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Sodium ferric gluconate complex (Intravenous route)

Pronunciation:

SOE-dee-um FER-rik Gloo-koe-nate KOM-plex

Brand Names:

  • Ferrlecit
  • Nulecit

Dosage Forms:

  • Solution

Classifications:

Therapeutic—

Parenteral Mineral-Trace Mineral

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast-feeding—

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

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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
Abdominal or stomach pain
anxiety
arm, back, or jaw pain
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
bloody, black, or tarry stools
blue lips and fingernails
blurred vision
chest pain or discomfort
chest tightness or heaviness
cold sweats
confusion
convulsions
cool, pale skin
cough or hoarseness
coughing that sometimes produces a pink frothy sputum
decreased level of consciousness
decreased urine
depression
diarrhea
difficult or labored breathing
difficult, burning, or painful urination
difficult, fast, or noisy breathing, sometimes with wheezing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
eye pain
fainting
fast or slow heartbeat
fast, pounding, or irregular heartbeat or pulse
feeling of warmth or heat
fever or chills
flushing or redness of the skin, especially on the face and neck
frequent urge to urinate
general feeling of discomfort or illness
headache
increased hunger
increased sweating
increased thirst
irregular heartbeat
joint pain
leg cramps
lightheadedness
loss of appetite
lower back or side pain
mood changes
muscle aches and pains
muscle cramps
nausea or vomiting
nervousness
nightmares
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, back, or neck
pale skin
pounding in the ears
rapid weight gain
rapid, shallow breathing
runny nose
shakiness
shivering
shortness of breath
slow or irregular heartbeat
slurred speech
sore throat
sweating
swelling in the legs and ankles
swollen, painful, or tender lymph glands in the neck, armpit, or groin
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
trouble sleeping
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
weakness or heaviness of the legs
weight gain
wheezing
Incidence not known
Bleeding gums
bluish color
changes in skin color
cold, clammy skin
coughing up blood
excessive muscle tone
face is warm or hot to touch
fast, weak pulse
hives
increased menstrual flow or vaginal bleeding
itching
muscle stiffness
muscle tension or tightness
nosebleeds
paralysis
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red or black, tarry stools
red or dark brown urine
skin rash
sweating
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
Accumulation of pus
acid or sour stomach
anxiety
belching
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
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning, dry, or itching eyes
cramps
deafness
difficulty with moving
discharge or excessive tearing
double vision
ear congestion
excess air or gas in the stomach or intestines
feeling unusually cold
full feeling
heartburn
hyperventilation
increased sweating
indigestion
irritability
longer or heavier menstrual periods
loss of appetite
loss of voice
passing of gas
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
restlessness
rolling of the eyes
seeing double
shivering
sleepiness or unusual drowsiness
sneezing
stomach discomfort or upset
swollen, red, or tender area of infection
voice changes
watery eyes
weight loss
Incidence not known
Change in taste
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.


Last Updated: 4/4/2014

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