IRONSUPPLEMENTS (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; IronDextran; Iron-Polysaccharide; Iron Sorbitol; Iron Sucrose; Sodium Ferric Gluconate
• Nutritional supplement, mineral?Ferrous Fumarate; Ferrous Gluconate; Ferrous Sulfate; IronDextran; Iron Sorbitol; Iron-Polysaccharide

Description

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

Although many people in the U.S. get enough iron from their diet, somemust take additional amounts to meet their needs. For example, iron is sometimeslost with slow or small amounts of bleeding in the body that you would notbe aware of and which can only be detected by your doctor. Your doctor candetermine 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 decreasein physical performance, and learning problems in children and adults, andmay 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-ironformulas, may need additional iron.

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

Injectable iron is administered only by or under the supervision of yourhealth care professional. Other forms of iron are available without a prescription;however, your health care professional may have special instructions on theproper 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 ofiron, but they contain less than red meat. Cereals, beans, and some vegetablescontain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrusfruits and fresh vegetables), eaten with small amounts of heme iron-containingfoods, such as meat, may increase the amount of nonheme iron absorbed fromcereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach,fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbedfrom 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 vitaminsand 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 physicalcondition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labelsto indicate the percent of the recommended daily amount of each nutrient thata serving provides. DV replaces the previous designation of United StatesRecommended Daily Allowances (USRDAs).

For Canada?
• Recommended Nutrient Intakes (RNIs) are used to determine the amountsof vitamins, minerals, and protein needed to provide adequate nutrition andlessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for iron are generallydefined as follows (Note that the RDA and RNI are expressed as an actual amountof iron, which is referred to as ?elemental?' iron. The productform [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a differentstrength):

Persons	U.S. (mg)	Canada (mg)
Infantsand children Birth to 3 years of age	6-10	0.3-6
4 to 6 yearsof age	10	8
7 to 10 years of age	10	8-10
Adolescentand adult males	10	8-10
Adolescent and adult females	10-15	8-13
Pregnant females	30	17-22
Breast-feedingfemales	15	8-13

Before Using This Dietary Supplement

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

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

Pregnancy?It is especially important that you are receivingenough vitamins and minerals when you become pregnant and that you continueto receive the right amount of vitamins and minerals throughout your pregnancy.Healthy fetal growth and development depend on a steady supply of nutrientsfrom mother to fetus. During the first 3 months of pregnancy, a proper dietusually provides enough iron. However, during the last 6 months, in orderto meet the increased needs of the developing baby, an iron supplement maybe recommended by your health care professional.

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

Breast-feeding?It is especially important that you receive theright amounts of vitamins and minerals so that your baby will also get thevitamins and minerals needed to grow properly. Iron normally is present inbreast 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 beforetaking iron supplements or any other medication. Taking large amounts of adietary supplement while breast-feeding may be harmful to the mother and/orinfant and should be avoided.

Children?Problems in children have not been reported withintake of normal daily recommended amounts. Iron supplements, when prescribedby your health care professional, are not expected to cause different sideeffects in children than they do in adults. However, it is important to followthe directions carefully, since iron overdose in children is especially dangerous.

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

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

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

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

• Antacids?Use with iron supplements may make the iron supplementsless effective; iron supplements should be taken 1 or 2 hours before or afterantacids

• Dimercaprol?Iron supplements and dimercaprol may combine inthe body to form a harmful chemical

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

Other medical problems?The presence of other medicalproblems may affect the use of iron supplements. Make sure you tell your healthcare 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 supplementmay 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 conditionsworse

• 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 levelsin anemias not associated with iron deficiency

Proper Use of This Dietary Supplement

Dosing?The amount of iron needed to meet normal dailyrecommended intakes will be different for different individuals. The followinginformation 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 normaldaily 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 determinedby your doctor, based on your condition.
• For injection dosage forms:
  • Adults, teenagers, and children? The dose will be determinedby your doctor, based on your condition.

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

Iron is best absorbed when taken on an empty stomach, with water or fruitjuice (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 possibilityof 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 dietarysupplement was prescribed.
• Follow the manufacturer's package directions if you are treatingyourself. 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 stainthe teeth. To prevent, reduce, or remove these stains:

• Mix each dose in water, fruit juice, or tomato juice. You may usea drinking tube or straw to help keep the iron supplement from getting onthe 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 orjuice.
• Iron stains on teeth can usually be removed by brushing with bakingsoda (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 doubledoses.

Storage?To store this dietary supplement:

• Keep out of the reach of children because iron overdose is especiallydangerous in children. As few as 3 or 4 adult iron tablets can cause seriouspoisoning in small children. Vitamin-iron products for use during pregnancyand 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 otherdamp 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 takenin very small amounts, for at least 1 hour before or 2 hours after you takeiron:

• 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 thesame 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 monthswithout checking with your health care professional. People differ in theirneed for iron, and those with certain medical conditions can gradually becomepoisoned by taking too much iron over a period of time. Also, unabsorbed ironcan mask the presence of blood in the stool, which may delay discovery ofa serious condition.

If you have been taking a long-acting or coated iron tablet and your stoolshave not become black, check with your healthcare 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 availableat home to be taken in case of an iron overdose emergency when a doctor, poisoncontrol center, or emergency room orders its use.

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

• Immediate medical attention is very important.
• Call your doctor, a poison control center, orthe nearest hospital emergency room at once. Always keep these phonenumbers readily available.
• Follow any instructions given to you.If syrup of ipecac has been ordered and given, do not delay going to the emergencyroom while waiting for the ipecac syrup to empty the stomach, since it mayrequire 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 supplementmay 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 effectsoccur:

More common?with injection only

Backache , groin, side, or muscle pain; chest pain; chills; dizziness; fainting; fast heartbeat; fever with increased sweating; flushing; headache; metallictaste; nausea or vomiting; numbness, pain, or tingling of hands or feet; painor redness at injection site; redness of skin; skin rash or hives; swelling of mouthor throat; troubled breathing

More common?when taken by mouth only

Abdominal or stomach pain; cramping(continuing) or soreness

Less common or rare?with injection only

Double vision; general unwell feeling; weakness without feeling dizzy or faint

Less common or rare?when taken by mouth only

Chest or throat pain, especially when swallowing; stools with signs of blood (red or black color)

Early symptoms of iron overdose

Diarrhea (may contain blood); fever; nausea; stomach pain orcramping (sharp); vomiting, severe (may contain blood)

Note:

Symptoms of iron overdose may not occur for up to 60 minutes or moreafter the overdose was taken. By this time you should have had emergency roomtreatment. Do not delay going to emergency room while waiting for signs toappear.

Late symptoms of iron overdose

Bluish-colored lips, fingernails, and palms of hands; convulsions (seizures); drowsiness; pale, clammy skin; shallow and rapidbreathing; unusual tiredness or weakness; weak and fast heartbeat

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the dietary supplement. However, check with your healthcare professional if any of the following side effects continue or are bothersome:

More common

Constipation; diarrhea; leg cramps; nausea; vomiting

Less common

Darkened urine; heartburn; stained teeth

Stools commonlybecome dark green or black when iron preparations are taken by mouth. Thisis caused by unabsorbed iron and is harmless. However, in rare cases, blackstools of a sticky consistency may occur along with other side effects suchas red streaks in the stool, cramping, soreness, or sharp pains in the stomachor abdominal area. Check with your health care professional immediately ifthese side effects appear.

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

Other side effects not listed above may also occur insome individuals. If you notice any other effects, check with your healthcare professional.