Fosteum

Generic name: Cholecalciferol/Genistein/Zinc Chelazome
Drug class: Vitamin and mineral combinations

Medically reviewed by  A Ras MD.

What is Fosteum used for?

Fosteum is a multivitamin complex that is used to aid diet needs.

Description

FOSTEUM® consists of a specially formulated proprietary blend of high purity genistein aglycone from a natural source, citrated zinc bisglycinate and cholecalciferol (vitamin D3). Genistein aglycone reduces osteoclast activity and stimulates osteoblast activity. Citrated zinc bisglycinate works synergistically with genistein aglycone, while both citrated zinc bisglycinate and vitamin D3 also work independently to promote mineralization activity in bone. Vitamin D3 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 D3. Vitamin D3 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 C27H44O; 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.

Before taking Fosteum, tell your doctor:

  • If you are allergic to Fosteum; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have ever had breast cancer or cancer in a body part needed to have a baby.
  • If you are pregnant or may be pregnant. Do not take Fosteum if you are pregnant.
  • If you are breast-feeding. Do not breast-feed while you take Fosteum.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fosteum with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fosteum?

  • Tell all of your health care providers that you take Fosteum. This includes your doctors, nurses, pharmacists, and dentists.
  • Talk with your doctor before you take another drug or product that has zinc in it.
  • This medicine prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Fosteum.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Fosteum, call your doctor right away.
  • Use birth control that you can trust to prevent pregnancy while taking Fosteum.

How is Fosteum best taken?

Use Fosteum as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Fosteum that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Fosteum?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Fosteum?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

PRINCIPAL DISPLAY PANEL

 

Fosteum Package Label

Imprint FOSTEUM 52003 - Fosteum 200 intl units-27 mg-20 mg

 

 

SRC: NLM .