Public statement on Salvia officinalis L., aetheroleum. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 19 October 2010. [Accessed 2012 April 27] Available from: http://www.ema.europa.eu/
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  • Kennedy DO, Dodd FL, Robertson BC, Okello EJ, Reay JL, Scholey AB, Haskell CF. Monoterpenoid extract of sage (Salvia lavandulaefolia) with cholinesterase inhibiting properties improves cognitive performance and mood in healthy adults. Journal of Psychopharmacology 2011;25(8):1088-1100.
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  • 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? British Journal of Nutrition 2006; 92(2):326-333.
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