UBIQUINOL

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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

August 28, 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)	Preparation
Ubiquinol	Ubiquinol	Ubiquinol	Synthetic

References: Proper name: ChemID 2018; Common name: ChemID 2018; Source material: ChemID 2018.

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)

• 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 symptoms such as 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 Ubiquinol, per day (Langsjoen and Langsjoen 2008; Rosenfeldt et al. 2007; Baggio et al. 1994; Langsjoen et al. 1988).

Cardiovascular health

15 - 300 milligrams of Ubiquinol, per day (Langsjoen and Langsjoen 2008; Rosenfeldt et al. 2007; Baggio et al. 1994; Langsjoen et al. 1988).

Migraine prophylaxis/prevention

75 - 300 milligrams of Ubiquinol, per day (Langsjoen and Langsjoen 2008; Hershey et al. 2007; 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 (Langsjoen and Langsjoen 2008; Rosenfeldt et al. 2007; Engelsen et al. 2003; Singh et al. 1999; Landbo and Almdal 1998; Spigset 1994).

Products providing more than 100 mg of Ubiquinol, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (Langsjoen and Langsjoen 2008; 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

• Baggio E, Gandini R, Plancher AC, Passeri M, Carmosino G. Italian multicenter study on the safety and efficacy of coenzyme Q10 as adjunctive therapy in heart failure. CoQ10 Drug Surveillance Investigators. Molecular Aspects of Medicine 1994;15(Supplement 1):S287-S294.
• 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.
• ChemID 2018. ChemIDplus advanced [Internet]. Bethesda (MD): United States National Library of Medicine. [Accessed 2018 June 6]. Available from: http://chem.sis.nlm.nih.gov/chemidplus
• 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 beta-thalassemia/Hb E patients. BioFactors 2005;25(1-4):225-234.
• Landbo C, Almdal TP. [Interaction between warfarin and coenzyme Q10]. Ugeskr Laeger 1998;160(22):3226-3227 (in Danish).
• 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.
• Langsjoen PH, Langsjoen AM. Supplemental ubiquinol in patients with advanced congestive heart failure. Biofactors 2008;32(1-4):119-28.
• 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.