Sodium ferric gluconate complex (Intravenous route)
SOE-dee-um FER-rik Gloo-koe-nate KOM-plex
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:
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.
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.
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.
|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.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
- Mycophenolic Acid
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:
- More common
- Abdominal or stomach pain
- 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
- cool, pale skin
- cough or hoarseness
- coughing that sometimes produces a pink frothy sputum
- decreased level of consciousness
- decreased urine
- difficult or labored breathing
- difficult, burning, or painful urination
- difficult, fast, or noisy breathing, sometimes with wheezing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- eye pain
- 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
- increased hunger
- increased sweating
- increased thirst
- irregular heartbeat
- joint pain
- leg cramps
- loss of appetite
- lower back or side pain
- mood changes
- muscle aches and pains
- muscle cramps
- nausea or vomiting
- 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
- shortness of breath
- slow or irregular heartbeat
- slurred speech
- sore throat
- 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
- 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
- increased menstrual flow or vaginal bleeding
- muscle stiffness
- muscle tension or tightness
- 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
- More common
- Accumulation of pus
- acid or sour stomach
- 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
- 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
- increased sweating
- 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
- rolling of the eyes
- seeing double
- sleepiness or unusual drowsiness
- 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
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:
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:
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: 11/4/2014