Carbonyl iron

Carbonyl iron is an iron replacement product. You normally get iron from the foods you eat. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs.

Carbonyl iron is used to treat or prevent iron deficiency and iron deficiency anemia.

Carbonyl iron may also be used for purposes not listed in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Carbonyl iron may be taken with food if it upsets your stomach.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need a blood transfusion, tell your caregivers that you are using carbonyl iron.

Do not take this medicine for longer than 6 months without your doctor's advice.

Store at room temperature, away from moisture and heat. Keep this medicine out of the reach of children. An accidental overdose of iron can be fatal to a child.

Avoid taking carbonyl iron within 2 hours before or 2 hours after you take other medicines. Carbonyl iron can make it harder for your body to absorb other medicines.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• diarrhea, constipation;

• nausea, vomiting, stomach pain;

• tooth discoloration; or

• dark-colored bowel movements.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Iron Deficiency Anemia:

50 mg orally three times a day.

Usual Pediatric Dose for Iron Deficiency Anemia:

Premature neonates:
2 to 4 mg elemental iron/kg/day divided every 12 to 24 hours (maximum daily dose = 15 mg).

Infants and children

Applies to carbonyl iron: oral suspension

Applies to carbonyl iron: oral suspension, oral tablet, oral tablet chewable

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. They have included diarrhea (45%) vs. placebo (3%), cramping (38%) vs. placebo (0%), nausea (30%) vs. placebo (8%), constipation (25%) vs. placebo (14%), heartburn (17%) vs. placebo (6%), and epigastric discomfort (16%) vs. placebo (11%).[Ref]

Constipation may be relieved by administering docusate sodium 100 mg to 200 mg per day in addition to increasing the intake of oral fluids, such as water.[Ref]

Other

Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.

Stained teeth have been reported primarily following ingestion of iron liquid preparations. Liquid dosage forms should be diluted in juice or water and sipped through a straw to aid in prevention of staining.[Ref]

Other side effects have included iron overload (hemosiderosis) and stained teeth. Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely. An unpleasant taste following carbonyl iron ingestion has been reported in 40% to 70% of patients.[Ref]

Nervous system

Nervous system side effects have included headache (29%) vs. placebo (25%), and weakness (11%) vs placebo (9%).[Ref]

Some side effects of carbonyl iron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Premature neonates:
2 to 4 mg elemental iron/kg/day divided every 12 to 24 hours (maximum daily dose = 15 mg).

Infants and children <12 years:
Prophylaxis: 1 to 2 mg elemental iron/kg/day (maximum 15 mg) in 1 to 2 divided doses.

Mild to moderate iron deficiency anemia:
3 mg elemental iron/kg/day in 1 to 2 divided doses.

Severe iron deficiency anemia:
4 to 6 mg elemental iron/kg/day in 3 divided doses.

Data not available