Description and Brand Names

药物信息提供方:IBM 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, it cannot produce the number of normal red blood cells. 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.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

  • Baloxavir Marboxil
  • Bictegravir
  • Dimercaprol
  • Eltrombopag
  • Erdafitinib
  • Magnesium Sulfate
  • Raltegravir

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.

  • Delafloxacin
  • Minocycline
  • 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:

  • Heart disease or
  • Hypotension (low blood pressure)—Use with caution. May make these conditions 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 and Kounis syndrome, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, chest pain or discomfort, pain or discomfort in arms, jaw, back or neck, nausea, sweating, or vomiting after you receive the medicine.

This medicine may cause hypotension (low blood pressure). Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

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

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, itching, skin rash
  10. increased menstrual flow or vaginal bleeding
  11. muscle stiffness, tension, or tightness
  12. nosebleeds
  13. paralysis
  14. prolonged bleeding from cuts
  15. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  16. red or black, tarry stools
  17. red or dark brown urine
  18. sweating
  19. 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. belching
  4. 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
  5. body aches or pain
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. burning, dry, or itching eyes
  8. cramps
  9. deafness
  10. difficulty with moving
  11. discharge or excessive tearing
  12. double vision
  13. ear congestion
  14. excess air or gas in the stomach or intestines
  15. feeling unusually cold
  16. full feeling
  17. heartburn
  18. hyperventilation
  19. increased sweating
  20. indigestion
  21. irritability
  22. longer or heavier menstrual periods
  23. loss of appetite
  24. loss of voice
  25. passing of gas
  26. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  27. restlessness
  28. rolling of the eyes
  29. seeing double
  30. shivering
  31. sleepiness or unusual drowsiness
  32. sneezing
  33. stomach discomfort or upset
  34. swollen, red, or tender area of infection
  35. voice changes
  36. watery eyes
  37. 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.