Coenzyme Q10 Capsules

Coenzyme Q10 (CoQ10), also known as ubiquinone and ubidecarenone, is an endogenously synthesized vitamin-like compound that is involved in a variety of cellular processes. It is a fat-soluble antioxidant and a member of the quinone family with a structural similarity to vitamin K. Coenzyme Q10 was first isolated from bovine hearts at the University of Wisconsin in 1957; it is found naturally in small amounts in foods, particularly meat and seafood. Endogenous levels of CoQ10 decline with age. In addition, endogenous deficiencies of CoQ10 have been noted in patients with heart failure, cardiomyopathies, cancer, and some neurological diseases (e.g., Parkinson’s disease). The use of coenzyme Q10 has been postulated to be of benefit in a variety of disorders; it is possible that a pre-existing state of CoQ10 deficiency may be necessary to observe any clinical benefit from supplementation. CoQ10 has been studied as an athletic performance enhancer, adjunctive treatment for cardiovascular diseases, acute myocardial infarction, adjuvant treatment for metastatic breast cancer, prophylaxis of doxorubicin-induced cardiomyopathy, familial cerebellar ataxia, periodontal disease, muscular dystrophy, Parkinson’s disease, and mitochondrial disorders. Most of these uses are based on speculative data or limited, uncontrolled clinical trials. No firm conclusion can be made in regard to the efficacy of CoQ10 in these conditions, although the controlled data suggest that CoQ10 does not offer benefit to patients with heart failure. The use of CoQ10 for mitochondrial disorders will need controlled trials to support clinical efficacy. Despite initial studies showing little proof of efficacy, in December 1999, the FDA granted orphan drug status for the treatment of mitochondrial cytopathies to one manufacturer of CoQ10, the GelTec/Tishcon Corporation, for the study of its proprietary supplement UbiQGel. Quinzyme tablets, manufactured by Zyber Pharmaceuticals, are a medical food, and are intended for use under the supervision of physician.^[1]

Co-enzyme Q10, Ubiquinone (CoQ10) is a fat-soluble, vitamin-like compound that acts as a carrier for electron-transfer within the inner mitochondrial membrane. It also plays a vital role in ATP production (oxidative phosphorylation). Antioxidant properties, such as free radical scavenging, have also been noted. CoQ10 may possess mild inotropic activity and may also influence prostaglandin metabolism, specifically prostacyclin. The highest endogenous concentrations of CoQ10 are found in the heart, liver, kidney, and pancreas. CoQ10 levels are thought to be low in several diseases including CHF, hypertension, periodontal disease, certain muscular diseases, Parkinson’s disease, migraine headaches, and AIDS.^[2]

Antioxidant actions: The role of CoQ10 in the treatment of mitochondrial disorders and CHF is thought to involve its antioxidant properties. In patients with disorders of mitochondrial function, serum lactate and lactate/pyruvate ratio are increased due to impaired oxidative metabolism. These levels are reduced with supplementation of CoQ10 resulting in improved exercise tolerance and function. In CHF patients, levels of CoQ10 are often low. The mechanism of CoQ10 in the treatment of CHF may involve supplementation of these levels as well as prevention of oxidative damage. In CHF, the greatest benefit of CoQ10 appears to be in patients with the largest CoQ10 deficiency.^[2]

ATP generation/oxidative phosphorylation: CoQ10 may aid the production of ATP by preventing the depletion of metabolites necessary for ATP resynthesis. Increased production of ATP may produce antianginal effects. Additionally, in patients with migraine headaches, CoQ10 may improve mitochondrial oxidative phosphorylation, which may be impaired in some patients.^[2]

Membrane stabilization: CoQ10 appears to possess direct membrane stabilizing properties due to phospholipid-protein interactions. The antioxidant and membrane stabilizing properties of CoQ10 may contribute to its ability to protect myocardial tissue during ischemic reperfusion.^[2]

Safety and efficacy of Co-enzyme Q10, Ubiquinone (CoQ10) in pregnancy have not been established. CoQ10 100 mg twice daily has been safely used in pregnant women at risk for pre-eclampsia; treatment resulted in decreased risk of pre-eclampsia when CoQ10 was administered from 20 weeks gestation until term.^[3] Because adequate, well-controlled studies are lacking, avoiding its use during pregnancy in most women may be prudent until more information is available.

Safety and efficacy of Co-enzyme Q10, Ubiquinone in breastfeeding have not been established. There have been no adequate and well-controlled studies conducted on the safe use of CoQ10 supplements in breast-feeding women. However, it is known that CoQ10 (obtained from dietary sources) is a natural component of early breast milk (colostrum), and maternal plasma and milk concentrations appear to decline with time and levels are not as concentrated in mature milk.^[4] Avoiding supplemental use during breastfeeding may be prudent until more information is available.^[5] Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breastfeeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Safety and efficacy of Co-enzyme Q10, Ubiquinone (CoQ10) in pregnancy have not been established. CoQ10 100 mg twice daily has been safely used in pregnant women at risk for pre-eclampsia; treatment resulted in decreased risk of pre-eclampsia when CoQ10 was administered from 20 weeks gestation until term.^[3] Because adequate, well-controlled studies are lacking, avoiding its use during pregnancy in most women may be prudent until more information is available.

Safety and efficacy of Co-enzyme Q10, Ubiquinone in breastfeeding have not been established. There have been no adequate and well-controlled studies conducted on the safe use of CoQ10 supplements in breast-feeding women. However, it is known that CoQ10 (obtained from dietary sources) is a natural component of early breast milk (colostrum), and maternal plasma and milk concentrations appear to decline with time and levels are not as concentrated in mature milk.^[4] Avoiding supplemental use during breastfeeding may be prudent until more information is available.^[5] Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breastfeeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

1. Matthews PM, Ford B, Dandurand RJ, et al. Coenzyme Q10 with multiple vitamins is generally ineffective in treatment of mitochondrial disease. Neurology 1993;43:884—90.
2. Greenberg S, Frishman WH. Co-enzyme Q10: a new drug for cardiovascular disease. J Clin Pharmacol 1990;30:596-608.
3. Teran E, Hernandez I, Nieto B, et al. Coenzyme Q10 supplementation during pregnancy reduces the risk of pre-eclampsia. Int J Gynaecol Obstet 2009;105:43-5.
4. Niklowitz P, Menke T, Giffei J, Andler W. Coenzyme Q10 in maternal plasma and milk throughout early lactation. Biofactors. 2005; 25: 67-72.
5. Natural Medicines Comprehensive Database. Jellin JM, ed. Stockton; 1995-2010.