COENZYME Q₁₀ (UBIQUINONE-10)

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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

July 31, 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)
		Proper name(s)	Common name(s)	Part(s)	Preparation(s)
2,5-Cyclohexadiene-1,4-dione, 2-[(2E,6E,10E,14E,18E,22E,26E ,30E,34E)-3,7,11,15,19, 23,27,31,35,39-decamethyl-2,6,10,14,18,22,26,30,34, 38-tetracontadecaenyl] -5,6-dimethoxy-3-methyl	Coenzyme Q10 CoQ10 Ubidecarenone Ubiquinone-10	Agrobacterium rhizogenes Agrobacterium tumefaciens Aspergillus clavatus Escherichia coli Gluconobacter suboxydans Leucosporidium scotti Paracoccus denitrificans Rhodobacter sphaeroides Rhodospirillum rubrum Saccharomyces cerevisiae Schizosaccharomyces pombe	N/A	Whole	Biosynthesis
		N/A	Coenzyme Q10	N/A	Synthetic

References: Proper name: USP 30 2007; Common names: Storch et al. 2007, Sweetman 2007, USP 30 2007, Park et al. 2005, O'Neil et al. 2001; Source materials: Lipshutz et al. 2005, Kawamukai 2002, Lipshutz et al. 2002, Szkopinska 2000, Yoshida et al. 1998, Zhao et al.1997.

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 form 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)

• Helps to maintain and/or support cardiovascular health (Rosenfeldt et al. 2007; Baggio et al. 1994; Langsjoen et al. 1988).
• Helps to reduce the frequency of migraine headaches and associated nausea and vomiting when taken as a prophylactic/preventative (Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).
• (Provides) An antioxidant (Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Crane 2001; Chello et al. 1994).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

Not to exceed 300 milligrams of Coenzyme Q₁₀, per day (Bonakdar and Guarneri 2005; Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Chello et al. 1994; Langsjoen 1994; Langsjoen et al. 1988; Tanaka et al. 1982)

Cardiovascular health

30 - 300 milligrams of Coenzyme Q₁₀, per day (Bonakdar and Guarneri 2005; Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Chello et al. 1994; Langsjoen 1994; Langsjoen et al. 1988; Tanaka et al. 1982)

Migraine prophylaxis

150 - 300 milligrams of Coenzyme Q₁₀, per day (Sandor et al. 2005; Rozen et al. 2002)

Direction(s) for use

No statement required

Duration(s) of use

Migraine prophylaxis/prevention

Use for at least 3 months to see beneficial effects (Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).

Other uses

No statement required.

Risk information

Caution(s) and warning(s)

All products

• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.
• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood pressure medication (Rosenfeldt et al. 2007; Singh et al. 1999).

Products providing more than 100 mg of Coenzyme Q₁₀ per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (Engelsen et al. 2003; Landbo and Almdal 1998; Spigset 1994).

Migraine prophylaxis/prevention

Consult a health care practitioner/health care provider/health care professional/doctor/physician if migraine frequency increases and associated nausea and vomiting 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 (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

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• Bonakdar RA, Guarneri E. Coenzyme Q10. American Family Physician 2005;72(6):1065-1070.
• Chello M, Mastroroberto P, Romano R, Bevacqua E, Pantaleo D, Ascione R, Marchese AR, Spampinato N. Protection by Coenzyme Q10 from myocardial reperfusion injury during coronary artery bypass grafting. Annals of Thoracic Surgery 1994;58(5):1427-1432.
• Crane FL. Biochemical functions of coenzyme Q10. Journal of the American College of Nutrition 2001;20(6):591-598.
• Engelsen J, Nielsen JD, Hansen KF. [Effect of coenzyme Q10 and Ginkgo biloba on warfarin dosage in patients on long-term warfarin treatment. A randomized, double-blind, placebo-controlled cross-over trial]. Ugeskr Laeger 2003;165(18):1868-1871 (in Danish).
• Hershey AD, Powers SW, Vockell AL, Lecates SL, Ellinor PL, Segers A, Burdine D, Manning P, Kabbouche MA. Coenzyme Q10 deficiency and response to supplementation in pediatric and adolescent migraine. Headache 2007;47(1):73-80.
• Kalpravidh RW, Wichit A, Siritanaratkul N, Fucharoen S. Effect of coenzyme Q10 as an antioxidant in β-thalassemia/Hb E patients. BioFactors 2005;25(1-4):225-234.
• Kawamukai M. Biosynthesis, bioproduction and novel roles of ubiquinone. Journal of Bioscience and Bioengineering 2002;94(6):511-517.
• Landbo C, Almdal TP. [Interaction between warfarin and coenzyme Q10]. Ugeskr Laeger 1998;160(22):3226-3227 (in Danish).
• Langsjoen PH. Introduction to coenzyme Q10. Online in: A Physician's Update on Coenzyme Q10 in U.S. Medicine. University of Washington faculty webpage of John T.A. Ely, Ph.D. Tyler (TX); 1994. [Accessed 2018 June 1]. Available from: https://www.grc.com/sr6dev/misc/coq10/coenzyme%20q10.pdf
• Langsjoen PH, Folkers K, Lyson K, Muratsu K, Lyson T, Langsjoen P. Effective and safe therapy with coenzyme Q10 for cardiomyopathy. Klinische Wochenschrift 1988;66(13):583-590.
• Lipshutz BH, Lower A, Berl V, Schein K, Wetterich F. An improved synthesis of the "miracle nutrient" coenzyme Q10. Organic Letters 2005;7(19):4095-4097.
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• 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.
• Park YC, Kim SJ, Choi JH, Lee WH, Park KM, Kawamukai M, Ryu YW, Seo JH. Batch and fed-batch production of coenzyme Q10 in recombinant Escherichia coli containing the decaprenyl diphosphate synthase gene from Gluconobacter suboxydans. Applied Microbiology and Biotechnology 2005;67(2):192-196.
• Rosenfeldt F, Marasco S, Lyon W, Wowk M, Sheeran F, Bailey M, Esmore D, Davis B, Pick A, Rabinov M, Smith J, Nagley P, Pepe S. Coenzyme Q10 therapy before cardiac surgery improves mitochondrial function and in vitro contractility of myocardial tissue. Journal of Thoracic Cardiovascular Surgery 2005;129(1):25-32.
• Rosenfeldt FL, Haas SJ, Krum H, Hadj A, Ng K, Leong JY, Watts GF. Coenzyme Q10 in the treatment of hypertension: a meta-analysis of the clinical trials. Journal of Human Hypertension 2007;21(4):297-306.
• Rozen TD, Oshinsky ML, Gebeline CA, Bradley KC, Young WB, Shechter AL, Silberstein SD. Open label trial of coenzyme Q10 as a migraine preventative. Cephalgia 2002;22(2):137-141
• Sandor PS, Di Clemente L, Coppola G, Saenger U, Fumal A, Magis D, Seidel L, Agosti RM, Schoenen J. Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial. Neurology 2005;64(4):713-715.
• Singh RB, Niaz MA, Rastogi SS, Shukla PK, Thakur AS. Effect of hydrosoluble coenzyme Q10 on blood pressures and insulin resistance in hypertensive patients with coronary artery disease. Journal of Human Hypertension 1999;13(3):203-208.
• Spigset O. Reduced effect of warfarin caused by ubidecarenone. Lancet 1994;344(8933):1372-1373.
• Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Müller T, Kupsch A, Henningsen H, Oertel WH, Fuchs G, Kuhn W, Niklowitz P, Koch R, Herting B, Reichmann H, German Coenzyme Q10 Study Group. Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q10 in Parkinson disease. Archives of Neurology 2007;64(7):938-944.
• Sweetman SC, editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
• SzkopiÅ„ska A. Review: Ubiquinone. Biosynthesis of quinone ring and its isoprenoid side chain. Intracellular localization. Acta Biochimica Polonica 2000;47(2):469-480.
• Tanaka J, Tominaga R, Yoshitoshi M, Matsui K, Komori M, Sese A, Yasui H, Tokunaga K. Coenzyme Q10: the prophylactic effect on low cardiac output following cardiac valve replacement. Annals of of Thoracic Surgery 1982;33(2):145-151.
• USP 30 2007: United States Pharmacopeia and the National Formulary (USP 30 - NF 25). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2007.
• Yoshida H, Kotani Y, Ochiai K, Araki K. Production of ubiquinone-10 using bacteria. Journal of General and Applied Microbiology 1998;44(1):19-26.
• Zhao J, Wang C, Sun X. [Determination of solanesol in the extracts of tobacco leaves by high performance liquid chromatography (HPLC)]. Chinese Journal of Chromatography 1997;15(6):544-545 (in Chinese).

References reviewed

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