Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Ubiquinol

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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

June 11, 2014

Proper name(s)

Ubiquinol (NHPID)

Common name(s)

Ubiquinol (NHPID)

Source materials

Synthetic (NHPID)

Route(s) of administration

Oral

Dosage 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)

  • 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 (Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).
  • Provides antioxidants (Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Crane 2001; Chello et al. 1994).

Dose(s)

Subpopulations

Adults (≥ 18 years)

Quantity(ies)

Antioxidant:

Up to 300 mg, per day (Langsjoen and Langsjoen 2008; Rosenfeldt et al. 2007; Baggio et al. 1994; Langsjoen et al. 1988).

Cardiovascular Health; Heart Function:

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

Migraine Prophylaxis:

75-100 mg, 2-3 times per day (Langsjoen and Langsjoen 2008; Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).

Directions for use (optional):

Statement(s) to the effect of Take with meals.

Duration of use

Statement(s) to the effect of:

Migraine Prophylaxis

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

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

All products
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
  • If you are taking blood pressure medication, consult a health care practitioner prior to use (Langsjoen and Langsjoen 2008; Rosenfeldt et al. 2007; Engelsen et al. 2003; Singh et al. 1999; Landbo and Almdal 1998; Spigset 1994).
Doses ≥ 100mg, per day:

If you are taking blood thinner medication, consult a health care practitioner prior to use (Langsjoen and Langsjoen 2008; Engelsen et al. 2003; Landbo and Almdal 1998; Spigset 1994).

Migraine Prophylaxis:

If migraine frequency increases, and associated nausea and vomiting persist or worsen, consult a health care practitioner.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required

Non-medicinal ingredients

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

Storage conditions

No statement required

Specifications

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.
  • 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).
  • Fuke C, Krikorian SA, Couris RR. Coenzyme Q10: a review of essential functions and clinical trials. US Pharmacist 2000;28-41.
  • 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.
  • 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.
  • 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.
  • 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.