Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Ferrlecit
  2. Nulecit

Descriptions


Sodium ferric gluconate complex injection is used to treat iron deficiency anemia (not enough iron in the blood). It is used in patients with kidney disease who are receiving dialysis and a medicine called epoetin to prevent anemia. Sodium ferric gluconate complex is an iron replacement product.

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, the number of red blood cells is lower than normal. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving sodium ferric gluconate complex injection.

Pregnancy

Information about this sodium-ferric-gluconate-complex-intravenous-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Eltrombopag

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Minocycline
  • Mycophenolic Acid
  • Zinc

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Phytic Acid Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hypotension (low blood pressure)—Use with caution. May make this condition worse.
  • Iron overload—Use is not recommended in patients with this condition.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital or dialysis clinic. This medicine is given through a needle placed in one of your veins.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you or your child begin using this medicine, or when the dose is increased.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Abdominal or stomach pain
  2. anxiety
  3. arm, back, or jaw pain
  4. bladder pain
  5. bloating or swelling of the face, arms, hands, lower legs, or feet
  6. bloody or cloudy urine
  7. bloody, black, or tarry stools
  8. blue lips and fingernails
  9. blurred vision
  10. chest pain or discomfort
  11. chest tightness or heaviness
  12. cold sweats
  13. confusion
  14. convulsions
  15. cool, pale skin
  16. cough or hoarseness
  17. coughing that sometimes produces a pink frothy sputum
  18. decreased level of consciousness
  19. decreased urine
  20. depression
  21. diarrhea
  22. difficult or labored breathing
  23. difficult, burning, or painful urination
  24. difficult, fast, or noisy breathing, sometimes with wheezing
  25. dizziness
  26. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  27. dry mouth
  28. eye pain
  29. fainting
  30. fast or slow heartbeat
  31. fast, pounding, or irregular heartbeat or pulse
  32. feeling of warmth or heat
  33. fever or chills
  34. flushing or redness of the skin, especially on the face and neck
  35. frequent urge to urinate
  36. general feeling of discomfort or illness
  37. headache
  38. increased hunger
  39. increased sweating
  40. increased thirst
  41. irregular heartbeat
  42. joint pain
  43. leg cramps
  44. lightheadedness
  45. loss of appetite
  46. lower back or side pain
  47. mood changes
  48. muscle aches and pains
  49. muscle cramps
  50. nausea or vomiting
  51. nervousness
  52. nightmares
  53. numbness or tingling in the hands, feet, or lips
  54. pain or discomfort in the arms, jaw, back, or neck
  55. pale skin
  56. pounding in the ears
  57. rapid weight gain
  58. rapid, shallow breathing
  59. runny nose
  60. shakiness
  61. shivering
  62. shortness of breath
  63. slow or irregular heartbeat
  64. slurred speech
  65. sore throat
  66. sweating
  67. swelling in the legs and ankles
  68. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  69. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  70. trouble sleeping
  71. troubled breathing with exertion
  72. unusual bleeding or bruising
  73. unusual tiredness or weakness
  74. unusual weight gain or loss
  75. weakness or heaviness of the legs
  76. weight gain
  77. wheezing

Incidence not known

  1. Bleeding gums
  2. bluish color
  3. changes in skin color
  4. cold, clammy skin
  5. coughing up blood
  6. excessive muscle tone
  7. face is warm or hot to touch
  8. fast, weak pulse
  9. hives
  10. increased menstrual flow or vaginal bleeding
  11. itching
  12. muscle stiffness
  13. muscle tension or tightness
  14. nosebleeds
  15. paralysis
  16. prolonged bleeding from cuts
  17. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  18. red or black, tarry stools
  19. red or dark brown urine
  20. skin rash
  21. sweating
  22. tenderness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Accumulation of pus
  2. acid or sour stomach
  3. anxiety
  4. belching
  5. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  6. body aches or pain
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. burning, dry, or itching eyes
  9. cramps
  10. deafness
  11. difficulty with moving
  12. discharge or excessive tearing
  13. double vision
  14. ear congestion
  15. excess air or gas in the stomach or intestines
  16. feeling unusually cold
  17. full feeling
  18. heartburn
  19. hyperventilation
  20. increased sweating
  21. indigestion
  22. irritability
  23. longer or heavier menstrual periods
  24. loss of appetite
  25. loss of voice
  26. passing of gas
  27. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  28. restlessness
  29. rolling of the eyes
  30. seeing double
  31. shivering
  32. sleepiness or unusual drowsiness
  33. sneezing
  34. stomach discomfort or upset
  35. swollen, red, or tender area of infection
  36. voice changes
  37. watery eyes
  38. weight loss

Incidence not known

  1. Change in taste
  2. loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.