Monograph: St. John's Wort - Oral
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Date:
2023-01-27
See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
NHPID name
Hypericum perforatum ( Germplasm Resources Information Network Taxonomy )Proper name(s)
Hypericum perforatum ( USDA 2008 )Common name(s)
- Goatweed ( Unavailable )
- Hypericum ( Anghelescu et al. 2006 , Gastpar et al. 2006 , Szegedi et al. 2005 , Wichtl 2004 )
- St. John's wort ( McGuffin et al. 2000 )
- St. John's-wort ( Unavailable )
Source material
Herb top ( Bradley 2006 , Mills and Bone 2005 , Hoffmann 2003 , Blumenthal et al. 2000 , Felter and Lloyd 1983[1898] , Wren 1907 )Route Of administration
OralDosage form(s)
- The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, 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 to help relieve restlessness and/or nervousness (calmative). (Mills and Bone 2005, Hoffmann 2003, Blumenthal et al. 2000, Felter and Lloyd 1983[1898], Grieve 1971[1931])
- (Used in Herbal Medicine to) help(s) promote healthy mood balance and relieve sleep disturbances associated with mood imbalance.
- (Used in Herbal Medicine to) help(s) promote healthy mood balance. (Anghelescu et al. 2006, Gastpar et al. 2006, Kasper et al. 2006, Fava et al. 2005, Mills and Bone 2005, Szegedi et al. 2005, Uebelhack et al. 2004, ESCOP 2003, Hoffmann 2003, Lecrubier et al. 2002, Volz et al. 2002, Kalb et al. 2001)
Dose(s)
Adults:
Dose(s):
1 Day per day
Duration of use
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician for use beyond 18 weeks. (Anghelescu et al. 2006, Gastpar et al. 2006, Kasper et al. 2006, Fava et al. 2005, Mills and Bone 2005, Szegedi et al. 2005, Uebelhack et al. 2004, ESCOP 2003, HDTSG 2002, Lecrubier et al. 2002, Volz et al. 2002, Kalb et al. 2001)
- Use for at least 1 week to see beneficial effects. (Papakostas et al. 2007, Kalb et al. 2001)
Risk information
Statement(s) to the effect of:
Caution(s) and Warning(s):- Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy. (Brinker 2010, Barnes et al. 2007, Mills and Bone 2005, ESCOP 2003, Hoffmann 2003, McGuffin et al. 1997)
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking antianxiety or seizure medications, antihistamines, bronchodilators, muscle relaxants and/or opiates. (Brinker 2010, Barnes et al. 2007, Mills and Bone 2005)
- Some people may experience mild gastrointestinal disturbances, nausea, restlessness and/or headaches. (Barnes et al. 2007, ESCOP 2003)
- Stop use if hypersensitivity/allergy occurs. (Barnes et al. 2007, ESCOP 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 medicinal ingredient may comply with the specifications outlined in one of the following pharmacopoeial monographs: (i) 'St. John's wort' from European Pharmacopoeia (Ph. Eur.) and (ii) 'St. John's wort' or 'Powdered St. John's wort' or 'Powdered St. John's wort extract' in US Pharmacopoeia (USP)
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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use
ORAL:
Dried aerial parts:
2-4 g, per day (Blumenthal et al. 2000; BHP 1983)
Infusion:
- 2-4 g dried flowering tops, per day (Wichtl 2004; ESCOP 2003)
- 1.8-3.6 g dried herb, 3 times per day (Hoffmann 2003)
- Directions for use: Pour 250 ml (1 cup) of boiling water over 1 to 2 teaspoons of dried herb (flower) and infuse for 5-15 minutes (Wichtl 2004; Hoffmann 2003). 1 tsp =1.8 g (Wichtl 2004)
Fluid extract:
2-4 g dried equivalent, 3 times per day (1:1, 25% alcohol, 2-4 ml)(BHP 1983)
Tincture:
- 0.6-0.9 g dried equivalent, per day (1:5, 60 % ethanol, 3-4.5 ml)(ESCOP 2003)
- 0.4-0.8 g dried equivalent, 3 times per day (1:5, 40 % ethanol, 2-4 ml) (Hoffmann 2003)
- 0.2-0.4 g dried equivalent, 3 times per day (1:10, 45% ethanol, 2-4 ml) (BHP 1983)
Dry hydroalcoholic extract/solild hydroalcoholic extract:
- 300-600 mg, 3 times per day (3-7:1) (Anghelescu et al. 2006)
- 900 mg, per day (Gastpar et al. 2006)
- 600 mg, per day (3-7:1, 80% methanol) (Kasper et al. 2006)
- 1,200 mg, per day (3-7:1, 80% methanol) (Kasper et al. 2006)
- 300 mg, 3 times per day standardized to 0.12%-0.28% hypericin (Fava et al. 2005)
- 300 mg, 3 times per day (3-7:1) standardized to 3%-6% hyperforin and 0.12%-0.28% hypericin (Szegedi et al. 2005)
- 600 mg, 3 times per day (3-7:1) standardized to 3%-6% hyperforin and 0.12%-0.28% hypericin (Szegedi et al. 2005)
- 900 mg, per day (Uebelhack et al. 2004)
- 300 mg, 3 times per day (4-7:1) standardized to 3%-6% hyperforin and 0.12%-0.28% hypericin. (Lecrubier et al. 2002)
- 300 mg, 2 times per day (Volz et al. 2002)
- 300 mg, 3 times per day (2.5-5.0:1) standardized to 5% hyperforin (Kalb et al. 2001)
- 300 mg, 3 times per day (5-7:1) (Blumenthal et al. 2000)
Appendix 2: Examples of classes of medications that can be affected by St. John's wort
- Anti-cancer agents (Brinker 2008; Sparreboom et al. (2004); Frye et al. 2004; Smith et al. 2004; Hoffmann 2003; Mathijssen et al. 2002; Wang et al. 2001; Roby et al. 2001.);
- Anticoagulants (blood thinners) (Brinker 2008; Mills and Bone 2005; Jiang et al. 2004; Wichtl 2004; Brinker 2001; Maurer et al. 1999);
- Anticonvulsants (seizure medications) (Barnes et al. 2007; Burstein et al. 2000);
- Antidepressants such as SSRIs (selective serotonin reuptake inhibitors) (Brinker 2008; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Brinker 2001);
- Antihistamines (Mills and Bone 2005; Hoffman 2003; Dresser et al. 2003; Xie et al. 2003; Wang et al. 2002);
- Anti-HIV agents (Brinker 2008; Barnes et al. 2007; ESCOP 2003; Hoffmann 2003; De Maat et al. 2001; Piscitelli et al. 2000);
- Anxiolytics (anti-anxiety) (Kawaguchi et al. 2004; Markowitz et al. 2003; Dannawi 2002; Spinella and Eaton 2002; Wang et al. 2001; Parker et al. 2001);
- Bronchodilators (Mills and Bone 2005; Morimoto et al. 2004; Nebel et al. 1999);
- Cardiovascular medications (Brinker 2008; Barnes et al. 2007; Bradley 2006; Mills and Bone 2005; Tannergren et al. 2004; Mueller et al. 2004; Sugimoto et al. 2001; Durr et al. 2000; Johne et al. 1999);
- Immunosuppressants (Brinker 2008; Bradley 2006; Hebert et al. 2004; Alscher and Klotz 2003; Bauer et al. 2003; Dresser et al. 2003; Bolley 2002; Ahmed et al. 2001; Moschella and Jaber 2001; Turton-Weeks 2001; Barone et al. 2000; Karliova et al. 2000; Mai et al. 2000; Ruschitzka et al. 2000; Ernst 1999; Rey and Walter 1998);
- Muscle relaxants (Gurley et al. 2002);
- Opiates (Brinker 2008; Mills and Bone 2005; Eich-Höchli et al. 2003; Brinker 2001)