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Drugs and Health Products

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

Date

April 24, 2008

Proper name(s)

Pulmonaria officinalis L. (Boraginaceae) (USDA 2004)

Common name(s)

Lungwort (USDA 2004; McGuffin et al. 2000)

Source material(s)

Leaf (Williamson 2003, BHP 1983)

Route(s) of Administration

Oral, topical.

Dosage Form(s)

Those suited to the allowable routes of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use or Purpose

Statement to the effect of:
Oral
  • Traditionally used in Herbal Medicine as an expectorant to help relieve the symptoms of bronchitis and catarrhs of the upper respiratory tract (Wichtl 2004; Williamson 2003; BHP 1983; Remington et al. 1918)
  • Traditionally used in Herbal Medicine as a demulcent (Sayre 1917) to help relieve sore throat (Williamson 2003; Bisset and Wichtl 2001; BHP 1983).
  • Traditionally used in Herbal Medicine as an astringent and/or a demulcent (Sayre 1917) to help relieve diarrhoea (Wichtl 2004; Williamson 2003; BHP 1983; Lust 1974).
  • Traditionally used in Herbal Medicine as an astringent and/or a demulcent (Sayre 1917) to help relieve haemorrhoids (Williamson 2003; BHP 1983; Lust 1974).
  • Traditionally used in Herbal Medicine as a mild diuretic (Bisset and Wichtl 2001; Lust 1974).
Topical

Used in Herbal Medicine to aid in the healing of minor wounds and cuts (vulnerary) (Williamson 2003; BHP 1983; Lust 1974).

Dose(s)

Preparations equivalent to 2-4 g dried leaves, 3 times per day (Williamson 2003; BHP 1983)
Directions for use (topical only)

Apply to affected area(s).

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

Diuretic:
For occasional use only (Berardi et al. 2002; CPA 2002)

Other uses:
No statement required.

Risk information

Statement(s) to the effect of:

Caution(s)/Warning(s)

Oral:
Consult a health care practitioner prior to use if you are pregnant or breastfeeding.

All routes of administration:
Consult a health care practitioner if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

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

Specifications

Must comply with the minimum specifications outlined in the current NNHPD Compendium of Monographs.

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.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
  • Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.
  • CPA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Lust J. The Herb Book. New York (NY): Bantam Books Incorporated, published by arrangement with Benedict Lust Publications; 1974.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Remington JP and Woods HC, et al. editors. Next link will take you to another Web site  The Dispensatory of the United States of America, 20th edition. 1918. [Accessed 2008-04-24].
  • Sayre LE. Next link will take you to another Web site  A Manuel of Organic Materia Medica and Pharmacognosy, 4th edition. Philadelphia (PA): P. Blakiston's Son & Co; 1917. [Accessed 2008-04-24].
  • USDA 2004: United States Department of Agriculture, Agricultural Research Service, Next link will take you to another Web site  National Germplasm Resources Laboratory (GRIN). Pulmonaria officinalis L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-04-24].
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.

References reviewed

  • Blumenthal M. The Complete German Commission E Monographs. Austin (TX): American Botanical Council; 1998.
  • Chevallier A. The Encyclopedia of Medicinal Plants. London (UK): Dorling Kindersley Limited; 1996.
  • Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke PK.  Handbook of Medicinal Herbs, 2nd edition.  Boca Raton (FL): CRC Press; 2002.
  • Gruenwald J, Bendler T, Jaenicke C, editors. PDR for Herbal Medicines, 3rd edition.  Montvale (NJ): Thompson PDR; 2004.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Oral and topical:

Dried leaf: 2-4 g, 3 times per day (Williamson at al. 2003; BHP 1983)

Infusion: 2-4 g dried leaf, 3 times per day (BHP 1983)

Fluidextract: 2-4 g dried equivalent, 3 times per day (1:1, 25% alcohol, 2-4 ml) (BHP 1983)

Directions for use (topical only):

Apply to affected area(s).