Santé Canada
Symbole du Gouvernement du Canada
Médicaments et produits de santé

COENZYME Q10 (UBIQUINONE-10)

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La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.

Nota

  • Les parenthèses contiennent des éléments d'information additionnels (facultatifs) qui peuvent être inclus dans la DLMM ou sur l'étiquette du produit à la discrétion du demandeur.
  • La barre oblique (/) indique que les termes et/ou les énoncées sont synonymes. Le demandeur peut utiliser n'importe lequel des termes ou énoncés indiqués.

Date

31 juillet 2018

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

Tableau 1. Nom(s) propre(s), Nom commun(s), Matière(s) d'origine
Nom(s) propre(s) Nom commun(s) Matière(s) d'origine
Nom(s) propre(s) Nom commun(s) Partie(s) Préparation
2,5-Cyclohexadiène-1,4-
dione, 2-[(2E,6E,10E,14E,18E,22E,
26E,30E,
34E)-3,7,11,15,19,23,27,31,
35,39-décaméthyl-2,6,10,14,18,22,26,30,34,
38-tétracontadécaényl]-5,6-diméthoxy-3-méthyl
  • Coenzyme Q10
  • CoQ10
  • Ubidécarénone
  • 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 Cellule entière Biosynthèse
N/A Coenzyme Q10N/ASynthètique

Références: Nom propre: USP30 2006; Noms communs: Storch et al. 2007, Sweetman 2007, USP30 2006, Park et al. 2005, O'Neil et al. 2001; Matières d'origine: Lipshutz et al. 2005, Kawamukai 2002, Lipshutz et al. 2002, Szkopinska 2000, Yoshida et al. 1998, Zhao et al.1997.

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiquè dans le document de rèfèrence Compendium des monographies.

Les formes posologiques acceptables pour les catégories d'âge listées dans cette monographie et la voie d'administration spécifiée sont indiqué dans le document de référence Compendium des monographies.

Usage(s) ou fin(s)

  • Aide au maintien et/ou au soutien de la santé cardiovasculaire (Rosenfeldt et al. 2007; Baggio et al. 1994; Langsjoen et al. 1988).
  • Aide à réduire la fréquence des migraines ainsi que les nausées et vomissements qui les accompagnent lorsqu’elle est prise à titre prophylactique/préventif (Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).
  • (Fournit) Un antioxydant (Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Crane 2001; Chello et al. 1994).

Dose(s)

Sous-population(s)

Adultes 18 ans et plus

Quantité(s)

Antioxydant

Ne pas dépasser 300 milligrammes de Coenzyme Q10, par jour (Bonakdar et Guarneri 2005; Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Chello et al. 1994; Langsjoen 1994; Langsjoen et al. 1988; Tanaka et al. 1982)

Santé cardiovasculaire  

30 à 300 milligrammes de Coenzyme Q10, par jour (Bonakdar et Guarneri 2005; Kalpravidh et al. 2005; Rosenfeldt et al. 2005; Chello et al. 1994; Langsjoen 1994; Langsjoen et al. 1988; Tanaka et al. 1982)

Prophylaxie/prévention de la migraine

150 à 300 milligrammes de Coenzyme Q10, par jour (Sandor et al. 2005; Rozen et al. 2002)

Mode(s) d'emploi

Énoncé non requis.

Durée(s) d'utilisation

Prophylaxie/prévention de la migraine

Utiliser pour au moins 3 mois afin d'observer les effets bénéfiques (Hershey et al. 2007; Sandor et al. 2005; Rozen et al. 2002).

Autres usages

Énoncé non requis.

Mention(s) de risque

Précaution(s) et mise(s) en garde

Tous les produits

  • Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d’en faire l’usage si vous êtes enceinte ou si vous allaitez.
  • Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d’en faire l’usage si vous prenez des médicaments pour la pression sanguine (Rosenfeldt et al. 2007; Singh et al. 1999).

Produits fournissant plus de 100 mg de Coenzyme Q10 par jour

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d’en faire l’usage si vous prenez des anticoagulants (Engelsen et al. 2003; Landbo et Almdal 1998; Spigset 1994).

Prophylaxie/prévention de la migraine

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si la fréquence des migraines augmente ou si les nausées et les vomissements qui les accompagnent persistent ou s’aggravent.

Contre-indications(s)

Énoncé non requis.

Réaction(s) indésirable(s) connue(s)

Énoncé non requis

Ingrédients non-médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Énoncé non requis.

Spécifications

  • Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
  • L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN.

Références citées

  • 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.
  • 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 (en danois).
  • 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. [Consulté le 11 juin 2018]. Disponible à :  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.
  • Lipshutz BH, Mollard P, Pfeiffer SS, Chrisman W.  A short, highly efficient synthesis of coenzyme Q10.  Journal of the American Chemical Society 2002;124(48):14282-14283.
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  • 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, éditeur.  Martindale: The Complete Drug Reference, 35e édition.  London (UK): Pharmaceutical Press; 2007.
  • Szkopinska 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:  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 (en chinois).

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