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Drugs and Health Products

Magnesium

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.


Date: November 15, 2007

Proper name(s): Magnesium (Sweetman 2007; O'Neil et al. 2001)

Common name(s): Magnesium (Sweetman 2007; O'Neil et al. 2001)

Source material(s):

  • Magnesium acetate (Sweetman 2007; O'Neil et al. 2001)
  • Magnesium acetate tetrahydrate (Sweetman 2007; O'Neil et al. 2001)
  • Magnesium ascorbate (Sweetman 2007)
  • Magnesium aspartate (Firoz and Graber 2001)
  • Magnesium bisglycinate (Albion 2003; Albion 2000)
  • Magnesium carbonate (IOM 2003)
  • Magnesium chloride (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
  • Magnesium chloride hexahydrate (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
  • Magnesium citrate (Sweetman 2007; O'Neil et al. 2001)
  • Magnesium fumarate (HC 2007)
  • Magnesium gluceptate (Sweetman 2007)
  • Magnesium gluconate (Sweetman 2007; IOM 2003)
  • Magnesium gluconate dihydrate (Sweetman 2007; IOM 2003)
  • Magnesium glutarate (HC 2007)
  • Magnesium glycerophosphate (Sweetman 2007)
  • Magnesium hydrolyzed animal protein (HAP) chelate (Albion 2004; Albion 2003; Albion 1997)
  • Magnesium hydrolyzed vegetable protein (HVP) chelate (Albion 2004; Albion 2003; Albion 1997)
  • Magnesium hydroxide (IOM 2003; O'Neil et al. 2001)
  • Magnesium lactate (Sweetman 2007; O'Neil et al. 2001)
  • Magnesium malate (Albion 2004)
  • Magnesium oxide (IOM 2003; O'Neil et al. 2001)
  • Magnesium phosphate dibasic trihydrate/Magnesium hydrogen
  • phosphate trihydrate/Dimagnesium phosphate trihydrate
    (IOM 2003)
  • Magnesium phosphate tribasic tetra-, penta-, or
  • octahydrate/Trimagnesium phosphate tetra-, penta- or octahydrate
    (IOM 2003)
  • Magnesium pidolate (Sweetman 2007)
  • Magnesium succinate (HC 2007)
  • Magnesium sulfate (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
  • Magnesium sulfate heptahydrate (Sweetman 2007; IOM 2003; O'Neil et al. 2001)

Note: The slash (/) indicates that the terms are synonyms. Either term may be selected by the applicant.

Route(s) of administration: Oral

Dosage form(s): Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewable tablets, caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons, or tablespoons are acceptable. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s): Statement(s) to the effect of:

General: A factor in the maintenance of good health (IOM 2006).

Specific:

  • Helps the body to metabolize carbohydrates, fats and proteins (Shils et al. 2006; Groff and Gropper 2000; IOM 1997).
  • Helps in the development and maintenance of bones (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).
  • Helps in the development and maintenance of teeth (IOM 2006; Meisel et al. 2005).
  • Helps in tissue formation (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).
  • Helps to maintain proper muscle function (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).

Dose-specific: For products providing daily doses of magnesium at or above the Recommended Dietary Allowance (RDA) (adjusted for the life stage groups), the following use or purpose is acceptable:
Helps to prevent magnesium deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).

For products providing a daily dose of magnesium above the Tolerable Upper Intake Level (UL) (intended for adults 19 years and older only) at least one of the Specific and/or the Dose-specific Use(s) or Purpose(s) indicated above is required.

See Appendix 1 for definitions and Table 2 and 3 in Appendix 2 for RDA and UL values.

Dose(s):

Table 1: Dose information for magnesium presented as dose per day (IOM 2006)

Life stage group Magnesium (mg/day)
Minimum1 Maximum2
Children 1-3 y 12 65
4-8 y 12 110
Adolescents 9-13 y 12 350
14-18 y 20 350
Adults3 ≥19 y 20 500

1 Based on approximately 5% of the highest RDA (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for RDA values.
2 Maximum doses for children and adolescents are based on the UL which applies to magnesium intake from supplements only (IOM 2006). Maximum dose for adults supported by the following references: Lopez-Ridaura et al. 2004; Rude 1998.
3 Includes pregnant and breastfeeding women.

Duration of use: No statement required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s): When magnesium HAP or HVP chelate is used as a source material:
For an adult subpopulation only.

Contraindication(s):No statement required.

Known adverse reaction(s): For products providing magnesium at doses greater than 350 mg, per day, the following statement is required:
Some people may experience diarrhoea (IOM 2006; IOM 1997).

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications: Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

References:

Albion 2004: Magnesium: A role in the therapy for asthma. Albion Research Notes 2004;13(3) [Accessed 2007-03-21]. Available from:
http://www.albion-an.com/human/newsletter/sept2004.pdf

Albion 2003: Magnesium- clinical and health benefits still without limits. Albion Research Notes 2003;12(3) [Accessed 2007-03-21]. Available from:
http://www.albion-an.com/human/newsletter/2003Oct.pdf

Albion 2000: Implications of the "other half" of a mineral compound. Albion Research Notes 2000;9(3) [Accessed 2007-03-21]. Available from:
http://www.albion-an.com/human/Newsletter/2000October.pdf

Albion 1997: Magnesium: mineral link to energy. Albion Research Notes 1997;6(1) [Accessed 2007-03-21]. Available from: http://www.albion-an.com/human/Newsletter/1997January.pdf

Firoz M, Graber M. Bioavailability of US commercial magnesium preparations. Magnesium Research 2001;14(4):257-262.

Groff J, Gropper S. Advanced Nutrition and Human Metabolism. 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.

HC 2007: Health Canada. Drug Product Database. 2007. Ottawa (ON): Health Canada; 2007. [Accessed 2007-03-21]. Available from:
http://search.hc-sc.gc.ca/cgi-bin/query?mss=dpd/english/active/simple

IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.

IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.

IOM 1997: Institute of Medicine. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academy Press; 1997.

Lopez-Ridaura R, Willett WC, Rimm EB, Liu S, Stampfer MJ, Manson JE, Hu FB. Magnesium intake and risk of type 2 diabetes in men and women. Diabetes Care 2004;27(1):134-140.

Meisel P, Schwahn C, Luedemann J, John U, Kroemer HK, Kocher T. Magnesium deficiency is associated with periodontal disease. Journal of Dental Research 2005;84(10):937-941.

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2001.

Rude RK. Magnesium deficiency: a cause of heterogeneous disease in humans. Journal of Bone and Mineral Research 1998;13(4):749-758.

Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease. 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 35rth edition. London (UK): Pharmaceutical Press; 2007.

Appendix 1: Definitions

Recommended Dietary Allowances (RDA): The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Tolerable Upper Intake Level (UL): The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).

Appendix 2: RDA Values

The RDA values for magnesium are provided below. For the purpose of this monograph, these values are intended to:

  • provide targets for setting appropriate supplement dosage levels
  • provide the minimum dose for the use of the dose specific claim: "Helps to prevent magnesium deficiency"
  • facilitate the optional labelling of % RDA values

Table 2: Recommended Dietary Allowance values for magnesium based on life stage group (IOM 2006)

Life stage group Magnesium (mg/day)
Children 1-3 y 80
4-8 y 130
Adolescent males 9-13 y 240
14-18 y 410
Adult males 19-30 y 400
31-50 y 420
51-70 y 420
>70 y 420
Adolescent females 9-13 y 240
14-18 y 360
Adult females 19-30 y 310
31-50 y 320
51-70 y 320
>70 y 320
Pregnancy 14-18 y 400
19-30 y 350
31-50 y 360
Breastfeeding 14-18 y 360
19-30 y 310
31-50 y 320

Table 3: Tolerable Upper Intake Level values for magnesium for adults ≥ 19 years (IOM 2006)

Life stage group Magnesium (mg/day)
Adults1 350

1 Includes pregnant and breastfeeding women.