Magnesium Supplement (Oral Route, Parenteral Route)

20 May.,2024

 

Magnesium Supplement (Oral Route, Parenteral Route)

Description and Brand Names

Drug information provided by: Merative, Micromedex®

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US Brand Name

  1. Almora
  2. Citrate Of Magnesia
  3. Dewees Carminative
  4. Elite Magnesium
  5. Mag-Gel 600
  6. Maginex
  7. Mag-Tab SR
  8. Phillips Milk of Magnesia

Canadian Brand Name

  1. Citracal Slow Release
  2. Mag 2
  3. Mag Citrate
  4. Magnesium-Rougier
  5. Royvac Magnesium Citrate

Descriptions


Magnesium is used as a dietary supplement for individuals who are deficient in magnesium. Although a balanced diet usually supplies all the magnesium a person needs, magnesium supplements may be needed by patients who have lost magnesium because of illness or treatment with certain medicines.

Lack of magnesium may lead to irritability, muscle weakness, and irregular heartbeat.

Injectable magnesium is given only by or under the supervision of a health care professional. Some oral magnesium preparations are available only with a prescription. Others are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of magnesium include green leafy vegetables, nuts, peas, beans, and cereal grains in which the germ or outer layers have not been removed. Hard water has been found to contain more magnesium than soft water. A diet high in fat may cause less magnesium to be absorbed. Cooking may decrease the magnesium content of food.

The daily amount of magnesium needed is defined in several different ways.

For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for magnesium are generally defined as follows:

Information about this magnesium-supplement-oral-route-parenteral-route Persons U.S.
(mg)
Canada
(mg) Infants birth to 3 years of age 40 to 80 20–50 Children 4 to 6 years of age 120 65 Children 7 to 10 years of age 170 100–135 Adolescent and adult males 270–400 130–250 Adolescent and adult females 280–300 135–210 Pregnant females 320 195–245 Breast-feeding females 340–355 245–265

This product is available in the following dosage forms:

  • Capsule
  • Tablet, Extended Release
  • Tablet
  • Tablet, Chewable
  • Capsule, Liquid Filled
  • Powder for Solution
  • Powder

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Magnesium stearate, a widely-used food additive, exhibits ...

Magnesium stearate is widely used in the production of dietary supplement and pharmaceutical tablets, capsules and powders as well as many food products, including a variety of confectionery, spices and baking ingredients. Although considered to have a safe toxicity profile, there is no available information regarding its potential to induce genetic toxicity. To aid safety assessment efforts, magnesium sulfate was evaluated in a battery of tests including a bacterial reverse mutation assay, an in vitro chromosome aberration assay, and an in vivo erythrocyte micronucleus assay. Magnesium stearate did not produce a positive response in any of the five bacterial strains tested, in the absence or presence of metabolic activation. Similarly, exposure to magnesium stearate did not lead to chromosomal aberrations in CHL/IU Chinese hamster lung fibroblasts, with or without metabolic activation, or induce micronuclei in the bone marrow of male CD-1 mice. These studies have been used by the Japanese government and the Joint FAO/WHO Expert Committee on Food Additives in their respective safety assessments of magnesium stearate. These data indicate a lack of genotoxic risk posed by magnesium stearate consumed at current estimated dietary exposures. However, health effects of cumulative exposure to magnesium via multiple sources present in food additives may be of concern and warrant further evaluation.

1. Introduction

Magnesium stearate is the magnesium salt of the fatty acid, stearic acid ( ). It has been widely used for many decades in the food industry as an emulsifier, binder and thickener, as well as an anticaking, lubricant, release, and antifoaming agent. It is present in many food supplements, confectionery, chewing gum, herbs and spices, and baking ingredients. Magnesium stearate is also commonly used as an inactive ingredient in the production of pharmaceutical tablets, capsules and powders.

For food applications, magnesium stearate is typically manufactured by one of two processes. The direct or fusion process involves direct reaction of fatty acids with a source of magnesium, such as magnesium oxide, to form magnesium salts of the fatty acids. In the indirect or precipitation process, a sodium soap is produced by reacting fatty acids with sodium hydroxide in water and precipitating the product through addition of magnesium salts to the soap. The fatty acids used as raw material are derived from edible fats and oils and consist mainly of stearic and palmitic acid. The final product contains 4.0-5.0% magnesium, on a dried basis, and the fatty acid fraction is composed of ≥90% stearic and palmitic acids, at least 40% of which are stearic acid. It is a very fine powder that is greasy to the touch and practically insoluble in water.

Upon ingestion, magnesium stearate is dissolved into magnesium ion and stearic and palmitic acids. Magnesium is absorbed primarily in the small intestine, and to a lesser extent, in the colon. Magnesium is an essential mineral, serving as a cofactor for hundreds of enzymatic reactions and is essential for the synthesis of carbohydrates, lipids, nucleic acids and proteins, as well as neuromuscular and cardiovascular function [1], [2]. The majority of magnesium content in the body is stored in bone and muscle [1], [3]. A small amount (∼1%) is present in serum and interstitial body fluid, mostly existing as a free cation while the remainder is bound to protein or exists as anion complexes [3]. The kidney is largely responsible for magnesium homeostasis and maintenance of serum concentration [1], [3]. Excretion occurs primarily via the urine, but also occurs in sweat and breast milk. Stearic and palmitic acids are products of the metabolism of edible oils and fats for which the metabolic fate has been well established. These fatty acids undergo ß-oxidation to yield 2-carbon units which enter the tricarboxylic acid cycle and the metabolic products are utilized and excreted [4].

Magnesium stearate is permitted for use in the European Union and other countries including China, Japan, Australia and New Zealand, and was granted generally recognized as safe (GRAS) status in the United States [5]. However, there are no published data available related to the genotoxic potential of magnesium stearate. For the safety assessment of food ingredients, the U.S. Food and Drug Administration (FDA) recommends a bacterial reverse mutation test [6], [7], [8], an in vitro test for chromosomal damage or gene mutation in mammalian cells, as well as an in vivo test for chromosomal damage using mammalian hematopoietic cells [9], such as the rodent erythrocyte micronucleus assay [10], [11] which has proven utility for predicting carcinogens [12]. The European Food Safety Authority (EFSA) guidances [13], [14] recommend a similar, albeit tiered, approach for assessing genotoxic potential. To provide requested genotoxicity data to support initial assessment of the safety of magnesium stearate conducted by the Japanese government, and subsequently, reassessment by the Joint FAO/WHO Expert Committee on Food Additives [15], [16], magnesium stearate was evaluated in a bacterial gene mutation assay using Salmonella and E. coli tester strains, an in vitro mammalian chromosome aberration assay using Chinese Hamster Lung cells and a micronucleus assay in the bone marrow of male CD-1 mice. This combination of tests is commonly used to evaluate the genotoxicity of food additives [17], [18]. The studies reported here were performed as Good Laboratory Practice (GLP) experiments in accordance with Japanese Ministry of Health, Labour and Welfare and OECD testing guidelines current at the time the studies were conducted [19], [20], [21], [22].

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