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IRON SUPPLEMENTS (Systemic)

Some commonly used brand names are:

In the U.S.—

• DexFerrum ⁴
• Femiron ¹
• Feosol Caplets ³
• Feosol Tablets ³
• Feostat ¹
• Feostat Drops ¹
• Feratab ³
• Fer-gen-sol ³
• Fergon ²
• Fer-In-Sol Drops ³
• Fer-In-Sol Syrup ³
• Fer-Iron Drops ³
• Fero-Gradumet ³
• Ferospace ³
• Ferralet ²
• Ferralet Slow Release ²
• Ferralyn Lanacaps ³
• Ferra-TD ³
• Ferretts ¹
• Ferrlecit ⁸
• Fumasorb ¹
• Fumerin ¹
• Hemocyte ¹
• Hytinic ⁵
• InFeD ⁴
• Ircon ¹
• Mol-Iron ³
• Nephro-Fer ¹
• Niferex ⁵
• Niferex-150 ⁵
• Nu-Iron ⁵
• Nu-Iron 150 ⁵
• Simron ²
• Slow Fe ³
• Span-FF ¹
• Venofer ⁷

In Canada—

• Apo-Ferrous Gluconate ²
• Apo-Ferrous Sulfate ³
• DexIron ⁴
• Fer-In-Sol Drops ³
• Fer-In-Sol Syrup ³
• Ferodan Infant Drops ³
• Ferodan Syrup ³
• Fertinic ²
• Jectofer ⁶
• Neo-Fer ¹
• Novofumar ¹
• Palafer ¹
• Slow Fe ³

Category

• Antianemic—Ferrous Fumarate; Ferrous Gluconate; Ferrous Sulfate; Iron Dextran; Iron-Polysaccharide; Iron Sorbitol; Iron Sucrose; Sodium Ferric Gluconate
• Nutritional supplement, mineral—Ferrous Fumarate; Ferrous Gluconate; Ferrous Sulfate; Iron Dextran; Iron Sorbitol; Iron-Polysaccharide

Description

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

• Bleeding problems
• Burns
• Hemodialysis
• Intestinal diseases
• Stomach problems
• Stomach removal
• Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

Iron supplements are available in the following dosage forms:

• Oral
• Ferrous Fumarate
  • Capsules (Canada)
  • Extended-release capsules (U.S.)
  • Oral solution (U.S.)
  • Oral suspension (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S.)
• Ferrous Gluconate
  • Capsules (U.S.)
  • Elixir (U.S.)
  • Syrup (Canada)
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S.)
• Ferrous Sulfate
  • Capsules (U.S.)
  • Extended-release capsules (U.S.)
  • Oral solution (U.S.)
  • Syrup (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Delayed-release tablets (U.S. and Canada)
  • Extended-release tablets (U.S. and Canada)
• Iron-Polysaccharide
  • Capsules (U.S.)
  • Oral solution (U.S.)
  • Tablets (U.S.)

• Parenteral
• Iron Dextran
  • Injection (U.S. and Canada)
• Iron Sorbitol
  • Injection (Canada)
• Iron Sucrose
  • Injection (U.S.)
• Sodium Ferric Gluconate Complex
  • Injection (U.S.)

Importance of Diet

Iron is found in the diet in two forms—heme iron, which is well absorbed, and nonheme iron, which is poorly absorbed. The best dietary source of absorbable (heme) iron is lean red meat. Chicken, turkey, and fish are also sources of iron, but they contain less than red meat. Cereals, beans, and some vegetables contain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables), eaten with small amounts of heme iron-containing foods, such as meat, may increase the amount of nonheme iron absorbed from cereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach, fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbed from foods. Additional iron may be added to food from cooking in iron pots.

The daily amount of iron 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 iron are generally defined as follows (Note that the RDA and RNI are expressed as an actual amount of iron, which is referred to as “elemental”" iron. The product form [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a different strength):

Before Using This Dietary Supplement

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For iron supplements, the following should be considered:

Allergies—Tell your health care professional if you have ever had any unusual or allergic reaction to iron medicine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. Healthy fetal growth and development depend on a steady supply of nutrients from mother to fetus. During the first 3 months of pregnancy, a proper diet usually provides enough iron. However, during the last 6 months, in order to meet the increased needs of the developing baby, an iron supplement may be recommended by your health care professional.

However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast-feeding—It is especially important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. Iron normally is present in breast milk in small amounts. When prescribed by a health care professional, iron preparations are not known to cause problems during breast-feeding. However, nursing mothers are advised to check with their health care professional before taking iron supplements or any other medication. Taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or infant and should be avoided.

Children—Problems in children have not been reported with intake of normal daily recommended amounts. Iron supplements, when prescribed by your health care professional, are not expected to cause different side effects in children than they do in adults. However, it is important to follow the directions carefully, since iron overdose in children is especially dangerous.

Studies on sodium ferric gluconate have shown that this supplement is safe to use in children ages 6 to 15 years. The safety of sodium ferric gluconate has not been determined in patients who are younger than 6 years of age.

Older adults—Problems in older adults have not been reported with intake of normal daily recommended amounts. Elderly people sometimes do not absorb iron as easily as younger adults and may need a larger dose. If you think you need to take an iron supplement, check with your health care professional first. Only your health care professional can decide if you need an iron supplement and how much you should take.

Medicines or other dietary supplements—Although certain medicines or dietary supplements should not be used together at all, in other cases they may be used together even if an interaction might occur. In these cases, your health care professional may want to change the dose, or other precautions may be necessary. When you are taking iron supplements, it is especially important that your health care professional know if you are taking any of the following:

• Acetohydroxamic acid (e.g., Lithostat)—Use with iron supplements may cause either medicine to be less effective

• Antacids—Use with iron supplements may make the iron supplements less effective; iron supplements should be taken 1 or 2 hours before or after antacids

• Dimercaprol—Iron supplements and dimercaprol may combine in the body to form a harmful chemical

• Etidronate or
• Fluoroquinolones (e.g., ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, ofloxacin) or
• Tetracyclines (taken by mouth) (medicine for infection)—Use with iron supplements may make these medicines less effective; iron supplements should be taken 2 hours before or after these medicines

Other medical problems—The presence of other medical problems may affect the use of iron supplements. Make sure you tell your health care professional if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Blood transfusions (with high red blood cell iron content) or
• Kidney infection or
• Liver disease or
• Porphyria cutaneous tarda—Higher blood levels of the iron supplement may occur, which may increase the chance of side effects

• Arthritis (rheumatoid) or
• Asthma or allergies or
• Heart disease—The injected form of iron may make these conditions worse

• Colitis or other intestinal problems or
• Iron overload conditions (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies) or
• Stomach ulcer—Iron supplements may make these conditions worse

• Other anemias—Iron supplements may increase iron to toxic levels in anemias not associated with iron deficiency

Proper Use of This Dietary Supplement

Dosing—The amount of iron needed to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of iron.

• For oral dosage forms (capsules, tablets, oral solution):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    • Adult and teenage males—10 milligrams (mg) per day.
    • Adult and teenage females—10 to 15 mg per day.
    • Pregnant females—30 mg per day.
    • Breast-feeding females—15 mg per day.
    • Children 7 to 10 years of age—10 mg per day.
    • Children 4 to 6 years of age—10 mg per day.
    • Children birth to 3 years of age—6 to 10 mg per day.
    • For Canada
    • Adult and teenage males—8 to 10 mg per day.
    • Adult and teenage females—8 to 13 mg per day.
    • Pregnant females—17 to 22 mg per day.
    • Breast-feeding females—8 to 13 mg per day.
    • Children 7 to 10 years of age—8 to 10 mg per day.
    • Children 4 to 6 years of age—8 mg per day.
    • Children birth to 3 years of age—0.3 to 6 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
• For injection dosage forms:
  • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: 1/2 glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

• Follow your health care professional"s instructions if this dietary supplement was prescribed.
• Follow the manufacturer"s package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

• Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth.
• When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice.
• Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%).

Missed dose—If you miss a dose of this dietary supplement, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this dietary supplement:

• Keep out of the reach of children because iron overdose is especially dangerous in children. As few as 3 or 4 adult iron tablets can cause serious poisoning in small children. Vitamin-iron products for use during pregnancy and flavored vitamins with iron often cause iron overdose in small children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the dietary supplement to break down.
• Keep the liquid form of this dietary supplement from freezing.
• Do not keep outdated dietary supplements or those no longer needed. Be sure that any discarded dietary supplement is out of the reach of children.

Precautions While Using This Dietary Supplement

When iron is combined with certain foods it may lose much of its value. If you are taking iron, the following foods should be avoided, or only taken in very small amounts, for at least 1 hour before or 2 hours after you take iron:

• Cheese and yogurt
• Eggs
• Milk
• Spinach
• Tea or coffee
• Whole-grain breads and cereals and bran

Do not take iron supplements and antacids or calcium supplements at the same time. It is best to space doses of these 2 products 1 to 2 hours apart, to get the full benefit from each medicine or dietary supplement.

If you are taking iron supplements without a prescription :

• Do not take iron supplements by mouth if you are receiving iron injections. To do so may result in iron poisoning.
• Do not regularly take large amounts of iron for longer than 6 months without checking with your health care professional. People differ in their need for iron, and those with certain medical conditions can gradually become poisoned by taking too much iron over a period of time. Also, unabsorbed iron can mask the presence of blood in the stool, which may delay discovery of a serious condition.

If you have been taking a long-acting or coated iron tablet and your stools have not become black, check with your health care professional. The tablets may not be breaking down properly in your stomach, and you may not be receiving enough iron.

It is important to keep iron preparations out of the reach of children. Keep a 1-ounce bottle of syrup of ipecac available at home to be taken in case of an iron overdose emergency when a doctor, poison control center, or emergency room orders its use.

If you think you or anyone else has taken an overdose of iron medicine :

• Immediate medical attention is very important .
• Call your doctor, a poison control center, or the nearest hospital emergency room at once . Always keep these phone numbers readily available.
• Follow any instructions given to you . If syrup of ipecac has been ordered and given, do not delay going to the emergency room while waiting for the ipecac syrup to empty the stomach, since it may require 20 to 30 minutes to show results.
• Go to the emergency room without delay .
• Take the container of iron with you .

Early signs of iron overdose may not appear for up to 60 minutes or more. Do not delay going to the emergency room while waiting for signs to appear.

Side Effects of This Dietary Supplement

Along with its needed effects, a dietary supplement may cause some unwanted effects. Although not all of these effects may occur, if they do occur they may need medical attention.

Check with your health care professional if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the dietary supplement. However, check with your health care professional if any of the following side effects continue or are bothersome:

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

Other side effects not listed above may also occur in some individuals. If you notice any other effects, check with your health care professional.

Revised: 10/13/2004

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