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(iron dextran) Injection USP
RISK FOR ANAPHYLACTIC-TYPE REACTIONS
Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.
- Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.
- Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose.
- During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated.
- Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
- Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD.
INFeD (Iron Dextran Injection USP) is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.
Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 5.2 and 6.5.
Therapeutic Class: Hematinic
What are the possible side effects of iron dextran (DexFerrum, Infed)?
Cases of severe, sometimes fatal, allergic reactions (loss of consciousness, collapse, difficulty breathing, hives, swelling, or convulsions) and severe low blood pressure (hypotension) have been reported with the use of iron dextran. This medication should be administered under the supervision of a healthcare professional.
Other less serious side effects are more likely to occur. Continue using iron dextran and talk to your doctor or pharmacist if you experience:
- nausea or vomiting;
- fever, sweating, or...
What are the precautions when taking iron dextran (Infed)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood count not due to low iron (e.g., vitamin B12/folate deficiency), active kidney infection.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe allergic reactions, asthma, bleeding problems (e.g., hemophilia), heart disease (e.g., chest pain, heart attack, heart failure), Hodgkin's disease, autoimmune...
Last reviewed on RxList: 2/23/2016
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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