sodium ferric gluconate complex

Generic Name: sodium ferric gluconate complex (SOE dee um FER ik GLU koe nate KOM plex)
Brand Name: Ferrlecit, Nulecit

What is sodium ferric gluconate complex?

Sodium ferric gluconate is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Sodium ferric gluconate complex is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body) in adults and children who are at least 6 years old. Sodium ferric gluconate complex is for people with kidney disease who are on dialysis.

Sodium ferric gluconate complex may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sodium ferric gluconate complex?

You should not use this medication if you are allergic to sodium ferric gluconate complex or benzyl alcohol.

Before using this medication, tell your doctor if you have iron overload syndrome, or if you receive regular blood transfusions.

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Tell your doctor about all other medicines you use, especially iron supplements you take by mouth.

Also tell your doctor if you are pregnant or breast-feeding a baby.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking sodium ferric gluconate complex?

You should not use this medication if you are allergic to sodium ferric gluconate complex or benzyl alcohol.

To make sure you can safely use sodium ferric gluconate complex, tell your doctor if you have any of these other conditions:

  • iron overload syndrome; or

  • if you receive regular blood transfusions.

FDA pregnancy category B. Sodium ferric gluconate complex is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether sodium ferric gluconate complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Sodium ferric gluconate complex should not be given to a child younger than 6 years old.

How should I take sodium ferric gluconate complex?

Sodium ferric gluconate complex is injected into a vein through an IV during your dialysis session. This medication must be given slowly, and the IV infusion can take at least 1 hour to complete.

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Sodium ferric gluconate complex must be mixed with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Do not mix sodium ferric gluconate complex with any other medication or solution in your IV.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of sodium ferric gluconate complex.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe weakness, loss of balance or coordination, rapid breathing, tremor, or seizure (convulsions).

What should I avoid while taking sodium ferric gluconate complex?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Sodium ferric gluconate complex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, sweating, vomiting; severe lower back pain; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;

  • chest pain, trouble breathing;

  • flushing (warmth, redness, or tingly feeling);

  • fast or uneven heart rate; or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure).

Less serious side effects may include:

  • pain, leg cramps;

  • dizziness, general ill feeling;

  • mild headache;

  • nausea, vomiting, diarrhea; or

  • pain, redness, swelling, or irritation around the IV needle.

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.

See also: Side effects (in more detail)

Sodium ferric gluconate complex dosing information

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

For repletion treatment of iron deficiency in hemodialysis patients receiving supplemental epoetin therapy:

10 mL (125 mg of elemental iron) intravenously during dialysis; may be diluted in 100 mL of 0.9% sodium chloride and administered by intravenous infusion over one hour, or administered undiluted as a slow intravenous injection at a rate of up to 1 mL/min (12.5 mg/min).

This dosage should not be exceeded. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

Most patients will require a minimum cumulative dose of 1 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. After that, patients may continue to receive treatment with intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits.

Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure:

For repletion treatment of iron deficiency in hemodialysis patients receiving supplemental epoetin therapy:

6 years or older: 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL of 0.9% sodium chloride and administered by intravenous infusion over one hour at eight sequential dialysis sessions.

The maximum dose should not exceed 125 mg. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

What other drugs will affect sodium ferric gluconate complex?

Tell your doctor about all other medicines you use, especially iron supplements you take by mouth.

There may be other drugs that can interact with sodium ferric gluconate complex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about sodium ferric gluconate complex.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2012-08-15, 12:04:27 AM.

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