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|Sodium Ferric Gluconate

Sodium Ferric Gluconate

Sodium Ferric Gluconate is used for:

Treating iron deficiency anemia in patients undergoing hemodialysis who are also receiving epoetin therapy.

Sodium Ferric Gluconate is an iron complex. It works by providing the body with its necessary level of iron.

Do NOT use Sodium Ferric Gluconate if:

• you are allergic to any ingredient in Sodium Ferric Gluconate
• you have anemia not associated with iron deficiency
• you have iron overload

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sodium Ferric Gluconate :

Some medical conditions may interact with Sodium Ferric Gluconate . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had multiple blood transfusions
• if you have colitis, Crohn disease, diverticulitis, an ulcer, the blood disease porphyria, or thalassemia

Some MEDICINES MAY INTERACT with Sodium Ferric Gluconate . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Doxycycline, mycophenolate, quinolones (eg, ciprofloxacin), or thyroid hormones (eg, levothyroxine) because the effectiveness may be decreased by Sodium Ferric Gluconate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sodium Ferric Gluconate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sodium Ferric Gluconate :

Use Sodium Ferric Gluconate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sodium Ferric Gluconate is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Sodium Ferric Gluconate at home, carefully follow the injection procedures taught to you by your health care provider.
• If Sodium Ferric Gluconate contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• Sodium Ferric Gluconate should be taken 3 hours apart from the following medicines: bisphosphonates (eg, disodium pamidronate), cephalosporins (eg, cephalexin), methyldopa, penicillamine, tetracyclines (eg, doxycycline).
• If you miss a dose of Sodium Ferric Gluconate , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Sodium Ferric Gluconate .

Important safety information:

• LAB TESTS, including iron levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sodium Ferric Gluconate with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sodium Ferric Gluconate , discuss with your doctor the benefits and risks of using Sodium Ferric Gluconate during pregnancy. It is unknown if Sodium Ferric Gluconate is excreted in breast milk. If you are or will be breast-feeding while you are using Sodium Ferric Gluconate , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sodium Ferric Gluconate :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

General feeling of discomfort; lightheadedness; tiredness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nausea; pain, redness, or swelling at the injection site; severe pain in the chest, back, groin, or sides of the body; shortness of breath; vomiting; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include abdominal pain; diarrhea; difficulty breathing; drowsiness; vomiting.

Sodium Ferric Gluconate is usually handled and stored by a health care provider. If you are using Sodium Ferric Gluconate at home, store Sodium Ferric Gluconate as directed by your pharmacist or health care provider. Keep Sodium Ferric Gluconate out of the reach of children and away from pets.

General information:

• If you have any questions about Sodium Ferric Gluconate , please talk with your doctor, pharmacist, or other health care provider.
• Sodium Ferric Gluconate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sodium Ferric Gluconate . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.