Fosteum

Fosteum

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Fosteum Recall
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Fosteum Recall

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Uses

Indications FOSTEUM is indicated for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.
Usage FOSTEUM should be taken with sufficient calcium and vitamin D 3 as directed by a physician. In clinical trials of the genistein in FOSTEUM, patients also received 1,000 mg of calcium carbonate and 800 IU vitamin D 3 per day in two divided doses. See Dosage and Administration for additional information.
Interactions with Food FOSTEUM can be taken with or without other foods. FOSTEUM may be taken with any beverage desired.

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FOSTEUM® consists of a specially formulated proprietary blend of high purity genistein aglycone from a natural source, citrated zinc bisglycinate and cholecalciferol (vitamin D 3). Genistein aglycone reduces osteoclast activity and stimulates osteoblast activity. Citrated zinc bisglycinate works synergistically with genistein aglycone, while both citrated zinc bisglycinate and vitamin D 3 also work independently to promote mineralization activity in bone. Vitamin D 3 also facilitates calcium absorption from the intestine.

Genistein aglycone

Each FOSTEUM capsule contains 27 mg of genistein aglycone (genistein), derived from a natural source, for a total daily intake of 54 mg. In clinical trials, this level of intake has been shown to increase bone mineral density (BMD). Genistein is chemically described as 4',5,7-trihydroxyisoflavone or 5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one. It is the aglycone form of the glucoside isoflavone molecule genistin. The empirical formula of genistein is C15H10O5; its molecular weight is 270.2. The structural formula is:

Genistein aglycone molecule

Citrated Zinc Bisglycinate

Each FOSTEUM capsule contains 20 mg citrated zinc bisglycinate, a glycine amino acid chelate of zinc formed in the presence of citric acid that provides approximately 4 mg of elemental zinc per capsule. Zinc is an essential mineral co-factor required by enzymes involved in bone metabolism and has important physiological functions in other tissues throughout the body. Elemental zinc has also been shown to have synergistic effects with genistein on bone formation. This zinc bisglycinate, formed in the presence of citric acid, has been shown to have improved absorption over inorganic zinc salts, such as zinc sulfate. Zinc bisglycinate, a chelate of zinc, is complex with an empirical formula of C4H8O4Zn; its molecular weight is 215.5. Its structural formula is:

Citrated zinc bisglycinate molecule


When generated in the presence of citric acid, citrate and additional glycinate ions (not shown) also participate in this structure, forming citrated zinc bisglycinate, contributing to the complexity of the molecule.

Cholecalciferol Each FOSTEUM capsule contains cholecalciferol equivalent to 200 IU vitamin D 3. Vitamin D 3 is the natural form of vitamin D produced when skin is exposed to the sun. Vitamin D is necessary for proper absorption of calcium from the intestine and the use of absorbed calcium in the mineralization of bone. Cholecalciferol is the natural precursor of calcitriol (1,25-dihydroxy-cholecalciferol), the physiologically active form of vitamin D in bone. It is described as (3ßμ,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3-ol. The empirical formula is C 27H 44O; its molecular weight is 384.6. The structural formula is:

Cholcalciferol molecule

Other Ingredients FOSTEUM contains the following other ingredients as excipients: dicalcium malate, magnesium oxide, micro-crystalline cellulose, magnesium stearate and silicon dioxide in a capsule made from plant sources. FD&C Blue #2 is used for the imprint on the capsule. FOSTEUM does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, flavors or products of animal or seafood origin. FOSTEUM is suitable for vegans.
Medical Food Medical Food products are used under a physician's supervision for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. The U.S. Congress defined "medical food" in the Orphan Drug Act and Amendments of 1988 as "a food which is formulated to be consumed or administered enterally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." FOSTEUM has been developed, manufactured and labeled in accordance with both the statutory and the FDA regulatory definition of a medical food. FOSTEUM is to be used only under a physician's supervision.
Generally Recognized As Safe The ingredients in FOSTEUM are Generally Recognized As Safe (GRAS). This is the statutory safety standard that the U.S. Food and Drug Administration (FDA) requires of all ingredients added to food products. The standard for an ingredient to achieve GRAS status requires technical demonstration of non-toxicity and safety, general recognition of safety through widespread usage and agreement of that safety by experts in the field.

Fosteum Manufacturers

  • Primus Pharmaceuticals, Inc.
    Fosteum (Genistein, Zinc Glycinate Citrate, And Cholecalciferol) Capsule [Primus Pharmaceuticals, Inc.]
    No Recall
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