Description
Ferric citrate is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) who are on dialysis.
Ferric citrate is also used to treat iron deficiency anemia in patients with CKD who are not on dialysis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 have not been performed on the relationship of age to the effects of ferric citrate in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ferric citrate in the elderly.
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 taking 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
- Carbidopa
- Dimercaprol
- Dolutegravir
- Eltrombopag
- Elvitegravir
- Erdafitinib
- Ethinyl Estradiol
- Levodopa
- Magnesium Sulfate
- Mycophenolate Mofetil
- Mycophenolic Acid
- Raltegravir
- Vadadustat
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.
- Cefdinir
- Ciprofloxacin
- Delafloxacin
- Demeclocycline
- Doxycycline
- Gatifloxacin
- Grepafloxacin
- Levofloxacin
- Levothyroxine
- Lomefloxacin
- Methyldopa
- Minocycline
- Moxifloxacin
- Mycophenolate Mofetil
- Mycophenolic Acid
- Norfloxacin
- Ofloxacin
- Omadacycline
- Omeprazole
- Penicillamine
- Temafloxacin
- Tetracycline
- Trovafloxacin Mesylate
- 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.
- Dairy Food
- 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:
- Hemochromatosis (a genetic disorder which causes too much iron in the blood)—Should not be used in patients with this condition.
- Inflammatory bowel disease or
- Stomach or bowel problem (eg, bleeding)—This medicine has not been studied in patients with these conditions, but should be monitored for more serious side effects.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Take this medicine with meals.
Do not chew or crush the tablets because doing so may cause discoloration of your mouth and teeth.
If you are taking doxycycline, take it at least 1 hour before you take ferric citrate.
If you are using ciprofloxacin, take it at least 2 hours before or after you take this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For control of phosphorus levels in patients with chronic kidney disease on dialysis:
- Adults—At first, 2 tablets three times a day with meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
- Children—Use and dose must be determined by your doctor.
- For iron deficiency anemia in patients with chronic kidney disease not on dialysis:
- Adults—At first, 1 tablet three times a day with meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
- Children—Use and dose must be determined by your doctor.
- For control of phosphorus levels in patients with chronic kidney disease on dialysis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Tell your doctor if you have severe or persistent diarrhea, constipation, nausea, or vomiting while using this medicine.
This medicine may cause dark-colored stools. This is normal when you take medicines containing iron and is nothing to worry about.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 immediately if any of the following side effects occur:
More common
- Confusion
- difficulty breathing
- irregular heartbeat
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- stomach pain
- vomiting
- weakness or heaviness of the legs
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
- Cough
- dark-colored stools
- diarrhea
- difficulty having a bowel movement
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.
DRG-20122539
