Ferric citrate

Ferric citrate helps manage phosphorus levels in adults with chronic kidney disease who are on dialysis.

Ferric citrate is also used to treat iron deficiency anemia in adults with chronic kidney disease who are not on dialysis.

Ferric citrate may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take ferric citrate with meals. You will need to follow a special diet. Follow all instructions from your doctor or dietitian. Learn about the foods you should eat or avoid.

Swallow the tablet whole and do not crush, chew, or break it. The pill may discolor your teeth or mouth.

You will need frequent blood tests to check your iron levels.

Ferric citrate may cause discolored (dark) stools, but this discoloration is considered normal.

Store at room temperature, away from moisture and heat.

Keep ferric citrate away from children. Taking too much ferric citrate by mistake can be deadly.

You should not use ferric citrate if you have an iron overload disorder (hemochromatosis).

Tell your doctor if you have or have ever had:

• high levels of iron in your blood; or
• any other medical conditions.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Ferric citrate may cause serious side effects. Call your doctor right away if you have:

• severe stomach problems--stomach pain, vomiting, constipation, diarrhea, nausea; or
• high blood potassium--weakness, tingling sensation, chest pain, irregular heartbeats, loss of movement.

Common side effects of ferric citrate may include:

• diarrhea, constipation;
• dark colored stools;
• nausea, vomiting, stomach pain; or
• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 gInitial dose: 2 tablets orally 3 times a day with meals-Adjust dose in increments/decrements of 1 to 2 tablets per day per week or longer intervals to maintain serum phosphorous at target levelsAverage dose: 8 to 9 tablets per dayMaximum dose: 12 tablets per dayComments:-Monitor serum phosphorous and titrate dose accordingly.-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.Use: Control of serum phosphorous levels in patients with chronic kidney disease on dialysis.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 gInitial dose: 1 tablet orally 3 times a day with meals-Adjust dose as needed to achieve and maintain target hemoglobin levelsAverage dose: 5 tablets per dayMaximum dose: 12 tablets per dayComments:-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.Use: Treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis.

Usual Adult Dose for Iron Deficiency Anemia:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 gInitial dose: 1 tablet orally 3 times a day with meals-Adjust dose as needed to achieve and maintain target hemoglobin levelsAverage dose: 5 tablets per dayMaximum dose: 12 tablets per dayComments:-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.Use: Treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis.

Take the medicine (with food) as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of iron can be fatal to a child who accidentally takes ferric citrate.

Do not take a vitamin or mineral supplement that contains iron while you are taking ferric citrate, unless your doctor tells you to.

Ferric citrate can make it harder for your body to absorb other medicines you take by mouth. Avoid taking other medicines at the same time as ferric citrate.

If you take any of the following medicines, take them as follows:

• An antibiotic called doxycycline: take ferric citrate at least 1 hour before you take doxycycline.
• An antibiotic called ciprofloxacin: take it at least 2 hours before or 2 hours after you take ferric citrate.

Tell your doctor about all your other medicines, especially:

• iron supplements or any other medications that contain iron.

This list is not complete. Other drugs may affect ferric citrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.