LYSINE

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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

December 18, 2018

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

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

Proper name(s)	Common name(s)	Source material(s)
		Common name(s)
(S)-2,6-Diaminohexanoic acid L-Lysine	L-Lysine Lysine	L-Lysine L-Lysine monohydrochloride L-Lysine acetate L-Lysine dihydrochloride

References: Proper names: O'Neil et al. 2001; Common names: O'Neil et al. 2001; Source materials: O'Neil et al. 2001, USP 30 2007.

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/(an) essential amino acid for the maintenance of good health (Sweetman 2007; IOM 2002).
• Source of/(an) essential amino acid involved in muscle protein synthesis (Sweetman 2007; IOM 2002).
• Helps to reduce the recurrence of herpes simplex virus (HSV) infection (e.g. cold sores) (Wright 1994; Griffith et al. 1987; Simon et al. 1985; McCune et al. 1984; Miller et al. 1984; Thein et al. 1984; Walsh et al. 1983; Griffith et al. 1978).
• Helps in collagen formation (Shils et al. 2006; IOM 2002; Groff and Gropper 2000).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Reduce the recurrence of HSV infection

1000 - 3000 milligrams, per day (Wright 1994; Griffith et al. 1987; Simon et al. 1985; McCune et al. 1984; Miller et al. 1984; Thein et al. 1984; Walsh et al. 1983; Griffith et al. 1978).

Other uses

133 - 3000 milligrams, per day (Wright 1994; Griffith et al. 1987; Simon et al. 1985; McCune et al. 1984; Miller et al. 1984; Thein et al. 1984; Walsh et al. 1983; Griffith et al. 1978).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing more than 300 mg of lysine, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding(Goldman and Ausiello 2004).

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 (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

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.

References Cited

• Goldman L, Ausiello D, editors. Cecil Textbook of Medicine, Volume 1, 22nd edition. Philadelphia (PA): Saunders; 2004. Griffith RS, Norins AL, Kagen C. A multicentered study of lysine therapy in herpes simplex infection. Dermatologica 1978;156(5):257-267.
• Griffith RS, Walsh DE, Myrmel KH, Thompson RW, Behforooz A. Success of L-lysine therapy in frequently recurring herpes simplex infection. Treatment and prophylaxis. Dermatologica 1987;175(4):183-190.
• Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3^rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
• IOM 2002: Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington (DC): National Academies Press; 2002.
• McCune MA, Perry HO, Muller SA, O'Fallon WM. Treatment of recurrent herpes simplex virus infection with L-lysine monohydrochloride. Cutis 1984;34(4):366-373.
• Miller CS, Foulke CN. Use of lysine in treating recurrent oral herpes simplex infections. General Dentistry 1984;32(6):490-493.
• O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.; 2001.
• Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease, 10^th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
• Simon CA, Van Melle GD, Ramelet AA. Failure of lysine in frequently recurrent herpes simplex infection. Archives of Dermatology 1985;121(2):167-168.
• Sweetman SC, editor. Martindale: The Complete Drug Reference, 35^th edition. London (UK): Pharmaceutical Press; 2007.
• Thein DJ, Hurt WC. Lysine as a prophylactic agent in the treatment of recurrent herpes simplex labialis. Oral Surgery, Oral Medicine and Pathology 1984;58(6):659-666.
• USP 30 2007: United States Pharmacopeia and the National Formulary (USP 30 - NF 25). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2007.
• Walsh DE, Griffith RS, Behforooz A. Subjective response to lysine in the therapy of herpes simplex. The Journal of Antimicrobial Chemotherapy 1983;12(5):489-496.
• Wright EF. Clinical effectiveness of lysine in treating recurrent aphthous ulcers and herpes labialis. General Dentistry 1994;42(1):40-42.

References Reviewed

• Ahmad G, Mushtaq T, Mirza MA, Ahmed Z. Comparative bioefficacy of lysine from L-lysine hydrochloride or L-lysine sulfate in basal diets containing graded levels of canola meal for female broiler chickens. Poultry Science 2007;86(3):525-530.
• Caramia G, Gagliardini R, Ruffini E, Osimani P, Nobilini A. The management of cystic fibrosis with carbocysteine lysine salt: single-blind comparative study with ambroxol hydrochloride. The Journal of International Medical Research 1995;23(4):284-293.
• Chromiak JA, Antonio J. Use of amino acids as growth hormone-releasing agents by athletes. Nutrition 2002;18(7-8):657-661.
• Civitelli R, Villareal DT, Agnusdei D, Nardi P, Avioli LV, Gennari C. Dietary L-lysine and calcium metabolism in humans. Nutrition 1992;8(6):400-405.
• Cohlan SQ, Stone SM. Effects of dietary and intraperitoneal excess of L-lysine and L-leucine on rat pregnancy and offspring. The Journal of Nutrition 1961;74:93-95.
• DerMarderosian A, Beutler JA, editors. The Review of Natural Products, 3^rd edition. St. Louis (MO): Facts and Comparisons, A Wolters Kluwer Company; 2002.
• DiGiovanna JJ, Blank H. Failure of lysine in frequently recurrent herpes simplex infection. Treatment and prophylaxis. Archives of Dermatology 1984;120(1):48-51.
• Feldman EB. The scientific evidence for a beneficial health relationship between walnuts and coronary heart disease. The Journal of Nutrition 2002;132(5):1062S-1101S.
• Flodin NW. The metabolic roles, pharmacology, and toxicology of lysine. Journal of the American College of Nutrition 1997;16(1):7-21.
• Fragakis AS, Thomson C. The Health Professional's Guide to Popular Dietary Supplements, 3^rd edition. Chicago (IL): American Dietetic Association; 2007.
• Frey J, Raby N. [Lysine and collagen]. Annales de Biologie Clinique 1991;49(1):36-39 (in French).
• Funk DN, Worthington-Roberts B, Fantel A. Impact of supplemental lysine or tryptophan on pregnancy course and outcome in rats. Nutrition Research 1991;11(5):501-512.
• Garrison R, Somer E. The Nutrition Desk Reference, 3^rd edition. New Canaan (CT): Keats Publishing, Inc.; 1995.
• Hendler SS, Rorvik D, editors. PDR for Nutritional Supplements, 1st edition. Montvale (NJ): Thomson PDR; 2001.
• Krajvcovivcová-Kudlávcková M, Ginter E, Blavzícvek P, Klvanová J, Babinská K. [Nutritional status in adults on an alternative or traditional diet]. Casopís Lékaru Ceských 2001;140(5):142146 (in Slovak).
• Lasekan JB, Koo WW, Walters J, Neylan M, Luebbers S. Growth, tolerance and biochemical measures in healthy infants fed a partially hydrolyzed rice protein-based formula: a randomized, blinded, prospective trial. Journal of the American College of Nutrition 2006;25(1):12-19.
• Lo JC, Chertow GM, Rennke H, Seifter JL. Fanconi's syndrome and tubulointerstitial nephritis in association with L-lysine ingestion. American Journal of Kidney Diseases 1996;28(4):614617.
• Mack PB, Vose GP, Kinard Cl, Campbell HB. Effects of lysine supplemented diets on growth and skeletal density of preadolescent children. The American Journal of Clinical Nutrition 1962;11(4):255-262.
• Marcason W. Will taking the amino acid supplement lysine prevent or treat the herpes simplex virus? Journal of the American Dietetic Association 2003;103(3):351.
• Matsueda S, Niiyama Y. The effects of excess amino acids on maintenance of pregnancy and fetal growth in rats. Journal of Nutritional Science and Vitaminology 1982;28(5):557-573.
• McClure FJ, Folk JE. Lysine and cariogenicity of two experimental rat diets. Science 1955;122(3169):557-558.
• Milman N, Scheibel J, Jessen O. Lysine prophylaxis in recurrent herpes simplex labialis: a double-blind, controlled crossover study. Acta Dermato-Venereologica 1980;60(1):85-87.
• Milman N, Scheibel J, Jessen O. Failure of lysine treatment in recurrent herpes simplex labialis. Lancet 1978;2(8096):942.
• Passàli D, Volonté M, Passàli GC, Damiani V, Bellussi L, MISTRAL Italian Study Group. Efficacy and safety of ketoprofen lysine salt mouthwash versus benzydamine hydrochloride mouthwash in acute pharyngeal inflammation: a randomized, single-blind study. Clinical Therapeutics 2001;23(9):1508-1518.
• Raven AM, Lengemann FW, Wasserman RH. Studies of the effect of lysine on the absorption of radiocalcium and radiostrontium by the rat. The Journal of Nutrition 1960;72(1):29-36.
• Spencer H, Samachson J. Effect of lysine on calcium metabolism in man. The Journal of Nutrition 1963;81(4):301-306.
• Tortora GJ, Funke BR, Case CL. Microbiology: An Introduction, 7th edition. San Francisco (CA): Benjamin Cummings; 2001.
• USP 25: United States Pharmacopeia and the National Formulary (USP 25 - NF 20). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2002.
• Uzawa K, Yeowell HN, Yamamoto K, Mochida Y, Tanzawa H, Yamauchi M. Lysine hydroxylation of collagen in a fibroblast cell culture system. Biochemical and Biophysical Research Communications 2003;305(3):484-487.
• Wasserman RH, Comar CL, Nold MM. The influence of amino acids and other organic compounds on the gastrointestinal absorption of calcium 45 and strontium 89 in the rat. The Journal of Nutrition 1956;59(3):371-383.
• Windholz M, Budavari S, Blumetti RF, Otterbein ES, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 10th edition. Rahway (NJ): Merck & Co., Inc.; 1983.
• Yamauchi M, Shiiba M. Lysine hydroxylation and crosslinking of collagen. Methods in Molecular Biology 2002;194:277-290.