Infed

Name: Infed

Dosing & Uses

Dosage Forms & Strengths

injectable solution

  • 50mg (Fe)/mL

Iron-deficiency Anemia

25-100 mg IV or deep IM qDay PRN

Not to exceed 100 mg (2 mL)/day

Iron deficiency: Dose = 0.0442(Desired Hgb - Observed Hgb) x Lean BW(kg) + (0.26 × Lean BW)

Blood loss: total iron dose in mg = blood loss (mL) x HCT

Dosage Forms & Strengths

injectable solution

  • 50mg (Fe)/mL

Iron-deficiency Anemia

>15 kg: 0.0442(Desired Hgb - Observed Hgb) x Lean BW(kg) + (0.26 × Lean BW)

5-15 kg

  • Not to be given in first 4 months of life
  • Dose = 0.0442(Desired Hgb - Observed Hgb) x BW(kg) + (0.26 × BW)
  • Desired hemoglobin usually 12 g/dL

What Is Iron Dextran?

Iron dextran is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Iron dextran is used to treat iron deficiencies and iron deficiency anemia (low red blood cells).

Iron dextran may also be used for purposes not listed in this medication guide.

You should not receive iron dextran if you have a type of anemia that is not caused by iron deficiency.

Iron dextran can cause severe and sometimes fatal allergic reactions or severely low blood pressure. Tell your caregiver right away if you feel light-headed (like you might pass out), or if you suddenly have trouble breathing.

You should not receive iron dextran if you are allergic to it, or if you have a type of anemia that is not caused by iron deficiency.

To make sure iron dextran is safe for you, tell your doctor if you have:

  • heart disease;
  • liver disease;
  • kidney disease (or if you are on dialysis);
  • rheumatoid arthritis;
  • bleeding or blood clotting disorder such as hemophilia;
  • stomach bleeding;
  • asthma or allergies;
  • if you are allergic to any medication; or
  • if you use a beta-blocker medicine (atenolol, carvedilol, metoprolol, nebivolol, propranolol, sotalol, and others).

FDA pregnancy category C. It is not known whether iron dextran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Iron dextran can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What is iron dextran (dexferrum, infed)?

Iron dextran is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Iron dextran is used to treat iron deficiencies and iron deficiency anemia.

Iron dextran may also be used for purposes other than those listed in this medication guide.

What should i discuss with my healthcare provider before using iron dextran (dexferrum, infed)?

Iron dextran should not be used by people who have an overload of iron in their body or by patients with anemia not caused by iron deficiency.

Before using iron dextran, tell your doctor if you have

  • a history of allergies or asthma;
  • heart disease;
  • rheumatoid arthritis;
  • kidney disease; or
  • liver disease.

You may nto be able to use iron dextran or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Iron dextran is the FDA pregnancy category C. This means that it is not known whether dextran will be harmful to an unborn baby. Do not use iron dextran without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Iron dextran passes into breast milk and may affect a nursing baby. Do not use iron dextran without first talking to your doctor if you are breast feeding a baby.

  • Anemia

What other drugs will affect Infed (iron dextran)?

Other drugs may interact with iron dextran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Uses of Infed

  • It is used to treat or prevent low iron in the body.

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

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Infed.
  • Do not take other iron products with this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Infed while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Infed?

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:

  • Loose stools (diarrhea).
  • Headache.
  • Dizziness.
  • Belly pain.
  • Upset stomach or throwing up.
  • Change in taste.
  • Feeling tired or weak.
  • Pain where the shot was given.
  • Irritation or swelling where the shot was given.
  • Brown skin where the shot was given.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Sample Outer Label

Infed 
iron dextran injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52584-931(NDC:52544-931)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iron Dextran (FERRIC CATION) FERRIC CATION 50 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:52584-931-07 1 VIAL, SINGLE-DOSE in 1 BAG
1 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017441 09/01/2010
Labeler - General Injectables & Vaccines, Inc (108250663)
Revised: 08/2017   General Injectables & Vaccines, Inc
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